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
Phase: NA
Conditions: HIV Infections, Behavioral Symptoms, Depression, Anxiety, Opioid-use Disorder, Virus Infection, Immune System Diseases, Opioid Dependence
Sponsor: University of North Carolina, Chapel Hill

 
 
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 
 
 
NCT number NCT04790201 
Document Date 10/01/2023 
 

 
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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 
Sponsored by:  
National Institute of Drug Abuse (NIDA) at the National Institutes of Health (NIH) 
R34 DA 051933 
 
 
 
Protocol Chair: Bradley N. Gaynes 
 
 
 
 
 
 
 
 
Version 3.0  
October 1, 2023 
 
 

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ABSTRACT 
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 opiate use disorder (OUD), have low rates of HIV testing, 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 and are strongly associated with negative outcomes for HIV patients, 
including worsening course of HIV, more rapid progression to AIDS, increased ART non-adherence, and 
increased mortality rates. 
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 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 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. 
Our objective in this proposal is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in 
Hanoi. Our 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 our adapted FB protocol in 
improving HIV, mental health, and drug use treatment outcomes for this vulnerable population. 
 
 
 
 
 
 
 

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TABLE OF CONTENTS  
ABSTRACT ................................................................................................................................... 2 
TABLE OF CONTENTS ................................................................................................................ 3 
HISTORY OF PROTOCOL CHANGES ........................................................................................ 4 
PROTOCOL TEAM ROSTER ....................................................................................................... 5 
GLOSSARY OF TERMS/ACRONYMS ......................................................................................... 6 
1.0 INTRODUCTION .................................................................................................................... 7 
1.1 Background and Literature Review ................................................................................. 7 
1.2 Study Rationale ............................................................................................................... 8 
2.0 STUDY OBJECTIVES ............................................................................................................ 9 
2.1 Hypotheses ...................................................................................................................... 9 
2.2 Study Objectives .............................................................................................................. 9 
3.0 METHODOLOGY .................................................................................................................... 9 
3.1 Study Sites .................................................................................................................... 13 
3.2 Population ...................................................................................................................... 13 
3.3 Duration ......................................................................................................................... 14 
3.4 Sample Size .................................................................................................................. 14 
3.5 Data Sources ................................................................................................................. 15 
3.5.1 Record Availability ...................................................................................................... 15 
4.0 ANALYSIS ............................................................................................................................ 15 
5.0 ETHICAL CONCERNS ......................................................................................................... 16 
5.1 Human Subjects ............................................................................................................ 16 
5.1.1 Institutional Review Board .......................................................................................... 16 
5.1.2 Confidentiality, Risks, and Risk Minimization ............................................................. 16 
5.1.3 Benefits to Participants ............................................................................................... 18 
5.1.4 Costs and Compensation ........................................................................................... 18 
5.1.5 Informed Consent ....................................................................................................... 18 
5.2 Adverse Event Reporting ............................................................................................... 18 
5.3 Study Discontinuation .................................................................................................... 19 
6.0 PUBLICATION AND DISSEMINATION OF RESEARCH FINDINGS ................................... 19 
7.0 WORKPLAN ......................................................................................................................... 19 
7.1 Project Management ..................................................................................................... 20 
8.0 REFERENCES ..................................................................................................................... 21 
 

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HISTORY OF PROTOCOL CHANGES 
Version 1.0, 21 May 2020 
• 
None to date. 
Version 2.0, 23 September 2020 
• 
Addition of formative phase in-depth interviews and focus groups to Section 3, Aim 1. 
 
Version 3.0, 1 October 2023 
• 
Updated outcome measures.  
 
 
 

 
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5
PROTOCOL TEAM ROSTER 
UNC Principal Investigator 
Bradley Gaynes, MD, MPH 
UNC School of Medicine 
Department of Psychiatry 
CH# 7160, 130 Mason Farm Rd 
Chapel Hill, NC 27599 USA 
Phone: 919-445-0214 
Fax: 919-445-0234 
Email:  bradley_gaynes@med.unc.edu 
 
Co-Investigators 
Brian Pence, PhD, MPH 
UNC School of Public Health 
Department of Epidemiology  
CB# 7435, 2102-E McGavran-Greenberg 
Chapel Hill, NC 27599-7435, USA 
Phone: 1-919-966-7446 
Fax:     1-919-966-2089 
Email: bpence@unc.edu 
 
Vivian Go, PhD 
UNC School of Public Health 
Department of Health Behavior  
CB# 7440, 361 Rosenau Hall  
Chapel Hill, NC 27599-7440, USA 
Phone: 1-919-966-3908 
Fax:     1-919-966-2921 
Email: vgo@email.unc.edu 
 
Dr. Le Minh Giang 
Hanoi Medical University 
1 Ton That Tung Street 
Room 605, Building A1 
Hanoi, Vietnam 
Phone: 84435746825 
Fax: n/a    
Email: leminhgiang@hmu.edu.vn 
 
Dr. Viet Tran Ha 
UNC School of Public Health 
Department of Health Behavior 
Yen Hoa Health Clinic, Lot E2, Duong Dinh 
Nghe Street 
Yen Hoa Ward, Cau Giay District 
Hanoi, Vietnam 
Phone: 84912785886 
Fax: n/a 
Email: vietha@live.unc.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dr. Dixon Chibanda 
The Friendship Bench Trust 
4 Weale Road, Milton Park 
Harare, Zimbabwe 
Phone: n/a 
Fax: n/a 
Email: dichi@zol.co.zw; 
dixon.chibanda@friendshipbench.io 
 
 
Dr. Ruth Verhey  
The Friendship Bench Trust 
4 Weale Road, Milton Park 
Harare, Zimbabwe 
Phone: n/a 
Fax: n/a 
Email: ruth.verhey@friendshipbench.io 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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6
GLOSSARY OF TERMS/ACRONYMS 
AIDS  
Acquired Immunodeficiency Syndrome 
ART 
 
Antiretroviral Therapy 
CDC 
 
Center for Disease Control 
CMD   
Common Mental Disorder 
DASS-21 
Depression, Anxiety, and Stress Scale -21 
EUC   
Enhanced Usual Care 
FB  
 
Friendship Bench 
GEE 
 
generalized estimating equation  
HIV 
 
Human Immunodeficiency Virus 
IRB 
 
Institutional Review Board 
LMIC   
Low- and Middle-Income Country 
MINI 
 
Mini International Neuropsychiatric Interview 
MMT  
Methadone Maintenance Therapy 
MOH  
Ministry of Health 
NIDA  
National Institute of Drug Abuse 
NIH  
 
National Institutes of Health 
OHRP  
Office for Human Research Protections  
OUD   
Opiate Use Disorder 
PI 
 
Principal Investigator 
PLWH   
People Living with HIV 
PST 
 
Problem-solving Therapy 
PWID  
People Who Inject Drugs 
RCT 
 
Randomized Clinical Trial 
SAE 
 
Serious Adverse Event 
UNC 
 
University of North Carolina 

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1.0 INTRODUCTION 
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 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 our adapted FB protocol in improving HIV, mental health, and 
drug use treatment outcomes for this vulnerable population.    
1.1 Background and Literature Review 
Injection drug use is the primary driver of the HIV epidemic in Southeast Asia.1 Parenteral 
exposure to infected blood is one of the most efficient means of HIV transmission,2-4 which 
has resulted in rapid and uncontrolled HIV epidemics among PWID.5 In Southeast Asia, as 
in many other LMICs, HIV prevalence among people who inject drugs (PWID) is several 
times higher than HIV prevalence in the general population and involves users from all 
genders.5 In 2017, the HIV prevalence among PWID in Southeast and Central Asia was 
15% and 11%, respectively.6 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,7-10 
reflecting the marginalized and stigmatized nature of this group.11 PWID also experience 
high rates of HIV-related and all-cause mortality at all stages of the HIV care continuum.12-14 
Policy makers have identified the urgent need to increase the reach and effectiveness of 
HIV treatment programs in this population.5,11,15   
 
 
Common mental disorder (CMDs), a collective term referring to depressive, anxiety, and 
stress-related disorders,16 are highly prevalent among PLWH and OUD.17-21 Depression is 
the most common psychiatric comorbidity – and one of the most common comorbidities 
overall – among adults living with HIV worldwide.22,23 Depression affects an estimated 20-
40% of people living with HIV.22,24-29  Anxiety or traumatic stress disorders are also common, 
occurring in 10-20% of HIV-infected individuals,30 and are often comorbid with MDD in this 
population.18,27,28,31,32 Compared to the general population of people living with HIV, PWID 
living with HIV are even more prone to CMDs due to economic hardship, incarceration, and 
HIV and drug related stigmatization and discrimination.33,34 One study reported that the 
prevalence of moderate to severe depressive and anxious symptoms among PWID living 
with HIV was 69%35 with up to 63% meeting diagnostic criteria for a depressive disorder.19-21  
 
Despite serious consequences of mental illness on health and HIV progression, mental 
illness remains under-diagnosed and under-treated in HIV populations, especially in LMIC 
countries, such as many countries in Southeast Asia.36 In LMICs, between 76% and 85% of 
people with mental disorders receive no treatment for their disorder,37 with an even greater 
risk for under treatment for those with HIV and coexisting substance use.36 Collectively, the 
cluster of diagnoses – HIV, common mental disorders, and substance abuse disorders – 
has emerged as a distinct clinical condition wherein patients experience a complex set of 
medical, psychological and social complications that need to be tackled through integrated 
care.38 Treatment for mental health conditions is a critical step in improving the emotional 
and physical well-being of HIV-infected PWID.39,40 While appropriate management tools are 
increasingly available,18,41-45 healthcare services for CMDs remain scarce in LMICs.46,47 

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Feasible and effective task-shifting mental health interventions are key to addressing this 
need. To respond to the high burden of mental disorders globally and the vast unmet need 
for mental health treatment in low and middle income countries,48 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.49  Such 
approaches will be critical to respond to the large unmet need for mental health treatment 
among PLWH/OUD. However, such task-shifting interventions to address CMDs among 
PLWH and OUD have received limited testing in Southeast Asia. 
1.2 Study Rationale 
Vietnam is an ideal setting to evaluate the potential of task-shifting mental health 
approaches to address CMDs and improve HIV care outcomes among PLWH and OUD. 
First, as with other countries in Southeast Asia, the HIV epidemic in Vietnam is heavily 
concentrated among those with OUD (primarily heroin). Vietnam has been identified as one 
of six countries accounting for half of the global population of PWID, with the prevalence of 
HIV among this group ranging from 15-30%.15,50,51 Second, the Vietnam Ministry of Health 
(MOH) has dramatically expanded methadone maintenance therapy (MMT) clinics for those 
with OUD as well as integrated MMT/ART care for PLWH with OUD; this integrated care 
model, providing HIV treatment in the MMT clinics where most individuals with OUD receive 
care, provides an ideal platform to additionally address CMDs. Third, the Vietnam MOH has 
prioritized development of CMD care for PLWH and OUD.52 Nevertheless, substantial 
barriers to care exist. Key challenges to mental health treatment in the general population in 
Vietnam include the lack of mental health legislation and of personnel and psychiatric 
facilities, and few mental health treatment resources are currently available to this highly 
stigmatized population.53,54  
 
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 addressing CMDs among primary care patients when delivered by lay 
counselors.55 FB is designed to respond to CMDs generally rather than one psychiatric 
diagnosis specifically, and to meet the needs of low-resource settings with few mental health 
specialists.  
 
