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Minority AIDS Initiative Retention and Re-Engagement Project

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Enhanced Peer Intervention
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring HIV/AIDS, Peer support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Care Resource
  • Center for Advancing Health Policy and Practice
  • PATH Center, The Brooklyn Hospital
  • Puerto Rico Community Network for Clinical Research on AIDS

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard-of-care

Enhanced Peer Intervention

Arm Description

Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services.

Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.

Outcomes

Primary Outcome Measures

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).
Number of participants who are virally suppressed

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 7, 2012
Last Updated
March 21, 2017
Sponsor
Boston University
Collaborators
Care Resource, The Brooklyn Hospital Center, Puerto Rico Community Network for Clinical Research on AIDS, Justice Resource Institute, Kansas City Free Health Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01616940
Brief Title
Minority AIDS Initiative Retention and Re-Engagement Project
Official Title
Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Care Resource, The Brooklyn Hospital Center, Puerto Rico Community Network for Clinical Research on AIDS, Justice Resource Institute, Kansas City Free Health Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Peer support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Description
Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services.
Arm Title
Enhanced Peer Intervention
Arm Type
Experimental
Arm Description
Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Peer Intervention
Other Intervention Name(s)
Peer Re-Engagement Project (PREP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants retained continuously in quality HIV care
Description
"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).
Time Frame
1 year
Title
Number of participants who are virally suppressed
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change from Baseline in Health-related Quality of Life
Description
Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.
Time Frame
1 year
Title
Change from Baseline in Self-Efficacy
Description
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.
Time Frame
1 year
Title
Change from Baseline in HIV knowledge
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Fox, MPH
Organizational Affiliation
Center for Advancing Health Policy and Practice, Boston University School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serena Rajabiun, MA, MPH
Organizational Affiliation
Center for Advancing Health Policy and Practice, Boston University School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard Cabral, MPH, PhD
Organizational Affiliation
Department of Biostatistics, Boston University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Care Resource
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Center for Advancing Health Policy and Practice
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
PATH Center, The Brooklyn Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11226
Country
United States
Facility Name
Puerto Rico Community Network for Clinical Research on AIDS
City
San Juan
ZIP/Postal Code
00928-0850
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
29306990
Citation
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.
Results Reference
derived

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Minority AIDS Initiative Retention and Re-Engagement Project

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