Clinical trial NCT04790201: Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Behavioral Symptoms
Depression
Anxiety
Opioid-use Disorder
Virus Infection
Immune System Diseases
Opioid Dependence
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Hanoi Medical University
name: The Friendship Bench Trust
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm individually randomized trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility)
timeFrame: Baseline
measure: Study Retention (Study Feasibility)
timeFrame: Through study completion, an average of 12 months
measure: Percent of FB Sessions Attended (Intervention Feasibility)
timeFrame: 6 weeks
measure: Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)
timeFrame: 6 weeks
measure: Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants Achieving HIV Viral Suppression
timeFrame: 6 months after enrollment
measure: Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period
timeFrame: Study baseline through 12 months of follow-up
measure: Total CMD Symptoms Score for Participants
timeFrame: 6 weeks after enrollment
measure: Change in CMD Symptoms
timeFrame: Baseline, 6 weeks after enrollment
measure: Mean Depressive Disorder Score Among Participants
timeFrame: 6 weeks after enrollment
measure: Absolute Reduction in Depressive Symptoms
timeFrame: 6 weeks after enrollment
measure: Mean Anxiety Disorder Score Among Participants
timeFrame: 6 weeks after enrollment
measure: Absolute Reduction in Anxiety Symptoms
timeFrame: 6 weeks after enrollment
measure: Mean Stress Disorder Score Among Participants
timeFrame: 6 weeks after enrollment
measure: Absolute Reduction in Stress Symptoms
timeFrame: 6 weeks after enrollment
measure: Mean Proportion of Days With MMT Adherence
timeFrame: Study baseline through 6 months of follow-up
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: CDC Hanoi
state: Hanoi City
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Bradley Gaynes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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