Lay counselors may prove effective in delivering FB to PLWH with OUD; indeed, in other 
work we have demonstrated the effectiveness of peer counselors in improving ART 
adherence in this population.56 That said, CMDs may prove more difficult to treat in a 
population with OUD than among primary care patients,39,57 requiring the higher skill level of 
professional counselors for FB to be effective with this key population. A number of health 
care professionals in Vietnam have training in counseling, and the MOH could invest in 
expanding this cadre if evidence suggests that the higher level of training is critical. 
However, if lay counselors are equally effective then their deployment would be less 
expensive.   
 
Our objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics 
where we have worked successfully in the past. We will compare FB delivered by 
professional counselors and FB delivered by lay counselors vs. enhanced usual care to 
improve CMDs and HIV care outcomes among PLWH and OUD in Vietnam. This work will 

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generate critical data to inform a fully powered R01 trial. We hypothesize that adapted FB 
will be acceptable to patients and providers, prove feasible to integrate into MMT clinics, be 
delivered with fidelity, and demonstrate preliminary indications of impact with both counselor 
groups. 
2.0 HYPOTHESES AND STUDY OBJECTIVES 
2.1 Hypotheses 
There are not specific hypotheses for this pilot study. Our objective in this proposal is to 
complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi.  
We will adapt the evidence-based FB intervention for the specific needs of adult PLWH and 
OUD in Vietnam (Aim 1).  
We will then pilot the adapted FB protocol in a three-armed randomized controlled pilot trial 
(professional counselors, lay counselors, or enhanced usual care) with 75 adult HIV patients 
with OUD. We will assess feasibility and acceptability of the adapted FB protocol through 
semi-structured interviews with patients and providers, while evaluating fidelity of delivery 
and preliminary indicators of impact in improving HIV (primary outcome in subsequent R01), 
mental health (secondary), and drug use treatment (secondary) outcomes (Aim 2) 
2.2 Study Objectives  
AIM 1: To adapt the proven Friendship Bench (FB) protocol to be optimized for PLWH and 
OUD in Vietnam. 
Key outcome of Aim 1.  The primary outcome of Aim 1 will be the finalized revised FB 
protocol that is adapted for PLWH and OUD in Vietnam.   
AIM 2: To assess the feasibility, fidelity, and acceptability of the adapted FB as well as 
preliminary indicators of its impact in improving CMD and engagement in HIV care and drug 
use treatment via a small three-arm individually randomized trial, comparing FB by 
professional counselors to FB by lay counselors to enhanced usual care for PLWH and 
OUD with CMDs. 
The primary outcomes of the pilot trial will be the feasibility, acceptability, and fidelity of 
delivery of the adapted FB protocol. Secondary outcomes will include preliminary 
indicators of impact of the adapted FB protocol in improving HIV-related outcomes (eventual 
R01 primary outcomes) and MMT and mental health outcomes (eventual R01 secondary 
outcomes).   
3.0 METHODOLOGY 
AIM 1: Adaptation process: ADAPT-ITT.  Our team has an established manual for FB, and 
procedures for adapting the FB manual for specific settings and contexts (e.g., our protocols 
for adapting for HIV, perinatal, and noncommunicable disease settings in our prior work in 
Malawi).58,59 We will engage in a collaborative process with the full range of stakeholders 
who will use the manual to ensure contextual and patient relevance.  

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During the first 6 months of the project, we will follow the ADAPT-ITT model60 to adapt the 
FB protocol for our population and outcomes.  ADAPT-ITT consists of 8 steps (Figure).  The 
first 2 steps, Assessment of needs of the patient population and Decision about the 
evidence-based intervention to select, as summarized in the Specific Aims and Significance 
sections, have guided the development of this proposal and the selection of FB to address 
CMDs among patients with HIV on MMT.   
 
 
Step 3 (Adaptation) involves presenting FB to members of 
the target population and soliciting responses, 
encompasses feedback from potential clients and 
counselors. We will present the FB protocol to 5 distinct 
groups: patients (in-depth individual interviews, n=16), 
family members of patients (in-depth individual interviews, 
n=16), HIV/MMT clinicians and staff (2 focus groups, n=10 
total), and directors of HIV/MMT clinics (individual 
interviews, n=6). We will solicit their feedback through in-
depth interviews and focus group discussions.   
 
Specific inclusion criteria and study activities for each group: 
• 
HIV/MMT patients (n=16): Patients receiving both HIV and MMT care, who also have 
elevated symptoms of depression, anxiety, or stress on the DASS-21: a depression 
subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 
10. These cut-offs indicate at least a moderate severity of symptomatology (see Trial 
Phase below).  We will purposively sample participants to enroll at least 4 patients 
with depression, at least 4 with anxiety, and at least 4 with stress (one individual can 
help meet more than one of these targets if they are elevated on more than one 
domain).  These individuals will complete one-time individual in-depth interviews 
lasting approximately one hour.   
• 
Family members (n=16): We will ask each patient if we may speak with their spouse, 
mother, or other primary household caregiver.  We will ask if they have disclosed 
their HIV and injection drug use status to that family member, and will only approach 
the family member if the patient has disclosed to them and is willing for us to talk with 
them about these issues. These individuals will complete one-time individual in-depth 
interviews lasting approximately one hour.   
• 
HIV/MMT clinic providers and staff (2 focus groups, up to n=10 total): We will invite 
HIV/MMT clinic providers and staff who have meaningful involvement in the delivery 
of care for participating patients. These individuals will participate in a one-time focus 
group lasting approximately one and a half hours.   
• 
HIV/MMT clinic directors (n=6): We will invite directors of the HIV/MMT clinics, CDC 
Hanoi, DOH Hanoi to complete individual interviews lasting approximately one hour.   
 
