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

NCT04790201 | Completed Results

• 3 other identifiers: 20-1689R34DA051933IGHID 12028
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility)

  This measure of feasibility will be measured as the ability to successfully enroll people living with HIV (PLWH) and opioid use disorder (OUD) with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

  Baseline

• Study Retention (Study Feasibility)

  This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.

  Through study completion, an average of 12 months

• Percent of FB Sessions Attended (Intervention Feasibility)

  The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.

  6 weeks

• Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)

  The number of patients who were either very satisfied or somewhat satisfied with the FB among all participants who received the FB. Satisfaction will be measured using a single question with a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.

  6 weeks

• Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)

  The total number of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.

  6 weeks

Secondary Outcomes (11)

• Number of Participants Achieving HIV Viral Suppression

  6 months after enrollment

• Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period

  Study baseline through 12 months of follow-up

• Total CMD Symptoms Score for Participants

  6 weeks after enrollment

• Change in CMD Symptoms

  Baseline, 6 weeks after enrollment

• Mean Depressive Disorder Score Among Participants

  6 weeks after enrollment

Study Arms (3)

Friendship Bench Delivered by Professional Counselor

EXPERIMENTAL

Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1).

Behavioral: Friendship Bench Delivered by Professional Counselor

Friendship Bench Delivered by Lay Counselor

EXPERIMENTAL

Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a trained lay counselor. Individuals enrolled in this arm arm will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1).

Behavioral: Friendship Bench Delivered by Lay Counselor

Enhanced Usual Care

ACTIVE COMPARATOR

Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Enhanced usual care 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.

Behavioral: Enhanced Usual Care

Interventions

Friendship Bench Delivered by Professional Counselor BEHAVIORAL

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

Friendship Bench Delivered by Professional Counselor

Friendship Bench Delivered by Lay Counselor BEHAVIORAL

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

Friendship Bench Delivered by Lay Counselor

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible individuals will meet the following criteria:
• Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
• Medical record indicates infection with HIV
• Have been screened with the Depression Anxiety Stress Scale-21 (DASS-21) which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD. The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.

You may not qualify if:

• Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Hanoi Medical University: collaborator
• The Friendship Bench Trust: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CDC Hanoi

Hanoi, Hanoi City, Vietnam

Location

Related Publications (21)

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• Bouhnik AD, Preau M, Vincent E, Carrieri MP, Gallais H, Lepeu G, Gastaut JA, Moatti JP, Spire B; MANIF 2000 Study Group. Depression and clinical progression in HIV-infected drug users treated with highly active antiretroviral therapy. Antivir Ther. 2005;10(1):53-61.

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• Jones DL, Waldrop-Valverde D, Gonzalez P, Mack A, Kumar AM, Ownby R, Weiss SM, Kumar M. Mental health in HIV seronegative and seropositive IDUs in South Florida. AIDS Care. 2010 Feb;22(2):152-8. doi: 10.1080/09540120903039851.

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• WHO Secretariat. HIV/AIDS and mental health. World Health Institution; 2008.

  BACKGROUND

• Gaynes BN, Tran HV, Nong HTT, Filipowicz TR, Landrum KR, Tran TTT, Nguyen VQ, Verhey R, Nguyen HN, Giang LM, Pence BW. An Adapted Friendship Bench Counseling Intervention (FB) to Improve Mental Health and HIV Care Engagement Outcomes Among People Living with HIV (PWH) Who Inject Drugs in Hanoi, Vietnam: Results from the VITAL Pilot Randomized Controlled Trial. AIDS Behav. 2025 Jun;29(6):1761-1774. doi: 10.1007/s10461-025-04645-7. Epub 2025 Feb 2.

  PMID: 39894853 DERIVED

• Tran HV, Filipowicz TR, Landrum KR, Nong HTT, Tran TTT, Pence BW, Go VF, Le GM, Nguyen MX, Verhey R, Chibanda D, Ho HT, Gaynes BN. Stigma experienced by people living with HIV who are on methadone maintenance treatment and have symptoms of common mental disorders in Hanoi, Vietnam: a qualitative study. AIDS Res Ther. 2022 Dec 14;19(1):63. doi: 10.1186/s12981-022-00491-y.

  PMID: 36517849 DERIVED

• Tran HV, Nong HTT, Tran TTT, Filipowicz TR, Landrum KR, Pence BW, Le GM, Nguyen MX, Chibanda D, Verhey R, Go VF, Ho HT, Gaynes BN. Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study. JMIR Form Res. 2022 Jul 8;6(7):e37211. doi: 10.2196/37211.

  PMID: 35802402 DERIVED

MeSH Terms

Conditions

HIV Infections; Behavioral Symptoms; Depression; Anxiety Disorders; Opioid-Related Disorders; Virus Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Behavior; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Bradley Gaynes, MD, MPH
• Organization: University of North Carolina at Chapel Hill

bradley_gaynes@med.unc.edu

(919) 445-0214

Study Officials

• Bradley Gaynes, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm individually randomized trial

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 10, 2021
• Study Start: February 28, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

VN (1)