Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT01327651
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mli2@fredhutch.org', 'phone': '2066676035', 'title': 'Maoji Li (Statistical Research Associate)', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'otherDetails': 'All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts and five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'eventGroups': [{'id': 'EG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 60, 'otherNumAffected': 59, 'seriousNumAtRisk': 60, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 60, 'otherNumAffected': 58, 'seriousNumAtRisk': 60, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.', 'otherNumAtRisk': 59, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 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'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 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'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}, {'units': 'sexual exposures', 'counts': [{'value': '1952', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '1542', 'groupId': 'OG002'}, {'value': '1485', 'groupId': 'OG003'}, {'value': '1337', 'groupId': 'OG004'}, {'value': '1018', 'groupId': 'OG005'}, {'value': '1081', 'groupId': 'OG006'}, {'value': '1311', 'groupId': 'OG007'}, {'value': '1502', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'title': '% completely covered', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}]}, {'title': '% pre-exposure coverage', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}]}]}, {'title': '% post-exposure coverage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': '% uncovered', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.', 'unitOfMeasure': 'percentage of sexual exposures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sexual exposures', 'denomUnitsSelected': 'sexual exposures', 'populationDescription': 'For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm'}, {'type': 'PRIMARY', 'title': 'The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}, {'units': 'sexual exposure', 'counts': [{'value': '1952', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '1542', 'groupId': 'OG002'}, {'value': '1485', 'groupId': 'OG003'}, {'value': '1337', 'groupId': 'OG004'}, {'value': '1018', 'groupId': 'OG005'}, {'value': '1081', 'groupId': 'OG006'}, {'value': '1311', 'groupId': 'OG007'}, {'value': '1502', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'categories': [{'measurements': [{'value': '2097', 'groupId': 'OG000'}, {'value': '1552', 'groupId': 'OG001'}, {'value': '1906', 'groupId': 'OG002'}, {'value': '1746', 'groupId': 'OG003'}, {'value': '1573', 'groupId': 'OG004'}, {'value': '1268', 'groupId': 'OG005'}, {'value': '1244', 'groupId': 'OG006'}, {'value': '1390', 'groupId': 'OG007'}, {'value': '1582', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are "covered"; Note: sex act is considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)', 'unitOfMeasure': 'Number of pills needed for 100% coverage', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sexual exposure', 'denomUnitsSelected': 'sexual exposure', 'populationDescription': 'For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm'}, {'type': 'PRIMARY', 'title': 'The Total Pills Actually Used Over the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'categories': [{'measurements': [{'value': '7349', 'groupId': 'OG000'}, {'value': '2852', 'groupId': 'OG001'}, {'value': '2000', 'groupId': 'OG002'}, {'value': '8285', 'groupId': 'OG003'}, {'value': '3713', 'groupId': 'OG004'}, {'value': '2157', 'groupId': 'OG005'}, {'value': '5507', 'groupId': 'OG006'}, {'value': '2468', 'groupId': 'OG007'}, {'value': '2356', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design', 'unitOfMeasure': 'Number of pills actually used', 'reportingStatus': 'POSTED', 'populationDescription': 'For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm'}, {'type': 'PRIMARY', 'title': 'Self-reported Side Effect or Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'title': 'Neurologic side effect', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '7.8', 'groupId': 'OG002'}, {'value': '14.2', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}, {'value': '6.1', 'groupId': 'OG006'}, {'value': '3.3', 'groupId': 'OG007'}, {'value': '4.5', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal side effects', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}, {'value': '13.1', 'groupId': 'OG003'}, {'value': '8.5', 'groupId': 'OG004'}, {'value': '10.5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5.8', 'groupId': 'OG007'}, {'value': '7.1', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects', 'unitOfMeasure': 'percent of visits between week 6 to 30', 'reportingStatus': 'POSTED', 'populationDescription': 'For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm'}, {'type': 'SECONDARY', 'title': 'Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization', 'description': 'Below we presented the percentages of total cohort with TFV-DP concentrations consistent with \\>=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC \\>5.2 