Data collection and storage.  All in-depth interviews and focus group discussions will be 
audio-recorded, stored on a secure server, transcribed and translated for analysis.   
 
In step 4 (Production), this patient and provider feedback will be incorporated into a first 
draft of the adapted FB protocol. Steps 5 and 6 involve solicitation and integration of topical 
expert input. We will identify three individuals external to the study team with expertise in FB 
and in behavioral interventions for people with HIV and/or OUD to review the adapted 
ADAPT-ITT Model Steps 
1 Assess population needs 
2 D ecide on intervention 
3 Adaptation with stakeholders 
4 Production of adapted protocol 
5 T opical expert input
6 Integration of expert input 
7 T raining
8 T esting of adapted protocol
Wingood et al. JAIDS 2008 

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protocol.  Feedback from this review will inform the development of the next draft of the 
protocol.  In steps 7 and 8, an interventionist will be trained and this second draft will be 
piloted with 5 eligible patients to further refine session content.  The process will culminate 
with a final version of the adapted FB protocol that will be ready for formal evaluation in Aim 
2 in a three-arm pilot study.   
 
AIM 2: To assess the feasibility, fidelity, and acceptability of the adapted FB as well as 
preliminary indicators of its impact in improving CMD and engagement in HIV care 
and drug use treatment via a small three-arm individually randomized trial, comparing 
FB by professional counselors to FB by lay counselors to enhanced usual care for 
PLWH and OUD with CMDs. 
 
Study Design.  We will complete a pilot trial in which we will randomize 75 eligible patients 
to either the FB by a professional counselor (n=25), or FB by a lay counselor (n-25), or 
enhanced usual care (n=25). Patients will be enrolled from 4 MMT clinics under CDC Hanoi 
jurisdiction and with which we have previous successful collaborations. Patients meeting full 
eligibility criteria (see below) will be invited to provide written informed consent to participate 
in the study. As a pragmatic effectiveness trial, the purpose of the eventual R01 will be to 
compare the effectiveness of the adapted FB protocol delivered by a professional counselor 
and delivered by a lay counselor relative to enhanced usual care in improving HIV/MMT 
care engagement and outcomes (primary outcomes for the future trial).61 Therefore in this 
pilot, consenting participants will be individually randomized in the same way, to one of 
those three arms (described below).  
 
Study Procedures.  
After enrollment but before randomization, enrolled participants will complete a baseline 
research assessment including:  
• 
sociodemographic information;  
• 
self-reported health;  
• 
Although a full psychiatric diagnosis is not required for eligibility (see D.7.c above), 
enrolled participants will complete a diagnostic reference standard assessment, the 
Mini International Neurological Interview (MINI),62 so as to fully characterize the 
prevalence of psychiatric diagnoses among this group with elevated symptoms 

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• 
To the standard MINI we will add additional questions regarding family history and 
course of illness to 
characterize severity of 
illness, a potential 
modifier;  
• 
a urine drug screen;  
• 
a systematic Time Line 
Follow Back past 30 
days assessment of 
alcohol and other 
substance use;63  
• 
and key related 
structural and 
psychosocial factors 
and potential mediators 
and moderators 
including housing 
stability, exposure to 
violence/intimate 
partner violence, 
coping, social support, 
and experiences of 
stigma related to 
mental health, 
substance use, and 
accessing mental health and substance use treatment. 
 
Randomization: Participants will then be randomized 1:1:1 either to the adapted FB 
protocol delivered by a professional counselor, or to FB by a lay counselor, or to enhanced 
usual care (EUC).  Given the R34 focus on feasibility and acceptability, we will not stratify 
randomization by any factors; if we observe problematic imbalance, we will conduct adjusted 
analyses when comparing preliminary indicators of efficacy between arms. 
 
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. We will collect information 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.   
 
FB arms (by professional or lay counselor): Participants randomized to professional 
counseling or lay counseling will initiate FB with the trained counselor. Patients in these 
arms will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1).   
 
Compensation: Per our prior standard in HIV/MMT counseling studies, clients will 
receive nominal compensation when attending each counseling session to offset 
transportation costs.   
 
Research interviews: Participants in the enhanced usual care arm will complete a follow-
up research assessment at 6 weeks post-baseline. Participants in the adapted FB arms will 
complete this assessment after the final FB session, also expected to be at approximately 6 
weeks post-baseline.  All participants will complete research assessments at 3, 6, and 12 
months post-baseline. These follow-up assessments will assess the same domains as the 
baseline assessment and will specifically collect information on non-study psychiatric 
treatments in all arms, including both counseling and medications (both expected to be 

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extremely rare). Follow-up interviews will also repeat the MINI (all time points) to have a 
structured assessment of change in psychiatric diagnoses over time, as well as repeating 
the urine drug screen (6 months only) and Time Line Follow-Back alcohol and substance 
use assessment (all time points).  Participants in all arms will receive standard financial 
compensation for their time after completing each research interview. All follow-up 
assessments will be conducted by trained research interviewers who are blinded to the 
participant’s trial arm.   
 
Health care provider eligibility: Health care providers will also provide feedback on use of the 
adapted protocol. These participants will include a total of 10 different HIV and MMT care 
providers employed at the study clinics. The HIV/MMT care providers will be a mix of clinic 
staff delivering the intervention, HIV support service providers and other care providers that 
are determined to have meaningful involvement in the delivery of care for participating 
patients. These provider participants will complete semi-structured interviews at baseline, 6-
weeks post enrollment, and at 3 months, 6 months, and 12 months to provide feedback on 
feasibility and acceptability of the adapted FB protocol. 
 
