Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa
Phase: NA
Conditions: Substance-Related Disorders, Substance Use, Substance Use Disorders, Stigma, Social, Stigmatization, Attitude of Health Personnel, Treatment Adherence, Treatment Adherence and Compliance, Health Care Seeking Behavior, HIV, Mental Health Recovery, Delivery of Health Care, Global Health, South Africa, Health Personnel Attitude, Health Personnel, Community Health Workers, Substance Use Recovery
Sponsor: University of Maryland, College Park

Protocol – NCT05907174                                                                      
       Uploaded September 2024 
 
 
Study Protocol & Statistical Analysis Plan for ClinicalTrials.gov  
Protocol for NCT05907174 on ClinicalTrials.gov | Uploaded September 2024 
 
 
Official Title: 
Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in 
South African HIV Care  
 
NCT Number: 
NCT05907174 
 
Document Date: 
23-August-2024  
Document contains clinical trial-specific procedures, compiled for clearer formatting on 18-September-2024. 
Most recent protocol changes (Version 6) approved by South African Medical Research Council on 23-August-
2024.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SIYAKHANA - P 

Protocol – NCT05907174                                                                      
       Uploaded September 2024 
 
 
2 
 
Study Protocol & Statistical Analysis Plan for ClinicalTrials.gov  
 
Ethics Information 
 
 
IRB: South African Medical Research Council (SAMRC) Human Research Ethics Committee 
(HREC) 
 
 
Study Name 
(Ethics): 
Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care 
Outcomes in South Africa: Aim 3. SIYAKHANA – P. 
 
 
Short Names: “Siyakhana – P” / “Siyakhana – Peer” / “Siyakhana – PRC” 
 
 
Ethics ID: EC016-7/2022 
 
 
Most Recent 
Protocol: 
Version 6 | Approved 23 August 2024 
 
 
 
 
 
Multiple Principal Investigators 
 
 
Bronwyn Myers, PhD 
South African Medical Research Council (South Africa) | Curtin University (Australia) 
 
 
Jessica Magidson, PhD  
University of Maryland, College Park (United States of America) 
 
 
 
Funder 
 
 
National Institute on Drug Abuse (NIDA), R21DA053212  
Awarded to Drs. Magidson & Myers  
“Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South 
Africa” 
 
 
 
Primary Research Support 
 
 
 
South African Medical Research Council – Cape Town, Western Cape, South Africa 
 
Kim Johnson, MA 
Sibabalwe Ndamase, BA 
Nonceba Ciya 
 
 
 
University of Maryland – College Park, Maryland, United States of America 
 
Kristen Regenauer, MS 
Rithika Baskar, BS 
Imani Brown, MPH  
 
 
 
 
 
 

Protocol – NCT05907174                                                                      
       Uploaded September 2024 
 
 
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TABLE OF CONTENTS  
 
TABLE OF CONTENTS ............................................................................................................... 3 
LIST OF ABBREVIATIONS ........................................................................................................ 5 
1. 
OVERALL AIM AND SPECIFIC OBJECTIVES ............................................................ 6 
1.1 Overall Aim ........................................................................................................................................ 6 
1.2 Specific Objectives ............................................................................................................................. 6 
2. 
INTRODUCTION ............................................................................................................... 7 
Background and Rationale ..................................................................................................................... 7 
3. 
Research Work Plan ........................................................................................................... 9 
Aims: ......................................................................................................................................................... 9 
Study Sites ................................................................................................................................................ 9 
Study Design ............................................................................................................................................. 9 
Participants and Eligibility ..................................................................................................................... 9 
3.1.1 
COPC HCW: Eligibility ...................................................................................................................... 9 
3.1.2 
COPC Patient: Eligibility .................................................................................................................. 10 
3.1.3 
Stakeholders (Qualitative Interviews): Eligibility ............................................................................. 10 
Recruitment ............................................................................................................................................ 11 
3.1.4 
COPC HCWs: Recruitment ............................................................................................................... 11 
3.1.5 
COPC Patients: Recruitment ............................................................................................................. 11 
3.1.6 
Stakeholders (Qualitative Interviews): Recruitment ......................................................................... 12 
Study Procedures ................................................................................................................................... 12 
3.1.1 
COPC HCWs: Procedures ................................................................................................................. 12 
3.1.2 
COPC Patients: Procedures ............................................................................................................... 13 
3.1.3 
Stakeholders (Qualitative Interviews): Procedures ........................................................................... 16 
3.1.4 
Additional Procedures ....................................................................................................................... 16 
Participant Compensation .................................................................................................................... 16 
3.1.1 
COPC HCWs: Compensation ............................................................................................................ 16 
3.1.2 
COPC Patients: Compensation .......................................................................................................... 17 
3.1.3 
Stakeholders (Qualitative Interviews): Compensation ...................................................................... 17 
Phone ....................................................................................................................................................... 17 
4. 
STATISTICAL ANALYSIS PLAN ................................................................................... 18 
Type and Purpose of Data ..................................................................................................................... 18 
Effectiveness Outcomes ......................................................................................................................... 18 
4.1.1 
Primary Outcome: HCW Stigma Towards SU .................................................................................. 18 
4.1.2 
Other Outcome: Patient Engagement in HIV Care ............................................................................ 18 
Implementation Outcomes .................................................................................................................... 18 
4.1.3 
Secondary Outcomes: HCW Feasibility and Acceptability ............................................................... 18 
4.1.4 
Other Outcomes: Patient Feasibility & Acceptability ....................................................................... 19 
5. 
ETHICAL CONSIDERATIONS ...................................................................................... 20 

Protocol – NCT05907174                                                                      
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Potential Risks to Participants ............................................................................................................. 20 
Protections Against Risks ...................................................................................................................... 20 
5.1.4 
Informed consent ............................................................................................................................... 20 
5.1.5 
Preventing breaches to confidentiality ............................................................................................... 20 
5.1.6 
Protections against psychological or mental discomfort ................................................................... 21 
5.1.7 
Health and safety: COVID-19 ........................................................................................................... 22 
Potential Benefits of Proposed Research to Human Subjects and Others ....................................... 22 
5.1.8 
COPC HCW Participants ................................................................................................................... 22 
5.1.9 
COPC Patient Participants ................................................................................................................. 22 
5.1.10 
Importance of the knowledge to be gained ........................................................................................ 22 
Protection of Personal Information (POPI) Act 4 of 2013 ................................................................. 22 
6. 
DATA MANAGEMENT ................................................................................................... 24 
Data Storage ........................................................................................................................................... 24 
6.1.1 
Data acquisition and transmission ..................................................................................................... 24 
6.1.2 
Data entry methods ............................................................................................................................ 24 
6.1.3 
Quality assurance ............................................................................................................................... 25 
Data safety and monitoring plan .......................................................................................................... 25 
6.1.4 
Regulatory issues ............................................................................................................................... 25 
6.1.5 
Amendments ...................................................................................................................................... 25 
6.1.6 
Reporting definitions ......................................................................................................................... 25 
6.1.7 
Protocol violations ............................................................................................................................. 26 
6.1.8 
Adverse events and unanticipated problems ...................................................................................... 26 
Responsibility ......................................................................................................................................... 26 
Disclosure of Any Conflict of Interest .................................................................................................. 26 
7. 
MANAGEMENT DETAILS ............................................................................................. 27 
Management Approach ......................................................................................................................... 27 
7.1.1 
SAMRC ............................................................................................................................................. 27 
7.1.2 
UMD .................................................................................................................................................. 27 
7.1.3 
Both Sites ........................................................................................................................................... 27 
Staff and Scientific Collaboration ........................................................................................................ 27 
Facilities .................................................................................................................................................. 27 
7.1.4 
Field Site ............................................................................................................................................ 27 
7.1.5 
Data Management Site ....................................................................................................................... 28 
8. 
ADDITIONAL DETAILS ................................................................................................. 29 
Research Translation ............................................................................................................................. 29 
8.1.1 
Manuscripts ........................................................................................................................................ 29 
8.1.2 
Scientific Conferences. ...................................................................................................................... 29 
8.1.3 
Training Materials. ............................................................................................................................ 29 
8.1.4 
Data Sharing Plan. ............................................................................................................................. 29 
8.1.5 
Clinical Trial Registration ................................................................................................................. 29 
Scientific Validity ................................................................................................................................... 29 
REFERENCES ............................................................................................................................ 30 
 
 
 

Protocol – NCT05907174                                                                      
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LIST OF ABBREVIATIONS 
 
