NCT01616940

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

June 7, 2012

Last Update Submit

March 21, 2017

Conditions

Keywords

HIV/AIDSPeer support

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change from Baseline in Health-related Quality of Life

    1 year

  • Change from Baseline in Self-Efficacy

    1 year

  • Change from Baseline in HIV knowledge

    1 year

Study Arms (2)

Standard-of-care

NO INTERVENTION

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

Enhanced Peer Intervention

EXPERIMENTAL

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

Behavioral: Enhanced Peer Intervention

Interventions

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.

Also known as: Peer Re-Engagement Project (PREP)
Enhanced Peer Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Care Resource

Miami, Florida, 33137, United States

Location

Center for Advancing Health Policy and Practice

Boston, Massachusetts, 02118, United States

Location

PATH Center, The Brooklyn Hospital

Brooklyn, New York, 11226, United States

Location

Puerto Rico Community Network for Clinical Research on AIDS

San Juan, 00928-0850, Puerto Rico

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 12, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations