A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Omar Martinez, JD
- Phone Number: 786-208-4340
- Email: tug29454@temple.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Recruiting
- Temple University
-
Contact:
- Omar Martinez, JD
- Phone Number: 786-208-4340
- Email: tug29454@temple.edu
-
Contact:
- Omar Valentin, MPH
- Email: omar.valentin@temple.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be at least 18 years old;
- 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);
- self-identify as Latino/Hispanic or identify as having a main partner who identifies as Latino/Hispanic;
- reports sexual activity in the past 90 days as described in the screening instrument;
- identify each other as their main partner;
- able to speak English and/or Spanish;
- plan to remain in the area for the next 8 months.
Exclusion Criteria:
Couples will be excluded if:
- either partner reports that participating in a study that talks about sex, relationship issues and alcohol/drugs will put him in danger;
- either partner has a language or cognitive impairment that would prevent comprehension of study procedures;
- either partner is currently on PrEP and fully adherent, or enrolled in any other HIV prevention study;
- either partner is planning to move outside the area in the next 8 months;
- either partner is planning on ending the relationship with his partner in the next 8 months; and
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months post-intervention
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Omar Martinez, JD, Temple University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
Other Study ID Numbers
- 24120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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