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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Friendship Bench Delivered by Professional Counselor
* Behavioral: Friendship Bench Delivered by Lay Counselor
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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 DASS-21 which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD (Henry & Crawford 2005; Le et al. 2017; Tran et al. 2013). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm individually randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Friendship Bench Delivered by Professional Counselor<br>25 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<br>* Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.<br>|
| Experimental: Friendship Bench Delivered by Lay Counselor<br>25 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<br>* Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.<br>|
| Active Comparator: Enhanced Usual Care<br>25 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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate (Intervention Feasibility) | This measure of feasibility will be measured as the ability to successfully enroll PLWH and 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 | 
| Number of FB sessions Attended (Intervention Feasibility) | The number of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks. | 6 weeks | 
| Overall Satisfaction with the FB among Participants (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 on 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving HIV Viral Suppression | 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. | 6 months after enrollment | 
| Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up period | 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. | Study baseline through 12 months of follow-up. | 
| Total CMD symptoms score for participants | 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. | 6 weeks after enrollment | 
| Absolute reduction in CMD symptoms | The absolute reduction in CMD symptoms from baseline to 6 weeks in the DASS-21 total score. | 6 weeks after enrollment | 
| Mean depressive disorder score among participants | 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 ≥ 14 on the depression subscale indicate a depressive disorder. | 6 weeks after enrollment | 
| Absolute reduction in depressive symptoms | The absolute reduction of depressive symptoms from baseline to 6 weeks will be evaluated via the DASS-21 depression subscale. | 6 weeks after enrollment | 
| Mean anxiety disorder score among participants | 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 ≥ 10 on the anxiety subscale indicate an anxiety disorder | 6 weeks after enrollment | 
| Absolute reduction in anxiety symptoms. | The absolute reduction of anxiety symptoms from baseline to 6 weeks will be evaluated via the DASS-21 anxiety subscale. | 6 weeks after enrollment | 
| Mean stress disorder score among participants | 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 ≥ 19 on the stress subscale indicate a stress disorder. | 6 weeks after enrollment | 
| Absolute reduction in stress symptoms. | The absolute reduction of stress symptoms from baseline to 6 weeks will be evaluated via the DASS-21 stress scale. | 6 weeks after enrollment | 
| Proportion of days with MMT adherence: | Out of the first 365 days of study participation, the total number of days a participant took their MMT dose divided by 365 days. | Study baseline through 12 months of follow-up. |