fmol/10\\^6 cells is considered as participants taken \\>=2 tablets per week; DBS \\>=326 fmol/punch is considered as participants taken \\>=2 tablets per week', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days'}, {'type': 'SECONDARY', 'title': 'A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'title': 'Blood and lymphatic system disorders : Mild', 'categories': [{'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Potentically Life Threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'None', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '58', 'groupId': 'OG007'}, {'value': '58', 'groupId': 'OG008'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Potentically Life Threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'None', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}]}, {'title': 'Ear and labyrinth disorders', 'categories': [{'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 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'0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'None', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}]}, {'title': 'Vascular disorders', 'categories': [{'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Potentically Life Threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'None', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}]}, {'title': 'Neoplasms benign, malignant, and unspecified', 'categories': [{'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Potentically Life Threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'None', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cape Town, South Africa', 'description': 'The University of Cape Town in Cape Town is the IRB of record for the Cape Town site'}, {'id': 'OG001', 'title': 'Bangkok, Thailand', 'description': 'The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site'}, {'id': 'OG002', 'title': 'Harlem, United States', 'description': 'Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.'}], 'classes': [{'title': 'Before Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Drug Resistance', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'No Drug Resistance', 'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}]}, {'title': 'After Randomization (Daily dosing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Drug Resistance', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'No Drug Resistance', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'After Randomization (Time-driven dosing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Drug Resistance', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'No Drug Resistance', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'After Randomization (Event-driven dosing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Drug Resistance', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'No Drug Resistance', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here'}, {'type': 'SECONDARY', 'title': 'The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}, {'value': '41', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'unitOfMeasure': '% of Correctly Timed Adherence', 'reportingStatus': 'POSTED', 'populationDescription': 'For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm'}, {'type': 'SECONDARY', 'title': 'The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'categories': [{'title': 'Pregnancy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'HIV-positive result', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Other adverse experience', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 6 to Week 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants had product hold or product discontinuation log'}, {'type': 'SECONDARY', 'title': 'A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'OG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'classes': [{'title': 'Blood and lymphatic system disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Cardiac disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Ear and labyrinth disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Eye disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}]}, {'title': 'General disorders and administration site conditio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Hepatobiliary disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Immune system disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Infections and infestations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}]}, {'title': 'Investigations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Metabolism and nutrition disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Neoplasms benign, malignant, and unspecified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Nervous system disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Pregnancy, puerperium and perinatal conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Psychiatric disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Renal and urinary disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Reproductive system and breast disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Social