 
Outcomes, Measures and Data Collection. The primary outcomes of the pilot trial will be 
the feasibility, acceptability, and fidelity of delivery of the adapted FB protocol. Secondary 
outcomes will include preliminary indicators of impact of the adapted FB protocol in 
improving HIV-related outcomes (eventual R01 primary outcomes) and MMT and mental 
health outcomes (eventual R01 secondary outcomes).   
 
Primary Outcomes: Feasibility will be defined as the ability to successfully enroll and 
retain PLWH and OUD with CMDs in the pilot intervention. Feasibility will be evaluated by 
measuring the recruitment rate (number of patients approached to accrue the final sample).  
Additional indicators of feasibility will include study retention, defined as the ability to retain 
PLWH and OUD with CMDs in the pilot trial. Study retention 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.  An additional measure of 
intervention feasibility will be defined as the number of FB sessions attended by participants 
out of total FB sessions offered during the target intervention duration of 6 weeks.   
 
Acceptability will be defined as the ability to deliver a culturally and resource-appropriate 
intervention. Acceptability will be assessed through brief exit interviews with all patient 
participants (n=75), HIV providers treating patients in the FB protocol, professional 
counselors (n=3), lay counselors (n=3), and supervising Master Trainers (n=1 per clinic, n=2 
or 3 total). Exit interviews with patients will occur after the final FB session, while exit 
interviews with other groups will occur after the end of FB activities at each site. Exit 
interviews will include both closed and open-ended questions and will assess how easy the 
intervention was to participate in or deliver, the perceived usefulness of the intervention, and 
suggestions for improvement.  The primary measure of acceptability will be overall 
participant satisfaction defined by 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. 
Fidelity will be defined as adherence to the intervention protocol. Fidelity to session 
content for individual counseling sessions will be assessed by a Master Trainer by using a 
checklist of counseling session elements either during direct monitoring or using audio 
recording of up to 3 randomly chosen sessions per counselor. As we have defined in prior 
work, meeting or exceeding expectations at least 75% of checklist items during each 

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session will be considered fidelity to the intervention protocol.   
Secondary Outcomes: Secondary outcomes will be used to provide preliminary 
information about effectiveness, taking into consideration the limited sample size for the pilot 
project. HIV-related outcomes (the primary outcomes for the eventual full-scale trial) will be 
defined as (a) viral suppression at 6 months, and (b) HIV appointment adherence between 
baseline and 12 months of follow up. Viral load will be captured from clinical records, or 
ordered by the study if no viral load is collected in the appropriate window. HIV appointment 
attendance will be evaluated by measuring 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.   
 
Mental health outcomes (the secondary outcomes for the eventual full-scale trial) will be 
defined as DASS-21 total score indicating any CMD symptoms as well as mean subgroup 
scores for depression, anxiety, and stress at 6 weeks after enrollment (FB: treatment exit) 
across all study arms. We will consider both the simple severity level at follow-up as well as 
the absolute reduction in symptoms from baseline.  
 
Methadone maintenance engagement (another secondary outcome for the full trial) will 
be defined as the proportion of days with methadone maintenance therapy adherence 
measured from study baseline through 12 months of follow up. 
 
Additional (tertiary) outcomes: Tertiary HIV-related outcomes will be defined as (a) 
viral suppression at 12 months and (b) consistent ART use over 12 months as confirmed by 
clinical records. Tertiary mental health outcomes will be defined as DASS-21 total score 
indicating any CMD symptoms as well as subgroup scores for depression, anxiety, and 
stress at 3 months, 6 months, and 12 months across all study arms.  We will consider both 
the simple severity level at follow-up as well as the absolute reduction in symptoms from 
baseline.  
3.1 Study Sites 
The proposed study will be at conducted at 4 public MMT clinics in the Hanoi, Vietnam area 
where we have successfully enrolled patients in prior studies. Each of the 4 health centers 
provides methadone maintenance treatment (MMT) to individuals with opioid use disorder 
as well as integrated HIV/ART care to those additionally living with HIV. Male users make up 
the vast majority of individuals with opioid use disorder here. In Vietnam, PLWH and OUD 
typically get integrated treatment with ART and methadone at district health centers. Thus, 
the co-location of HIV and MMT services makes these health centers ideal locations to 
serve PLWH with OUD. CMD screening and assessment are rare to nonexistent at 
HIV/MMT clinics in Hanoi, as in most clinical settings in Vietnam. 
UNC Project in Vietnam will serve as the administrative home for the study and has 
longstanding relationships with all 4 proposed study sites, the Ministry of Health, and CDC 
Hanoi. Approximately 80 individuals living with HIV and with OUD present monthly at each 
site, providing adequate numbers for aim 2. UNC Project has previously successfully 
recruited and enrolled PLWH on MMT 
3.2 Population 
Inclusion criteria 
 
Eligible individuals will be adult patients (18 years and older) being treated at the MMT clinic 

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whose medical record indicates infection with HIV will be screened with the DASS-21,64 
which has been translated, standardized and validated in the Vietnamese population.65,66 
The DASS-21 assesses symptoms of depression, anxiety and stress among adults. The 
respondent is asked to think about their experiences in the past seven days and to rate each 
of the 21 items along a 4-point scale from 0 (“Did not apply to me at all–Never”) to 3 
(“Applied to me very much, or most of the time–Almost always”). There are three subscales, 
each with 7 items (DASS-21-Depression, DASS-21-Anxiety, and DASS-21-Stress) allowing 
calculation of three subgroup scores (0-21) and a total score (0-63). We then use these 
totals to identify the likelihood of a depressive disorder, an anxiety disorder, a stress-related 
disorder, or any of the three. Consistent with our prior work67 and with prior validation 
studies in the Vietnamese population,66 we will consider as eligible all patients with a 
depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale 
score ≥ 10. These cut-offs indicate at least a moderate severity of symptomatology. Further, 
to ensure that we are identifying clinically meaningful CMDs rather than transient mood 
fluctuations, we will require that elevated depressive symptoms be present for ≥2 weeks and 
elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. We 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 will be excluded. 
3.3 Duration  
Aim 1 (protocol adaptation) will be conducted over a 9-month period in year 1 (July 2020 – 
March 2021). Aim 2 (pilot trial) will begin in the last 3 months of year 1 (April 2021) and has 
two parts: implementation of the pilot study with enrollment and 3 months of treatment 
sessions (April 2021 – December 2021) and ongoing assessment of key outcomes at 3, 6, 
and 12 months (through December 2022). 
3.4 Sample Size 
A total of 75 patients will be enrolled over time, recruited over a three-month period in year 
2.   
 