3MFU 
3-Month Follow-Up Assessment 
6MFU 
6-Month Follow-Up Assessment 
AE 
Adverse Event 
AOD 
Alcohol or Other Drug use  
APA 
American Psychological Association 
ART 
Antiretroviral Therapy 
BL 
Baseline Assessment 
CFIR 
Consolidated Framework for Implementation Research 
CHW 
Community Health Worker 
COPC 
Community Oriented Primary Care 
ETAU 
Enhanced Treatment As Usual 
GCP 
Good Clinical Practice 
HCW 
Health Care Worker 
HREC 
Human Research Ethics Committee 
LMIC 
Low- and Middle-Income Countries 
MPI 
Multi-Principal Investigator 
NIDA 
National Institute on Drug Abuse 
NIH 
National Institutes of Health (US) 
PI 
Principal Investigator 
PLWH 
People living with HIV 
PPE 
Personal Protective Equipment 
PRC 
Peer Recovery Coach 
SA 
South Africa 
SAE 
Serious Adverse Event 
SAMRC 
South African Medical Research Council 
SANCA 
South African National Council on Alcoholism and Drug Dependence 
SDS 
Social Distance Scale 
SU 
Substance Use 
SU-SMS 
Substance Use Stigma Mechanism Scale 
SUD 
Substance Use Disorder 
UMD 
University of Maryland 
US 
United States 
WBOT 
Ward-Based Outreach Team 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol – NCT05907174                                                                      
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1. OVERALL AIM AND SPECIFIC OBJECTIVES  
 
1.1 Overall Aim 
The overall aim of this study is to assess the feasibility, acceptability, and preliminary effectiveness of 
integrating peer recovery coaches (PRCs) into Community Oriented Primary Care (COPC) teams to help 
people living with HIV (PLWH) and problematic substance use (SU) better engage in health care.  
 
PRCs are lay people with lived SU experience who are trained to help people with current SU problems. 
They have been lauded as an innovative, acceptable, and cost-effective strategy for supporting SU outcomes 
in some high-income settings. PRC models are scaling in the US, but their implementation in HIV care in 
low- and middle-income countries (LMICs) has been limited. To adapt a PRC model to this context, we 
previously conducted qualitative interviews with stakeholders and patients about their attitudes towards 
integrating PRCs into COPCs (Protocol ID #EC046-10/2020). From these interviews, we were able to 
assess barriers and facilitators to this integration, which informed our development of a draft model. We 
then conducted workshops with stakeholders and patients (Protocol ID #EC049-11/2021) to obtain 
stakeholder feedback on our proposed model. Based on workshop feedback, we then further adapted the 
model and received confirmatory feedback on the final proposed model. In the present study, we propose 
to test this final co-designed model by comparing health care engagement outcomes for PLWH and SU 
who are seen by a COPC with an integrated PRC to those who are seen by a matched COPC without an 
integrated PRC. 
 
1.2 Specific Objectives 
To evaluate the feasibility, acceptability, and preliminary effectiveness of this PRC COPC integrated model 
(called “Siyakhana”), we will:  
 
1. Primary: Evaluate the pilot effectiveness of Siyakhana reducing healthcare worker stigma towards 
substance use (SU), compared to a control condition (COPC enhanced treatment as usual (ETAU)):  
a. Healthcare worker stigma towards SU at the three-month follow-up, measured using the Social 
Distance Scale (SDS2–4; n=30) 
 
2. Secondary: Evaluate the implementation of Siyakhana using the following measures:  
a. Feasibility and Acceptability (COPC perspective) 
1. Feasibility and Acceptability subscales of an adapted Implementation and 
Dissemination measure,1 completed by healthcare workers (HCWs) in the Siyakhana 
condition at the six-month follow-up (n=15)  
2. Semi-structured qualitative interviews with HCWs in the Siyakhana condition after 
the six-month follow-up (n=15)  
 
3. Other: Additionally evaluate the following outcomes using the following measures:  
a. Feasibility and Acceptability (patient perspective)  
1. Feasibility and Acceptability subscales of an adapted Implementation and 
Dissemination measure,1 completed by patients (HCWs) in the Siyakhana condition 
at the three-month follow-up (n=25)  
2. Semi-structured qualitative interviews with patients in the Siyakhana condition after 
the six-month follow-up (up to n=25)  
b. Feasibility and Acceptability (other stakeholder perspectives)  
1. Semi-structured qualitative interviews with key stakeholders (e.g., policymakers, 
organization and clinic heads, etc.,) at the end of the study (up to n = 15) 
c. Pilot effectiveness of Siyakhana patients (intervention) re-engaging in HIV care, compared to 
patients in the ETAU (control) condition, over three-months  
1. Patient engagement in clinic-based HIV care between baseline assessment and three-
month follow-up assessment from medical records (dichotomous yes/no) 

Protocol – NCT05907174                                                                      
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2. INTRODUCTION 
 
Background and Rationale  
 
South Africa (SA) is home to the highest burden of HIV globally, with over 7.7 million PLWH.6,7 SA 
has scaled up its response to the HIV epidemic, including expanding access to antiretroviral therapy (ART) 
so the virus can remain undetectable and untransmittable. Yet, over 60% of PLWH have not achieved viral 
suppression largely due to poor ART adherence and disengagement from care.7 This lack of engagement in 
care contributes to HIV morbidity and mortality, as well as ongoing transmission of the virus.8 
 
Substance use disorder (SUD) is prevalent among PLWH and contributes to poor engagement in HIV 
care.9,10 There have been alarming increases in SUD among PLWH in SA, including methamphetamine, 
heroin, and other opioid use.11 SA also has one of the highest global rates of per capita alcohol 
consumption,12 with approximately one-third of PLWH on ART reporting problematic drinking.13 
Untreated SUD is associated with worse engagement in HIV care, lower likelihood of being on ART,14 
worse ART adherence, and lower rates of viral suppression.9,10,15,16 Identifying PLWH who use 
substances and supporting them to stay retained in HIV care is critical for increasing rates of 
adherence and viral suppression.  
 
Recent innovations in SA to improve access to and engagement in HIV care for PLWH include the 
use of Community Oriented Primary Care (COPC) teams, previously called ward-based outreach teams 
(WBOTs). The goal of COPC teams is to reach vulnerable, out-of-care patients in communities and re-link 
them to facility-based services.17,18 COPC teams include community health workers (CHWs), one 
supervisor, and one nurse team leader. Each COPC works in a specific “indawo” (i.e., place/community), 
and CHWs receive one week of HIV/TB training.  
 
Untreated SUD undermines recent innovations to improve engagement in HIV care for PLWH, 
including the success of COPC teams. In Cape Town, the success of COPC teams in improving 
engagement in HIV care is limited by untreated SUDs. Currently SUD screening and interventions are not 
part of COPC services—a missed opportunity to address a key barrier to patient re-engagement in 
HIV care.  
 
SUD stigma among health care workers (HCWs) is a barrier to integrating SUD screening and brief 
interventions into HIV care. Preliminary qualitative work by our team19 and others20 suggests that HCWs 
have stigmatizing views towards PLWH with SUD. This can result in HCW reluctance to provide SUD 
screening and interventions, less time spent with patients who use substances, and lower likelihood of 
providing evidence-based practices and patient-centred care.20 SUD stigma among HCWs is a significant 
barrier that must be addressed for COPC teams to successfully reach and improve care outcomes for PLWH 
with SUD.  
 
SUD stigma also contributes to patients’ poor engagement in HIV care. Our preliminary work has 
shown that patients with SUD anticipate being stigmatised, scolded, and disrespected, and this anticipated 
stigma is a barrier to initiating and engaging in HIV care.19,21,22 When stigma is internalised, SUD stigma is 
also a barrier to engagement in care.23,24 The impact of internalised SUD stigma on care engagement is 
worsened by the presence and intersection of internalised HIV stigma, which persists even in the context 
of a generalised epidemic.25 Following evidence that supports measuring HIV, SUD and other stigmas 
separately, we will explore the contribution of SUD stigma to treatment engagement for PLWH as well as 
how SUD stigma intersects with other stigmas to impact engagement in care. Given SUD stigma’s 
pervasiveness, its impact on health care engagement, and that members of COPC teams are likely to 
hold SUD stigma, COPC teams may therefore have limited success re-engaging PLWH in care 
without strategies to reduce SUD stigma.  

