HIV/AIDS Clinical Trial
Official title:
A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
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.
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.
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