Recruiting

HIV Prevention

Sponsor:

University of Central Florida

Code:

NCT06131931

Conditions

HIV

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

CLP Intervention

WP Intervention

Study Details

Brief summary:

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.

Conditions

HIV

Study ID

NCT06131931

Start date

Jun 21, 2023

Status verified date

Dec, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • at least 18 years
  • reside in the 50 local jurisdictions identified by the EHE initiative or 17 jurisdictions with most HIV diagnoses among Latinxs
  • identify as Latinx/Hispanic/Afro-Latinx or reports having a main partner who identifies as Latinx/Hispanic/Afro-Latin
  • report having a main/primary male partner operationalized as a man with whom he has a primary ongoing sexual relationship, for at least 3 months
  • at least one member of the dyad report three acts of unprotected of anal sex (with main or other partners)
  • able to speak English and/or Spanish

Exclusion Criteria:

Either partner:

  • reports severe intimate partner violence (IPV) within the dyad during the past year on the Revised Conflict Tactic Scale\[1-4\]
  • has a language or cognitive impairment that would prevent informed consent. Inclusion of dyads reporting severe IPV could pose dangers and ethical concerns and will be referred to domestic abuse organizations for screening and services.
  • adults unable to consent
  • pregnant women
  • prisoners
  • individuals who are not yet adults

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

CLP Intervention

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Omar Martinez, JD, MPH, MS

4072668742omar.martinez@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32816

Contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Erica Martin, BS

4072668742erica.martin@ucf.edu

More Information

Sponsor

University of Central Florida

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • HIV
  • Latino
  • male
  • couples

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2024-12-06.