Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT04289116
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sylvie.naar@med.fsu.edu', 'phone': '18506442334', 'title': 'Sylvie Naar, PhD; Distinguished Endowed Professor', 'organization': 'Florida State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'We Test - Index Participants', 'description': 'Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nWe Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nIHTC: Individual HIV Testing and Counseling', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Individual Counseling and Testing - Partner Participants', 'description': 'Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV Transmission Risk Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'We Test - Index Participants', 'description': 'Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nWe Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.'}, {'id': 'OG001', 'title': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nIHTC: Individual HIV Testing and Counseling'}, {'id': 'OG002', 'title': 'Individual Counseling and Testing - Partner Participants', 'description': 'Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Chi Square', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.36', 'groupDescription': 'Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Chi Square', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'groupDescription': 'Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, month 3, month 6', 'description': 'Self-reported Condomless anal sex with a casual partner', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.'}, {'type': 'SECONDARY', 'title': 'Communication Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'We Test - Index Participants', 'description': 'Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nWe Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.'}, {'id': 'OG001', 'title': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nIHTC: Individual HIV Testing and Counseling'}, {'id': 'OG002', 'title': 'Individual Counseling and Testing - Partner Participants', 'description': 'Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '121.19', 'spread': '12.78', 'groupId': 'OG001'}, {'value': '129.00', 'groupId': 'OG002'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '125.04', 'spread': '10.04', 'groupId': 'OG000'}, {'value': '119.04', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '125.27', 'spread': '12.81', 'groupId': 'OG000'}, {'value': '117.68', 'spread': '11.30', 'groupId': 'OG001'}, {'value': '129.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.82', 'groupDescription': 'Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.5', 'groupDescription': 'Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, month 3, month 6', 'description': 'Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'We Test - Index Participants', 'description': 'Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nWe Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.'}, {'id': 'FG001', 'title': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. This includes 1 index partner who completed the intervention with their partner.\n\nIHTC: Individual HIV Testing and Counseling'}, {'id': 'FG002', 'title': 'Individual Counseling and Testing - Partner Participants', 'description': 'Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'We Test - Index Participants', 'description': 'Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nWe Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.'}, {'id': 'BG001', 'title': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.\n\nIHTC: Individual HIV Testing and Counseling'}, {'id': 'BG002', 'title': 'Individual Counseling and Testing - Partner Participants', 'description': 'Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.91', 'spread': '1.86', 'groupId': 'BG000'}, {'value': '22.38', 'spread': '1.77', 'groupId': 'BG001'}, {'value': '24.00', 'groupId': 'BG002'}, {'value': '22.18', 'spread': '1.82', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Identity', 'classes': [{'title': 'Gay', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'Other/Queer', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender Identity', 'classes': [{'title': 'Cisgender Male', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Transgender, gender nonconforming, or assigned male at birth', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Insurance', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Yes, my own', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Yes, my guardian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current PrEP Use', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Main Partner Age', 'classes': [{'categories': [{'measurements': [{'value': '25.45', 'spread': '7.89', 'groupId': 'BG000'}, {'value': '26.11', 'spread': '6.59', 'groupId': 'BG001'}, {'value': '24.00', 'spread': '0.00', 'groupId': 'BG002'}, {'value': '25.77', 'spread': '7.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Relationship Length (in months)', 'classes': [{'categories': [{'measurements': [{'value': '19.21', 'spread': '25.03', 'groupId': 'BG000'}, {'value': '21.14', 'spread': '26.56', 'groupId': 'BG001'}, {'value': '2.00', 'spread': '0.00', 'groupId': 'BG002'}, {'value': '19.97', 'spread': '25.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-12', 'size': 332664, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-22T14:54', 'hasProtocol': True}, {'date': '2020-05-01', 'size': 208543, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-22T14:57', 'hasProtocol': False}, {'date': '2021-05-12', 'size': 1380481, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-22T14:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At baseline participants will be randomized to one of two conditions: Condition 1: MI-CST + observation of ACT videos + CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2020-02-14', 'resultsFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-20', 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Transmission Risk Behavior', 'timeFrame': 'baseline, month 3, month 6', 'description': 'Self-reported Condomless anal sex with a casual partner'}], 'secondaryOutcomes': [{'measure': 'Communication Skills', 'timeFrame': 'baseline, month 3, month 6', 'description': 'Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.', 'detailedDescription': 'Investigators will conduct a comparative effectiveness trial (CET) of CHTC for adolescent-age (15-24 years) same-sex male couples. This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the individual or couple together and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. Youth will be randomized to receive one of two conditions: Condition 1: watch videos on ACT, participate in Communication Skills Training (MI-CST), and complete an individual HIV test, or if participating as a couple will receive CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Identifies as male, nonbinary, genderqueer or gender nonconforming.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least one partner must be HIV-negative or status unknown\n* THE INDEX PARTNER must be 15-24 years old\n* YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN YEARS OLD.\n* INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO ORGASM)\n* CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A RELATIONSHIP\n* HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON\n* Both partners must be able to communicate in English.\n* LIVE IN OR NEAR NEW YORK CITY OR DETROIT OR SAN DIEGO\n* GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER NONCOMFORMING\n\nExclusion Criteria:\n\n* Unstable, serious psychiatric symptoms\n* Current suicidal/homicidal ideation\n* Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner\n* IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY STUDY WHEN THEY DID NOT WANT TO."}, 'identificationModule': {'nctId': 'NCT04289116', 'acronym': 'WeTestATN156', 'briefTitle': "Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM", 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': "Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM", 'orgStudyIdInfo': {'id': 'ATN 156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'We Test - Index Participants', 'description': 'Each participant will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.', 'interventionNames': ['Behavioral: We Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual HIV Testing and Counseling - Index Participants', 'description': 'Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.', 'interventionNames': ['Behavioral: IHTC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Counseling and Testing - Partner Participants', 'description': 'Referred partner who participates in Individual HIV Testing and Counseling with their partner.', 'interventionNames': ['Behavioral: IHTC']}], 'interventions': [{'name': 'We Test', 'type': 'BEHAVIORAL', 'description': 'This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.', 'armGroupLabels': ['We Test - Index Participants']}, {'name': 'IHTC', 'type': 'BEHAVIORAL', 'description': 'Individual HIV Testing and Counseling', 'armGroupLabels': ['Individual Counseling and Testing - Partner Participants', 'Individual HIV Testing and Counseling - Index Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10018', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The City University of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tyrel Starks, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'City University of New York'}, {'name': 'Sarah W Feldstein Ewing, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rhode Island'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, there is no plan to share the study data at this time; however, the study team is currently in the process of developing a plan to share data, while protecting the privacy and confidentiality of participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hunter College of City University of New York', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Wayne State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sylvie Naar', 'investigatorAffiliation': 'Florida State University'}}}}