Protocol – NCT05907174                                                                      
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However, stigma reduction interventions for SUD are rare and under-researched in low- and middle-
income countries (LMICs). Strategies for reducing HIV stigma have been researched in LMICs and have 
been efficacious for reducing discriminatory practices among HCWs and improving engagement in HIV 
care.26–29 Intervention efforts to reduce SUD stigma and/or the intersection of HIV and substance use stigma 
have however been limited.  Although strategies for reducing SUD stigma have rarely been evaluated, the 
limited evidence available suggests that social contact with peers is essential to reduce mental health and 
substance use stigma among HCWs.26,30,31 Interventions that incorporate social contact with peers during 
HCW training have been tested, but this contact is often limited to the training period and has not focused 
on SUD.32 Although prior work has shown that the effects of short-term peer contact are unlikely to be 
maintained, it is unclear how to sustain social contact between HCWs and peers in a way that does not 
interfere with health service delivery. In response to this gap, we propose testing whether introducing peers 
into COPC teams could enable sustained peer contact and reduce SUD stigma among these HCWs.  
 
Peer Recovery Coaches (PRCs) may offer a solution for addressing SUD stigma while also improving 
HIV care engagement among PLWH with SUDs. Our team has found that PRCs—trained individuals 
with their own lived experience with SUD integrated into health care teams—allow for sustained social 
contact with other HCWs that can shift SUD stigma among HCWs.33,34 PRCs can also help patients address 
internalised stigma and structural and health system barriers to care engagement.34 Our preliminary work 
in the United States (US) has shown that PRCs can be integrated into health care teams with the peer contact 
associated with a significant increase in outpatient care engagement and increased substance use treatment 
engagement.33,34 Further, in other preliminary work in a low-income setting of the US, a PRC we trained 
was able to successfully link 89% of individuals who were not engaged in care to care.35  
 
Our previous qualitative work also suggests that PRC-delivered services are likely to be acceptable to 
PLWH in SA. For instance, we found that PLWH with SUD in Khayelitsha had an overwhelming 
preference for peer-delivered SUD screening and interventions.19 These patients expressed that peers may 
be more likely to understand them, work with them in a non-judgmental and supportive way, and feasibly 
address barriers to care, including stigma, compared to other HCWs. We have also found that many 
individuals who receive SUD interventions begin acting as “informal” PRCs by sharing the information 
and materials with others,36,37 supporting the feasibility of recruiting peers for a more formalised PRC role 
that includes training, structure and support. Yet, the feasibility and acceptability of incorporating PRCs 
into community-based teams in a setting with a generalised HIV epidemic like SA and into an already 
constrained health care system is in a nascent stage.  
 
We previously conducted two studies (SAMRC HREC Protocol IDs: EC046-10/2020, EC049-
11/2021) to adapt a PRC model to a South African HIV context. In EC046-10/2020, we conducted 
(N=40) qualitative interviews with PLWH and SUD and stakeholders. Key themes that emerged in these 
interviews included that HIV and SUD stigmas negatively impacted patient HIV care engagement; 
participants believed integrating PRCs into community-based services like COPC teams would be highly 
acceptable; and participants believed that PRCs’ lived experience could enhance the quality of services and 
shift stigma among patients and providers. Based on these qualitative findings, in EC049-11/2021, we 
showed a general PRC model to N=24 PLWH and SUD and stakeholders, gathered their feedback, adapted 
the PRC model based on their feedback, and presented the model to them again for final feedback. Based 
on this feedback, we have now adapted the final PRC model, which we hope to test.  
 
Therefore, the purpose of this study is to test this final adapted PRC model by comparing a COPC 
team with an integrated PRC to COPC usual care without an integrated PRC. Using a pilot Type 1 
effectiveness-implementation design,38 we will examine whether the PRC model is feasible, acceptable, 
and potentially beneficial (preliminary effectiveness) for improving patient re-engagement in healthcare 
and reducing SUD stigma.  

Protocol – NCT05907174                                                                      
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3. Research Work Plan  
 
Aims:  
The overall aim of this study is to examine the feasibility, acceptability, and preliminary effectiveness of 
our adapted PRC-COPC model “Siyakhana”. The main goal of this model is to increase engagement in HIV 
care for PLWH with SU and decrease HCW stigma towards SU.  
 
Using a pilot hybrid Type 1 effectiveness-implementation design,38 we will explore whether our adapted 
Siyakhana model is feasible, acceptable, and potentially beneficial for improving engagement in health care 
for PLWH with SU, and reducing SUD stigma among HCWs. We will compare two matched COPC teams 
(i.e., similar in HCW makeup and patient population). Both COPC teams will provide treatment as usual, 
which we will enhance by providing a brief psychoeducational training on SU and SU screening (enhanced 
treatment as usual; ETAU). One of the COPC teams will also be randomized to receive the PRC model 
integration (described more below).  
 
Study Sites 
At the time of initial ethics submission, COPC teams were active in four clinics in the Western Cape: 
Asanda, Nomzamo, Ikhwezi, and Lwandle. Through ongoing conversations with Masincedane—the 
nonprofit organization that oversees these COPCs—Nomzamo and Ikhwezi were selected as our two COPC 
sites. 
 
Both Nomzamo Community Health Centre and Ikhwezi Clinic are located within the larger community of 
Nomzamo, in the Helderberg Basin and Eastern Suburbs of the Cape Town Metropolitan Area. The clinics 
are located approximately 1.5km apart. 
 
Study Design 
The present study is a pilot study with the intent to establish the pilot effectiveness (not efficacy; primary), 
feasibility, and acceptability (secondary) of a PRC model (“Siyakhana”). The study uses a pilot hybrid Type 
1 effectiveness-implementation design.38 In this study, a COPC team using our integrated Siyakhana PRC 
model will be compared to a COPC team without an integrated PRC.  
 
Additional patient-level measures will be collected through this study (patient-level implementation) and 
NIDA grant R36DA057167 (patient-level stigma; PI: Regenauer). However, the primary focus of the 
present study is on the COPC staff level (i.e., HCW level).  
 
Participants and Eligibility  
 
3.1.1 
COPC HCW: Eligibility 
A minimum of N=30 HCWs will be enrolled in this study.  
 
Rationale for Enrolment Numbers.  
Exact enrollment numbers will depend on the size of each COPC team at the time of enrollment.  
 
At the time of initial ethics submission—based on feedback from the Western Cape Department of 
Health—the largest COPC team was comprised of approximately n = 24 HCWs (22 CHWs, 1 outreach 
team leader (supervisor; often a nurse by training), and 1 clinic-based nurse). The HCW numbers on 
each COPC may vary slightly at the time of enrollment due to staff members leaving and new hires. 
However, based on these numbers, we feel confident that each COPC team will employ at least n=15 
HCWs at the time of enrolment.  
 

Protocol – NCT05907174                                                                      
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Therefore, we expect to enroll a minimum of N = 30 HCWs (approximately 15 HCWs per COPC).  
 
HCW Eligibility 
HCW eligibility criteria consists of:  
 
Inclusion:  
- 
Employed as a HCW (e.g., nurse, supervisor, CHW) for one of the COPC teams partnered 
with this study  
- 
18 years or older (expected for all HCWs employed by COPCs)  
 
Exclusion:  
- 
Unable or unwilling to complete informed consent and study procedures (i.e., brief trainings, 
self-report assessments) in English, isiXhosa, or Afrikaans  
 
 
3.1.2 
COPC Patient: Eligibility 
We aim to enroll N=50 patient participants in this study (n=25 patients per COPC team).  
 
Rationale for Enrolment Numbers.  
As this is a pilot study with the primary goal of establishing feasibility and acceptability, we view our 
effectiveness effect size as preliminary. However, based on prior work in this population and with 
PRCs, we expect to find a small improvement in patient re-engagement in care in enhanced treatment 
as usual (ETAU; previous studies have found about 14% re-engagement in ETAU39) and a larger 
improvement in the PRC condition (previous studies have found 66-89% improvement7,34). Assuming 
ETAU re-engages at an even higher rate (i.e., 24%), and Siyakhana (PRC condition) re-engages at the 
low end of previous studies (i.e., 66%), enrolling 50 patients will give us approximately 85% power to 
detect a difference in patient re-engagement after accounting for up to 20% attrition and/or missing 
records.  
 
Patient Eligibility.  
Patients will be eligible if they meet the criteria in the table below.  
 
