Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01769456
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2013-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bobharris@westat.com', 'phone': '301-251-1500', 'title': 'Dr. Bob Harris', 'organization': 'Westat'}, 'certainAgreement': {'otherDetails': 'The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications, and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).', 'description': 'Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.', 'eventGroups': [{'id': 'EG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP", 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 6, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}], 'seriousEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.\n\nParticipants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '2.59', 'spread': '3.22', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'pValueComment': 'Reported p-value is the calculated value provided by SAS output.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48.'}, {'type': 'PRIMARY', 'title': 'Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '3.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0236', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with DXA data at both baseline and Week 48.'}, {'type': 'PRIMARY', 'title': 'Total Body Bone Mineral Density: Percent Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '2.28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in total body BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with DXA data at both baseline and Week 48.'}, {'type': 'PRIMARY', 'title': 'Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '3.71', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0236', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with DXA data at both baseline and Week 48.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Decrease in Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'title': 'Decrease in absolute BMD >=1% baseline to Wk48', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Decrease in absolute BMD >=5% baseline to Wk48', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Decrease in absolute BMD >10% baseline to Wk48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects with DXA results for baseline and Week 48'}, {'type': 'PRIMARY', 'title': 'Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48', 'description': 'Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:\n\n"Of these males \\[male partners\\], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0.\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants providing data for this question at Week 48.'}, {'type': 'PRIMARY', 'title': 'Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '1.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': 'Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:\n\n"Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?"\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.', 'unitOfMeasure': 'male sexual partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants providing data for this question at Week 48.'}, {'type': 'PRIMARY', 'title': 'Acceptability of PrEP Regimen and Study Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'title': 'Size of the pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Taste of the pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Color of the pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Taking the pill every day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Taking part in the study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'HIV test at every visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Risk Reduction Counseling at every visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Questions about sexual behavior at every visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Physician exam by a doctor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Health clinic for study visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Did not like it at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not like', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Liked', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Liked a lot', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.\n\nAcceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question)'}, {'type': 'PRIMARY', 'title': 'Estimation of Medication Adherence by Dried Blood Spot (DBS) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'title': 'DBS RBC TFV-DP (fmol/punch), Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'DBS RBC TFV-DP (fmol/punch), Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'DBS RBC TFV-DP (fmol/punch), Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'DBS RBC TFV-DP (fmol/punch), Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'DBS RBC TFV-DP (fmol/punch), Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'DBS RBC TFV-DP (fmol/punch), Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Below level of quantification', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': '<2 days', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': '2 days', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4 days', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Daily', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, Week 12, Week 24, Week 36, Week 48', 'description': "This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.\n\nMedication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.\n\nThe TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '\\<2 days' is defined as \\<350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as \\>700 to 1250 (fmol/punch), and 'Daily' as \\>1250 (fmol/punch).\n\nThe TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '\\<2 days' is defined as \\<275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as \\>525 to 950 (fmol/punch),and 'Daily' as \\>950 (fmol/punch)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week.'}, {'type': 'SECONDARY', 'title': 'Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."}], 'timeFrame': '48 weeks', 'description': "Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was session interesting, was it relevant to their life, and did they learn from the session)", 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected; only one type of risk reduction intervention was ultimately implemented.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Text Messaging Reminders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'title': 'Signed up for text message reminders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued reminders while on study agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued reminders while still on study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Week 48', 'description': 'This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders.'}, {'type': 'SECONDARY', 'title': 'Rating of the Reasons for Missing Medications on a 4-point Likert Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP"}], 'classes': [{'title': 'Were away from home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Were too busy with other things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Simply forgot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Had too many study pills to take', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Wanted to avoid side effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Did not want others to notice you taking meds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Had a change in daily routine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Rarely', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Sometimes', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Often', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.\n\nSubjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.\n\nQuestion: In the past month, how often have you missed taking your study pills because you:', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question.'}, {'type': 'SECONDARY', 'title': 'Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Process of Protocol Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."}], 'timeFrame': '48 weeks', 'description': "Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.\n\nNOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:\n\nGilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9.", 'reportingStatus': 'POSTED', 'populationDescription': 'Quantitative data were not collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP\n\nPCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.\n\nEmtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP)."}], 'timeFrame': '48 weeks', 'description': 'Behavioral disinhibition/risk compensation endpoints will be compared.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "1 subject inadvertently enrolled, discontin'd after baseline, re-enrolled later and completed study", 'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Did not receive PCC intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Moved out of the area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'No wk 0 visit w/in 30 days of screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Parental request to youth to withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This research was conducted at 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PCC Behavioral Intervention Group', 'description': "PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.52', 'spread': '0.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African-American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Black/African-American', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Non-Black/African-American', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Modified binary variable for race, distinguishing only those who identified as Black/African-American from those who did not.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Asian/Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black/African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White/Hispanic', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Other/Mixed Race', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Derived variable combining information on race and ethnicity.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lumbar spine bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects with DXA data at baseline.'}, {'title': 'Femoral neck bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects with DXA data at baseline.'}, {'title': 'Total body bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects with DXA data at baseline.'}, {'title': 'Total hip bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects with DXA data at baseline.'}, {'title': 'Number of participants reporting unprotected sex with a male partner in the past month', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'From the participant ACASI question referring to male partners in the past month:\n\n"Of these males, how many did you have unprotected oral or anal sex with in the past month?"\n\nAn event is defined as an answer of greater than 0.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants who provided a response to this question on the ACASI survey.'}, {'title': 'Number of male sexual partners in the last month', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '2.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'From the participant ACASI question:\n\n"During the past month, how many male partners have you had sexual contact with (oral or anal)?"', 'unitOfMeasure': 'male sexual partners', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants who provided a response to this question on the ACASI survey.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-08', 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study', 'timeFrame': '48 weeks', 'description': 'This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.\n\nParticipants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).'}, {'measure': 'Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Total Body Bone Mineral Density: Percent Change From Baseline to Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in total body BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:\n\nPercent change= \\[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\\] x 100\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Number of Participants With Decrease in Bone Mineral Density', 'timeFrame': '48 weeks', 'description': 'The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex', 'timeFrame': 'Week 48', 'description': 'Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:\n\n"Of these males \\[male partners\\], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0.\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners', 'timeFrame': 'Week 48', 'description': 'Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:\n\n"Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?"\n\nThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.'}, {'measure': 'Acceptability of PrEP Regimen and Study Visits', 'timeFrame': 'Week 12', 'description': 'This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.\n\nAcceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.'}, {'measure': 'Estimation of Medication Adherence by Dried Blood Spot (DBS) Results', 'timeFrame': 'Week 4, Week 12, Week 24, Week 36, Week 48', 'description': "This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.\n\nMedication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.\n\nThe TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '\\<2 days' is defined as \\<350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as \\>700 to 1250 (fmol/punch), and 'Daily' as \\>1250 (fmol/punch).\n\nThe TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '\\<2 days' is defined as \\<275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as \\>525 to 950 (fmol/punch),and 'Daily' as \\>950 (fmol/punch)"}], 'secondaryOutcomes': [{'measure': 'Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation', 'timeFrame': '48 weeks', 'description': "Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was session interesting, was it relevant to their life, and did they learn from the session)"}, {'measure': 'Number of Participants Using Text Messaging Reminders', 'timeFrame': 'Baseline through Week 48', 'description': 'This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.'}, {'measure': 'Rating of the Reasons for Missing Medications on a 4-point Likert Scale.', 'timeFrame': '48 weeks', 'description': 'This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.\n\nSubjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.