An interventional study of Friendship Bench Delivered by Professional Counselor and Friendship Bench Delivered by Lay Counselor in HIV Infections, Behavioral Symptoms and Depression, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
Eligible individuals will meet the following criteria:
Exclusion Criteria:
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
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
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
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
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. Viral suppression is defined as \<20 copies of HIV-1 RNA per milliliter.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks after enrollment
Change in CMD Symptoms
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.
Time frame: Baseline, 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 on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder.
Time frame: 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. 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.
Time frame: 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 on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder.
Time frame: 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. 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.
Time frame: 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 on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder.
Time frame: 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. 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.
Time frame: 6 weeks after enrollment
Mean Proportion of Days With MMT Adherence
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.
Time frame: Study baseline through 6 months of follow-up
Study recruitment began in February 2022. Recruitment occurred in Methadone Maintenance Treatment (MMT) clinics located in Hanoi, Vietnam.
| Milestone | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Started | 26 | 25 | 26 |
| Completed | 25 | 24 | 23 |
| Not completed | 1 | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
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).
| Participants | Study Population |
|---|---|
| Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) | 75 |
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.
| Participants | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Study Retention (Study Feasibility) | 25 | 25 | 23 |
The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.
| percent of FB Sessions Attended | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Percent of FB Sessions Attended (Intervention Feasibility) | 100 | 100 | — |
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.
| Participants | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Number of Participants Satisfied With Friendship Bench (Intervention Acceptability) | 25 | 25 | — |
The total number of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.
| Number of sessions meeting fidelity | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity) | 66 | 42 | — |
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.
| Participants | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Number of Participants Achieving HIV Viral Suppression | 19 | 21 | 21 |
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.
| proportion of scheduled visits attended | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period | 0.95 | 0.94 | 0.92 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Total CMD Symptoms Score for Participants | 27.28 ± 26.4 | 23.9 ± 21.4 | 32.3 ± 22.7 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Change in CMD Symptoms | -24.2 ± 25.8 | -23.5 ± 30.2 | -13.4 ± 25.4 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Mean Depressive Disorder Score Among Participants | 8.2 ± 12.3 | 6.2 ± 7.4 | 9.0 ± 9.1 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Absolute Reduction in Depressive Symptoms | -8.2 ± 10.6 | -7.8 ± 10.5 | -5.4 ± 10.7 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Mean Anxiety Disorder Score Among Participants | 8.2 ± 8.3 | 8.3 ± 8.7 | 11.0 ± 7.9 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Absolute Reduction in Anxiety Symptoms | -6.4 ± 6.7 | -5.9 ± 10.6 | -3.9 ± 9.4 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Mean Stress Disorder Score Among Participants | 10.9 ± 9.8 | 9.4 ± 8.2 | 12.3 ± 7.8 |
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.
| score on a scale | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Absolute Reduction in Stress Symptoms | -9.5 ± 11.1 | -9.8 ± 11.9 | -4.1 ± 10.2 |
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.
| proportion of days | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Mean Proportion of Days With MMT Adherence | 0.99 ± 0.03 | 0.99 ± 0.01 | 0.96 ± 0.14 |
Collected over Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Friendship Bench Delivered by Professional Counselor | 0/26 (0%) | 1/26 (3.8%) | 2/26 (7.7%) |
| Friendship Bench Delivered by Lay Counselor | 1/25 (4%) | 0/25 (0%) | 1/25 (4%) |
| Enhanced Usual Care | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Event | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| PancreatitisHepatobiliary disorders | 1/26 | 0/25 | 0/26 |
| Event | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care |
|---|---|---|---|
| Suicidal Thoughts / IdeationsPsychiatric disorders | 2/26 | 1/25 | 0/26 |
Two of the randomized participants (1-Friendship Bench Delivered by Professional Counselor and 1-Enhanced Usual Care) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses.
| Age, Continuous(years) | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Mean | 44.1 ± 5.0 | 44.9 ± 7.2 | 44.9 ± 5.2 | 44.6 ± 5.8 |
| Sex: Female, Male(Participants) | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 1 | 2 |
| Male | 25 | 24 | 24 | 73 |
| Race and Ethnicity Not Collected(Participants) | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Vietnam | 25 | 25 | 25 | 75 |
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Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
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