A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men

Not Applicable

Terminated

• Conditions: HIV

• Registration Number: NCT04225832
• Lead Sponsor: RAND

Brief Summary

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).

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 Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-01-20
• Status Verified: 2023-11
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Results First Submitted: 2025-06-20
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 289

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV Test at Least Annually	from baseline to 12-months	Participants report being tested for HIV at least once in the 12 months after baseline
Took PrEP in the Past 12 Months	from baseline to 12-months	Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)

Secondary Outcome Measures

Name	Time	Method
Level of Adaptive Coping	measured at 4-months, 8-months, and 12-months post baseline	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".; Higher values indicate more use of these coping strategies.

Trial Locations

Locations (1)

Bienestar Human Services, Inc; 🇺🇸 Los Angeles, California, United States