circumstances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Vascular disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Below "Number analyzed" population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product'}, {'type': 'SECONDARY', 'title': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cape Town, South Africa, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG001', 'title': 'Cape Town, South Africa, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG002', 'title': 'Cape Town, South Africa, Seroconverted Participant #3', 'description': '#3 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG003', 'title': 'Cape Town, South Africa, Seroconverted Participant #4', 'description': '#4 seroconverted participants in Cape Town, South Africa, daily arm'}, {'id': 'OG004', 'title': 'Cape Town, South Africa, Seroconverted Participant #5', 'description': '#5 seroconverted participants in Cape Town, South Africa, time-driven arm'}, {'id': 'OG005', 'title': 'Cape Town, South Africa, Seroconverted Participant #6', 'description': '#6 seroconverted participants in Cape Town, South Africa, time-driven arm'}, {'id': 'OG006', 'title': 'Cape Town, South Africa, Seroconverted Participant #7', 'description': '#7 seroconverted participants in Cape Town, South Africa, event-driven arm'}, {'id': 'OG007', 'title': 'Cape Town, South Africa, Seroconverted Participant #8', 'description': '#8 seroconverted participants in Cape Town, South Africa, event-driven arm'}, {'id': 'OG008', 'title': 'Bangkok, Thailand, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Bangkok, Thailand, not randomized'}, {'id': 'OG009', 'title': 'Bangkok, Thailand, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Bangkok, Thailand, not randomized'}, {'id': 'OG010', 'title': 'Harlem, United States, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Harlem, United States, not randomized'}, {'id': 'OG011', 'title': 'Harlem, United States, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Harlem, United States, daily arm'}], 'classes': [{'title': 'Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG008'}, {'value': '78450', 'groupId': 'OG009'}, {'value': '400', 'groupId': 'OG010'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3460', 'groupId': 'OG000'}, {'value': '3667690', 'groupId': 'OG001'}, {'value': '749590', 'groupId': 'OG008'}, {'value': '710', 'groupId': 'OG009'}, {'value': '40900', 'groupId': 'OG010'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5732050', 'groupId': 'OG000'}, {'value': '3938670', 'groupId': 'OG001'}, {'value': '1570', 'groupId': 'OG009'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG003'}, {'value': '92960', 'groupId': 'OG008'}, {'value': '5070', 'groupId': 'OG009'}, {'value': '83260', 'groupId': 'OG010'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '416070', 'groupId': 'OG000'}, {'value': '93040', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG003'}, {'value': '1799950', 'groupId': 'OG008'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '93660', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG003'}, {'value': '2100', 'groupId': 'OG005'}, {'value': '119720', 'groupId': 'OG008'}, {'value': '1567040', 'groupId': 'OG011'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '114520', 'groupId': 'OG001'}, {'value': '650', 'groupId': 'OG003'}, {'value': '3710', 'groupId': 'OG005'}, {'value': '83010', 'groupId': 'OG006'}, {'value': '127330', 'groupId': 'OG008'}, {'value': '73030', 'groupId': 'OG011'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '178210', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG003'}, {'value': '5887760', 'groupId': 'OG004'}, {'value': '127480', 'groupId': 'OG005'}, {'value': '136310', 'groupId': 'OG006'}, {'value': '178070', 'groupId': 'OG008'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '89970', 'groupId': 'OG001'}, {'value': '503950', 'groupId': 'OG002'}, {'value': '220830', 'groupId': 'OG005'}, {'value': '25020', 'groupId': 'OG006'}, {'value': '400', 'groupId': 'OG007'}, {'value': '96180', 'groupId': 'OG008'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '35210', 'groupId': 'OG001'}, {'value': '10910', 'groupId': 'OG002'}, {'value': '193130', 'groupId': 'OG005'}, {'value': '29390', 'groupId': 'OG006'}, {'value': '400', 'groupId': 'OG007'}, {'value': '36140', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.', 'unitOfMeasure': 'viral load', 'reportingStatus': 'POSTED', 'populationDescription': "Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented"}, {'type': 'SECONDARY', 'title': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cape Town, South Africa, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG001', 'title': 'Cape Town, South Africa, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG002', 'title': 'Cape Town, South Africa, Seroconverted Participant #3', 'description': '#3 seroconverted participants in Cape Town, South Africa, not randomized'}, {'id': 'OG003', 'title': 'Cape Town, South Africa, Seroconverted Participant #4', 'description': '#4 seroconverted participants in Cape Town, South Africa, daily arm'}, {'id': 'OG004', 'title': 'Cape Town, South Africa, Seroconverted Participant #5', 'description': '#5 seroconverted participants in Cape Town, South Africa, time-driven arm'}, {'id': 'OG005', 'title': 'Cape Town, South Africa, Seroconverted Participant #6', 'description': '#6 seroconverted participants in Cape Town, South Africa, time-driven arm'}, {'id': 'OG006', 'title': 'Cape Town, South Africa, Seroconverted Participant #7', 'description': '#7 seroconverted participants in Cape Town, South Africa, event-driven arm'}, {'id': 'OG007', 'title': 'Cape Town, South Africa, Seroconverted Participant #8', 'description': '#8 seroconverted participants in Cape Town, South Africa, event-driven arm'}, {'id': 'OG008', 'title': 'Bangkok, Thailand, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Bangkok, Thailand, not randomized'}, {'id': 'OG009', 'title': 'Bangkok, Thailand, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Bangkok, Thailand, not randomized'}, {'id': 'OG010', 'title': 'Harlem, United States, Seroconverted Participant #1', 'description': '#1 seroconverted participants in Harlem, United States, not randomized'}, {'id': 'OG011', 'title': 'Harlem, United States, Seroconverted Participant #2', 'description': '#2 seroconverted participants in Harlem, United States, daily arm'}], 'classes': [{'title': 'Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels', 'unitOfMeasure': 'viral load', 'reportingStatus': 'POSTED', 'populationDescription': "Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors'}, {'id': 'FG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'FG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}], 'periods': [{'title': 'Self-administered Dosing Period', 'milestones': [{'type': 'STARTED', 'comment': 'Week 6 (Randomization visit)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '60'}]}, {'type': 'Week 10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '57'}, {'groupId': 'FG007', 'numSubjects': '57'}, {'groupId': 'FG008', 'numSubjects': '56'}]}, {'type': 'Week 14', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '54'}, {'groupId': 'FG007', 'numSubjects': '51'}, {'groupId': 'FG008', 'numSubjects': '54'}]}, {'type': 'Week 18', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '57'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '53'}, {'groupId': 'FG007', 'numSubjects': '49'}, {'groupId': 'FG008', 'numSubjects': '53'}]}, {'type': 'Week 22', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '50'}, {'groupId': 'FG007', 'numSubjects': '50'}, {'groupId': 'FG008', 'numSubjects': '51'}]}, {'type': 'Week 26', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '50'}, {'groupId': 'FG007', 'numSubjects': '51'}, {'groupId': 'FG008', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'comment': 'Week 30', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '50'}, {'groupId': 'FG008', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '10'}]}, {'type': 'Ineligible (retrospective result)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}, {'title': 'Post Study Follow-up', 'milestones': [{'type': 'STARTED', 'comment': 'Week 30', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '50'}, {'groupId': 'FG008', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'comment': 'Week 34', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '59'}, {'groupId': 'FG006', 'numSubjects': '45'}, {'groupId': 'FG007', 'numSubjects': '49'}, {'groupId': 'FG008', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014', 'preAssignmentDetails': 'Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '535', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG001', 'title': 'Time-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG002', 'title': 'Event-driven Dosing, Cape Town', 'description': 'Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG003', 'title': 'Daily Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG004', 'title': 'Time-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG005', 'title': 'Event-driven Dosing, Bangkok', 'description': 'Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG006', 'title': 'Daily Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF daily.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG007', 'title': 'Time-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG008', 'title': 'Event-driven Dosing, Harlem', 'description': 'Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.\n\nEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '37'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '33'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '37'}, {'value': '31', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '34'}, {'value': '28', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '31', 'groupId': 'BG005', 'lowerLimit': '27', 'upperLimit': '34'}, {'value': '28', 'groupId': 'BG006', 'lowerLimit': '23', 'upperLimit': '43'}, {'value': '31', 'groupId': 'BG007', 'lowerLimit': '24', 'upperLimit': '41'}, {'value': '32', 'groupId': 'BG008', 'lowerLimit': '24', 'upperLimit': '46'}, {'value': '29', 'groupId': 'BG009', 'lowerLimit': '24', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-24 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '157', 'groupId': 'BG009'}]}]}, {'title': '25-29 