Minority AIDS Initiative Retention and Re-Engagement Project

NCT ID: NCT01616940

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-03-31

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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Enhanced Peer Intervention

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

Group Type EXPERIMENTAL

Enhanced Peer Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Peer Re-Engagement Project (PREP)

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Care Resource

UNKNOWN

Sponsor Role collaborator

The Brooklyn Hospital Center

OTHER

Sponsor Role collaborator

Puerto Rico Community Network for Clinical Research on AIDS

OTHER

Sponsor Role collaborator

Justice Resource Institute

OTHER

Sponsor Role collaborator

Kansas City Free Health Clinic

UNKNOWN

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Fox, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Advancing Health Policy and Practice, Boston University School of Public Health

Serena Rajabiun, MA, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Advancing Health Policy and Practice, Boston University School of Public Health

Howard Cabral, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biostatistics, Boston University School of Public Health

Locations

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Care Resource

Miami, Florida, United States

Site Status

Center for Advancing Health Policy and Practice

Boston, Massachusetts, United States

Site Status

PATH Center, The Brooklyn Hospital

Brooklyn, New York, United States

Site Status

Puerto Rico Community Network for Clinical Research on AIDS

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 29306990 (View on PubMed)

Other Identifiers

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U69HA23262

Identifier Type: -

Identifier Source: org_study_id

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