Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-05 @ 1:36 AM
Study NCT ID:
NCT03396367
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2018-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention and Risk: Treatment With a New Emphasis on Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tstarks@hunter.cuny.edu', 'phone': '212-772-5550', 'title': 'Dr. Tyrel Starks', 'organization': 'Hunter College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'PARTNER Intervention', 'description': 'This intervention is a four-session intervention designed to increase PrEP uptake, increase PrEP adherence, and reduce drug use and HIV transmission risk behaviors of individuals in relationships.\n\nPARTNER: The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education Intervention', 'description': 'This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning.\n\nEducation Intervention: The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Illicit Drug Use Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'OG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.49', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '.80', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '1.16', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': '6-month', 'categories': [{'measurements': [{'value': '.67', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '.56', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': '9-month', 'categories': [{'measurements': [{'value': '1.08', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '.81', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': '12-month', 'categories': [{'measurements': [{'value': '.66', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '.67', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.433', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.372', 'ciLowerLimit': '-.558', 'ciUpperLimit': '1.302', 'pValueComment': 'Condition (referent = education control).', 'estimateComment': 'Variable:', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.017', 'ciLowerLimit': '-.121', 'ciUpperLimit': '.087', 'estimateComment': 'Variable: Communication Compentence', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.073', 'ciLowerLimit': '-.121', 'ciUpperLimit': '.087', 'estimateComment': 'Moderating Variable: Communication Competence by Condition', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.799', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.027', 'ciLowerLimit': '-.182', 'ciUpperLimit': '.236', 'estimateComment': 'Variable: Relationship Satisfaction', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.211', 'ciLowerLimit': '-.514', 'ciUpperLimit': '.092', 'estimateComment': 'Moderating Variable: Relationship Satisfaction by Condition', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The self-reported number of illicit drug use days (not including marijuana) in the past 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent-to-treat population'}, {'type': 'PRIMARY', 'title': 'Cannabis Use Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'OG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.68', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '7.59', 'spread': '10.64', 'groupId': 'OG001'}]}]}, {'title': '3-Month', 'categories': [{'measurements': [{'value': '9.28', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '10.33', 'groupId': 'OG001'}]}]}, {'title': '6-Month', 'categories': [{'measurements': [{'value': '9.13', 'spread': '11.63', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': '9-Month', 'categories': [{'measurements': [{'value': '10.04', 'spread': '12.24', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '10.73', 'groupId': 'OG001'}]}]}, {'title': '12-Month', 'categories': [{'measurements': [{'value': '10.04', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '10.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.427', 'ciLowerLimit': '-.186', 'ciUpperLimit': '1.04', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.054', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.281', 'ciLowerLimit': '-.623', 'ciUpperLimit': '.061', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.125', 'ciLowerLimit': '-.011', 'ciUpperLimit': '.260', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The self-reported number of cannabis drug use days in the past 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent-to-treat population'}, {'type': 'PRIMARY', 'title': 'Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'OG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3-Month', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '6-Month', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '9-Month', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '12-Month', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.679', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.245', 'ciLowerLimit': '-.913', 'ciUpperLimit': '1.403', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.301', 'ciLowerLimit': '-1.938', 'ciUpperLimit': '1.336', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.048', 'ciLowerLimit': '-.496', 'ciUpperLimit': '.593', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intent-to-treat population'}, {'type': 'PRIMARY', 'title': 'The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'OG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': '3-Month', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': '6-Month', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': '9-Month', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': '12-Month', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.326', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.251', 'ciLowerLimit': '-3.814', 'ciUpperLimit': '1.311', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.246', 'ciLowerLimit': '-1.383', 'ciUpperLimit': '1.875', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.856', 'ciLowerLimit': '.052', 'ciUpperLimit': '1.659', 'pValueComment': 'A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.', 'statisticalMethod': 'Latent Growth Curve', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month,', 'description': 'The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intent-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'FG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Partner Intervention', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.'