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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 19, 2011
January 4, 2013
December 2012
October 2013   (final data collection date for primary outcome measure)
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
  • Percent Retained in Care [ Time Frame: Eight month follow up ] [ Designated as safety issue: No ]
    The number of subjects in each group that are retained in medical care.
  • Percent with 3+ visits in six months [ Time Frame: Eight month follow up ] [ Designated as safety issue: No ]
    Percent of participants with three or more visits to their healthcare provider in six months of the intervention.
  • Percent of ER visits [ Time Frame: Eight month follow ups ] [ Designated as safety issue: No ]
    Percent of participants who had an emergency room visit in the eight months of the intervention.
  • Any ARV medication [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    Number of patients who were on anti retrovirals in the eight months of the intervention.
  • CD4 under 350 [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    The number and percent of patients who had a CD 4 count below 350 during the intervention.
  • Viral load under 400 [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    Number and percent of patients whose viral load was under 400 during the follow up.
Complete list of historical versions of study NCT01457066 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM
Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM

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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV
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.
  • Experimental: Intervention
    This group will receive the peer navigator intervention.
    Intervention: Behavioral: Peer Navigator Intervention
  • No Intervention: Control
    This group will receive usual care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
October 2013
October 2013   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact: William E Cunningham, MD, MPH 310.794.0314 wcunningham@mednet.ucla.edu
Contact: Danielle Seiden, MPP 310.463.7898 dseiden@mednet.ucla.edu
United States
 
NCT01457066
R34MH089719-01A1
Yes
William Cunningham, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: William E Cunningham, MD, MPH University of California, Los Angeles
University of California, Los Angeles
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP