HIV Prevention for Latino Male Couples

Overseen By Amoy Fraser, PhD, CCRP, PMP

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Severe IPV, Cognitive impairment, Pregnant, others

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

Compensation: Varies

Number of Visits: 7

400 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Connecting Latinxs en Pareja (CLP) for HIV prevention in Latino male couples?

The pilot study of the CLP intervention showed it was highly feasible and acceptable, with participants reporting improved relationship functioning and communication skills, which are important for safer sex practices. Although the study wasn't large enough to show a significant impact on HIV prevention, there were promising trends in reducing risky behaviors and improving quality of life. ^{1 2 3 4 5}

Is the CLP Intervention safe for Latino male couples?

The CLP Intervention, tested as a couples-based HIV prevention program for Latino male couples, showed high feasibility and acceptability, with no safety concerns reported in the pilot study. Participants found the intervention effective in improving communication and safer sex practices. ^{1 2 3 4 6}

How is the CLP Intervention treatment for HIV prevention in Latino male couples different from other treatments?

The CLP Intervention is unique because it is a couples-based approach specifically designed for Latino male couples, focusing on improving relationship dynamics and communication skills to promote safer sex practices. Unlike other treatments, it emphasizes cultural and linguistic appropriateness, making it more relatable and effective for this specific community. ^{1 7 8 9 10}

What is the purpose of this trial?

The primary objective of this proposal is to test the efficacy of Connecting Latinxs en Pareja (CLP). CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework. The investigators will examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts to those assigned to a Wellness Promotion (WP) time and attention matched control condition. The primary outcome, relates to use of HIV protection.

Eligibility Criteria

This trial is for Latino male couples where at least one partner is 18 or older, living in certain high HIV risk areas, and identifies as Latinx/Hispanic/Afro-Latinx. Couples must be in a relationship for at least 3 months with a history of unprotected sex. Participants must speak English or Spanish.

Inclusion Criteria

You are of Latinx/Hispanic/Afro-Latinx descent or have a main partner who is of Latinx/Hispanic/Afro-Latinx descent.

I can speak English or Spanish.

I have been in a primary sexual relationship with a man for at least 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a four-session intervention via Zoom, focusing on HIV prevention for the CLP group and wellness promotion for the WP group.

4 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with follow-up every 3 months over 9 months.

9 months

3 follow-up assessments (virtual)

Treatment Details

Interventions

• CLP Intervention
• WP Intervention

Trial Overview The study tests the effectiveness of Connecting Latinxs en Pareja (CLP), a four-session intervention aimed at increasing HIV protected anal sex acts among participants compared to those receiving Wellness Promotion (WP) sessions focused on general health.

Participant Groups

Group I: Connecting Latinxs en Pareja (CLP) Experimental Treatment 1 Intervention

CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.

Group II: Wellness Promotion (WP) Active Control 1 Intervention

WP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of San Francisco

Collaborator

Trials

10

Recruited

1,300+

Findings from Research

The Connecting Latinos en Pareja (CLP) intervention for Latino male couples showed high feasibility and acceptability, with an 80% retention rate and 100% completion of the intervention over 6 months, involving 46 individuals (23 couples).

While the study was not designed to measure significant impacts on HIV prevention, couples in the intervention group reported improved relationship functioning and positive trends in safer sex practices and communication skills, indicating potential effectiveness for future larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples. Martinez, O., Fernandez, MI., Yang, C., et al.[2023]

In a study of 393 couples, 39.7% were found to be serodiscordant, indicating a significant prevalence of couples where one partner is HIV-positive and the other is not, highlighting the need for targeted prevention strategies.

Most HIV-infected partners (83.5%) were on antiretroviral therapy (ART) with high adherence rates (>95%) and 90.3% had undetectable HIV RNA, suggesting effective treatment outcomes, but interventions to reduce transmission risk in serodiscordant couples are still necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of HIV infection, access to HIV care, and response to antiretroviral therapy among partners of HIV-infected individuals in Thailand. Kiertiburanakul, S., Wongprasit, P., Phuphuakrat, A., et al.[2018]

A couple-based HIV counseling and testing intervention significantly reduced HIV risk among African-American and Latina women drug users compared to standard individual counseling, based on a study involving 110 couples (220 individuals) in New York City from 2005 to 2007.

