A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
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|ClinicalTrials.gov Identifier: NCT03048838|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Risk reduction behavioral intervention Behavioral: Wellness Promotion Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be assigned to either risk-reduction group (Conectado Latinos en Parejas, CLP) or wellness-promotion (WP) control condition|
|Masking:||None (Open Label)|
|Official Title:||A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
Behavioral: Risk reduction behavioral intervention
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.
Behavioral: Wellness Promotion Intervention
- Change in proportion of HIV protected anal sex acts between baseline and six months [ Time Frame: 6 months post-intervention ]Change in proportion of anal sex acts involving protective measures (condoms, PrEP, TasP) to reduce risk of HIV transmission between baseline and six months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048838
|Contact: Lisa Landsberg, MEdemail@example.com|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19122|
|Contact: Omar Martinez, JD 786-208-4340 firstname.lastname@example.org|
|Contact: Omar Valentin, MPH email@example.com|
|Principal Investigator:||Omar Martinez, JD||Temple University|