HIV Prevention Intervention for Latino Male Couples

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Central Florida
Study ID
NCT06131931
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • CLP Intervention — OTHER
    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.
  • WP Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 21, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Connecting Latinxs en Pareja (CLP)
    CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.
  • Active Comparator: Wellness Promotion (WP)
    WP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management.

Primary Outcome Measure

HIV Prevention sessions and assessments [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Central FloridaOrlandoFlorida32816
Amoy Fraser, PhD, CCRP, PMP
[email protected]
4072668742
Erica Martin, BS
[email protected]
4072668742
Omar Martinez, JD, MPH, MS

Find similar trials in Orlando, FL

By condition
HIV
By specialty
Infectious disease
By research site
University of Central Florida· Orlando, FL

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