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

HIV Clinical Trial

— PODER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457066
• Other study ID #: R34MH089719-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 19, 2011
• Last updated: May 26, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

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.

Locations

Country	Name	City	State
United States	AltaMed	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intermediate outcome variables	Social support, perceived social norms, retention knowledge, retention self-efficacy, outcome expectations	Six month follow up	No