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '117', 'groupId': 'BG009'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '161', 'groupId': 'BG009'}]}]}, {'title': '40+ years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '100', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '178', 'groupId': 'BG009'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '59', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}, {'value': '350', 'groupId': 'BG009'}]}]}, {'title': 'Transgender woman', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}]}, {'title': 'Gender queer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Less than secondary', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '159', 'groupId': 'BG009'}]}, {'title': 'Secondary and above', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}, {'value': '53', 'groupId': 'BG008'}, {'value': '376', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of sex partners in the past 3 months', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '3', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '3', 'groupId': 'BG005', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG006', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG007', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4', 'groupId': 'BG008', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '2', 'groupId': 'BG009', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Median number of sex partners in the past 3 months, measured at baseline', 'unitOfMeasure': 'sex partners', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of anal intercourse without a condom', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'BG005', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '3', 'groupId': 'BG006', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG007', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5', 'groupId': 'BG008', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '1', 'groupId': 'BG009', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'anal intercourse', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'For daily dosing arm in Cape Town, we dropped one participant from analysis, since retrospective test of HIV infection in central lab shows that this participant was seroconverted on week 6(randomization week), so she was not eligible to be randomized. Because of this, total baseline population dropped from 536 to 535.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-10', 'size': 1558613, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2025-03-20T17:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One arm is daily TDF/FTC. One arm is twice weekly TDF/FTC with a post-exposure dose. One arm is as needed TDF/FTC with a post-exposure dose.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2010-12-01', 'resultsFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-30', 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.'}, {'measure': 'The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are "covered"; Note: sex act is considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)'}, {'measure': 'The Total Pills Actually Used Over the Follow-up Period', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design'}, {'measure': 'Self-reported Side Effect or Symptom Scores', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects'}], 'secondaryOutcomes': [{'measure': 'Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)', 'timeFrame': 'week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization', 'description': 'Below we presented the percentages of total cohort with TFV-DP concentrations consistent with \\>=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC \\>5.2 fmol/10\\^6 cells is considered as participants taken \\>=2 tablets per week; DBS \\>=326 fmol/punch is considered as participants taken \\>=2 tablets per week'}, {'measure': 'A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product'}, {'measure': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'timeFrame': 'From enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.'}, {'measure': 'The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)'}, {'measure': 'The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews', 'timeFrame': 'From Week 6 to Week 30'}, {'measure': 'A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm', 'timeFrame': 'From week 6 (randomization week) to week 30 (end of self-administered dosing)', 'description': 'Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.'}, {'measure': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'timeFrame': 'From Enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.'}, {'measure': 'A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study', 'timeFrame': 'From Enrollment to week 30 (end of self-administered dosing)', 'description': 'Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Administration Schedule', 'Nucleoside Reverse Transcriptase Inhibitors', 'Pharmacokinetics'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21091279', 'type': 'BACKGROUND', 'citation': 'Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.'