Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam

NCT04790201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-08-13

Study results available
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Summary

This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Conditions

  • HIV Infections
  • Behavioral Symptoms
  • Depression
  • Anxiety
  • Opioid-use Disorder
  • Virus Infection
  • Immune System Diseases
  • Opioid Dependence

Interventions

BEHAVIORAL

Friendship Bench Delivered by Professional Counselor

Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.

BEHAVIORAL

Friendship Bench Delivered by Lay Counselor

Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.

BEHAVIORAL

Enhanced Usual Care

Enhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm.

Sponsors & Collaborators

  • Hanoi Medical University

    collaborator OTHER
  • The Friendship Bench Trust

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Bradley Gaynes, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Vietnam

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790201 on ClinicalTrials.gov