Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM (PODER)

The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Peer Navigator Intervention

Detailed Description

While early receipt of and adherence to antiretroviral therapy are critical for effective HIV treatment, engagement with and retention in HIV care are essential first steps. Retention in HIV care is particularly important for traditionally disadvantaged groups, such as Latino MSMs, who are over-represented in the HIV epidemic. HIV+ Latino MSM therefore urgently need interventions to improve their retention in HIV care, which may be affected by a number of culture-specific factors. The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control). The study will be conducted among insufficiently retained HIV+ Latino MSM at AltaMed, the largest provider of HIV medical services for Latinos in Los Angeles. The proposed intervention is designed to retain participants in HIV care by addressing barriers to and facilitators of HIV care salient to Latinos, using group-based as well as one-on-one, peer-based learning approaches.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90023
      • AltaMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria include: 1) being HIV+; 2) > 18 years old; 3) male; 4) fluent in Spanish; 5) self-identify as having Latino or Hispanic ethnicity; 6) Self-identify as gay or as ever having sex with men; 7) Must have scheduled visit with AltaMed in the prior 12 months and have a) fewer than one visit in the prior four months or b) detectable viral load

Exclusion Criteria include 1) not having a scheduled visit with AltaMed in the prior 12 months and having a) more than one visit in the prior four months or b) undetectable viral load; 2) being unable to give informed consent; 3) Lack of Spanish language skills

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; This group will receive the peer navigator intervention.	Behavioral: Peer Navigator Intervention; Peer navigators will teach HIV retention and linkage skills and knowledge using group-based as well as one-on-one, peer-based learning approaches.
NO_INTERVENTION: Control; This group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in care	Retention in care will be assessed through the following measures: HIV medical care visits, ART use, self-reported adherence, acute care utilization, viral load, and health-related quality of life	Six month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate outcome variables	Social support, perceived social norms, retention knowledge, retention self-efficacy, outcome expectations	Six month follow up

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (ESTIMATE): October 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: R34MH089719-01A1 (NIH)