Patient Eligibility Criteria  
Inclusion Criteria 
Exclusion 
1. 18 years or older 
1. Unable or unwilling to complete informed 
consent or study procedures in a language 
spoken by members of our team (i.e., 
English, isiXhosa, Afrikaans)  
2. Living with HIV 
3. Problematic alcohol or other drug use 
(AOD) defined a CAGE score >2 
4. Seen by a HCW from one of the COPC 
teams partnered with this study 
 
 
3.1.3 
Stakeholders (Qualitative Interviews): Eligibility 

Protocol – NCT05907174                                                                      
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Participants will be up to n=15 HCWs (not previously enrolled in the study), leaders, policymakers or 
others involved in administration/supervision at COPCs, clinics, the Department of Health, or other 
relevant organizations.  
 
Rationale for these numbers 
This number of participants will allow us to represent a wide range of perspectives. The study team 
will identify stakeholders by asking people working in the health care system to refer stakeholders that 
are involved in NGO managed COPC and CHW services. We anticipate this number will allow us to 
reach theoretical saturation for qualitative analysis.  
 
Eligibility Criteria 
To be eligible, stakeholders must meet the following criteria: 
 
Inclusion:  
- 
Employed in a HCW role (not previously enrolled in the study), a leadership role, a 
policymaking role, or other administrative/supervision role for an organization 
associated with the COPC teams with whom this study partnered (e.g., partner non-
profit organization, affiliated clinics, Department of Health) 
- 
18 years or older (expected for all employed in the abovementioned positions)  
 
Exclusion:  
- 
Unable or unwilling to complete informed consent and study procedures (i.e., brief 
training(s), brief self-report assessments) in English, isiXhosa, or Afrikaans 
 
Recruitment  
 
3.1.4 
COPC HCWs: Recruitment 
Based on ongoing conversations with the Western Cape Department of Health, we will select two of 
the four COPC teams to partner with for this study. These teams will be located at two of the following 
four sites: Asanda, Nomzamo, Ikhwezi, Lwandle.  
 
All members of the two chosen partner COPC sites will be invited to join the study. Study staff will 
work with COPC supervisors to determine an appropriate time to approach the COPC members, tell 
them about the study, and ask them if they are interested in participating. Due to the nature of the study 
procedures (i.e., group COPC training delivered during normal work hours), HCWs colleagues will 
know whether they participate in the training. However, we will make it clear that colleagues will never 
see each other’s answers to assessment questions. We will also work with the supervisors to ensure that 
participation, or lack thereof, will not affect the HCWs employment.    
 
3.1.5 
COPC Patients: Recruitment 
After receiving the ETAU training (i.e., SU psychoeducation and screening), HCWs in both COPCs 
will be asked to screen their HIV patients for SU using the CAGE. HCWs will be trained on these 
screeners during ETAU training. If a participant screens positive on alcohol or other drug use (AOD), 
the HCW will ask the patient if they would be willing to be contacted by a researcher at the SAMRC 
about potentially participating in the study. If the patient says yes, the CHW will pass on any relevant 
contact information (e.g., phone number, address) to the study team. If a HCW on a COPC chooses not 
to screen a patient, they will be told they can still tell the patient about the study, and ask the patient if 
they would like to be contacted by a researcher at the SAMRC about potentially participating in the 
study. If the patient says yes, the CHW will pass on any relevant contact information to the study team. 
Finally, HCWs will be given study flyers that they can choose to hand out to their patients. These flyers 
have study contact information so that interested patients can contact the study team directly.  

Protocol – NCT05907174                                                                      
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It will be made clear to all potential patient participants that joining or not joining the study will in no 
way affect treatment from their COPC HCWs, from their clinic, or from anyone else. 
 
3.1.6 
Stakeholders (Qualitative Interviews): Recruitment 
NGO leaders, policymakers and other stakeholders (n=15) referred from health system leadership will 
be recruited. Trained study team members will approach stakeholders and tell them further about study 
procedures and ask if they would be interested in participating in a qualitative interview.   
 
Study Procedures 
 
3.1.1 
COPC HCWs: Procedures 
Study procedures for HCWs in the Pilot PRC Study are described below and illustrated in Figure 1.  
 
HCW Enrollment and Baseline Assessment: Eligible and interested HCWs in the two partner COPC 
teams will be enrolled upon completed the informed consent process. All HCWs will then complete an 
individual baseline assessment consisting of self-report measures to assess basic demographic and job 
information, and stigma towards SUD (primary).  
 
COPC Randomization & Training. After all 
HCW baseline assessments have been 
completed, one COPC will be randomly 
assigned to the ETAU condition (i.e., 
ETAU training only) and one COPC will be 
randomly assigned to the Siyakhana (i.e., 
ETAU and PRC integration training) 
condition. These trainings are described in 
more detail below.  
 
Randomization will be determined by 
flipping a coin on a video-call with multiple 
study staff members (including at least one 
PI) in attendance. 
 
ETAU Training (Psychoeducation): 
Both COPC teams will receive the 
ETAU training from our study team. 
This 
training 
will 
consist 
of 
psychoeducation around how to screen 
and refer for SU in HIV patients, the 
prevalence of SU in HIV, and the 
impact SU has on HIV care. This 
training will last for 1-2 days, depending on COPC availability. A brief psychoeducation refresher 
course (i.e., one afternoon a week or two after the original training) will also be offered. The 
purpose of this refresher will be to review how to screen and refer patients for substance use and 
answer any questions about screening and referring.  
 
PRC Integration Training: Only the COPC randomized to the Siyakhana (PRC+ETAU) condition 
will receive the Siyakhana PRC Integration Training. In this training, the already trained PRC will 
be introduced to HCWs in the Siyakhana COPC. Together, the PRC and these HCWs will be trained 
on the PRC role (i.e., the difference between a PRC and a CHW) and how to refer to the PRC. This 
Figure 1. HCW Procedures 

Protocol – NCT05907174                                                                      
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training will last from 1-2 days, depending on COPC availability. After the training, the PRC will 
join this COPC (e.g., shadow team members before patients are enrolled, work closely with the 
COPC team, attend weekly COPC supervision) for the remainder of the study.  
 
Active Treatment Phase: After the training(s), HCWs in both COPCs will continue visiting and treating 
patients as usual. The treatment as usual will potentially be enhanced (i.e., ETAU) by HCWs now being 
trained in how to screen patients for SU, and how to refer patients to local, publicly-funded SU treatment 
programs. The study team will provide each COPC with initial SU screeners, and let the COPCs know 
that the team can provide more screeners at any time during the active phase of the study. 
 
Siyakhana: HCWs in the Siyakhana COPC will be aware that any patients who enroll in the study 
will be invited to meet with the PRC. This PRC will be present at COPC meetings, supervisions, 
etc. 
 
HCW 3MFU: Approximately three-months after the PRC integration (i.e., enrollment of first patient 
participant), all HCW participants will be asked to complete a three-month follow-up (3MFU) 
assessment. This brief assessment will consist of the same self-report stigma measures as the HCW 
baseline assessment.  
 
HCW 6MFU Assessment. Approximately six-months after the PRC integration, all HCW participants 
will be asked to complete a six-month follow-up (6MFU) assessment. This assessment will consist of 
the same self-report stigma measures as the HCW baseline and 3MFU assessments. Additionally, HCW 
participants in the Siyakhana condition will be asked to complete the Feasibility, Acceptability, and 
Appropriateness subscales of an Implementation & Dissemination measure.1 
 
Qualitative Interviews. After the 6MFU assessment, all HCW participants in the Siyakhana 
condition will be invited to participate in a semi-structured, individual interview with a study team 
member. The purpose of this interview will be to assess the feasibility and acceptability of the PRC 
Model Integration. Ideally, these interviews will be conducted immediately after the 6MFU 
assessment. However, if it is not possible to conduct them on the same day as the 6MFU assessment, 
the interview will be scheduled for as soon as possible.  
 
3.1.2 
COPC Patients: Procedures 
Study procedures for patient participants in the Pilot PRC Study are described below and illustrated in 
Figure 2.  
 
Patient Screening & Enrolment. At least once a week, the study team will consult with enrolled COPC 
HCWs on patients who may be interested in participating in the study. The study team will contact 
these patients and briefly tell them about the study. If a patient is still interested in potentially 
participating, the study members will officially screen the patient. If the patient is still interested in 
participating after screening and met all eligibility criteria, a staff member will complete the informed 
consent process with the patient as soon as possible. The consent form will include all study procedures 
and state that we are seeking approval to extract information from medical records (i.e., information 
related to clinic visits (dates, attendance), HIV (viral load, CD4 count), care for other chronic diseases, 
referrals to other programs including SU treatment programs, etc.). It will also state that we are seeking 
approval to see if they attended local publicly funded SU treatment programs (date(s) of attendance, 
location(s) attended), provided through the South African Community Epidemiology Network on Drug 
Use (SACENDU). Finally, it will state that the study will only collect medical record and SU treatment 
program attendance data between the date of their baseline assessment and the date of 6MFU.  

