Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-11 @ 3:29 AM
Study NCT ID:
NCT01687218
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D005782', 'term': 'Gels'}], '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'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rdc27@pitt.edu', 'phone': '412-383-2054', 'title': 'Ross D. Cranston, MD, FRCP', 'organization': 'Division of Infectious Diseases - UPMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)', 'otherNumAtRisk': 192, 'otherNumAffected': 85, 'seriousNumAtRisk': 192, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)', 'otherNumAtRisk': 192, 'otherNumAffected': 103, 'seriousNumAtRisk': 192, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)', 'otherNumAtRisk': 191, 'otherNumAffected': 87, 'seriousNumAtRisk': 191, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal mucosa hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal tenesmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proctitis chlamydial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proctitis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Grade 2 or Higher Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.44', 'estimateComment': 'It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.', 'groupDescription': 'Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.21', 'estimateComment': 'It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.', 'groupDescription': 'Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.'}, {'type': 'PRIMARY', 'title': 'Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Disliked Very Much/A Little', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Liked Very Much/A Little', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.50', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.70', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.'}, {'type': 'PRIMARY', 'title': 'Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Very Difficult/Difficult', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Very Easy/Easy', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.08', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.56', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.'}, {'type': 'PRIMARY', 'title': 'Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Very Unlikely/Unlikely', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Very Likely/Likely', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.65', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.23', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.25', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Mid-Period TFV Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'End Period TFV Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.41', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-1.30', 'estimateComment': 'This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.82', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '-1.70', 'estimateComment': 'This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant periods with tenofovir concentrations (log10 ng/mL) in blood plasma among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.87', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.83', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.15', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant end periods with tenofovir concentrations (log10 ng/mg) in rectal tissue among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Initiate Period TFV Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.53', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-1.29', 'spread': '1.42', 'groupId': 'OG002'}]}]}, {'title': 'Mid-Period TFV Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '1.54', 'groupId': 'OG002'}]}]}, {'title': 'End Period TFV Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.66', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '1.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.50', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.47', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant periods with tenofovir concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Mid-Period FTC Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'End Period FTC Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.25', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '1.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.66', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '-2.50', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.65', 'ciLowerLimit': '-2.81', 'ciUpperLimit': '-2.49', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant periods with emtricitabine (FTC) concentrations (log10 ng/mL) in blood plasma among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.80', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.80', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant end periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Initiate Period FTC Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-1.57', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Mid-Period FTC Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'End Period FTC Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '0.87', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.00', 'ciLowerLimit': '-2.16', 'ciUpperLimit': '-1.84', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.90', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '-1.74', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.72', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.31', 'groupDescription': 'Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.', 'unitOfMeasure': 'log10 ng/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant end periods with tenofovir-diphosphate (TFV-DP) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Product 1', 'description': 'Oral (Daily FTC/TDF)'}, {'id': 'OG001', 'title': 'Product 2', 'description': 'Rectal (Daily TFV RG 1% gel)'}, {'id': 'OG002', 'title': 'Product 3', 'description': 'Rectal (RAI-associated TFV RG 1% gel)'}], 'classes': [{'title': 'Less Than 80%', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'At or Greater than 80%', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.63', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\\<80% adherence versus\\>80% adherence.', 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.81', 'estimateComment': 'Oral regimen is the reference group.', 'groupDescription': 'Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\\<80% adherence versus\\>80% adherence.', 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants with Final Converged Rates of prescribed doses.