University of Central Florida
Orlando, Florida, 32816, United States
Location status: Recruiting
Location contact
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Erica Martin, BS
CONTACT
Omar Martinez, JD, MPH, MS
CONTACT
NCT Number: NCT06131931
The primary objective of this proposal is to test the efficacy of Connecting Latinxs en Pareja (CLP). CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.
The investigators will examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts to those assigned to a Wellness Promotion (WP) time and attention matched control condition. The primary outcome, relates to use of HIV protection.
Interested in participating?
Request Info18 year–100 year
Male
Interventional
Not applicable
Orlando, Florida, 32816, United States
Location status: Recruiting
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Erica Martin, BS
CONTACT
Omar Martinez, JD, MPH, MS
CONTACT
The investigators will recruit 200 Latinx male couples (N=400 individuals) from 50 Ending the HIV Epidemic (EHE) jurisdictions and an additional 17 areas with high HIV burden among Latinxs. Building from our previous success in engaging sexual minority Latinx men, the investigators will implement a multipronged recruitment strategy, including social media and social networking apps and venue-based recruitment. Couples will be randomly assigned to CLP or a piloted Wellness Promotion (WP) time and attention matched control condition. Follow- up will occur every 3 months over 9 months, and biological (hair biomarkers for Pre-Exposure Prophylaxis (PrEP) and Antiretroviral Therapy (ART) adherence) and behavioral and psychosocial data collected. The primary outcome, HIV protection, is operationalized with a validated composite algorithm as protected acts of anal intercourse (i.e., anal sex acts in which condoms, PrEP, or Treatment as Prevention (TasP) are used to reduce risk of HIV transmission) within the couple and with outside partners. Guided by the Designing for Dissemination and Sustainability (D4DS) framework, the investigators will derive practical recommendations and considerations for sustainability and scaling up of the intervention (or other next steps). All intervention sessions will be conducted via Zoom by a facilitator. The facilitator will conduct all remote sessions from a private office at the University of Central Florida College of Medicine. Study participants will collect their own hair samples and mail it back to the University of California San Francisco. Participants will receive the collection toolkit and paid stamped mail package to ship samples. Hair sample collection is noninvasive and does not require specific skills, sterile equipment, or specialized storage. Samples can be stored at room temperature for long periods prior to analysis and shipped without taking the precautions associated with biohazardous materials.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Either partner:
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Connecting Latinxs en Pareja (CLP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
4 weekly sessions lasting approximately 60 minutes that will be audio recorded for quality assurance. Each couple will be assigned one RA who will serve as their facilitator and guide them through the Wellness Promotion (WP) sessions. The RA will deliver the appropriate intervention in either Spanish or English at the couple's preference. Sessions will be delivered via zoom (or comparable secure platform), using established procedures from the team's prior studies. Each participant will complete Qualtrics assessments at baseline, 3-, 6- and 9-months post randomization and biological (hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data collected.
Time frame: 4 years
The investigators will examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts to those assigned to a Wellness Promotion (WP) time and attention matched control condition by conducting weekly sessions and assessments.
Contact information is provided by the study sponsor or research team.
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Omar Martinez, JD, MPH, MS
CONTACT
University of Central Florida
Other
Connecting Latinos En Pareja: a Couples-based HIV Prevention Intervention for Latino Male Couples
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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