Protocol – NCT05907174                                                                      
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Patient Baseline Assessment: Upon completing informed consent, all patients will be asked to complete 
a self-report baseline assessment with a study team member. Ideally the baseline assessment will be 
completed immediately after informed consent is given. However, if the patient is unable to complete 
the baseline assessment immediately after consent, a time to complete the assessment will be scheduled 
for as soon as possible. The 
patient 
baseline 
assessment 
consists of self-report questions 
around demographics, SU, HIV, 
and stigma. After the baseline 
assessment, 
all 
patient 
participants 
will 
be 
given 
another referral to the nearest 
free SUD treatment program(s) 
(for example, the Help Me 
Network). 
 
Patient Active Treatment Phase: 
0 to 12 weeks post-baseline. 
Following the completion of the 
patient baseline assessment, the 
below procedures will occur.  
 
ETAU 
Patients. 
Patients 
seen by the ETAU COPC 
will continue to receive 
normal treatment from their 
COPC HCWs (i.e., normal 
efforts to re-engage patients in HIV care). These normal visits will be enhanced through (1) their 
COPC HCWs knowing how to, and therefore, potentially screening them for problem SU, and (2) 
their COPC HCWs knowing how to give referrals to local SU treatment programs. It is also possible 
that they will receive enhanced care from their COPC HCWs due to their COPC HCWs now 
knowing more about SU in the context of HIV. 
 
Siyakhana (PRC+ETAU) Patients. Patients seen by the Siyakhana COPC will be invited to attend 
sessions with a PRC after their baseline assessment.  
 
The structure and content of PRC sessions were designed based on patient and stakeholder feedback 
about PRCs (Protocol IDs: EC049-11/2021, EC046-10/2020). Siyakhana patient participants will 
be invited to meet with the PRC on a regular basis for approximately 12-weeks (3-months). Each 
meeting will be scheduled to last approximately 30 minutes, although an hour will be allocated for 
each meeting. The PRC and patient together will decide where to meet in a venue that is physically 
and psychologically safe for both the PRC and patient. Options deemed safe by stakeholders and 
patient participants in our formative work included the library, the local clinic, community centers, 
and for some, their homes. The location that the PRC and patient chooses will be recorded so that 
we have this information for future iterations of this project. The goal of these meetings will be for 
the PRC to motivate the patient to return to HIV care and seek SUD treatment. In training the PRC, 
the PRC will have attained competence in providing brief education around SU and HIV, 
supporting the patient in their recovery, and helping the patient problem-solve barriers to accessing 
both HIV and SU care.  
 
Figure 2. Patient Procedures 

Protocol – NCT05907174                                                                      
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Frequency of PRC sessions, and an overview of their content, are described in the table below. The 
proposed contact schedule was co-designed with patient and stakeholder feedback in our formative 
work but is only meant as a guideline for the PRCs. While it is expected that most patients will 
follow the below structure, additional sessions can be added or removed if needed in this pragmatic 
implementation study. Similarly, while the PRC will be instructed to complete all sessions within 
the 3-month period after baseline, there can be some flexibility (e.g., if a patient is away for a month 
in December/January, they may have the option to pause sessions for a month and pick them back 
up in late January). The frequency that patients meet with the PRC, and the general content of each 
session, will be recorded and used to inform further refinements to the PRC model for future trials.  
 
Flexible Guidelines for PRC Sessions (12-weeks) 
Week(s) 
Frequency & Content 
1 
First session: Introduction to PRC sessions. PRC and patient discuss 
meeting time and locations, boundaries, and what the PRC’s role is and is 
not. The PRC may also share their own story and experiences to engage 
the patient.  
 
2 – 4  
Weekly sessions: The PRC and patient meet approximately weekly. The 
PRC’s goal is to help the patient navigate challenges they may be 
experiencing in engaging in HIV/SU care. The PRC may do this by 
providing psychoeducation around SU and HIV, using basic counselling 
skills (e.g., motivational interviewing, problem-solving therapy, 
behavioural activation), and supporting the patient in their recovery 
journey. The PRC may also share his/her own experiences throughout to 
engage the patient.  
 
5 – 8  
Session every other week: The PRC and patient will meet approximately 
every other week. The PRC will continue to support the patient in their 
recovery and motivate them to re-engage in HIV care and engage in SUD 
treatment.  
  
9 – 12  
Sessions as needed: In the final month, the PRC and patient together will 
determine how many sessions are needed. The PRC’s goal this month will 
be to help the patient re-engage in HIV care and SUD treatment (if needed, 
if they have not already) and help them transition to using resources other 
than the PRC to support them in their recovery (e.g. peer support groups 
in the community). 
 
 
Patient 3MFU Assessment. Approximately 3-months after their baseline assessment, patient participants 
will be asked to complete a 3MFU assessment. The 3MFU assessment consists of the same self-report 
questions around SU, HIV, and stigma that were asked at the baseline assessment. Additionally, patients in 
the Siyakhana condition (i.e., patients who had the opportunity to meet with a PRC) will also be asked to 
complete the Feasibility, Acceptability, and Appropriateness subscales of an Implementation & 
Dissemination measure.1 
 
12 to 24 weeks (3-6 months) post-baseline. Following the active treatment phase (which lasts approximately 
12-weeks post-baseline), all participants will continue to receive their usual care. Participants in the 
intervention COPC will have the option to receive optional “booster sessions” with the PRC. These optional 
sessions will review material previously covered in normal sessions.  

Protocol – NCT05907174                                                                      
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Patient 6MFU Assessment. Approximately 6-months after their baseline assessment, patient participants 
will be asked to complete a 6MFU assessment. The 6MFU assessment consists of the same self-report 
questions around SU, HIV, and stigma that were assessed at the baseline assessment. Additionally, patients 
in the Siyakhana condition (i.e., patients who had the opportunity to meet with a PRC) will also be asked 
to complete the Feasibility, Acceptability, and Appropriateness subscales of an Implementation & 
Dissemination measure.1 
 
Qualitative Interviews. After their 6MFU, all participants in the Siyakhana condition will be invited 
to participate in an individual, semi-structured interview.   
Stigma. As part of a sub-study (R36DA057167), one part of the interview will assess 
patient perspectives on internalized SU stigma, potentially intersecting stigmas (e.g., HIV, 
gender, religion, ethnicity) from multiple levels (e.g., self, providers, community), 
experiences with the PRC, engagement in HIV and SU care, and relations between all these 
topics. The key domains of these interviews are perspectives on: (a) internalized SU 
stigma; (b) intersecting stigmas from multiple levels; (c) the PRC; (d) engagement in care; 
and (e) how these domains relate.  
Implementation. As part of the current study, the second part of the interview will assess 
patients’ perspectives on the implementation of the study. The main domains of interest 
will be feasibility and acceptability. However, other implementation domains, such as 
reach, adoption, and appropriateness, will also be assessed. 
 
 
3.1.3 
Stakeholders (Qualitative Interviews): Procedures 
Potentially eligible NGO stakeholders will be screened for eligibility. If eligible and interested in 
participating, they will undergo informed consent procedures. As part of this process, participants will 
be informed of all the potential risks and benefits to taking part in the one-time interview. Participants 
will be reminded that participation is voluntary and that they can decline to answer any questions that 
they are not comfortable answering and that they can withdraw from the study at any point. They will 
also consent to having the interview audio-recorded.  
 
 
3.1.4 
Additional Procedures 
We recognize the importance of ongoing support to PRCs in their recovery.  Therefore, we have come 
up with strategies to monitor and support PRCs’ ongoing recovery and self-care. We have successfully 
used these and similar strategies in previous studies.35,44–47 
 
Recovery Stability: All PRCs in this study will be well-established in their recovery (i.e., 
have been in self-reported recovery for at least one to two years, which is the threshold 
most commonly used in other settings for the PRC role). All PRCs hired will be selected 
based on their recovery length as well as supports for ongoing recovery.   
 
