Cognitive Behavioral Therapy for HIV Prevention in Latinx Sexual Minority Men

Overseen By Terry Marsh, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: HIV-positive, Cisgender women, Transgender women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of therapy called cognitive behavioral therapy (CBT) to help Latinx sexual minority men cope with stigma related to their ethnicity and sexual orientation. The goal is to improve HIV outcomes by helping participants develop better coping strategies. The trial includes both a therapy group and a control group receiving standard support. It seeks Latinx immigrant men who have had sex with other men in the past year and are HIV-negative or unsure of their status. Participants must be available for the next year and able to communicate in Spanish or English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to better support for their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this CBT Coping Intervention is safe?

Research has shown that cognitive behavioral therapy (CBT) is generally safe for participants. In similar studies, group CBT has helped with mental health issues and demonstrated positive effects, such as encouraging more HIV testing and reducing stress. These studies suggest that CBT is well-tolerated and usually does not cause serious problems.

CBT helps people change negative thinking patterns and develop better coping strategies. Participants often find this approach useful for handling stress and stigma. The reviewed studies have not reported significant negative effects or side effects from CBT, making it a promising option for those looking to improve their mental health and well-being.

Overall, CBT is considered a safe treatment, and previous studies support its use in similar situations without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CBT Coping Intervention for HIV prevention in Latinx sexual minority men because it uniquely addresses the stigma and identity challenges that often accompany HIV risk. Unlike standard treatments that might focus solely on medical aspects, this intervention enhances coping strategies related to intersectional identities like ethnicity, immigration status, and sexual orientation. By tackling issues of medical mistrust and structural stigma through group therapy led by facilitators who share similar backgrounds with participants, this approach aims to improve mental health and social support, which are crucial for effective HIV prevention.

What evidence suggests that the CBT Coping Intervention is effective for improving HIV outcomes in Latinx sexual minority men?

Research has shown that cognitive behavioral therapy (CBT) helps people manage stress and reduce feelings of stigma. Studies have found that CBT improves mental health for people with HIV by teaching better coping strategies. This trial will evaluate the CBT Coping Intervention, which aims to improve HIV outcomes for Latinx sexual minority men by strengthening their ability to handle societal pressures and discrimination. This therapy changes negative thinking and behaviors, assisting individuals in dealing with stigma related to their ethnicity, sexual identity, and health. These findings suggest that CBT might benefit this group in managing challenges related to their identities and HIV prevention. ^{1 2 3 4 6}

Who Is on the Research Team?

Laura Bogart, PhD

Principal Investigator

RAND

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are someone who has moved to a new country to live there permanently.

anticipate being available for the next 12 months to attend study visits

I have had sexual relations with men in the past year.

Exclusion Criteria

HIV-positive

I am a transgender woman.

I am a cisgender woman.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-session cognitive behavior therapy (CBT) group intervention to improve HIV outcomes by increasing adaptive, effective coping responses to stigma.

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for regular HIV testing and PrEP uptake, as well as changes in adaptive coping.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT Coping Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: CBT Coping Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

Bienestar Human Services, Inc.

Collaborator

Trials

4

Recruited

680+

Published Research Related to This Trial

A systematic review of ten intervention programs involving 2871 Latino men who have sex with men (MSM) found that four studies successfully reduced condomless anal intercourse, highlighting the potential effectiveness of targeted HIV prevention strategies.

While all studies included some cultural elements in their design, they often missed deeper cultural aspects like machismo and sexual silence, indicating a need for more culturally nuanced interventions to effectively address HIV risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Behavioral Interventions to Reduce Condomless Sex and Increase HIV Testing for Latino MSM. Pérez, A., Santamaria, EK., Operario, D.[2021]

The 'Connect 'n Unite' intervention was successfully adapted for predominantly Spanish-speaking Latino men who have sex with men (MSM) and their partners, ensuring that its key elements remained effective while being culturally relevant.

The adaptation process involved qualitative methods and community engagement, resulting in a new intervention called 'Latinos en Pareja' that focuses on enhancing sexual communication, risk reduction norms, and access to culturally appropriate health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of a Couple-Based HIV/STI Prevention Intervention for Latino Men Who Have Sex With Men in New York City. Martinez, O., Wu, E., Frasca, T., et al.[2021]

A pilot study involving 21 young Black and Latino gay, bisexual, and other men who have sex with men (GBM) demonstrated that a group therapy treatment addressing intersectional stigma was feasible and highly acceptable, helping participants feel less isolated.

The treatment showed promising results in improving stigma coping, mental health (reducing depression, anxiety, and stress), and sexual health behaviors, including increased condom use efficacy and pre-exposure prophylaxis uptake, while also indicating a potential reduction in HIV transmission risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to Jackson et al. (2022). [2022]

A community-based cognitive behavior therapy intervention was developed to help HIV-positive Latino sexual minority men cope with discrimination, showing strong acceptability among participants and stakeholders.

In a preliminary evaluation with 30 participants, the intervention demonstrated feasibility and resulted in significant reductions in negative emotional responses to discrimination, suggesting it may improve mental health outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Cognitive Behavior Therapy Group Intervention to Address Coping with Discrimination Among HIV-Positive Latino Immigrant Sexual Minority Men. Bogart, LM., Galvan, FH., Leija, J., et al.[2021]

In a 7-year study of 181 gay men with HIV, avoidance coping was linked to a slower decline in CD4 cell counts, suggesting it may help maintain immune function.

