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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:May 2016
End Date:April 2020
Contact:Lisa Landsberg, MEd
Email:lisa.landsberg@temple.edu
Phone:215-707-7303

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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.

Inclusion Criteria:

1. be at least 18 years old;

2. report having a main/primary male partner during the past 90 days (operationalized as
a man with whom he has had a sexual relationship during the past 90 days and has a
strong emotional bond);

3. self-identify as Latino/Hispanic or identify as having a main partner who identifies
as Latino/Hispanic;

4. reports sexual activity in the past 90 days as described in the screening instrument;

5. identify each other as their main partner;

6. able to speak English and/or Spanish;

7. plan to remain in the area for the next 8 months.

Exclusion Criteria:

Couples will be excluded if:

1. either partner reports that participating in a study that talks about sex,
relationship issues and alcohol/drugs will put him in danger;

2. either partner has a language or cognitive impairment that would prevent comprehension
of study procedures;

3. either partner is currently on PrEP and fully adherent, or enrolled in any other HIV
prevention study;

4. either partner is planning to move outside the area in the next 8 months;

5. either partner is planning on ending the relationship with his partner in the next 8
months; and

6. either partner reports being in a stable triadic relationship (operationalized as a
relationship in which all 3 men have a strong emotional bond and the 3 men are having
sex with each other).
We found this trial at
1
site
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 786-208-4340
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