The intervention was well-received by participants and interventionists, demonstrating its effectiveness and feasibility in high HIV prevalence urban communities, with potential for expansion to include additional prevention strategies like pre-exposure prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple-based HIV counseling and testing: a risk reduction intervention for US drug-involved women and their primary male partners. McMahon, JM., Pouget, ER., Tortu, S., et al.[2018]

A randomized trial with 330 couples showed that couple-based HIV counseling and testing (CB-HIV-CT) significantly reduced HIV risk behaviors over 9 months compared to standard interventions.

The CB-HIV-CT intervention was more effective than women-only relationship-focused counseling (WRF-HIV-CT) in lowering HIV risk, highlighting the importance of addressing both drug-related and sexual risk behaviors in couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Couple-Based HIV Counseling and Testing for Women Substance Users and Their Primary Male Partners: A Randomized Trial. McMahon, JM., Tortu, S., Pouget, ER., et al.[2022]

A qualitative study involving 20 HIV-discordant and 16 HIV-positive male couples identified key improvements needed for the MCAP eHealth intervention to better serve their relationship and HIV prevention needs.

Participants suggested that the toolkit should include biomedical prevention strategies and broaden the concept of sexual agreements to encompass mental health and wellness, indicating a desire for a more holistic approach to HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-discordant and concordant HIV-positive male couples' recommendations for how an eHealth HIV prevention toolkit for concordant HIV-negative male couples could be improved to meet their specific needs. Mitchell, JW., Lee, JY., Godoy, F., et al.[2019]

The study evaluates the effectiveness of adding communication training videos and a substance use module to standard Couples HIV Testing and Counseling (CHTC) for male couples, aiming to reduce drug use and sexual HIV transmission risk behaviors.

Couples aged 17-29 who are HIV-negative and report recent drug use will be randomized into four groups to assess the impact of these adjunct components over a 12-month follow-up, potentially enhancing the effectiveness of CHTC in preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. Starks, TJ., D Kyre, K., B Cowles, C., et al.[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]

Involving men in HIV prevention efforts is crucial for promoting shared responsibility and improving communication about sexual health within couples, as highlighted by focus groups conducted in Puerto Rico, the Dominican Republic, and Mexico.

Barriers to men's involvement include cultural taboos and power imbalances in relationships, suggesting that effective interventions should be designed to engage men in natural settings and utilize coed facilitators to foster open discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators of HIV prevention with heterosexual Latino couples: beliefs of four stakeholder groups. Pérez-Jiménez, D., Seal, DW., Serrano-García, I.[2021]

Predominantly Spanish-speaking Latino men who have sex with men (MSM) are disproportionately affected by HIV, influenced by factors such as substance use, intimate partner violence, and fear of discrimination.

Innovative couple-based interventions targeting relationship dynamics may significantly reduce HIV transmission among this population, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A couple-based approach: An innovative effort to tackle HIV infection among Latino gay men.] Martinez, O., Wu, E., Sandfort, T., et al.[2020]

In a study of 625 Latinx sexual minority men, those who exhibited caballerismo (a cultural value of chivalry and nurturing) and constructive communication were more likely to successfully recruit their partners for sexual health research.

Understanding and incorporating cultural values and communication styles can improve recruitment strategies for couples-based studies, which is crucial given the higher HIV incidence rates among this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with individual and couple participation in online sexual health research with Latinx sexual minority men. Robles, G., Dellucci, TV., Del Rosario, B., et al.[2023]

References

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

Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples. [2023]

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

Prevalence of HIV infection, access to HIV care, and response to antiretroviral therapy among partners of HIV-infected individuals in Thailand. [2018]

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

Couple-based HIV counseling and testing: a risk reduction intervention for US drug-involved women and their primary male partners. [2018]

4. Egypt pubmed.ncbi.nlm.nih.gov

Effectiveness of Couple-Based HIV Counseling and Testing for Women Substance Users and Their Primary Male Partners: A Randomized Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

HIV-discordant and concordant HIV-positive male couples' recommendations for how an eHealth HIV prevention toolkit for concordant HIV-negative male couples could be improved to meet their specific needs. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. [2021]

7. 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]

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

Barriers and facilitators of HIV prevention with heterosexual Latino couples: beliefs of four stakeholder groups. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[A couple-based approach: An innovative effort to tackle HIV infection among Latino gay men.] [2020]

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

Factors associated with individual and couple participation in online sexual health research with Latinx sexual minority men. [2023]