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

NCT ID: NCT04225832

Last Updated: 2025-08-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2024-11-27

Brief Summary

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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

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor does not randomize participant until after the baseline assessment

Study Groups

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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).

Group Type EXPERIMENTAL

CBT Coping Intervention

Intervention Type BEHAVIORAL

A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CBT Coping Intervention

A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bienestar Human Services, Inc.

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Bogart, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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Bienestar Human Services, Inc

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MH121256

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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