Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-31 @ 5:58 AM
Study NCT ID:
NCT04225832
Status:
TERMINATED
Last Update Posted:
2025-08-13
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lbogart@rand.org', 'phone': '3103830411', 'title': 'Laura Bogart, PhD', 'phoneExt': '7281', 'organization': 'RAND'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Objective HIV testing dates and PrEP prescription data were collected (e.g., from medical records), but the US federal government (NIH) terminated the grant prematurely on March 20, 2025 before these data could be processed. These data were not fully cleaned or tabulated, and thus were not analyzed as an outcome and cannot be entered at baseline: The number of records is unknown and therefore not reported here. Thus, the primary outcomes are reported based on self-reported survey responses.'}}, 'adverseEventsModule': {'timeFrame': '3 years, 9 months', 'eventGroups': [{'id': 'EG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 0, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will receive standard of care', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Potential confidentiality breach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'social threat/violence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery due to pre-existing condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV Test at Least Annually', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '1.01', 'ciUpperLimit': '6.26', 'pValueComment': 'a-priori threshold was p\\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.', 'estimateComment': 'Odds ratio is for indicator of intervention arm', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Regression results control for immigration status and length of time in U.S.', 'otherAnalysisDescription': 'Regression results control for immigration status and length of time in U.S.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from baseline to 12-months', 'description': 'Participants report being tested for HIV at least once in the 12 months after baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Took PrEP in the Past 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.81', 'pValueComment': 'a-priori threshold was p\\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.', 'estimateComment': 'Odds ratio is for indicator of intervention arm', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Regression results control for immigration status and length of time in U.S.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from baseline to 12-months', 'description': 'Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. Outcome measures are assessed for the remaining N=239'}, {'type': 'SECONDARY', 'title': 'Level of Adaptive Coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.'}], 'classes': [{'title': '4-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': '8-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.14', 'pValueComment': 'a-priori threshold was p\\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.09', 'estimateComment': 'Slope is adjusted regression coefficient for indicator of intervention arm', 'groupDescription': 'Unlike the "observed at any FU" primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Regression results control for immigration status, length of time in U.S., and baseline value of the outcome'}], 'paramType': 'MEAN', 'timeFrame': 'measured at 4-months, 8-months, and 12-months post baseline', 'description': 'Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven\'t been doing this at all," 2 = "I\'ve been doing this a little bit," 3 = "I\'ve been doing this a medium amount" and 4 = "I\'ve been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others".\n\nHigher values indicate more use of these coping strategies.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. An additional N=2 control participants did not respond to any of the 4 items in the scale, leaving N=237 for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will receive standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'No longer eligible (e.g., seroconversion)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unable to recontact or too busy/not recontacted or unknown reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited across Southern California using: in-person in-reach at the partner organization; in-person outreach at relevant events and businesses; passive recruitment via hard copy fliers left at the partner community-based organization and other relevant local organizations; social media recruitment via paid advertisements, video posts, and direct messaging. Participants also were offered $10 per referral, for up to three referrals.', 'preAssignmentDetails': 'Of 607 screened, 455 met inclusion criteria, of whom 289 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV testing in past 12 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test'}, {'title': 'Current PrEP use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief COPE: Social support-seeking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.12', 'spread': '.86', 'groupId': 'BG000'}, {'value': '2.28', 'spread': '.90', 'groupId': 'BG001'}, {'value': '2.20', 'spread': '0.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven\'t been doing this at all," 2 = "I\'ve been doing this a little bit," 3 = "I\'ve been doing this a medium amount" and 4 = "I\'ve been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others". Cronbach\'s alpha = .79.\n\nHigher values indicate more use of these coping strategies.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Coping missing for n=2 who did not respond to any of the 4 survey items in the scale'}], 'populationDescription': '9 withdrawn (3 control, 6 intervention); 41 no follow-up data (5 control, 36 intervention) Analysis sample = 136 control, 103 intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-06', 'size': 178101, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-06T18:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor does not randomize participant until after the baseline assessment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'whyStopped': 'Government executive order', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2020-01-07', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-21', 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Test at Least Annually', 'timeFrame': 'from baseline to 12-months', 'description': 'Participants report being tested for HIV at least once in the 12 months after baseline'}, {'measure': 'Took PrEP in the Past 12 Months', 'timeFrame': 'from baseline to 12-months', 'description': 'Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)'}], 'secondaryOutcomes': [{'measure': 'Level of Adaptive Coping', 'timeFrame': 'measured at 4-months, 8-months, and 12-months post baseline', 'description': 'Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven\'t been doing this at all," 2 = "I\'ve been doing this a little bit," 3 = "I\'ve been doing this a medium amount" and 4 = "I\'ve been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others".\n\nHigher values indicate more use of these coping strategies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latino/Hispanic/Latinx', 'men who have sex with men'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM).', 'detailedDescription': 'This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.\n\nThe Specific Aims are:\n\nAim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.\n\nAim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).\n\nAim 3. To conduct a cost-effectiveness analysis of the intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '* biologically male at birth\n* identify as male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years-old\n* biologically male at birth\n* identify as male\n* identify as Latino\n* is an immigrant\n* report having sex with men in the past 12 months\n* report HIV-negative or unknown serostatus\n* anticipate being available for the next 12 months to attend study visits\n* able to interact and communicate in spoken Spanish or English.\n\nExclusion Criteria:\n\n* HIV-positive\n* cisgender women\n* transgender women'}, 'identificationModule': {'nctId': 'NCT04225832', 'briefTitle': 'A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men', 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': 'A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men', 'orgStudyIdInfo': {'id': 'R01MH121256', 'link': 'https://reporter.nih.gov/quickSearch/R01MH121256', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT Coping Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).', 'interventionNames': ['Behavioral: CBT Coping Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.'}], 'interventions': [{'name': 'CBT Coping Intervention', 'type': 'BEHAVIORAL', 'description': 'A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.', 'armGroupLabels': ['CBT Coping Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Bienestar Human Services, Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Laura Bogart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bienestar Human Services, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}