A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples

HIV/AIDS Clinical Trial

Official title: A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples

Status Recruiting

Clinical Trial Summary

Epidemiological studies have attributed the source of many new HIV and STI infections among MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious interventions for Latino male couples have yet to be tested. The proposed study builds on the PI's post-doctoral research in which he adapted evidence based intervention for Black MSM couples, Connect `n Unite, for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV testing if appropriate given the couple's serostatus. The investigators will conduct a randomized control trial (RCT) to examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts (operationalized as using condoms, PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA and randomly assign them to CLP or WP. Participants will complete ACASIs to assess behavioral and psychosocial factors and be tested for sexually transmitted infections (STI) at baseline, 3 and 6 month post intervention. The investigators will conduct optional HIV/STI testing at baseline, 3, and 6 month post intervention. The primary study activities will be conducted at a large Latino serving CBO in North Philadelphia. To our knowledge, this study will be the first to examine the impact of a couple-based intervention to increase HIV protected anal sex acts for Latino male couples capable of being scaled up and replicated in various communities to provide continuous support and protection for this heavily impacted group.

Clinical Trial Description

Latino men who have sex with men (MSM) continue to be disproportionately affected by HIV. Experiences of stigma, discrimination, marginalization, sexual objectification, negative cultural perceptions of homosexuality, and cultural values such as 'familismo' and 'machismo' elevate their vulnerability to HIV infection. Many Latino MSM use substances as a way to cope with or alleviate these stressors, further increasing their risk. Although efficacious interventions for Latino MSM have been developed, not a single one has focused on Latino male couples, despite strong evidence from White MSM that HIV infection often occurs within primary couple relationships. Findings from the investigators formative study with Latino MSM suggest that the factors driving HIV risk for White male couples also operate among Latino male couples. For instance, Latino men in male couples were more likely to report condomless anal sex and problematic alcohol use than those who were not in a relationship. Developing and testing tailored interventions for Latino male couples, as the investigators are proposing, is warranted.

The proposed study builds on the PI's post-doctoral research which adapted an evidence based intervention for Black MSM couples, Connect 'n Unite (CNU), for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectando Latinos en Pareja (CLP), expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP); promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) for HIV-positive individuals and/or couples; and encouraging routine HIV testing, if appropriate given the couple's serostatus. The investigators have proposed a two-phase study to determine the preliminary efficacy of Conectando Latinos en Pareja to increase the proportion of anal sex acts that are HIV protected (i.e. anal sex acts in which condoms, PrEP, TasP, or combination thereof reduce risk of HIV transmission). During Phase 1, the investigators will develop and finalize the intervention manuals and assessment instruments, pilot test the intervention, and conduct the necessary preparatory activities for launching a randomized control trial (RCT). During Phase 2, the investigators will conduct a RCT to examine whether participants assigned to CLP report an increase in the proportion of HIV-protected anal sex acts compared to those assigned to a Wellness Promotion (WP), a time-matched attention control (the investigators will use an algorithm that incorporates use of condoms, PrEP, and/or TasP, depending on the serostatus of the couple to compute the dependent variable).

The investigators will recruit 150 Latino male couples (where at least one member of the dyad self-identifies as Latino) in the corridor between Philadelphia, PA and Trenton, NJ - an area with porous borders where many diverse subgroups of Latinos live. The investigators will randomly assign couples to CLP or WP. The investigators will assess sexual, alcohol and drug use behaviors and other psychosocial factors (e.g., depressive symptoms, anxiety symptoms) at baseline, 3, and 6 months post-intervention. Participants who consent to optional HIV/STI testing will be tested for HIV, chlamydia, and gonorrhea at baseline and at 3 and 6 months post-intervention. The primary assessment and project management activities will be conducted at GALAEI, a large Latino-serving CBO in North Philadelphia. Recruitment and screening will be done at community and internet venues. Intervention activities will be conduct at GALAEI, Temple University, and other safe spaces convenient to study participants. ;

Related Conditions & MeSH terms

• HIV/AIDS

• NCT number: NCT03048838
• Study type: Interventional
• Source: Temple University
• Contact: Omar Martinez, JD
• Phone: 786-208-4340
• Email: tug29454@temple.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Completion date: April 2020