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacodynamics', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mucosal Immunity', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation Between PK and Adherence', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To assess correlation of PK with adherence measures', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Factors Associated With Adherence', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sexual Activity and Condom Use', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To examine whether sexual activity or condom use varies by product used', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Product Sharing', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To determine the level of sharing of study products with non-participants and to assess with whom products are shared', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Problem Practices', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'FG003', 'title': 'Group 4', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'FG004', 'title': 'Group 5', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'FG005', 'title': 'Group 6', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Relocated, no follow-up planned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'HIV-uninfected males or transgender females who were 18 years of age or older who practice receptive anal intercourse were recruited from September 2013 through November 2014 from 8 sites in Peru, Puerto Rico, South Africa, Thailand and USA.', 'preAssignmentDetails': '349 persons were screened and 154 were excluded for various reasons. The study enrolled 195 participants, 187 of whom are evaluable. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '195', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG003', 'title': 'Group 4', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG004', 'title': 'Group 5', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG005', 'title': 'Group 6', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)\n\nOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)\n\nRectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)\n\nRectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '29.6', 'spread': '8.9', 'groupId': 'BG003'}, {'value': '32.2', 'spread': '10.6', 'groupId': 'BG004'}, {'value': '31.4', 'spread': '7.8', 'groupId': 'BG005'}, {'value': '31.1', 'spread': '9.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Under 20', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': '20-24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}]}, {'title': '25-29', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}]}, {'title': '30-34', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}, {'title': '35-39', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}, {'title': '40-44', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}]}, {'title': '45-49', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}, {'title': '50+', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Man', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '141', 'groupId': 'BG006'}]}]}, {'title': 'Woman', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Transgender/Transwoman', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}]}, {'title': 'Refuse to answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'One participant from Peru did not complete a baseline CASI.', 'unitOfMeasure': 'participants'}, {'title': 'Hispanic Origin', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest Level of Education', 'classes': [{'title': 'no schooling', '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'}]}]}, {'title': 'primary school, not complete', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'primary school, complete', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'secondary school, not complete', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}, {'title': 'secondary school, complete', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}]}, {'title': 'attended college or university', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '156', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sexual Orientation (CASI)', 'classes': [{'title': 'Gay/Homosexual', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '171', 'groupId': 'BG006'}]}]}, {'title': 'Bisexual', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}]}, {'title': 'Straight/Heterosexual', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'Refuse to answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'One participant from Peru did not complete a baseline CASI.', 'unitOfMeasure': 'participants'}, {'title': 'Nationality', 'classes': [{'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}, {'title': 'U.S.A.', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Country in which the site clinic resides.', 'unitOfMeasure': 'participants'}, {'title': 'Race - Puerto Rico', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Asian', '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'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Indigenous', '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'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race - Peru', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Asian', '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'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': 'Black', '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'}]}]}, {'title': 'Indigenous', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}]}, {'title': 'Other', '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'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race - South Africa', 'classes': [{'title': 'Other African tribe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'White', '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'}]}]}, {'title': 