- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04225832
A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Study Overview
Detailed Description
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.
The Specific Aims are:
Aim 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.
Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).
Aim 3. To conduct a cost-effectiveness analysis of the intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Bogart, PhD
- Phone Number: 7281 (310) 393-0411
- Email: lbogart@rand.org
Study Contact Backup
- Name: Terry Marsh, MPH
- Phone Number: 6846 (310) 393-0411
- Email: tmarsh@rand.org
Study Locations
-
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California
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Los Angeles, California, United States, 90022
- Recruiting
- Bienestar Human Services, Inc
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Contact:
- Ronald Brooks, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years-old
- biologically male at birth
- identify as male
- identify as Latino
- is an immigrant
- report having sex with men in the past 12 months
- report HIV-negative or unknown serostatus
- anticipate being available for the next 12 months to attend study visits
- able to interact and communicate in spoken Spanish or English.
Exclusion Criteria:
- HIV-positive
- cisgender women
- transgender women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT Coping Intervention
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).
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A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
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No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who are HIV tested at least annually
Time Frame: from baseline to 12-months
|
Participants report being tested for HIV at least once in the past 12 months
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from baseline to 12-months
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Proportion of participants who have taken PrEP in the past 12 months
Time Frame: from baseline to 12-months
|
Participants report taking PrEP at any follow-up time-point
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from baseline to 12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in average level of adaptive coping, measured by the Brief COPE
Time Frame: from baseline to 12-months
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Average adaptive coping rating on the Brief COPE scale (higher=better coping; range=1-4)
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from baseline to 12-months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Bogart, PhD, RAND
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01MH121256 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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