We recognize that the purpose of a pilot trial with limited sample size is not to be fully 
powered to detect statistically significant differences on patient outcomes but rather to 
provide reasonably precise estimates of parameters such as acceptability and fidelity, as 
well as preliminary evidence of the likely magnitude of effect of the intervention on the 
outcomes planned for the later trial. Assuming 80% retention (consistent with our team’s 
previous work in this population), our starting sample size of 50 intervention participants is 
sufficient to estimate parameters such as the proportion of participants rating the 
intervention as acceptable with a 95% confidence interval of ±10-15 percentage points, and 
parameters such as the proportion of FB sessions with acceptable fidelity with a 95% CI of 
±6-8 percentage points. Our starting sample size of 25 participants in each arm, with 80% 
retention, is sufficient to estimate risk ratios of the effect of the intervention on outcomes that 
have 95% CIs that are two- to three-fold wide (e.g., RR=0.63; 95%CI = 0.38-1.00 for the 
presence of elevated symptoms), depending on various assumptions about outcome 
frequency. For comparison of effect sizes, we note that the 24-clinic cluster-randomized trial 
of the FB found effect sizes much stronger than this (adjusted risk ratios of 0.21 [0.15-0.29] 
for presence of any symptoms and 0.28 [0.22-0.34] for presence of depressive symptoms). 
Thus the sample size is adequate to achieve our aims.   

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3.5 Data Sources 
Sources of data for this study include the participant baseline and follow-up assessments, 
provider semi-structured interviews, audio recordings of counseling sessions that will be 
rated for fidelity, and medical record data (to collect HIV appointment attendance and viral 
loads). We will capture viral load from medical records when possible; if no viral load is 
scheduled at the requisite time point for the study, then the study will order and pay for a 
viral load test. Blood samples for study viral loads will be drawn by the same clinic staff and 
in the same manner as clinic-ordered viral loads 
3.5.1 Record Availability 
The site investigator will make all data abstraction documents and records readily available 
for inspection by the local IRB and the Office for Human Research Protections (OHRP) as 
requested. 
4.0 ANALYSIS 
Statistical Analysis.  Feasibility, acceptability, and fidelity will be evaluated using 
descriptive statistics. We will compare mean fidelity scores between the professional FB and 
lay FB counselors using an intent-to-treat approach, using a robust variance estimator to 
account for multiple observations per counselor.   Means and proportions for HIV-related 
and mental health outcomes will be compared between arms using an intent-to-treat 
analysis approach.  
 
We will evaluate effectiveness measures comparing professional counselors to enhanced 
usual care and lay counselors to enhanced usual care. Considering the purpose of this 
small pilot trial, our focus will be on estimating effect size and precision rather than statistical 
significance and hypothesis testing. To take advantage of the repeated-measures nature of 
the outcome data, we will also fit generalized estimating equation (GEE) regression models, 
using a link appropriate for each outcome (i.e. identity link for continuous variables and log 
link for binary variables), to simultaneously examine differences in outcomes at 6 weeks, 3 
months, 6 months and 12 months between the arms. Given the relatively small sample size, 
it is possible that important predictors of outcome (such as baseline mental health symptom 
severity or time in HIV care) could end up being unbalanced between arms; if this is the 
case we will conduct secondary regression analyses adjusting for the unbalanced potential 
confounder.   
 
In secondary analyses, we will examine whether HIV-related, MMT, and mental health 
outcomes vary by proportion of FB sessions attended and by number of elevated symptom 
domains at baseline (depression, anxiety, and/or post-traumatic stress).   
 
In moderation analyses, we will explore whether severity of illness (duration; symptom 
severity; family history) modifies any preliminary evidence of efficacy in primary outcomes, 
while recognizing that a pilot trial is not designed to be powered to statistically test 
modification hypotheses.   
 
Missing data. Every effort will be made to minimize missing data, including collecting 
detailed locator information for the participant as well as for up to three individuals who 
could help reach the participant should they drop out of contact.  However, some missing 

