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Behavioral Intervention

Cognitive Behavioral Therapy for HIV Prevention in Latinx Sexual Minority Men

N/A
Recruiting
Led By Laura Bogart, PhD
Research Sponsored by RAND
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
report having sex with men in the past 12 months
identify as male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12-months
Awards & highlights

Study Summary

This trial will test a CBT intervention to help Latinx SMM deal with stigma from multiple identities, in the hope of improving HIV outcomes.

Who is the study for?
This trial is for Latinx sexual minority men who were biologically male at birth, are immigrants, have had sex with men in the past year, and expect to be available for monthly study visits over the next year. They must be HIV-negative or of unknown status, at least 18 years old, and able to communicate in Spanish or English.Check my eligibility
What is being tested?
The trial is testing a cognitive behavior therapy (CBT) group intervention designed to help participants cope better with stigma related to their ethnicity, immigration status, sexual orientation, and PrEP use. The goal is to increase HIV testing and PrEP adoption among these individuals.See study design
What are the potential side effects?
As this is a psychological intervention focusing on coping strategies rather than medication or medical procedures, traditional physical side effects are not expected. Participants may experience emotional discomfort discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had sexual relations with men in the past year.
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I identify as male.
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I am 18 years old or older.
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I was assigned male at birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who are HIV tested at least annually
Proportion of participants who have taken PrEP in the past 12 months
Secondary outcome measures
Change in average level of adaptive coping, measured by the Brief COPE

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CBT Coping InterventionExperimental Treatment1 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 II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

RANDLead Sponsor
137 Previous Clinical Trials
509,951 Total Patients Enrolled
Bienestar Human Services, Inc.OTHER
3 Previous Clinical Trials
379 Total Patients Enrolled
Laura Bogart, PhDPrincipal InvestigatorRAND
5 Previous Clinical Trials
1,080 Total Patients Enrolled

Media Library

CBT Coping Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04225832 — N/A
HIV/AIDS Research Study Groups: CBT Coping Intervention, Control
HIV/AIDS Clinical Trial 2023: CBT Coping Intervention Highlights & Side Effects. Trial Name: NCT04225832 — N/A
CBT Coping Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225832 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this research endeavor?

"Affirmative. Clinicaltrials.gov has details of this trial, which was first published on January 20th 2o2o and updated most recently on April 15th 2022, indicating that it is presently recruiting participants from one location with the aim to enrol 300 patients."

Answered by AI

Does this investigation currently accept new participants?

"Affirmative. According to the clinicaltrials.gov platform, this research is actively seeking participants, having been posted on January 20th 2020 and revised April 15th 2022. The study requires 300 patients from a single medical centre for enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
California
What site did they apply to?
Bienestar Human Services, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Bienestar Human Services, Inc: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
2020. "A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225832.
~65 spots leftby Jun 2025
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