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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Connecting Latinxs en Pareja (CLP) to help Latino male couples increase their use of protection during anal sex, reducing the risk of HIV. The study compares CLP to another program, the WP Intervention, which focuses on wellness habits like fitness and stress management. It seeks Latino or Hispanic male couples who have been together for at least three months and have had unprotected anal sex at least three times. Participants should live in areas with high rates of HIV among Latinxs and speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health outcomes for Latino male couples.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CLP (Connecting Latinxs en Pareja) program is designed to help Latino male couples use HIV protection more frequently. This program includes four sessions aimed at improving communication and interaction between couples, based on social cognitive theory. Although specific data on safety concerns for this program is not available, it focuses on education and behavior rather than medication or medical procedures, which typically indicates a low risk of negative effects.

The WP (Wellness Promotion) program, another part of the study, promotes healthy living through improved nutrition, exercise, healthcare, and stress management. Like the CLP, it is a behavioral program, generally considered safe and unlikely to cause harm.

In summary, both programs are educational and behavioral, suggesting they are safe for participants. Research has not reported any specific safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIV prevention approaches being tested for Latino male couples because they offer unique, culturally tailored interventions. The "Connecting Latinxs en Pareja" (CLP) intervention stands out by using a relationship-oriented ecological framework rooted in social cognitive theory, which focuses on strengthening partnerships and social support as a means to prevent HIV. This is distinct from the standard individual-focused prevention strategies. On the other hand, the "Wellness Promotion" (WP) intervention emphasizes a holistic approach, addressing factors such as nutrition, fitness, healthcare access, and stress management, alongside adherence to medical regimens. These innovative approaches aim to address both behavioral and environmental factors that affect HIV risk, providing a more comprehensive prevention strategy tailored to the needs of Latino male couples.

What evidence suggests that this trial's treatments could be effective for HIV prevention in Latino male couples?

In this trial, the Connecting Latinxs en Pareja (CLP) program is one of the interventions under study. It aims to help Latino male couples use HIV protection more frequently. Based on social cognitive theory, the program involves learning and changing behaviors by observing others, while considering the couple's environment and interactions. Although this approach is new and specifically tailored for Latino male couples, studies on similar programs have suggested they can effectively increase safe sex practices. By focusing on both partners and their relationship, CLP seeks to improve communication and decision-making about HIV protection. Early results indicate that these types of programs can lead to more frequent use of protection during sex. Another arm of this trial involves the Wellness Promotion (WP) intervention, which emphasizes nutrition, fitness, healthcare, and stress management, focusing on adherence to medical regimens and medication management. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/x1j7v-XCpECHM__IsYRVYw/project-details/10706860

A Couples-based HIV Prevention Intervention for Latino Male ... To our knowledge, this study will be the first to examine the efficacy of a couple-based intervention to increase HIV protection for Latinx male couples capable ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06131931

HIV Prevention Intervention for Latino Male Couples 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06131931/hiv-prevention-intervention-for-latino-male-couples

HIV Prevention Intervention for Latino Male Couples The primary objective of this proposal is to test the efficacy of Connecting Latinxs en Pareja (CLP). CLP is a four-session intervention ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5887179/

A couple-based HIV prevention intervention for Latino men ... This paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus.

5. nsuworks.nova.edu nsuworks.nova.edu/cgi/viewcontent.cgi?article=1481&context=hpd_facarticles

A Couples-Based HIV Prevention Intervention for Latino The study examined the feasibility and acceptability of the Connecting Latinos en Pareja. (CLP) intervention, a couples-based HIV prevention ...

6. reporter.nih.gov reporter.nih.gov/search/FKYEH9S8IUyyf4fkTRSwdA/project-details/11004980

RePORT RePORTER - National Institutes of Health (NIH) | The proposed study is a randomized controlled trial (RCT) of an HIV prevention couples-based intervention - Connecting Latinxs en Pareja (CLP). CLP is based ...

7. stacks.cdc.gov stacks.cdc.gov/view/cdc/53737

A couple-based HIV prevention intervention for Latino men ... The RCT will determine the preliminary efficacy of Connecting Latinos en Pareja (CLP) to increase the proportion of anal sex acts that are HIV protected ...