Avoidance coping also reduced the risk of developing a more aggressive HIV variant and dropping below critical CD4 cell levels, indicating a potential protective effect in managing HIV progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoidance as a predictor of the biological course of HIV infection over a 7-year period in gay men. Mulder, CL., de Vroome, EM., van Griensven, GJ., et al.[2019]

A randomized controlled trial (RCT) is being conducted to test the efficacy of a culturally tailored couple-based HIV prevention intervention called Connecting Latinos en Pareja (CLP) for Latino men who have sex with men (MSM) and their partners, aiming to increase the use of protective measures during anal sex acts.

The intervention incorporates biomedical prevention strategies like PrEP and treatment as prevention (TasP), and is designed to address socio-cultural factors influencing HIV risk, with assessments planned at baseline, 3 months, and 6 months post-intervention to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial. Martinez, O., Isabel Fernandez, M., Wu, E., et al.[2021]

Latino immigrants with HIV in the Southeastern US present with more advanced disease, as indicated by lower CD4 counts at clinic entry compared to US-born Latinos, highlighting a need for targeted early testing and prevention strategies.

Despite differences in sociodemographic and behavioral characteristics, both immigrant and US-born Latinos had similar rates of receiving antiretroviral therapy (ART) and achieving viral suppression, suggesting effective treatment access across both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV risk behaviors and sociodemographic features of HIV-infected Latinos residing in a new Latino settlement area in the Southeastern United States. Dennis, AM., Wheeler, JB., Valera, E., et al.[2022]

A study involving 104 HIV-positive men found that positive cognitive coping strategies, such as focusing on joyful thoughts and finding meaning in their condition, are linked to personal growth.

The research highlights the importance of goal self-efficacy, suggesting that interventions for people living with HIV should emphasize developing positive coping strategies and confidence in pursuing meaningful goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive coping, goal self-efficacy and personal growth in HIV-infected men who have sex with men. Kraaij, V., Garnefski, N., Schroevers, MJ., et al.[2015]

A culturally sensitive social media campaign successfully engaged 739 unique users, including 60 Latinx immigrant sexual minority men, to promote HIV testing and PrEP uptake, demonstrating the feasibility of using technology to reach this underserved population.

The study revealed that many participants faced barriers to HIV prevention, with over half lacking medical insurance and a significant portion not having tested for HIV recently, highlighting the urgent need for tailored outreach strategies in marginalized communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally Tailored Social Media Content to Reach Latinx Immigrant Sexual Minority Men for HIV Prevention: Web-Based Feasibility Study. Lee, JJ., Aguirre Herrera, J., Cardona, J., et al.[2022]

The eight-session cognitive behavior therapy intervention significantly improved antiretroviral treatment adherence among HIV-positive Latinx sexual minority men, with self-reported adherence showing a notable increase compared to the control group.

Participants in the intervention also experienced a significant reduction in medical mistrust and a trend towards decreased negative religious coping beliefs, suggesting the intervention may help address stigma and empower individuals in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of an Intervention to Improve Coping with Intersectional Stigma and Medication Adherence Among HIV-Positive Latinx Sexual Minority Men. Bogart, LM., Barreras, JL., Gonzalez, A., et al.[2022]

A 10-week cognitive behavioral stress management (CBSM) intervention significantly improved coping strategies and social support among 22 HIV-positive gay men, leading to reductions in dysphoria, anxiety, and mood disturbances compared to a control group of 18 participants.

The study found that enhanced cognitive coping, particularly acceptance of HIV, was strongly linked to improved psychological well-being, indicating that both coping skills and social support are crucial for managing distress in individuals with symptomatic HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in cognitive coping skills and social support during cognitive behavioral stress management intervention and distress outcomes in symptomatic human immunodeficiency virus (HIV)-seropositive gay men. Lutgendorf, SK., Antoni, MH., Ironson, G., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04225832

A Cognitive Behavioral Therapy Group Intervention to Increase ... A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men. ClinicalTrials.gov ID NCT04225832.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8336475/

A Pilot Cognitive Behavior Therapy Group Intervention to ... Cognitive behavior therapy (CBT) interventions have been developed to improve coping with stress and, in turn, mental health among people with HIV.

3. link.springer.com link.springer.com/article/10.1007/s10461-025-04906-5

Randomized Controlled Trial of a Group Cognitive ... Cognitive behavior therapy (CBT) interventions have been effective in improving stress management, as well as reducing internalized stigma, ...

4. withpower.com withpower.com/trial/phase-2020-20e9b

Cognitive Behavioral Therapy for HIV Prevention in Latinx ... Participants undergo an 8-session cognitive behavior therapy (CBT) group intervention to improve HIV outcomes by increasing adaptive, effective coping responses ...

5. trialx.com trialx.com/clinical-trials/listings/245294/a-cognitive-behavioral-therapy-group-intervention-to-increase-hiv-testing-and-prep-use-among-latinx-sexual-minority-men/

A Cognitive Behavioral Therapy Group Intervention to ... This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/32/NCT04225832/Prot_SAP_000.pdf

A Cognitive Behavioral Therapy Group Intervention to ... A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among. Latinx Sexual Minority Men. January 6, 2020.