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Completed

NCT Number: NCT04790201

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

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.

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Key information

Conditions

HIV Infections Anxiety Anxiety Disorders Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Depression Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Narcotic-Related Disorders Opioid Dependence Opioid-Related Disorders Opioid-use Disorder RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CDC Hanoi

Hanoi, Hanoi City, Vietnam

About this study

Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia.

To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes.

The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective.

The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with 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 adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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 Lay Counselor

Behavioral

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

Primary outcomes

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

    Time frame: Baseline

    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).

  2. Study Retention (Study Feasibility)

    Time frame: Through study completion, an average of 12 months

    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.

  3. Percent of FB Sessions Attended (Intervention Feasibility)

    Time frame: 6 weeks

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

  4. Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)

    Time frame: 6 weeks

    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.

  5. Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)

    Time frame: 6 weeks

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

Secondary outcomes

  1. Number of Participants Achieving HIV Viral Suppression

    Time frame: 6 months after enrollment

    HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window. Viral suppression is defined as <20 copies of HIV-1 RNA per milliliter.

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

    Time frame: Study baseline through 12 months of follow-up

    The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the "kept visit proportion"), with no-show defined as no appointment kept in the 30 days following a scheduled appointment. HIV appointment data will be abstracted from clinic records at the end of the study period.

  3. Total CMD Symptoms Score for Participants

    Time frame: 6 weeks after enrollment

    CMD symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. The total scale is calculated by summing the subscales, range 0-126, for depression (threshold ≥14), anxiety (threshold ≥10), and stress (threshold ≥19); higher scores indicate higher severity of symptoms.

  4. Change in CMD Symptoms

    Time frame: Baseline, 6 weeks after enrollment

    The change in CMD symptoms from baseline to 6 weeks in the DASS-21 total score is calculated as Baseline DASS-21 total score minus the Week 6 DASS-21 total score. CMD symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. The total scale is calculated by summing the subscales, range 0-126, for depression (threshold ≥14), anxiety (threshold ≥10), and stress (threshold ≥19); higher scores indicate higher severity of symptoms.

  5. Mean Depressive Disorder Score Among Participants

    Time frame: 6 weeks after enrollment

    Depression symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder.

  6. Absolute Reduction in Depressive Symptoms

    Time frame: 6 weeks after enrollment

    The absolute reduction of depressive symptoms from baseline to 6 weeks will be evaluated via the DASS-21 depression subscale. Depression symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder.

  7. Mean Anxiety Disorder Score Among Participants

    Time frame: 6 weeks after enrollment

    Anxiety symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder.

  8. Absolute Reduction in Anxiety Symptoms

    Time frame: 6 weeks after enrollment

    The absolute reduction of anxiety symptoms from baseline to 6 weeks will be evaluated via the DASS-21 anxiety subscale. Anxiety symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder.

  9. Mean Stress Disorder Score Among Participants

    Time frame: 6 weeks after enrollment

    Stress symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder.

  10. Absolute Reduction in Stress Symptoms

    Time frame: 6 weeks after enrollment

    The absolute reduction of stress symptoms from baseline to 6 weeks will be evaluated via the DASS-21 stress scale. Stress symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder.

  11. Mean Proportion of Days With MMT Adherence

    Time frame: Study baseline through 6 months of follow-up

    Out of the first 183 days of study participation, the total number of days a participant attended their MMT visit appointment divided by 183 days.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Hanoi Medical University
  • National Institute on Drug Abuse (NIDA)
  • The Friendship Bench Trust

Registry information

Official study title

Adaptation of the Friendship Bench Counseling Intervention to Improve Mental Health and HIV Care Engagement Outcomes Among People Living With HIV Who Inject Drugs in Vietnam

Acronym: VITAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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