Ongoing Supervision: The PRC(s) will receive regular (i.e., weekly or biweekly) 
supervision from the study team. The PRC(s) main supervisor will be a study team member 
who has previously worked with PRCs and is familiar on how to supervise this role. The 
supervisor will help the PRC monitor and reflect on their own recovery during supervision 
sessions, with ongoing attention to self-care following best practices for supervising PRCs.  
 
Participant Compensation  
 
3.1.1 
COPC HCWs: Compensation 

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Initially, HCW participants did not receive monetary compensation for their trainings or assessments. 
The rationale for not providing monetary compensation for trainings was that participation in trainings 
is a regular part of their professional development, and trainings were conducted during usual working 
hours (time negotiated with organization that oversees COPC). Attendees were provided with meals 
during trainings and received reimbursement for travel (or were provided with travel) if they had to 
travel outside of their normal work commute for trainings. The rationale for not providing monetary 
compensation for assessments was similar – assessments were conducted during normal work hours 
and at their place of work. However, based on participant feedback, an amendment was approved so 
that HCW participants will be reimbursed R150 rand for completing a 6MFU, and for completing a 
qualitative interview. 
 
3.1.2 
COPC Patients: Compensation 
Patients will be compensated 150 Rand for each assessment (baseline, 3MFU, 6MFU) they complete. 
They will be compensated an additional 150 Rand for completing a semi-structured interview after the 
6MFU.  
 
3.1.3 
Stakeholders (Qualitative Interviews): Compensation 
The stakeholders participating in the interviews will receive a 150 Rand gift voucher for consenting 
and completing the semi-structured qualitative interview.  
 
Phone 
All assessments and interviews may be completed in-person or over the phone. If over the phone, the 
research assistants will ask the participant if they feel free talking freely before beginning.  
 
Allowing assessments and interviews to occur in-person or over the phone will allow for more flexibility 
around scheduling. As patients living with HIV who have disengaged from care and are using substances 
is a hard-to-reach population, this flexibility may allow us to recruit and retain more patients.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol – NCT05907174                                                                      
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4. STATISTICAL ANALYSIS PLAN 
 
Type and Purpose of Data  
The purpose of this pilot hybrid Type 1 implementation-effectiveness trial is to examine the pilot 
effectiveness (primary) and implementation (secondary) of our adapted PRC model. This study will collect 
quantitative (self-report assessments) and qualitative (semi-structured interviews) data. Additionally, HIV 
and attendance-related data will be extracted from patients’ medical records, and attendance data will be 
extracted from patients’ SUD treatment records. 
 
Effectiveness Outcomes  
 
4.1.1 
Primary Outcome: HCW Stigma Towards SU 
HCW stigma towards SUD will be measured using the Social Distance Scale (SDS),2,3,54 a well-
validated measure of stigma used to capture health-related stigma across conditions and has 
been recommended for assessing mental health stigma among healthcare providers.  
 
A total SDS score will be calculated to represent HCW stigma towards the target population at 
each time point, with higher scores indicating greater desire for social distance. First, we will 
conduct descriptive analyses (e.g., mean, standard deviation) to summarize the CHW stigma, 
using the continuous SDS score. The data distribution will be assessed to see whether the 
underlying assumptions are met (e.g., normality). Then we will examine the trajectory of HCW 
SUD stigma scores over time across the two conditions using a generalized linear mixed model, 
which includes all data points. The primary parameter of interest will be the interaction between 
time and condition to test whether changes in SUD stigma over time differ between the two 
groups. 
 
Data will be analyzed over both three-months (3MFU) and six-months (6MFU). The primary 
timepoint is the 3MFU. 
 
4.1.2 
Other Outcome: Patient Engagement in HIV Care 
Throughout the study, patients’ medical records will be monitored and clinic attendance data 
will be extracted.   
 
We will compare the rate of re-engagement in HIV care in the Siyakhana condition to rate of 
re-engagement in HIV care in the ETAU condition. Our primary analysis will be a logistic 
regression examining re-engagement in care by group. We will examine engagement both 
between baseline and the 3MFU, and between baseline and the 6MFU. To supplement this 
dichotomous measure, we will also conduct a Poisson regression model to examine number of 
clinic visits by group over 3 and 6 months, and a Cox Proportional Hazard survival analysis to 
model time to re-engagement by group.  
 
Implementation Outcomes 
 
4.1.3 
Secondary Outcomes: HCW Feasibility and Acceptability 
Feasibility is defined as the extent to which a HCW could engage with the PRC given their 
available resources such as time, money, and family or job responsibilities. Acceptability is 
defined as the extent to which HCWs found the tested PRC model satisfying and agreeable. 
 
Quantitative Assessment: At their follow-up assessments (3MFU, 6MFU), HCWs will be given 
the Feasibility and Acceptability subscales (two separate scales) of a Dissemination & 

Protocol – NCT05907174                                                                      
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Implementation measure based on the Consolidated Framework for Implementation Research 
(CFIR).1 The measure will be adapted specifically to assessing the implementation of the PRC 
model for HCWs. We have used this subscale in previous studies in South Africa (for instance 
in Khayelitsha44). Items on this measure will be averaged for an overall feasibility rating from 
0 to 3, with higher scores indicating higher feasibility. The primary Feasibility and 
Acceptability timepoint for HCWs is their 6MFU. 
 
Qualitative Assessment: Brief semi-structured interviews assessing perceived feasibility and 
acceptability of the PRC model will be conducted with HCWs in the Siyakhana condition after 
their 6MFUs. 
 
4.1.4 
Other Outcomes: Patient Feasibility & Acceptability  
Feasibility is defined as the extent to which a patient could engage with the PRC (including in 
PRC sessions) given their available resources such as time, money, and family or job 
responsibilities. Acceptability is defined as the extent to which patients found the tested PRC 
model satisfying and agreeable. 
 
Quantitative Assessment: At their follow-up assessments (3MFU, 6MFU), patients will be 
given the Feasibility and Acceptability subscales (two separate scales) of a Dissemination & 
Implementation measure based on the Consolidated Framework for Implementation Research 
(CFIR).1 The measure will be adapted specifically to assessing the implementation of the PRC 
model for patients. We have used this subscale in previous studies in South Africa (for instance 
in Khayelitsha44). Items on this measure will be averaged for an overall feasibility rating from 
0 to 3, with higher scores indicating higher feasibility. The primary Feasibility and 
Acceptability timepoint for patients is their 3MFU. 
 
Qualitative Assessment: Brief semi-structured interviews assessing perceived feasibility and 
acceptability of the PRC model will be conducted with patients in the Siyakhana condition after 
their 6MFUs. These interviews will be combined with interviews on stigma (conducted for 
R36DA057167). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol – NCT05907174                                                                      
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5. ETHICAL CONSIDERATIONS 
 
Potential Risks to Participants  
There is minimal risk from the research procedures in the present study. However, the following risks are 
still possible:  
 
5.1.1 
Breach to confidentiality 
As with any study, breach of confidentiality is a potential risk. Ways to minimize this risk are described 
below.  
 
5.1.2 
Psychological or mental discomfort 
It is possible that participants will feel uncomfortable discussing certain topics in trainings, 
assessments, or PRC sessions. For instance, HCW participants may feel nervous discussing their 
judgments towards SU, patient participants may feel uncomfortable discussing sensitive topics related 
to SU and stigma with the peer or study staff, and peers may feel uncomfortable discussing these topics 
in their training.  
 
5.1.3 
COVID-19 transmission  
Due to the current COVID-19 pandemic, there is a potential risk for COVID-19 transmission between 
project staff and participants. Efforts to minimize these risks are described below. 
 
Protections Against Risks  
Every effort will be made to minimize all study-related risks. These efforts include:  
 
5.1.4 
Informed consent 
All participants will complete informed consent procedures. To join the study, participants must fully 
understand and sign the consent form (or, if over the phone, give verbal informed consent after going 
through the form with the study team member). All participants will have as much time as they want to 
review the consent form and ask questions. A study team member will also review the form with each 
participant. The consent form will include all study procedures, information about potential risks and 
benefits of participation, and information regarding whom they can contact for further questions. It will 
also state that participation is voluntary, that participants can refuse to answer any question, that 
participants can withdraw from the study at any time, and that participation (or lack thereof) is in no 
way related to their employment or care. All procedures and protocols will be approved by the South 
African Medical Research Council’s (SAMRC) Human Research Ethics Committee (HREC) before 
study initiation.  
 
