HIV/AIDS Clinical Trial
Official title:
A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
NCT number | NCT03048838 |
Other study ID # | 24120 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | April 2020 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Temple University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Centers for Disease Control and Prevention, Columbia University, Nova Southeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in proportion of HIV protected anal sex acts between baseline and six months | Change in proportion of anal sex acts involving protective measures (condoms, PrEP, TasP) to reduce risk of HIV transmission between baseline and six months | 6 months post-intervention |
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