}, {'id': 'BG001', 'title': 'Education Intervention', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '27', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Cisgender Male', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Latino or Hispanic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Asian, Pacific Islander', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Multiracial or another identity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Identity', 'classes': [{'title': 'Gay', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': 'Bisexual', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Queer or another Identity', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Residence', 'classes': [{'title': 'Northeast', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Elsewhere in the US', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'Less than a 4 year degree', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '4 year degree or higher', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PrEP status', 'classes': [{'title': 'Not taking PrEP', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Current PrEP perscription', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Interpersonal Communication Communication Competence Scale', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '44.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Interpersonal Communication Competence Scale (Rubin, 1994) assesses self-disclosure, social anxiety, assertiveness, and empathy. Each statement is evaluated on a 5- point Likert scale ranging from 0 (almost never) to 4 (almost always). Total score was summed and had a range of 0 to 48. Higher scores indicated greater communication competence.\n\nRubin RB, Martin MM. Development of a measure of interpersonal competence. Communication Research Reports. 1994;11(1):33-44.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Approximation to an Ideal subscale of the Multiple Determinants of Relationship Commitment Inventory', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '15.2', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Relationship satisfaction is assessed using the approximation to ideal subscale of the Multiple Determinants of Relationship Commitment Inventory (Kurdek, 1998). The subscale is 4 items with response options ranging from 1 (strongly disagree) to 5 (strongly agree). Total range is 4 to 20. Higher scores indicated greater relationship satisfaction.\n\nKurdek LA. Relationship outcomes and their predictors: Longitudinal evidence from heterosexual married, gay cohabiting, and lesbian cohabiting couples. Journal of Marriage and the Family. 1998;60(3):553-68.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-01', 'size': 645606, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-11T15:56', 'hasProtocol': True}, {'date': '2022-12-05', 'size': 281132, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-10T10:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2018-01-04', 'resultsFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-16', 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Illicit Drug Use Days', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The self-reported number of illicit drug use days (not including marijuana) in the past 30 days'}, {'measure': 'Cannabis Use Days', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The self-reported number of cannabis drug use days in the past 30 days'}, {'measure': 'Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month', 'description': 'The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).'}, {'measure': 'The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake', 'timeFrame': 'Baseline, 3-Month, 6-Month, 9-Month, 12-Month,', 'description': 'The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relationships', 'YMSM', 'HIV/AIDS', 'PrEP', 'Drug Use'], 'conditions': ['Adherence, Medication', 'Risk Reduction', 'Drug Use', 'Sex, Anal', 'HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '24364800', 'type': 'BACKGROUND', 'citation': 'Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.'}, {'pmid': '31274114', 'type': 'DERIVED', 'citation': 'Starks TJ, Robles G, Pawson M, Jimenez RH, Gandhi M, Parsons JT, Millar BM. Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol. JMIR Res Protoc. 2019 Jul 4;8(7):e13015. doi: 10.2196/13015.'}]}, 'descriptionModule': {'briefSummary': 'This research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence, HIV transmission risk behavior, and associated drug use.', 'detailedDescription': 'This study aims to evaluate a individual-focused intervention with an integrated focus on drug use and HIV prevention, including uptake of and adherence to PrEP. The investigators will recruit a sample of 240 partnered individuals.\n\nRecruitment occurs using a mix of in-person and Internet recruitment. Outreach workers will visit bars and events in the New York City area to recruit participants. Also,information on our project will be posted on social media sites (e.g.,Facebook, Grindr, Scruff). Interested individuals will complete a brief online screener to assess eligibility. A telephone screener will be conducted with participants who are preliminarily eligible based upon online screener responses. Participants who are eligible based upon telephone screening responses will be sent an email. The email contains a link for them to access the baseline online survey. It provides information which introduces the study to the recruited partner and a link to the baseline survey online. If participants indicate intimate partner violence (IPV) on the online baseline survey, participants will be rendered ineligible. Only the participant that indicated experiencing IPV will be given a list of local referrals to access IPV-related services.\n\nAn in-person baseline assessment appointment will be scheduled after both participants have completed the online survey.