Ensuring capacity to provide consent if a person uses substances. Ensuring that people are not 
intoxicated at the time of providing consent is important. If a potential participant appears acutely 
intoxicated, that person will not be consented into the study. The study team will be trained by Drs 
Myers and Magidson on how to detect simple signs of intoxication, such as impaired or slurred speech, 
smelling of alcohol, impaired co-ordination or balance- if any of these signs are present, we will not 
enrol a participant or continue with any research activities at subsequent appointments with those 
already enrolled in the study. To increase our confidence in potential participant’s capacity to consent, 
we include a simple assessment of intoxication in our screening form and assess capacity to provide 
consent in our consent form, that has been used in other studies with populations of patients who use 
alcohol.  
 
5.1.5 
Preventing breaches to confidentiality  

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The confidentiality of each participant will be respected and maintained. Participant confidentiality will 
be ensured at all stages of the study.  
 
All data will be kept confidential and only accessible to study staff. Participants’ data will be identified 
by a study identification (ID) number only and a link between the names and ID numbers will be kept 
separately on a secure server and in a password protected document. This link will be destroyed after 
the study, including data analysis, has ended. The only individuals who have access to the link are the 
trained study coordinators on this project in South Africa. The study team at UMD will only have access 
to data identified with participant ID. Participant documents which include personal identifiers (such 
as signed consent forms) will be kept in locked files at SAMRC with restricted access. All other de-
identified study documents will be kept in a secure location (such as UMD Box) and only study team 
members will have access to this location. 
 
As part of the informed consent process, all participants will be advised that they may decline to answer 
any study questions. All study personnel working on the project will receive training about strictly 
adhering to study protocols regarding participant confidentiality.  
 
Qualitative interviews and sessions will be audio-recorded for analysis. The purpose of the recording 
will be explained to all participants and informed consent and authorization for recording will be 
obtained. Digital audio recordings will be uploaded to the study computer immediately following 
session and the file will be deleted from the recorder/ recording program. Computer files will be secured 
by a password and will only be accessible to authorized study personnel. The digital recording will be 
uploaded and stored using a secure project drive (i.e., UMD Box). Following the South African good 
clinical practice (GCP) guidelines and guidelines set by the American Psychological Association (APA; 
APA Record Keeping Guidelines, Guideline #7), recordings will be maintained until seven years after 
the publication of the study. The ethics committee will review study procedures at least annually to 
review procedures pertaining to participant confidentiality. 
 
5.1.6 
Protections against psychological or mental discomfort 
All study staff conducting trainings and assessments will be trained to recognize signs of discomfort, 
distress, or anxiety. Participants will take breaks when necessary to help alleviate any discomfort. 
Participants will also be reminded that they can refuse to answer any question that makes them 
uncomfortable and may take breaks whenever they are needed. They will also be informed that they 
have the right to decline participation in the study, or to withdraw consent at any time without adverse 
consequences. All patient participants will also be given referrals to local SUD services. HCW 
participants will be given information about SUD referrals. If needed, mental health referrals will also 
be given. We have a network of referral resources in the area, established through previous studies in 
this area.14,16,32,38  
 
The PRC(s) will also be trained in recognizing signs of discomfort, distress, and anxiety in the patients 
they work with. The PRC(s) will be taught about local referral resources and taught to give patients the 
referrals when needed.  
 
Additionally, there is a study protocol for managing distressed participants that all study staff will 
receive training in as well as regular supervision and debriefing. This protocol was developed by Dr. 
Myers and has been used across multiple studies with highly vulnerable populations, including 
traumatized women who use substances, people living with HIV, depression and problem alcohol use, 
and adolescents with alcohol and depression. In all her studies, Dr. Myers has successfully managed all 
incident cases of distressed participants and there have been no serious adverse or adverse events related 
to mental health or substance use harms. For participants who are distressed and at risk of harm, we 
will actively refer and link them to appropriate resources to help them cope with and deal with their 

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distress.  Dr. Myers is a registered clinical psychologist (PS 007 1935) and given the size of this study, 
will be able to provide active and daily clinical oversight to determine the level of care needed for each 
distressed participant. Our strategies to actively link distressed participants to care include debriefing 
with the participant. Our study team includes registered psychological counsellors who are trained and 
have the correct competencies to do this Strategies will include making (and fast-tracking 
appointments) at the appropriate agency and accompanying the distressed participant to the agency for 
their appointment to ensure that they receive the recommended services. Dr Myers has worked in the 
target communities for more than 15 years and has an established network of mental health and 
substance use providers to whom we can refer participants should the need arise.   
 
5.1.7 
Health and safety: COVID-19 
To reduce the likelihood of COVID-19 transmission, all staff members will be trained in COVID-19 
safety protocols and the SAMRC standard operating procedures for the conduct of research during 
COVID-19. Staff members will have access to personal protective equipment (PPE) which will include 
masks. All staff members will wear PPE when required by the SAMRC, and can choose to wear PPE 
when it is not required by the SAMRC. When required by the SAMRC, social distancing (of 1.5m) 
between staff member and the participant will be practiced, and all surfaces used will be disinfected 
before and after any trainings/assessments are held. On a case-by-case basis (to be discussed with study 
managers and PIs), patients and PRCs may choose to have a session over a phone call rather than in-
person. 
 
Potential Benefits of Proposed Research to Human Subjects and Others 
 
5.1.8 
COPC HCW Participants 
It is possible that HCW participants will not directly benefit from this study. However, HCWs may find 
that they benefit from the additional information they learn in the training(s), such as general 
information on SU, SU in the context of HIV, how to screen for problem SU, and how to refer to 
publicly-funded SUD treatment programs. HCWs in the Siyakhana condition may also enjoy the 
opportunity to share their feedback on the tested PRC model.   
 
5.1.9 
COPC Patient Participants  
It is possible that patient participants will not directly benefit from this study. However, patients may 
find the treatment referrals—and their COPC HCWs potential increased knowledge of SU and 
referrals—helpful. Patient participants in the Siyakhana condition may find working with the PRC 
helpful in their recovery journey, and helpful in getting connected to services and re-engaged in HIV 
care. Finally, patient participants may enjoy the opportunity to share their feedback on this new PRC 
model.  
 
5.1.10 Importance of the knowledge to be gained  
From a broader perspective, the current study will be the first to our knowledge to test a novel, adapted 
PRC model in a low-resource setting for patients struggling with HIV care engagement. As SU stigma 
among HCWs and patients represent barriers to HIV care engagement, this project will help in 
understanding how to conduct outreach to people living with HIV and SUD and struggling with HIV 
care engagement. Further, since this knowledge is being generated within existing COPC teams 
managed by the Western Cape Department of Health, it has the potential for sustainability and scale-
up. Finally, this research will inform future iterations of this model powered to measure effectiveness.  
 
Protection of Personal Information (POPI) Act 4 of 2013  
In the consent form, all participants will consent to: their personal information (data) being collected, 
processed, shared and stored in accordance with this research protocol as approved by the SAMRC HREC;  
their anonymised data being shared, processed, and transferred by third parties and between third parties 

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where relevant beyond the jurisdictional borders of South Africa (i.e., to the research team in the United 
States); and to the findings and results flowing from their anonymised data being broadly shared and 
published on the conclusion of the research.  
 
In line with the South African POPI act, all data will only be shared securely as outlined in this research 
protocol. Researchers involved with this project at the University of Maryland in the United States will only 
have access to de-identified, anonymised data.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol – NCT05907174                                                                      
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6. DATA MANAGEMENT 
 
Data Storage 
6.1.1 
Data acquisition and transmission 
Data collection occurs only in SA at the specified data collection sites. All quantitative data will be 
entered into an electronic REDCap database (described below). All participants will be given a study 
ID. Personal identifying information of study participants will be kept entirely separate from their coded 
data.  
 
Data Integrity. All trainings and assessments will be facilitated by a trained member of the study staff 
who will be supervised throughout the study. The PRC(s) will also be trained before interacting with 
patients and will receive regular supervision from trained members of the study team.  
 
Recordings. Qualitative interviews and sessions will be audio recorded for data analysis. The purpose 
of recordings will be explained, confidentiality will be respected, and informed consent, including the 
authorization for recording, will be obtained. All recordings will be uploaded to the secure study drive 
immediately after the interview is complete. Computer recordings will be secured by password and will 
be accessed only by authorized study personnel. Digital recordings will be stored and moved between 
sites using a secure, password-protected storage site, such as Box through UMD. In line with the 
guidelines of the American Psychological Association (APA; APA Record Keeping Guidelines, 
Guideline #7), recordings will be maintained until seven years after the publication of the study.  
 
