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

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ClinicalTrials.gov Identifier: NCT01457066
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: Peer Navigator Intervention Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM
Study Start Date : December 2012
Primary Completion Date : June 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Retention in care [ Time Frame: Six month follow up ]
    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 :
  1. Intermediate outcome variables [ Time Frame: Six month follow up ]
    Social support, perceived social norms, retention knowledge, retention self-efficacy, outcome expectations


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457066


Locations
United States, California
AltaMed
Los Angeles, California, United States, 90023
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: William E Cunningham, MD, MPH University of California, Los Angeles
More Information

Responsible Party: William Cunningham, Prinicipal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01457066     History of Changes
Other Study ID Numbers: R34MH089719-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015