Minority AIDS Initiative Retention and Re-Engagement Project

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Enhanced Peer Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard-of-care<br>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<br>Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care. | Behavioral: Enhanced Peer Intervention<br>* 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.<br>* Other names: Peer Re-Engagement Project (PREP);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Peer support