\n\nThe in-person baseline assessment appointment consists of four components; written consent, a computer-assisted self interview (CASI), a timeline follow back interview, and biological testing.\n\nWritten consent is obtained prior to the start of any in-person baseline activity. Participants additionally complete a computer-assisted self interview (CASI). After this, participants will independently complete a TFLB. TLFB is a semi-structured interview to collect retrospective event-level data on drug use, sexual behavior and PrEP adherence (for those on PrEP) in the past 30 days.\n\nThe final part of the in-person baseline assessment consists of biological testing for STI (gonorrhea \\& chlamydia via urinalysis and rectal swabs), drug testing via 5-panel fingernail drug assay via finger or toe nail clippings. Drugs tested are 5 major drugs: Amphetamines, Cannabinoids, Cocaine, Opiates, and Phencyclidine (PCP). HIV testing will consist of a finder prick test using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay. Participants indicating current PrEP give an additional blood sample and fingernail sample to examine PrEP adherence using a dried blood spot for western blot analysis and fingernail assay.\n\nAfter the baseline assessment, participants will be randomized to receive their first PARTNER or Education session, of which will occur immediately following their baseline assessment.\n\nThe study will employ a stratified randomization procedure using an algorithm via Qualtrics. Participants will be randomized using three couple-level criteria as reported by the participant. Participants will be randomized based on relationship length difference (less than 2 years versus 2 or more), age difference (less than 3 years versus 3 or more), racial difference (both white versus all others combinations), PrEP use (Participant reports current PrEP use versus does not report current use).\n\nEach of the intervention arms consists of 4 sessions that occur once a week for four consecutive weeks.\n\nAll participants complete a 3-month, 6-month, 9-month, and 12-month follow ups. At the 3 month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use. For participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.\n\nAt the 6 month follow up month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use, biological testing for STI (gonorrhea \\& chlamydia via urinalysis and rectal swabs) and HIV testing using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay Also, for participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.\n\nAt the 9 month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use. For participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.\n\nAt final assessment (12 month follow up post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use, biological testing for STI (gonorrhea \\& chlamydia via urinalysis and rectal swabs) and HIV testing using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay Also, for participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Both gender at birth and current self-identified gender must be male.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 29 years of age (inclusive);\n* Main partner must be aged 18 or older.\n* Must be in a main partner relationship with another male (duration ≥ 1 months);\n* HIV-negative serostatus (confirmed by rapid test);\n* Recent (past 30 day) use of at least one of the substances identified as most commonly used by YMSM (marijuana, cocaine, methamphetamine, heroin or other opiates, MDMA, psychedelics, GHB, and/or ketamine);\n* Sexual behavior meeting CDC criteria for PrEP candidacy (TRB with a casual partner in the past 30 days or TRB with a non-monogamous or serodiscordant main partner).\n* Participants must reside in the NYC metro area\n* Ability to communicate in English\n\nExclusion Criteria:\n\n* Unstable, serious psychiatric symptoms (assessed by the Psychotic Disorder subsection of the Structured Clinical Interview for DSM-IV);\n* Current suicidal/homicidal ideation;\n* Evidence of gross cognitive impairment (a score of \\<24 on the mini-mental state examination)\n* A history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship in which participants report not currently feeling "safe" in their relationship and/or coerced to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03396367', 'acronym': 'PARTNER', 'briefTitle': 'Prevention and Risk: Treatment With a New Emphasis on Relationships', 'organization': {'class': 'OTHER', 'fullName': 'Hunter College of City University of New York'}, 'officialTitle': 'Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM', 'orgStudyIdInfo': {'id': 'R01DA045613', 'link': 'https://reporter.nih.gov/quickSearch/R01DA045613', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA045613', 'link': 'https://reporter.nih.gov/quickSearch/R01DA045613', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PARTNER Intervention', 'description': 'This intervention is a four-session intervention designed to increase PrEP uptake, increase PrEP adherence, and reduce drug use and HIV transmission risk behaviors of individuals in relationships.', 'interventionNames': ['Behavioral: PARTNER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education Intervention', 'description': 'This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning.', 'interventionNames': ['Behavioral: Education Intervention']}], 'interventions': [{'name': 'PARTNER', 'type': 'BEHAVIORAL', 'description': 'The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.', 'armGroupLabels': ['PARTNER Intervention']}, {'name': 'Education Intervention', 'type': 'BEHAVIORAL', 'description': 'The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.', 'armGroupLabels': ['Education Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10018', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hunter College- City University of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tyrel J Starks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunter College of City University of New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter College of City University of New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': 'Tyrel Starks', 'investigatorAffiliation': 'Hunter College of City University of New York'}}}}