A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
NCT03048838 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2019-05-21
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
Interventions
- BEHAVIORAL
-
Risk reduction behavioral intervention
- BEHAVIORAL
-
Wellness Promotion Intervention
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED - collaborator OTHER
-
Nova Southeastern University
collaborator OTHER -
Temple University
lead OTHER
Principal Investigators
-
Omar Martinez, JD · Temple University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2020-04-30
- Completion
- 2020-04-30
Countries
- United States
Study Locations
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