HIV Prevention Intervention for Latino Male Couples

NCT06131931 | Recruiting

• 2 other identifiers: STUDY000056501R01MD018963-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; Latino; male; couples

Outcome Measures

Primary Outcomes (1)

• HIV Prevention sessions and assessments

  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.

  4 years

Study Arms (2)

Connecting Latinxs en Pareja (CLP)

EXPERIMENTAL

CLP is a four-session intervention grounded in social cognitive theory and a relationship oriented ecological framework.

Other: CLP Intervention

Wellness Promotion (WP)

ACTIVE COMPARATOR

WP focuses on nutrition, fitness, healthcare, and stress management and emphasizes adherence to medical regimens and medication management.

Other: WP Intervention

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.

Connecting Latinxs en Pareja (CLP)

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.

Wellness Promotion (WP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Latinx men and their same-sex partners
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Either partner:
• reports severe intimate partner violence (IPV) within the dyad during the past year on the Revised Conflict Tactic Scale\[1-4\]
• adults unable to consent
• pregnant women
• prisoners
• individuals who are not yet adults

Sponsors & Collaborators

• University of Central Florida: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of San Francisco: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

RECRUITING

Central Study Contacts

Omar Martinez, JD, MPH, MS

CONTACT

4072668742; omar.martinez@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; amoy.fraser@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 15, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)