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data is likely to occur.  We will examine the data for patterns of missingness (for example, 
are the patients with the greatest mental health symptom severity at baseline the most likely 
to be lost to follow-up?), and if identified, will conduct sensitivity analyses using inverse 
probability weights68 to correct for the bias introduced by the missing data.   
5.0 ETHICAL CONCERNS 
5.1 Human Subjects 
Safety considerations.  Study staff will evaluate patients for safety who endorse any level of 
suicidal ideation whether or not they enroll in the trial.  Safety assessment results will be 
conveyed to the clinical team as appropriate for further follow-up according to the clinic’s 
standard operating procedures.   
5.1.1 Institutional Review Board 
Prior to implementation of this RCT, all protocol materials will be approved, as appropriate, 
by local institutional review boards (IRB)/ ethics committees (EC) responsible for oversight 
of the evaluation including the Hanoi Medical University Institutional Ethical Review Board  
and the Biomedical Institutional Review Board of the University of North Carolina at Chapel 
Hill. All research procedures will adhere to Vietnamese and US ethical standards for 
research involving human subjects.  
5.1.2 Confidentiality, Risks, and Risk Minimization  
Breach of confidentiality: There is always the possibility of a breach of confidentiality when 
conducting research. Disclosure of medical or other personal information about participants, 
particularly HIV, substance use disorder, and mental health status, may result in negative 
stigma being associated with the individual and/or family. Our research team is very aware 
of the need for absolute confidentiality and has extensive experience in dealing with highly 
sensitive personal medical and family information. While we acknowledge that a breach of 
confidentiality is possible, we anticipate that the likelihood is very low because of the 
precautions that will be taken to protect confidentiality. Research data will be coded (with 
identifiers removed). The linking file that connects the codes to individual identities will be 
securely stored by the study team. Research data will be stored securely on password-
protected machines or servers or in locked cabinets, with access restricted to study staff. 
For qualitative interviews: recording devices will be locked up when not in use, and audio 
files and transcripts will be stored securely on password-protected machines or servers with 
access restricted to study staff. Careful attention will be paid to anonymizing transcripts 
(removing potentially self-identifying references) and aggregating responses before sharing 
them with the full investigator team to prevent any potential for identification. 
Risk of sense of coercion to participate: As addressed under 2(a) above, the informed 
consent process will emphasize that the provider is free to participate or not; a decision not 
to participate will have no negative impact on his or her employment, evaluation, or anything 
else related to the workplace; and the provider is free to end participation at any time. For 
patients, the informed consent process will emphasize that the patient is free to participate 
or not; a decision not to participate will have no negative impact on any aspect of his or her 
clinical care; and the patient is free to end participation at any time. 

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Patients may experience embarrassment or emotional distress during screening or as a 
result of talking about their mental health:It is possible that patients may experience distress 
when completing clinical symptom survey instruments or discussing their mental health. 
Based on our prior experience, we expect the degree of distress will be very limited. In case 
distress does occur, our training for study staff and clinicians will include sessions on 
identifying and responding to symptoms of distress. Empathy and sensitivity will be stressed 
in these trainings. The clinic’s standard protocol for responding to distress during clinic 
encounters will be emphasized. 
Patients may disclose suicidal ideation or intent to harm others, including a spouse or child: 
Patients may reveal suicidal intent or intent to harm others during study interviews or when 
discussing their mental health with their provider. We will have a thorough response plan in 
place. In general, response to severe depression, anxiety, stress, and suicidality will follow 
procedures standardized at the clinic site and appropriate to the situation. All suicidality 
reported during research contacts will be documented for clinician review. Participants with 
active moderate or high-risk suicidality will be evaluated by clinicians and referred for mental 
health follow-up per the clinic’s standard protocol. 
Patients may disclose safety concerns for themselves or others (e.g., victim of domestic 
violence or child is victim of abuse) during clinical care: Patients may disclose safety 
concerns for themselves or others (e.g., victim of domestic violence or child is victim of 
abuse) which will need to be addressed appropriately and with sensitivity. Such disclosure 
will be handled appropriately within the framework of existing legal mandates for reporting. 
The informed consent form will note that such information may require disclosure to law 
enforcement officials. 
Health care providers: Risks to providers from this research include 
(1) Risk of sense of coercion to participate 
(2) Risk of breach of confidentiality of research data 
 
Patients: Risks to patients from this research include 
(1) Risk of sense of coercion to participate 
(2) Risk of breach of confidentiality of research data 
(3) Patients may experience embarrassment or emotional distress during screening or as a 
result of talking about their mental health; 
(4) Patients may disclose suicidal ideation or intent to harm others, including a spouse or 
child; 
(5) Patients may disclose safety concerns for themselves or others (e.g., victim of domestic 
violence or child is victim of abuse) 

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5.1.3 Benefits to Participants  
This study has some minimal risks associated with participation and we anticipate that few 
participants will experience negative events as a result of taking part in the study. This 
research will improve our understanding of how a problem-solving mental health intervention 
can be adapted to people with HIV and opiate use disorder to improve psychiatric disorders 
and engagement in HIV care. In the long term, supporting PLWH and OUD that have co-
occurring psychiatric conditions is expected to reduce psychiatric burden, improve 
engagement in HIV and MMT care, and ultimately improve CMDs and both HIV and MMT 
outcomes. Therefore, the risk to individual participants in our study is small relative to the 
potential benefit to be gained from the research. 
5.1.4 Costs and Compensation  
Study participants will receive standard compensation in line with CDC Hanoi practices for 
their enrollment visit and research outcome interviews. 
5.1.5 Informed Consent 
This protocol and the informed consent documents and any subsequent modifications will 
be reviewed and approved by the IRB and ethics committees responsible for oversight of 
the study. All procedures will conform to US and Vietnamese ethical standards regarding 
research involving human subjects. 
Written informed consent will be obtained. Informed consent will clearly explain the purpose 
of the research, what will be required of the individual, and the risks and benefits of 
participation. All informed consent will be administered by study staff. For health care 
providers, the informed consent process will emphasize that the care provider is free to 
participate or not; a decision not to participate will have no negative impact on his or her 
employment, evaluation, or anything else related to the workplace; and the health care 
provider is free to end participation at any time. For patients, the informed consent process 
will emphasize that the patient is free to participate or not; a decision not to participate will 
have no negative impact on any aspect of his or her clinical care; and the patient is free to 
end participation at any time. Participants will be presented an informed consent form with 
the above information and contact information for the PI, study personnel, and IRB. 
Patients will be approached for informed consent during clinical care appointments. Health 
care providers will be approached for informed consent during clinic working hours. In both 
cases, the informed consent process will take place in a private location in the clinic. 
Potential participants will be offered the opportunity to ask any questions they may have. 
Potential participants will have the opportunity to provide informed consent, decline to 
participate, or take additional time to consider participation (e.g. go home and return later). 
5.2 Adverse Event Reporting 
We do not anticipate any adverse events occurring given the nature of the minimal risks 
associated with this research. However, in the case that a breach of confidentiality does 
occur, the study team will immediately inform the IRBs.  
 