'Zulu', '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'}]}]}, {'title': 'Xhosa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}]}, {'title': 'Indian', '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'}]}]}, {'title': 'Colored', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race - Thailand', 'classes': [{'title': 'Indian', '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'}]}]}, {'title': 'Mixed', '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'}]}]}, {'title': 'Thai', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}, {'title': 'Chinese', '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'}]}]}, {'title': 'Other', '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'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race - U.S.A.', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'American Indian/Alaska Native', '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'}]}]}, {'title': 'Native-Hawaiian or other Pacific Islander', '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'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Includes all participants enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2015-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2012-08-27', 'resultsFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-07', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacodynamics', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs'}, {'measure': 'Mucosal Immunity', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use'}, {'measure': 'Correlation Between PK and Adherence', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To assess correlation of PK with adherence measures'}, {'measure': 'Factors Associated With Adherence', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)'}, {'measure': 'Sexual Activity and Condom Use', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To examine whether sexual activity or condom use varies by product used'}, {'measure': 'Product Sharing', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To determine the level of sharing of study products with non-participants and to assess with whom products are shared'}, {'measure': 'Problem Practices', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use'}], 'primaryOutcomes': [{'measure': 'Safety: Grade 2 or Higher Adverse Events', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).'}, {'measure': 'Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.'}, {'measure': 'Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.'}, {'measure': 'Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.'}, {'measure': 'Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period', 'timeFrame': '27 weeks (three 8-week product use periods with 1-week washout periods between them)', 'description': 'Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '27986684', 'type': 'RESULT', 'citation': 'Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis. 2017 Mar 1;64(5):614-620. doi: 10.1093/cid/ciw832.'}, {'pmid': '28750059', 'type': 'RESULT', 'citation': 'Carballo-Dieguez A, Balan IC, Brown W 3rd, Giguere R, Dolezal C, Leu CS, Marzinke MA, Hendrix CW, Piper JM, Richardson BA, Grossman C, Johnson S, Gomez K, Horn S, Kunjara Na Ayudhya RP, Patterson K, Jacobson C, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla C, Lama J, McGowan I, Cranston RD. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One. 2017 Jul 27;12(7):e0181607. doi: 10.1371/journal.pone.0181607. eCollection 2017.'}, {'pmid': '29025127', 'type': 'RESULT', 'citation': 'Giguere R, Brown W III, Balan IC, Dolezal C, Ho T, Sheinfil A, Ibitoye M, Lama JR, McGowan I, Cranston RD, Carballo-Dieguez A. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc. 2018 Apr 1;25(4):393-400. doi: 10.1093/jamia/ocx081.'}, {'pmid': '29119473', 'type': 'RESULT', 'citation': 'Carballo-Dieguez A, Giguere R, Dolezal C, Leu CS, Balan IC, Brown W 3rd, Rael C, Richardson BA, Piper JM, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla CD, Lama JR, McGowan I, Cranston RD; MTN-017 Protocol Team. Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men. AIDS Behav. 2017 Dec;21(12):3336-3345. doi: 10.1007/s10461-017-1969-1.'}, {'pmid': '28825142', 'type': 'RESULT', 'citation': 'Giguere R, Rael CT, Sheinfil A, Balan IC, Brown W 3rd, Ho T, Dolezal C, Leu CS, Liu A, Mayer KH, Lama JR, McGowan I, Carballo-Dieguez A, Cranston RD; MTN-017 Protocol Team. Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav. 2018 Feb;22(2):388-401. doi: 10.1007/s10461-017-1890-7.'}, {'pmid': '29501908', 'type': 'RESULT', 'citation': 'Brown W 3rd, Giguere R, Sheinfil A, Ibitoye M, Balan I, Ho T, Brown B, Quispe L, Sukwicha W, Lama JR, Carballo-Dieguez A, Cranston RD. Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform. 2018 Apr;80:78-86. doi: 10.1016/j.jbi.2018.02.018. Epub 2018 Mar 6.'}, {'pmid': '30336747', 'type': 'RESULT', 'citation': 'Cranston RD, Carballo-Dieguez A, Gundacker H, Richardson BA, Giguere R, Dolezal C, Siegel A, KunjaraNaAyudhya RP, Gomez K, Piper JM, Lama JR, McGowan I; MTN-017 Protocol Team. Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women. Int J STD AIDS. 2019 Feb;30(2):154-162. doi: 10.1177/0956462418797864. Epub 2018 Oct 18.'}, {'pmid': '30318905', 'type': 'RESULT', 'citation': 'Leu CS, Giguere R, Bauermeister JA, Dolezal C, Brown W 3rd, Balan IC, Richardson BA, Piper JM, Lama JR, Cranston RD, Carballo-Dieguez A. Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care. 2019 Mar;31(3):379-387. doi: 10.1080/09540121.2018.1533223. Epub 2018 Oct 14.'}, {'pmid': '31299013', 'type': 'RESULT', 'citation': 'Liu AY, Norwood A, Gundacker H, Carballo-Dieguez A, Johnson S, Patterson K, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Mayer KH, Zorrilla C, Buchbinder S, Piper JM, Lama JR, Cranston RD. Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017). J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):516-520. doi: 10.1097/QAI.0000000000002066.'}, {'pmid': '29076032', 'type': 'RESULT', 'citation': 'Balan IC, Giguere R, Brown W 3rd, Carballo-Dieguez A, Horn S, Hendrix CW, Marzinke MA, Ayudhya RPKN, Patterson K, Piper JM, McGowan I, Lama JR, Cranston RD; MTN-017 Protocol Team. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017. AIDS Behav. 