← Back to Search

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
Select...
I have had sexual relations with men in the past year.
Select...
I identify as male.
Select...
I am 18 years old or older.
Select...
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV/AIDS include antiretroviral therapy (ART) and non-pharmacological interventions like Cognitive Behavioral Therapy (CBT). ART works by inhibiting the replication of the HIV virus, reducing viral load, and improving immune function. CBT, on the other hand, helps patients develop adaptive coping mechanisms to manage the stigma and psychological stress associated with HIV/AIDS. This dual approach is crucial as it addresses both the biological and psychosocial aspects of the disease, leading to improved overall health outcomes for patients.
Cultural Adaptation of 2 Evidence-Based Alcohol Interventions for Antiretroviral Treatment Clinic Patients in Vietnam.

Find a Location

Who is running the clinical trial?

RANDLead Sponsor
138 Previous Clinical Trials
510,594 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
~55 spots leftby Jun 2025