Trial Outcomes & Findings for Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam (NCT NCT04790201)

NCT ID: NCT04790201

Last Updated: 2024-08-13

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-08-13

Participant Flow

Study recruitment began in February 2022. Recruitment occurred in Methadone Maintenance Treatment (MMT) clinics located in Hanoi, Vietnam.

Two of the randomized participants (1 in Friendship Bench delivered by Professional Counselor arm and 1 in Usual Care arm) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses.

Participant milestones

Measure	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 professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.	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. 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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 common mental disorder (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. Enhanced Usual Care: 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.
Overall Study STARTED	26	25	26
Overall Study COMPLETED	25	24	23
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Measure	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 professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.	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. 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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 common mental disorder (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. Enhanced Usual Care: 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.
Overall Study Lost to Follow-up	0	0	2
Overall Study Death	0	1	0
Overall Study Protocol Violation	1	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Friendship Bench Delivered by Professional Counselor n=25 Participants 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=25 Participants 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. Enhanced Usual Care: 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 n=75 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 5.0 • n=25 Participants	44.9 years STANDARD_DEVIATION 7.2 • n=25 Participants	44.9 years STANDARD_DEVIATION 5.2 • n=25 Participants	44.6 years STANDARD_DEVIATION 5.8 • n=75 Participants
Sex: Female, Male Female	0 Participants n=25 Participants	1 Participants n=25 Participants	1 Participants n=25 Participants	2 Participants n=75 Participants
Sex: Female, Male Male	25 Participants n=25 Participants	24 Participants n=25 Participants	24 Participants n=25 Participants	73 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Vietnam	25 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	75 Participants n=75 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The analysis population includes the total number of people approached for study eligibility and screening. 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.

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).

Outcome measures

Measure	Study Population n=287 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	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. 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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. Enhanced Usual Care: 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)	75 Participants	—	—

PRIMARY outcome

Timeframe: Through study completion, an average of 12 months

Population: The analysis population includes the total number of eligible study participants (n=75) enrolled. 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.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=25 Participants 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. Enhanced Usual Care: 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.
Study Retention (Study Feasibility)	25 Participants	25 Participants	23 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The analysis population includes the total number of planned intervention sessions across the two arms (FB delivered by professional counselor and FB delivered by lay counselor). Each arm had 25 participants with 6 planned, weekly sessions per participant for a total of (25\*6)150 sessions per arm. The enhanced usual care arm (n=25) did not receive an intervention and are not included in the analysis population.

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

Outcome measures

Measure	Study Population n=150 Intervention Sessions The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=150 Intervention Sessions 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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. Enhanced Usual Care: 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.
Percent of FB Sessions Attended (Intervention Feasibility)	100 percent of FB Sessions Attended	100 percent of FB Sessions Attended	—

PRIMARY outcome

Timeframe: 6 weeks

Population: The analysis population includes all participants who received the intervention \[FB delivered by professional counselor (n=25) and FB delivered by lay counselor(n=25)\] for a total of 50 analyzed participants. Participants who received enhanced usual care (n=25) are not included in the analysis population as they did not receive the intervention.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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. Enhanced Usual Care: 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.
Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)	25 Participants	25 Participants	—

PRIMARY outcome

Timeframe: 6 weeks

Population: The analysis population includes the total number of intervention sessions across the two arms (FB delivered by professional counselor and FB delivered by lay counselor) assessed for fidelity. Each FB counselor had \>=3 randomly-chosen sessions reviewed for fidelity. The FB delivered by professional counselors had n=92 sessions and the FB delivered by lay counselors has n=95 sessions. The enhanced usual care arm did not receive an intervention and are not included in the analysis population.

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

Outcome measures

Measure	Study Population n=92 Intervention Sessions The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=95 Intervention Sessions 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care 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. Enhanced Usual Care: 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.
Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)	66 Number of sessions meeting fidelity	42 Number of sessions meeting fidelity	—

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-month follow-up visit and provided a sample for viral load testing. Note not all participants were able to provide a blood sample for viral load testing. The professional counselor FB arm had n=25 participants, the lay counselor FB arm had n= 24 participants, and the enhanced usual care arm had (n=23) participants.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=24 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=23 Participants 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. Enhanced Usual Care: 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.
Number of Participants Achieving HIV Viral Suppression	19 Participants	21 Participants	21 Participants

SECONDARY outcome

Timeframe: Study baseline through 12 months of follow-up

Population: This analysis population includes the total number of scheduled HIV visits. The n = 25 participants in the Friendship Bench (FB) delivered by professional counselor arm contributed n= 201 HIV visits. The n = 25 participants in the FB delivered by lay counselor arm contributed n = 170 HIV appointments. The n=25 participants in the enhanced usual care arm contributed n = 179 HIV visits. The number of visits represents the total possible number of visits (regardless of attendance) in each arm.