\n\nQuestion: In the past month, how often have you missed taking your study pills because you:'}, {'measure': 'Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.', 'timeFrame': '48 weeks'}, {'measure': 'Evaluation of the Process of Protocol Implementation', 'timeFrame': '48 weeks', 'description': "Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.\n\nNOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:\n\nGilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9."}, {'measure': 'Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.', 'timeFrame': '48 weeks', 'description': 'Behavioral disinhibition/risk compensation endpoints will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV, PrEP, FTC/TDF, Truvada®'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '28873128', 'type': 'RESULT', 'citation': 'Hosek SG, Landovitz RJ, Kapogiannis B, Siberry GK, Rudy B, Rutledge B, Liu N, Harris DR, Mulligan K, Zimet G, Mayer KH, Anderson P, Kiser JJ, Lally M, Brothers J, Bojan K, Rooney J, Wilson CM. Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017 Nov 1;171(11):1063-1071. doi: 10.1001/jamapediatrics.2017.2007.'}, {'pmid': '31179503', 'type': 'DERIVED', 'citation': 'Havens PL, Perumean-Chaney SE, Patki A, Cofield SS, Wilson CM, Liu N, Anderson PL, Landovitz RJ, Kapogiannis BG, Hosek SG, Mulligan K. Changes in Bone Mass After Discontinuation of Preexposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine in Young Men Who Have Sex With Men: Extension Phase Results of Adolescent Trials Network Protocols 110 and 113. Clin Infect Dis. 2020 Feb 3;70(4):687-691. doi: 10.1093/cid/ciz486.'}], 'seeAlsoLinks': [{'url': 'http://www.atnonline.org', 'label': 'ATN website'}]}, 'descriptionModule': {'briefSummary': 'Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during the course of the study will be discontinued from the study agent and be followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.', 'detailedDescription': 'The aims of the study are to obtain additional data on the safety of FTC/TDF (Truvada®) and to evaluate acceptability, patterns of use, rates of adherence, and measured levels of drug exposure when YMSM are provided with open label FTC/TDF (Truvada®) and information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP based on prior studies in adults. The study will also examine patterns of sexual risk behavior among HIV-uninfected YMSM in the U.S. at high risk of acquiring HIV infection who are provided with open label FTC/TDF (Truvada®) as PrEP. The study will also explore the feasibility and acceptability of implementing an efficacious risk reduction behavioral intervention prior to the provision of PrEP- PCC. The inclusion of a behavioral intervention in this project not only addresses the ethical responsibility of providing at least the minimum risk reduction education to all subjects given the high HIV risk of the study population, but also builds behavioral skills to assist subjects in reducing their risk when not taking PrEP. Furthermore, the study will evaluate the process of protocol implementation to better understand how to best implement PrEP research and program practice at adolescent medicine sites, including an evaluation of consent procedures and the acceptability/feasibility of allowing youth minors to consent for their own participation in HIV prevention intervention, to the extent allowable by local laws and regulations, and to allow youth minor participation in a clinical trial without requiring disclosure of their sexual orientation and risk behaviors to their parents or legal guardians.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide written informed consent;\n* Male gender at birth;\n* Age 15 years and 0 days through 17 years and 364 days, inclusive, at the time of signed informed consent;\n* Self reports evidence of high risk for acquiring HIV infection including at least one of the following:\n\n * At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;\n * Anal intercourse with 3 or more male sex partners during the last 6 months;\n * Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;\n * Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;\n * Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or\n * At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;\n* Tests HIV antibody negative at time of screening;\n* Willing to provide locator information to study staff;\n* Willing to take PrEP;\n* Willing to participate in behavioral intervention;\n* Reports intention not to relocate out of AMTU study area during the course of the study; and\n* Does not have a job or other obligations that would require long absences from AMTU study area (greater than 4 weeks at a time).\n\nExclusion Criteria:\n\n* Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;\n* Intoxicated or under the influence of alcohol or other drugs at the time of consent;\n* Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 113 Protocol Team if they are having difficulty making the judgment.);\n* History of bone fractures not explained by trauma;\n* Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;\n* Confirmed renal dysfunction (Creatinine Clearance (CrCl) \\< 75 ml/min calculated based on bedside Schwartz formula: Glomerular filtration rate (GFR) = (0.413 x (height in centimeters)) / (serum creatinine in mg/dl)), or serum creatinine \\> upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;\n* Confirmed ≥ Grade 2 hypophosphatemia at time of screening;\n* Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;\n* Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;\n* Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio (UP/C);\n* UP/C \\> 0.37 g/g at time of screening, regardless of urine dipstick protein result;\n* Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (\\<120 mg/dL) at time of screening;\n* A confirmed Grade ≥ 3 toxicity on any screening evaluations;\n* Known allergy/sensitivity to the study agent or its components;\n* Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;\n* Use of disallowed medications; or\n* Inability to understand spoken English.'}, 'identificationModule': {'nctId': 'NCT01769456', 'briefTitle': 'An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) in the United States', 'orgStudyIdInfo': {'id': 'ATN 113 Version 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCC Behavioral Intervention Group', 'description': 'PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP', 'interventionNames': ['Behavioral: PCC', 'Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))']}], 'interventions': [{'name': 'PCC', 'type': 'BEHAVIORAL', 'otherNames': ['Personalized Cognitive Counseling'], 'description': "Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.", 'armGroupLabels': ['PCC Behavioral Intervention Group']}, {'name': 'Emtricitabine/tenofovir (FTC/TDF (Truvada®))', 'type': 'DRUG', 'otherNames': ['FTC/TDF', 'Truvada®', 'Emtricitabine/tenofovir', 'PrEP'], 'description': 'All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.', 'armGroupLabels': ['PCC Behavioral Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "University of Colorado - The Children's Hospital of Denver", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Stroger Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Childrens Hospital of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sybil Hosek, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stroger Hospital of Cook County'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}