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HIV Prevention Intervention for Latino Male Couples

NCT06131931 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-12-06

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • University of San Francisco

    collaborator OTHER

  • University of Central Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06131931 on ClinicalTrials.gov