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

This study is currently recruiting participants.

Verified January 2013 by University of California, Los Angeles

Sponsor:

Information provided by (Responsible Party):

William Cunningham, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01457066

First received: October 19, 2011

Last updated: January 4, 2013

Last verified: January 2013

History of Changes

Purpose

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).

Condition	Intervention	Phase
HIV	Behavioral: Peer Navigator Intervention	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Retention in care [ Time Frame: Six month follow up ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Intermediate outcome variables [ Time Frame: Six month follow up ] [ Designated as safety issue: No ]
Social support, perceived social norms, retention knowledge, retention self-efficacy, outcome expectations

Estimated Enrollment:	70
Study Start Date:	December 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457066

Contacts

Contact: William E Cunningham, MD, MPH	310.794.0314	wcunningham@mednet.ucla.edu
Contact: Danielle Seiden, MPP	310.463.7898	dseiden@mednet.ucla.edu

Locations

United States, California
AltaMed	Recruiting
Los Angeles, California, United States, 90023
Contact: William E Cunningham, MD, MPH 310-206-5838 wcunningham@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator:

William E Cunningham, MD, MPH

University of California, Los Angeles

More Information

No publications provided

Responsible Party:	William Cunningham, Prinicipal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01457066 History of Changes
Other Study ID Numbers:	R34MH089719-01A1
Study First Received:	October 19, 2011
Last Updated:	January 4, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013

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