Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-28 @ 2:42 AM
Study NCT ID:
NCT01632995
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2012-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
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': 'C075889', 'term': 'Racivir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'albert.liu@sfdph.org', 'phone': '415-437-7408', 'title': 'Dr. Albert Liu, Clinical Research Director', 'organization': 'Bridge HIV, San Francisco Department of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.', 'otherNumAtRisk': 557, 'otherNumAffected': 25, 'seriousNumAtRisk': 557, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Creatinine elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'suicidal ideation and/or attempt, bipolar disorder, or anxiety', 'notes': 'Assessed as not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension / Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 557, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of Acceptance Rate of PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1069', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Assessed for Participation', 'description': 'All participants who were assessed for study participation'}], 'classes': [{'title': 'Potentially eligible clients', 'categories': [{'measurements': [{'value': '921', 'groupId': 'OG000'}]}]}, {'title': 'Participants enrolled', 'categories': [{'measurements': [{'value': '557', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through enrollment (Week 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement of Refusal Rate of PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1069', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Assessed for Participation', 'description': 'All participants who were assessed for study participation'}], 'classes': [{'title': 'Potentially eligible clients', 'categories': [{'measurements': [{'value': '921', 'groupId': 'OG000'}]}]}, {'title': 'Declined participation', 'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through enrollment (Week 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Duration of PrEP Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Number of study drug interruptions', 'unitOfMeasure': 'interruptions', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Duration of PrEP Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Mean duration of interruptions', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement of Side Effects/Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine elevations', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement of PrEP Adherence by TFV-DP Levels in DBS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With DBS Testing', 'description': 'All study participants who had at least 1 DBS result'}], 'classes': [{'title': '% with protective TFV-DP levels at week 4', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': '% with protective TFV-DP levels at week 12', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': '% with protective TFV-DP levels at week 24', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': '% with protective TFV-DP levels at week 36', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': '% with protective TFV-DP levels at week 48', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample'}, {'type': 'PRIMARY', 'title': 'Number of Male Sexual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'title': 'Mean Anal sex partners at baseline', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '120'}]}]}, {'title': 'Mean Anal sex partners at week 48', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '240'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'unitOfMeasure': 'partners', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement of PrEP Adherence by Medication Possession Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean PrEP adherence by medication possession ratio'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Seroconvert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'title': 'Acute HIV infection at baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HIV seroconversion during follow-up', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'unitOfMeasure': 'participant with acquired HIV resistance', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'periods': [{'title': 'Pre-screening to Enrollment Period', 'milestones': [{'type': 'STARTED', 'comment': 'All participants who were assessed for study participation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1069'}]}, {'type': 'COMPLETED', 'comment': 'All participants who enrolled in study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '557'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '512'}]}]}, {'title': 'Main Study Follow-up Period', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who enrolled and initiated PrEP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '557'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed 48 weeks of follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '437'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}]}], 'recruitmentDetails': 'Participants were screened and enrolled at 3 sites in the US (San Francisco, Miami, Washington DC). Enrollment began on October 1, 2012 and ended February 10, 2015.', 'preAssignmentDetails': 'As this PrEP Demonstration project assessed acceptance of PrEP, all participants assessed for participation are included in the "start" category, and those who enrolled and initiated PrEP are indicated as a separate milestone.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.\n\nFTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '557', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '557', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 557}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2012-06-29', 'resultsFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-30', 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Acceptance Rate of PrEP', 'timeFrame': 'Measured through enrollment (Week 0)'}, {'measure': 'Measurement of Refusal Rate of PrEP', 'timeFrame': 'Measured through enrollment (Week 0)'}, {'measure': 'Duration of PrEP Use', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Number of study drug interruptions'}, {'measure': 'Duration of PrEP Use', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Mean duration of interruptions'}, {'measure': 'Measurement of Side Effects/Toxicities', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination'}, {'measure': 'Measurement of PrEP Adherence by TFV-DP Levels in DBS', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination'}, {'measure': 'Number of Male Sexual Partners', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination'}, {'measure': 'Measurement of PrEP Adherence by Medication Possession Ratio', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination', 'description': 'Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Seroconvert', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination'}, {'measure': 'Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected', 'timeFrame': 'Participants were followed for 48 weeks, or up to the point of early termination'}]}, 'conditionsModule': {'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.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.', 'detailedDescription': 'A previous study (iPrEx) showed that daily PrEP with FTC/TDF provided with a comprehensive package of prevention services is effective in preventing HIV infection among men who have sex with men (MSM). The PrEP administered in that study was given in the context of a research setting/controlled trial, but it is important to evaluate the acceptability, sustainability, and safety of PrEP in a "real world" setting. This study will evaluate PrEP administered to HIV-uninfected MSM and transgender females at two STD clinics and one community health center in the United States.\n\nEach participant will receive PrEP for up to 1 year and will have up to 8 study visits. PrEP will consist of one fixed-dose FTC/TDF combination tablet orally each day. All participants will have study visits at screening, enrollment, and 4 weeks after enrollment; participants will continue to have visits at Weeks 12, 24, 36, 48, and 52 if they do not seroconvert. Participants who seroconvert will discontinue PrEP and will have a post-drug discontinuation visit 4 weeks after discontinuing PrEP. At most visits, participants will undergo blood, urine, and hair sample collection; give a medical history; undergo a physical exam; receive risk-reduction counseling and condoms; undergo testing for HIV and other STDs; receive study drugs; and undergo a pill count and adherence assessment (follow-up visits only). For participants who stop taking the study drug but remain in the study, urine, blood, and hair samples will not be collected at 12-week follow-up visits if all stop procedures have been completed and if there are no lab abnormalities that require additional follow-up. Participants will also answer questionnaires at screening, 12-week visits, and at study exit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be either a man who has sex with men or a transgender female\n* Male sex (at birth)\n* Willing and able to provide written informed consent\n* HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening\n* No laboratory evidence of a detectable HIV viral load (San Francisco site only)\n* Evidence of risk of acquiring HIV-1 infection including any one of the following:\n\n (1) Condomless anal sex with two or more male or transgender female sex partners during the last 12 months; or (2) two or more episodes of anal sex with at least one HIV-positive partner during the last 12 months; or (3) sex with a male or transgender female partner and any of the following STDs diagnosed during the last 12 months or at screening: syphilis, rectal gonorrhea, or rectal chlamydia.\n* Able to provide a street address of residence or phone number for themselves or two personal contacts who would know their whereabouts during the period of the demonstration project\n* Adequate renal function: creatinine clearance of 60 ml/min or greater as estimated by the Cockcroft-Gault equation within 45 days of enrollment\n* A urine dipstick with a negative or trace result for protein within 45 days of enrollment\n* Fluent in English or in Spanish\n\nExclusion Criteria:\n\n* Signs or symptoms of acute HIV infection\n* Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment\n* Hepatitis B surface antigen (HBsAg) positive\n* History of pathological bone fractures not related to trauma\n* Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents\n* Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents\n* At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives'}, 'identificationModule': {'nctId': 'NCT01632995', 'briefTitle': 'Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project', 'orgStudyIdInfo': {'id': 'PrEP Demonstration Project'}, 'secondaryIdInfos': [{'id': '11879', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)', 'description': 'All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.', 'interventionNames': ['Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet']}], 'interventions': [{'name': 'FTC 200 mg/TDF 300 mg fixed-dose combination tablet', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': 'Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.', 'armGroupLabels': ['Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94103', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'SF City Clinic Non-Network CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman Walker Non-network CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami PrEP Non-Network CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Albert Liu, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'San Francisco Department of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}