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• 
Deaths related to study participation shall be reported by the PI to NIDA and IRBs 
immediately and no later than within 5 business days of the PI first learning of the 
death 
• 
Unexpected Serious Adverse Events related to study participation shall be reported 
by the PI to NIDA and IRBs within 10 business days of the study team becoming 
aware of the SAE 
• 
Unanticipated Problems Involving Risks to Subjects or Others shall be reported by 
the PI to NIDA and IRBs within 10 business days of the study team becoming aware 
of the problem 
• 
Adverse events and SAEs, including deaths, that are deemed expected and/or 
unrelated to the study shall be submitted in summary form to NIDA and IRBs with the 
annual progress report 
• 
Protocol violations shall be submitted in summary form to NIDA and IRBs with the 
annual progress report 
 
As a four-site pilot study, this project does not require a Data Safety Monitoring Board. 
5.3 Study Discontinuation 
The study may be discontinued at any time by the UNC IRB, the Hanoi Medical University 
Institutional Ethical Review Board, the Office for Human Research Protections (OHRP), or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
 
6.0 PUBLICATION AND DISSEMINATION OF RESEARCH FINDINGS 
We will disseminate our results locally with stakeholders at the 4 clinics, our colleagues at 
Hanoi Medical University, our collaborators at CDC Hanoi, and any other interested parties 
(e.g. governmental representatives of other Southeast Asian countries, WHO 
representatives from the Southeast Asia Regional Office). We will also present results at 
national and international conferences (e.g., IAS, IAPAC). Abstracts presented at 
conferences will also be prepared for publication in suitable scientific journals to disseminate 
results to the wider scientific community.  
Special considerations for clinical trials 
We will ensure that our study is registered and results information is submitted to 
ClinicalTrials.gov, in compliance with all NIH policies. We will also ensure that informed 
consent forms used in the study include a specific statement about posting clinical trial 
information on ClinicalTrials.gov. Finally, we verify that the University of North Carolina at 
Chapel Hill, through its Office of Clinical Trials, has an internal policy in place to ensure that 
clinical trials registration and results reporting all occur in compliance with NIH policy 
requirements.  
7.0 WORKPLAN 
Timeline. The Friendship Bench adaptation will be completed in year 1 quarter 3. The pre-
pilot RCT to test materials and study procedures will begin in year 1 quarter 4 and will last 3 
months. The 3-arm pilot study will begin in year 2 quarter 1, with recruitment completed 

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within a 3-month period. Given that MMT/ART patients attend clinic daily for directly 
observed MMT, we anticipate little difficulty fully enrolling within a 3-month period. However, 
we have enough leeway in our timeline to extend enrollment if needed to achieve our target 
sample size. Treatment will be completed by the middle of year 2, while research follow-up 
through 12 months will be completed by the middle of year 3. Feasibility and fidelity 
assessment will be ongoing throughout the trial, while patient acceptability assessments will 
be folded into the research outcome interviews. The remainder of year 3 will focus on data 
analysis and dissemination, manuscript preparation, and planning for the follow-up R01 
RCT. We expect to generate a minimum of 3 manuscripts from this pilot study.   
 
 
7.1 Project Management 
This proposal is led by Dr. Bradley Gaynes, PI, Professor of Psychiatry and Director of the 
Division of Global Mental Health at UNC, who will provide overall administrative and 
scientific leadership in collaboration with the other co-investigators. He is supported in the 
US by Dr. Brian Pence, Professor of Epidemiology at the UNC School of Public Health, who 
will provide overall guidance on trial design and outcome measurement, and oversee 
intervention implementation and Dr. Vivian Go, Professor of Health Behavior at the UNC 
School of Public Health, will help adapt FB to PLWH on MMT, inform study design, and 
assist in collaboration with MOH and CDC Hanoi. The team further includes Dr. Le Minh 
Giang, Associate Professor and Chair of the Department of Global Health at Hanoi Medical 
University, who will assist with adapting FB to specific needs of HIV/MMT population in 
Vietnam and piloting the adapted protocol for testing in the proposed clinics in Vietnam; Dr 
Viet Tran Ha, Research Assistant Professor of Health Behavior at UNC and in-country 
Director of UNC Project-Vietnam, who will Monitor and direct in-country research activities; 
and Drs. Dixon Chibanda, Head of the Psychiatry Division at Harare Hospital, Zimbabwe, 
and Dr. Ruth Verhey, Senior Clinical Psychologist for the Friendship Bench Program, who 
both will consult on FB adaptation and development of supervision and fidelity systems, and 
help train the trainers.   
 
 
 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
IRB Regulatory 
Adapt Friendship Bench; feedback; finalize
 
Prepilot followed by 3-arm pilot study recruitment: 3 months
Pilot study treatment sessions: ~3 months w/ follow-up through 12 months
Aim 2 Outcomes- Assessment of feasibility, acceptability, fidelity, and preliminary indicators of impact
Feasibility, acceptability, fidelity measurement 
Preliminary indicators of impact: Research interview at 3, 6, and 12 months
Dissemination
   Data analysis and dissemination, manuscript preparation, RCT planning
Activity
Year 1
Year 2
Year 3
Aim 2 Approach - Pilot study of Friendship Bench in PWID with HIV
Aim 1 - Adaptation to improve CMDs and engagement in PWID with HIV

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