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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225832
• Other study ID #: R01MH121256
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: RAND
• Contact: Laura Bogart, PhD
• Phone: (310) 393-0411
• Email: lbogart[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• CBT Coping Intervention
A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.

Locations

Country	Name	City	State
United States	Bienestar Human Services, Inc	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Bienestar Human Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who are HIV tested at least annually	Participants report being tested for HIV at least once in the past 12 months	from baseline to 12-months
Primary	Proportion of participants who have taken PrEP in the past 12 months	Participants report taking PrEP at any follow-up time-point	from baseline to 12-months
Secondary	Change in average level of adaptive coping, measured by the Brief COPE	Average adaptive coping rating on the Brief COPE scale (higher=better coping; range=1-4)	from baseline to 12-months