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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support Latinx sexual minority men by teaching them ways to manage challenges and improve their health.

Will I have to stop taking my current medications?

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

Is Cognitive Behavioral Therapy safe for Latinx sexual minority men?

Cognitive Behavioral Therapy (CBT) has been tested in various forms for different conditions, including coping with discrimination and stigma among HIV-positive Latinx sexual minority men. The studies show that CBT is generally well-accepted and feasible, with no safety concerns reported related to the therapy itself. ^{1 2 3 4 5}

How is the CBT Coping Intervention treatment different from other treatments for HIV prevention in Latinx sexual minority men?

The CBT Coping Intervention is unique because it focuses on improving coping skills to deal with stigma and medical mistrust, which are significant barriers for Latinx sexual minority men in adhering to HIV prevention strategies. Unlike other treatments, it uses cognitive behavioral therapy (a type of talk therapy) to empower individuals by leveraging their resilience and addressing cultural and social challenges specific to this group. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy Coping Intervention for HIV prevention in Latinx sexual minority men?

Research shows that cognitive behavioral therapy (CBT) can help improve coping with stigma and increase medication adherence in HIV-positive Latinx sexual minority men. Additionally, CBT has been found to reduce distress and improve mood in HIV-positive individuals, suggesting it may be effective in supporting mental health and adherence to prevention strategies. ^{2 3 9 10 11}

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

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 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]

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]

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]

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 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 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 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]

Citations

1. United States 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. [2022]

2. United States 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. [2021]

3. United States 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. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Cognitive coping, goal self-efficacy and personal growth in HIV-infected men who have sex with men. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Avoidance as a predictor of the biological course of HIV infection over a 7-year period in gay men. [2019]

6. England 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. [2021]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Behavioral Interventions to Reduce Condomless Sex and Increase HIV Testing for Latino MSM. [2021]

10. United States 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. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Culturally Tailored Social Media Content to Reach Latinx Immigrant Sexual Minority Men for HIV Prevention: Web-Based Feasibility Study. [2022]