2018 Mar;22(3):986-995. doi: 10.1007/s10461-017-1955-7.'}, {'pmid': '34541872', 'type': 'DERIVED', 'citation': 'McGowan IM, Kunjara Na Ayudhya RP, Brand RM, Marzinke MA, Hendrix CW, Johnson S, Piper J, Holtz TH, Curlin ME, Chitwarakorn A, Raengsakulrach B, Doncel G, Schwartz JL, Rooney JF, Cranston RD. An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate. AIDS Res Hum Retroviruses. 2022 Apr;38(4):279-287. doi: 10.1089/AID.2021.0115. Epub 2021 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or transgender female \\> age of 18 at Screening\n2. Able and willing to provide written informed consent\n3. HIV-1 uninfected at Screening and Enrollment\n4. Able and willing to provide adequate locator information, as defined in site SOP\n5. Available to return for all study visits, barring unforeseen circumstances and willing to comply with study participation requirements\n6. In general good health at Screening and Enrollment, as determined by the site IoR or designee\n7. Per participant report, a history of consensual RAI at least once in the past 3 months\n8. Per participant report at Screening and Enrollment, agrees not to engage in receptive or insertive sexual activity with another study participant for the duration of study participation.\n9. Willing to use study-provided condoms for the duration of the study for penetrative intercourse\n10. Willing to not take part in other research studies involving drugs, medical devices, vaccines or genital products for the duration of study participation (including the time between Screening and Enrollment)\n11. Men and transgender females who agree to take part in the PK, PD and Mucosal Immunology Subset, must also agree to abstain from:\n\n * Inserting anything into the rectum, including abstaining from RAI for 72 hours after the collection of biopsies\n * Taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and/or other drugs that are associated with increased likelihood of bleeding following mucosal biopsy collection for 72 hours prior to and following the collection of biopsies.\n\nExclusion Criteria:\n\n1. At Screening, participant-reported symptoms, and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection requiring treatment per current World Health Organization (WHO) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic Chlamydia trachomatis (CT) infection, Neisseria gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts.\n\n Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required.\n\n In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after the screening visit will be allowed\n2. History of inflammatory bowel disease as reported by participant history\n3. At Screening:\n\n * Positive for hepatitis B surface antigen\n * Positive for hepatitis C antibody\n * Hemoglobin \\< 10.0 g/dL\n * Platelet count less than 100,000/mm3\n * White blood cell count \\< 2,000 cells/mm3 or \\> 15,000 cells/mm3\n * Calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL)\n * Serum creatinine \\> 1.3 x the site laboratory upper limit of normal (ULN)\n * Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) \\> 2.5× the site laboratory ULN\n * PK, PD and Immunological Subset only: International normalized ratio (INR) \\> 1.5× the site laboratory ULN or partial thromboplastin time (PTT) \\> 1.25× the site laboratory ULN\n4. Known allergy to methylparaben and/or propylparaben\n5. Known allergy to any of the study products.\n6. Per participant report, use of the following medications and/or products within 12 weeks prior to screening, and/or anticipated use or unwillingness to abstain from use throughout study participation:\n\n * Any investigational products\n * Systemic immunomodulatory medications\n * Use of Heparin, including Lovenox®\n * Warfarin\n * Plavix® (clopidogrel bisulfate)\n * Rectally-administered medications or products, containing N-9 or corticosteroids\n7. By participant report, use of post-exposure prophylaxis (PEP) for HIV exposure within the 12 weeks prior to screening or anticipated use during study participation.\n8. Symptoms suggestive of acute HIV seroconversion at Screening and Enrollment\n9. Has any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements. Such conditions may include, but are not limited to, colorectal abnormalities, substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT01687218', 'briefTitle': 'Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel', 'organization': {'class': 'OTHER', 'fullName': 'CONRAD'}, 'officialTitle': 'A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel', 'orgStudyIdInfo': {'id': 'MTN-017'}, 'secondaryIdInfos': [{'id': '5UM1AI068633', 'link': 'https://reporter.nih.gov/quickSearch/5UM1AI068633', 'type': 'NIH'}, {'id': '11857', 'type': 'OTHER', 'domain': 'DAIDS protocol #'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': 'Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5', 'description': 'Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 6', 'description': 'Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)', 'interventionNames': ['Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)']}], 'interventions': [{'name': 'Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'HIV Research Section, San Francisco - Department of Public Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The Fenway Institute/Fenway Community Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center (UPMC)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Asociacion Civil Impacta Salud y Educacion (IMPACTA)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico Medical Sciences Campus - Maternal Infant Studies Center (CEMI)', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '50202', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Research Institute for Health Sciences - Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Thailand MOPH - US CDC Collaboration (TUC)', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}], 'overallOfficials': [{'name': 'Ross D. Cranston, MD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh Medical Center (UPMC)'}, {'name': 'Javier R. Lama, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociacion Civil Impacta Salud y Educacion (IMPACTA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CONRAD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}