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.

Outcome measures

Measure	Study Population n=201 scheduled HIV visits The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=170 scheduled HIV visits 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=179 scheduled HIV visits 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. Enhanced Usual Care: 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.
Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period	0.95 proportion of scheduled visits attended	0.94 proportion of scheduled visits attended	0.92 proportion of scheduled visits attended

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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 CMD Symptoms Score for Participants	27.28 score on a scale Standard Deviation 26.4	23.9 score on a scale Standard Deviation 21.4	32.3 score on a scale Standard Deviation 22.7

SECONDARY outcome

Timeframe: Baseline, 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who completed the 6 week followup visit. The professional counselor FB arm had n=25 participants, the lay counselor FB arm had n= 25 participants, and the enhanced usual care arm had n=24 participants.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Change in CMD Symptoms	-24.2 score on a scale Standard Deviation 25.8	-23.5 score on a scale Standard Deviation 30.2	-13.4 score on a scale Standard Deviation 25.4

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Mean Depressive Disorder Score Among Participants	8.2 score on a scale Standard Deviation 12.3	6.2 score on a scale Standard Deviation 7.4	9.0 score on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Absolute Reduction in Depressive Symptoms	-8.2 score on a scale Standard Deviation 10.6	-7.8 score on a scale Standard Deviation 10.5	-5.4 score on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Mean Anxiety Disorder Score Among Participants	8.2 score on a scale Standard Deviation 8.3	8.3 score on a scale Standard Deviation 8.7	11.0 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Absolute Reduction in Anxiety Symptoms	-6.4 score on a scale Standard Deviation 6.7	-5.9 score on a scale Standard Deviation 10.6	-3.9 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Mean Stress Disorder Score Among Participants	10.9 score on a scale Standard Deviation 9.8	9.4 score on a scale Standard Deviation 8.2	12.3 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 6 weeks after enrollment

Population: The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit.

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.

Outcome measures

Measure	Study Population n=25 Participants The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=25 Participants 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=24 Participants 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. Enhanced Usual Care: 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.
Absolute Reduction in Stress Symptoms	-9.5 score on a scale Standard Deviation 11.1	-9.8 score on a scale Standard Deviation 11.9	-4.1 score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Study baseline through 6 months of follow-up

Population: The analysis population includes the number of participant MMT visits for all participants who had complete MMT adherence data from baseline to 6 months (183 days in total). All participants (n=25) in each intervention arm had complete data for a total of 4575 (25\*183) visits, while n=23 participants in the usual care arm had complete data for a total of 4209 (23\*183) visits. Note: data was collected at the participant level.

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.

Outcome measures

Measure	Study Population n=4575 MMT visits The study population includes the total number of study participants enrolled (regardless of assigned study arm).	Friendship Bench Delivered by Lay Counselor n=4575 MMT visits 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=4209 MMT visits 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. Enhanced Usual Care: 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.
Mean Proportion of Days With MMT Adherence	0.99 proportion of days Standard Deviation 0.03	0.99 proportion of days Standard Deviation 0.01	0.96 proportion of days Standard Deviation 0.14

Adverse Events

Friendship Bench Delivered by Professional Counselor

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Friendship Bench Delivered by Lay Counselor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Enhanced Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Friendship Bench Delivered by Professional Counselor n=26 participants at risk 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.	Friendship Bench Delivered by Lay Counselor n=25 participants at risk 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=26 participants at risk 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. Enhanced Usual Care: 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.
Hepatobiliary disorders Pancreatitis	3.8% 1/26 • Number of events 1 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.	0.00% 0/25 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.	0.00% 0/26 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.

Other adverse events

Measure	Friendship Bench Delivered by Professional Counselor n=26 participants at risk 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.	Friendship Bench Delivered by Lay Counselor n=25 participants at risk 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.	Enhanced Usual Care n=26 participants at risk 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. Enhanced Usual Care: 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.
Psychiatric disorders Suicidal Thoughts / Ideations	7.7% 2/26 • Number of events 2 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.	0.00% 0/26 • Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.

Additional Information

Bradley Gaynes, MD, MPH

University of North Carolina at Chapel Hill

Phone: (919) 445-0214

Email: bradley_gaynes@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place