Minority AIDS Initiative Retention and Re-Engagement Project

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616940
• Other study ID #: U69HA23262
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: March 21, 2017
• Start date: September 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Community Network for Clinical Research on AIDS	San Juan
United States	Center for Advancing Health Policy and Practice	Boston	Massachusetts
United States	PATH Center, The Brooklyn Hospital	Brooklyn	New York
United States	Care Resource	Miami	Florida

Sponsors (6)

Lead Sponsor	Collaborator
Boston University	Care Resource, Justice Resource Institute, Kansas City Free Health Clinic, Puerto Rico Community Network for Clinical Research on AIDS, The Brooklyn Hospital Center

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants who are virally suppressed		1 year
Secondary	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
Secondary	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
Secondary	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