}, {'pmid': '35080038', 'type': 'DERIVED', 'citation': 'Hughes JP, Williamson BD, Krakauer C, Chau G, Ortiz B, Wakefield J, Hendrix C, Amico KR, Holtz TH, Bekker LG, Grant R. Combining information to estimate adherence in studies of pre-exposure prophylaxis for HIV prevention: Application to HPTN 067. Stat Med. 2022 Mar 15;41(6):1120-1136. doi: 10.1002/sim.9321. Epub 2022 Jan 25.'}, {'pmid': '31490342', 'type': 'DERIVED', 'citation': 'Holtz TH, Chitwarakorn A, Hughes JP, Curlin ME, Varangrat A, Li M, Amico KR, Mock PA, Grant RM; Thai HPTN 067/ADAPT Study Team. HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):e18-e26. doi: 10.1097/QAI.0000000000002131.'}, {'pmid': '29420695', 'type': 'DERIVED', 'citation': 'Grant RM, Mannheimer S, Hughes JP, Hirsch-Moverman Y, Loquere A, Chitwarakorn A, Curlin ME, Li M, Amico KR, Hendrix CW, Anderson PL, Dye BJ, Marzinke MA, Piwowar-Manning E, McKinstry L, Elharrar V, Stirratt M, Rooney JF, Eshleman SH, McNicholl JM, van Griensven F, Holtz TH. Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis. 2018 May 17;66(11):1712-1721. doi: 10.1093/cid/cix1086.'}, {'pmid': '28986029', 'type': 'DERIVED', 'citation': 'Bekker LG, Roux S, Sebastien E, Yola N, Amico KR, Hughes JP, Marzinke MA, Hendrix CW, Anderson PL, Elharrar V, Stirratt M, Rooney JF, Piwowar-Manning E, Eshleman SH, McKinstry L, Li M, Dye BJ, Grant RM; HPTN 067 (ADAPT) study team. Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV. 2018 Feb;5(2):e68-e78. doi: 10.1016/S2352-3018(17)30156-X. Epub 2017 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based.', 'detailedDescription': 'No single strategy for the prevention of HIV has emerged as consistently used and successful, so multiple strategies have been developed. PrEP involves delivering ARV medications to people before they are exposed to HIV, in order to prevent infection. The optimal method of delivering PrEP has not yet been determined. This study will examine the feasibility of delivering PrEP in three methods. Daily dosing involves receiving ARV medications every day; time-driven dosing involves receiving ARV medications twice weekly plus a post-exposure dose; and event-driven dosing involves receiving ARV medications before and after a potential exposure to HIV. The ARV medication that will be used in this study is a combination pill that contains emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). Recent research studies have shown that, if taken consistently, a daily oral dose of FTC/TDF can reduce the risk of HIV infection.\n\nThis study will enroll HIV-uninfected men who have sex with men and transgender women (MSM/TGW) and women who have sex with men (WSM). Participation will last 34 weeks. All participants will be given a combination pill that contains FTC/TDF. For the first 5 weeks, all participants will come to the study clinic weekly to receive a single dose of FTC/TDF.\n\nAt Week 6, participants will be randomly assigned to one of three groups. In the daily dosing group, participants will take FTC/TDF once a day. In the time-dosing group, participants will take FTC/TDF twice per week and another dose after sexual intercourse (a post-exposure dose). In the event-dosing group, participants will take FTC/TDF before and after sexual intercourse. During this part of the study, participants will be given FTC/TDF to take on their own. Every week, from Week 6 to Week 29, study officials will call to ask questions about how many pills participants have taken and when they have had sexual intercourse. Participants will also complete computer-assisted self-interviews (CASIs).\n\nStudy visits will occur at enrollment, once a week for the first 5 weeks, and then once a month until Week 34. Assessment will include recording of medical history, completing an interview about sexual practices and background, and collection of blood, urine, and hair samples. Select study visits will include vaginal practices assessment (including use of lubricants and vaginal cleansing practices), family planning assessments (for women), and sex hormones assessments (for men).\n\nParticipants who acquire HIV infection during the study will discontinue study product. These participants will continue to be followed after enrollment at Weeks 4, 6, 10, 14, 18, 22, 26, 30, and every 12 weeks thereafter, as appropriate, until the last study participant completes follow-up at the study site. Participants whose first reactive HIV rapid test is at Week 34 who are later confirmed to be HIV infected will also be followed every 12 weeks after their Week 30 visit until the last study participant completes follow-up at the study site. Participants who acquire HIV infection during the study will undergo select protocol procedures and will receive counseling and referrals for HIV treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literacy in one of the study languages (Thai, Xhosa, and/or English)\n* Able to provide written informed consent\n* Able to provide weekly telephonic updates\n* Within 70 days of enrollment:\n\n 1. Serum creatinine less than or equal to the upper limit of normal (ULN) and calculated creatinine clearance of at least 70 mL/min by the Cockcroft-Gault formula. More information on this criterion can be found in the protocol.\n 2. Serum phosphate greater than or equal to the lower limit of normal (LLN)\n 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times ULN\n 4. Hemoglobin greater than 10 g/dL\n 5. Hepatitis B surface antigen (HBsAg)-negative\n 6. Willing and able to provide adequate locator information\n\nInclusion Criteria for MSM/TGW:\n\n* Male at birth\n* Reporting anal intercourse and/or receptive neovaginal intercourse with at least one man or transgender woman in the past 6 months\n* One or more of the following risk factors for HIV acquisition in the past 6 months according to self-report: sexual intercourse with more than one man or transgender woman; history of an acute sexually transmitted infection (STI); sex in exchange for money, goods, or favors; condomless intercourse (oral, anal, vaginal, or neovaginal) with a partner known to be HIV-infected or of unknown HIV infection status according to self report\n\nInclusion Criteria for Women Who Have Sex With Men (WSM):\n\n* Female at birth or self identify as female\n* Not pregnant or breastfeeding\n* Not able to or not intending to become pregnant during the next year\n* If able to become pregnant, self reported use of an effective method of contraception at Enrollment, and intending to use an effective method for the next 34 weeks\n* One or more of the following risk factors for HIV acquisition in the past 6 months according to self report: sexual intercourse with more than one man; history of an acute STI; sex in exchange for money, goods or favors; condomless intercourse (oral, anal, or vaginal) with a partner known to be HIV-infected or of unknown HIV infection status\n\nExclusion Criteria:\n\n* Proteinuria 2+ or greater at screening\n* Glucosuria 2+ or greater at screening\n* Serious and active medical or mental illness\n* One or both HIV rapid tests is reactive at screening or enrollment, regardless of subsequent HIV diagnostic test results\n* Signs or symptoms suggestive of acute HIV infection\n* Use of hypoglycemic agents for diabetes or agents with known nephrotoxic potential\n* Use of ARV therapy (e.g., for post-exposure prophylaxis \\[PEP\\] or PrEP) in the 90 days prior to study entry\n* Serum phosphate level below site laboratory LLN\n* Current participation (or participation within 3 months of screening) in any HIV prevention study\n* Previous or current participation in the active arm of an HIV vaccine trial\n* Acute or chronic hepatitis B (HBV) infection (refers to chronic active HBV infection evidenced by a positive test for hepatitis B surface antigen (HBsAg)\n* Presence of a psychological or social condition or an addictive disorder that would preclude compliance with the protocol\n* Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives'}, 'identificationModule': {'nctId': 'NCT01327651', 'acronym': 'ADAPT', 'briefTitle': 'The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)', 'organization': {'class': 'NETWORK', 'fullName': 'HIV Prevention Trials Network'}, 'officialTitle': 'The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)', 'orgStudyIdInfo': {'id': 'HPTN 067 (ADAPT)'}, 'secondaryIdInfos': [{'id': '10852', 'type': 'REGISTRY', 'domain': 'DAIDS-ES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Daily dosing', 'description': 'Participants will receive oral FTC/TDF daily.', 'interventionNames': ['Drug: Daily dosing']}, {'type': 'EXPERIMENTAL', 'label': 'Time-driven dosing', 'description': 'Participants will receive oral FTC/TDF twice weekly with a post-exposure dose.', 'interventionNames': ['Drug: Time-driven dosing']}, {'type': 'EXPERIMENTAL', 'label': 'Event-driven dosing', 'description': 'Participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.', 'interventionNames': ['Drug: Event-driven dosing']}], 'interventions': [{'name': 'Daily dosing', 'type': 'DRUG', 'otherNames': ['Daily', 'TDF/FTC'], 'description': 'A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.', 'armGroupLabels': ['Daily dosing']}, {'name': 'Time-driven dosing', 'type': 'DRUG', 'otherNames': ['A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.'], 'description': 'TDF/FTC twice weekly with a post-exposure dose', 'armGroupLabels': ['Time-driven dosing']}, {'name': 'Event-driven dosing', 'type': 'DRUG', 'otherNames': ['A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.'], 'description': 'TDF/FTC as needed with a post exposure dose', 'armGroupLabels': ['Event-driven dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Prevention Center CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '7750', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Emavundleni CRS', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Silom Community Clinic CRS', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}], 'overallOfficials': [{'name': 'Robert M. Grant, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Frits van Griensven, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'School of Medicine, University of California at San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HIV Prevention Trials Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}