Minority AIDS Initiative Retention and Re-Engagement Project

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Enhanced Peer Intervention

• Registration Number: NCT01616940
• Lead Sponsor: Boston University

Brief Summary

The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.

Detailed Description

This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.

Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.

Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• HIV-positive; AND
• Age 18 years or older; AND
• Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
• New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
• The individual has been out of medical care at your clinic for 4 months or more.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Peer Intervention	Enhanced Peer Intervention	Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.

Primary Outcome Measures

Name	Time	Method
Number of participants who are virally suppressed	1 year
Number of participants retained continuously in quality HIV care	1 year	"In HIV care" is defined as having a medical visit with a provider with prescribing privileges in an HIV care setting two or more times at least 3 months apart during the measurement year (HAB Performance Measure and National AIDS Strategy).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Health-related Quality of Life	1 year	Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.
Change from Baseline in HIV knowledge	1 year	HIV Knowledge will be measured using The HIV Treatment Knowledge Scale\*.; \*Balfour, L., MacPherson, P., Garber, G., Beique, L. \& Cameron, D. (2007). Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care, 19, 1141-1148.
Change from Baseline in Self-Efficacy	1 year	This will be measured using a scale that was developed and tested for the Chronic Disease Self-Management study\*.; \* Lorig, K., Stewart, A., Ritter, P., Gonzalez, V., Laurent, D. \& Lynch, J. (1996). Outcome Measures for Health Education and other Health Care Interventions. Thousand Oaks CA: Sage Publications, 24-25, 41-45.

Trial Locations

Locations (4)

Center for Advancing Health Policy and Practice; 🇺🇸 Boston, Massachusetts, United States

Care Resource; 🇺🇸 Miami, Florida, United States

PATH Center, The Brooklyn Hospital; 🇺🇸 Brooklyn, New York, United States

Puerto Rico Community Network for Clinical Research on AIDS; 🇵🇷 San Juan, Puerto Rico