Minority AIDS Initiative Retention and Re-Engagement Project

Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Enhanced Peer Intervention

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 Type: Interventional
• Enrollment (Actual): 348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00928-0850
    • Puerto Rico Community Network for Clinical Research on AIDS
• United States
  • Florida
    • Miami, Florida, United States, 33137
      • Care Resource
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Center for Advancing Health Policy and Practice
  • New York
    • Brooklyn, New York, United States, 11226
      • PATH Center, The Brooklyn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard-of-care; Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services.
Experimental: Enhanced Peer Intervention; Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.	Behavioral: Enhanced Peer Intervention; Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention: Introduction and Assessment; HIV Transmission & Viral Life Cycle; Effective Communication and Self-Advocacy; Understanding Lab Values; HIV Medications; Drug Resistance & Adherence, and Understanding & Managing Side Effects; Disclosure and Stigma; Harm & Risk Reduction Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks: Are any services needed?; Have referrals or appointments been made?; Does patient need accompaniment to a visit?; Connect patient with services as needed.; Appointment reminders.; Overall well-being?; Schedule next peer contact.; Other Names: Peer Re-Engagement Project (PREP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants retained continuously in quality HIV care	"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).	1 year
Number of participants who are virally suppressed		1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Health-related Quality of Life	Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.	1 year
Change from Baseline in Self-Efficacy	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.	1 year
Change from Baseline in HIV knowledge	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.	1 year

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: The Brooklyn Hospital Center; Justice Resource Institute; Puerto Rico Community Network for Clinical Research on AIDS; Care Resource; Kansas City Free Health Clinic
• Investigators: Principal Investigator: Jane Fox, MPH, Center for Advancing Health Policy and Practice, Boston University School of Public Health; Principal Investigator: Serena Rajabiun, MA, MPH, Center for Advancing Health Policy and Practice, Boston University School of Public Health; Principal Investigator: Howard Cabral, MPH, PhD, Department of Biostatistics, Boston University School of Public Health

Publications and helpful links

General Publications

• Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. AIDS Behav. 2018 Aug;22(8):2627-2639. doi: 10.1007/s10461-017-1999-8.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: HIV/AIDS; Peer support
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: U69HA23262