Recruiting

HIV Prevention

Sponsor:

Temple University

Code:

NCT03048838

Conditions

HIV/AIDS

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Risk reduction behavioral intervention

Wellness Promotion Intervention

Study Details

Brief 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.

Conditions

HIV/AIDS

Study ID

NCT03048838

Start date

May, 2016

Status verified date

May, 2019

Completion date

Apr, 2020

Anticipated

Primary completion date

Apr, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Risk reduction behavioral intervention

Couples randomized to the risk reduction behavioral intervention ("Conectando Latinos en Pareja") will participate in four weekly sessions with a facilitator. Each session will last 2 hours. Participants will receive information and complete activities, participate in games and discussions to improve their relationship and improve health.

active comparator: Wellness Promotion Intervention

Couples randomized to the wellness promotion control group will receive the same number of hours of attention as the active experimental group but will not receive the risk reduction intervention. Information presented will consist of topics related to general health.

Interventions

Risk reduction behavioral intervention

Wellness Promotion Intervention

Primary outcome measure

  • Change in proportion of HIV protected anal sex acts between baseline and six months [ Time Frame: 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

More Information

Sponsor

Temple University

Last update posted

May 21, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2019-05-21.