Identifiable Data. Consent forms and any other documents with identifiable information will be kept in 
a separate, secure filing cabinet at the secure SAMRC study site.  
 
De-Identified Data. De-identified data will be kept in a secure electronic system, such as Box through 
UMD. Only authorized study staff will have access to this data. 
 
Link. The link between the names and ID numbers of participants will be kept separate from all other 
data on a secure server at SAMRC and in a password protected document. The link will be destroyed 
after data analysis for the study has ended. Only trained study staff in South Africa will have access to 
this link. 
 
6.1.2 
Data entry methods 
Qualitative.  
Interviews. Qualitative data will be collected from in-depth interviews which will be recorded and 
transcribed. Transcripts will be transferred into MS Word files before being uploaded to NVivo53 for 
analysis. 
Sessions. PRC sessions will be recorded for ongoing supervision purposes.  
 
Quantitative Assessments. 
Data entry will occur as close to real time as possible to facilitate data management and monitoring of 
study operations. If assessments are done on paper, they will be scanned by a research assistant as soon 
as possible and sent to the study’s secure server. The paper assessment will then be filed away at a 
secure location at the MRC and the scanned assessment will be entered on REDCap.  
REDCap. Demographic and measure data will utilize REDCap through UMD, a secure software 
toolset and workflow methodology for electronic collection and management of research and clinical 
trial data in real-time. SAMRC also uses REDCap for data collection. REDCap provides a web-based 
application with an intuitive interface for users to enter data and have real time validation rules (with 
automated data type and range checks) at the time of entry. REDCap data collection projects data on a 
thorough study-specific data dictionary defined in an iterative self-documenting process by all members 

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of the research team with planning assistance from UMD. All information entered on REDCap will be 
de-identified in order to protect participants’ identities. 
 
6.1.3 
Quality assurance 
Data Completeness. To ensure the usability of self-report data, a member of the research team will 
review all self-report measures to ensure their completeness. Using an electronic data capture system 
such as REDCap is meant to reduce errors in the data entry and management process. Using REDCap, 
missing data can be reduced by making items required to answer before moving on to the next item and 
effort and error associated with data entry can be reduced because there is no manual entering of data 
at a later timepoint by research assistants.  
 
Confidentiality. Participant data on study materials (including electronic study materials saved on a 
secure study drive such as Box) will be identified only by participant number and date of visit. By 
recording the study data in this manner, the information can be considered ‘de-identified.’  
 
Data safety and monitoring plan  
6.1.4 
Regulatory issues 
The procedures laid out in this document will be followed, in compliance with US National Institutes 
of Health (NIH) requirements as well as South African good clinical practice guidelines, to ensure the 
safety of study participants and the validity and integrity of data.  
 
Before initiation of this study, the protocol, informed consent, and all other materials used with 
participants in this study will be reviewed and approved by SAMRC ethics committee. The study team 
will additionally submit a report to SAMRC ethics committee on an annual basis. 
 
6.1.5 
Amendments  
Any changes to the protocol or amendments will be submitted to SAMRC ethics committee before they 
are implemented.   
 
6.1.6 
Reporting definitions 
Unanticipated problems are any incidents/ experiences/ outcomes that are (1) unexpected (in terms of 
nature, severity, or frequency), (2) related or possibly related to participation in the research, AND (3) 
suggest that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously recognized.  
 
Adverse events (AEs) are any untoward or unfavourable medical occurrences in a human subject, 
including any abnormal sign, symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s participation in the 
research.  
 
Serious adverse events (SAEs) are any adverse events that meet any of the following criteria: (1) results 
in death; (2) is life-threatening; (3) requires inpatient hospitalization or prolongation of existing 
hospitalization; (4) results in a persistent or significant disability/ incapacity; (5) results in a congenital 
anomaly/ birth defect; OR (6) may jeopardize the subject’s health and may require medical or surgical 
intervention to prevent one of the other outcomes listed in this definition.  
 
Labelling of AEs and SAEs.  
Severity. AEs and SAEs will be labelled according to severity by one or both of the PIs, based 
on their impact on the patient. An AE will be termed “mild” if it does not have a major impact on the 
patient, “moderate” if it causes the patient some minor inconvenience, and “severe” if it causes a 
substantial disruption to the patient’s well-being.  

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Relatedness. AEs will also be categorized according to the likelihood that they are related to 
participating in the study. Specifically, they will be labelled “definitely unrelated”, “possibly related”, 
“probably related”, or “definitely related”.  
 
6.1.7 
Protocol violations 
Study staff will inform the Principal Investigators (PI) as soon as they are aware of any violations to 
the protocol. The South African PI will report any violations and the corrective actions taken to prevent 
further violations within 7 days to the SAMRC ethics committee.   
 
6.1.8 
Adverse events and unanticipated problems 
As this study consists of low-risk meetings with a PRC, we do not anticipate having any study-related 
AEs, SAEs, or unanticipated problems. However, given that many participants in this study are from a 
vulnerable population (i.e., PLWH and SUD who have fallen out of HIV care), and are enrolled for 
about six-months, it is possible that AEs, SAEs, and unanticipated problems will arise. The plan for 
monitoring and reporting AEs, SAEs, and unanticipated problems is below.  
 
Monitoring. At follow-up assessments, study staff will ask participants if they experienced any AEs or 
SAEs since the last assessment (e.g., hospitalizations). The PRC(s) will also be trained to let the study 
team know if they are aware of any AEs or SAEs.  
 
Reporting to SAMRC HREC.  
 
AEs. If any AEs occur, they will be reported to the SAMRC HREC during the yearly progress 
report.  
 
SAEs. All SAEs will be reported to the SAMRC HREC within 48 hours of the team discovering 
the SAE, regardless of whether or not it is related to the study.  
 
Responsibility  
The Multi-PIs (MPIs) are ultimately responsible for data and safety monitoring. The processes described 
above ensure that the MPIs will be aware of important study related issues on a regular basis.  
 
Disclosure of Any Conflict of Interest  
Each investigator will complete a conflict of interest statement which will be kept on file by the study team. 
Any new investigators or key study staff will complete these forms, which will be stored and kept on record. 
At this time, there are no conflicts of interests in this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7. MANAGEMENT DETAILS  
 
Management Approach 
The present study will be led by the two PIs: Dr Bronwyn Myers and Dr Jessica Magidson.  
 
7.1.1 
SAMRC 
Dr Myers (MPI) will take primary responsibility for SAMRC ethics protocols, training materials, staff 
training and management, and quality assurance. She will also oversee data collection.  
 
7.1.2 
UMD  
Dr Magidson will oversee data management and the US based team who will support administrative 
coordination, oversight on regulatory issues and compliance, and all data management and cleaning.  
 
7.1.3 
Both Sites 
Dissemination & Implementation. Drs Myers and Magidson will work collaboratively on the 
dissemination of findings. Specifically, each PI will take responsibility for gathering and coordinating 
resources and ensuring outputs for each area of primary responsibility. Leadership will be shared, as 
will responsibilities, authority, data, and credit. All final scientific and study implementation decisions 
will be made collaboratively between PIs, with inputs from the project team.  
 
Communication. The PIs will communicate on a regular basis regarding study implementation and 
progress by telephone or video, in additional to regular email communication. Depending on travel 
guidelines (due to COVID-19 or other events), Dr Myers, Dr Magidson, and the US team will travel to 
Cape Town to support study training and implementation.  
 
Conflict Resolution. All final decisions will be made collaboratively between Drs Myers and Magidson. 
In the case of conflicts, the two PIs will work diligently to resolve any issues and will draw on the 
expertise and inputs of the Co-Is and study collaborators to reach consensus. In the unlikely case that 
the two PIs cannot come to a consensus, they will seek out a third-party mediator (Dr John Joska at the 
University of Cape Town) to help resolve this conflict.  
 
Staff and Scientific Collaboration  
Dr Bronwyn Myers (MPI) will have the overall responsibility of ensuring procedural and scientific integrity 
of the SA-based study operations, including overseeing the team at the SAMRC. This will include 
supporting training and supervising research staff on study measures and assisting with regulatory 
requirements.  
 
Dr Jessica Magidson (M PI) will have the overall responsibility of ensuring the procedural and scientific 
integrity of the US-based study operations, including data management and oversight. She will lead the 
team at UMD in coordinating research meetings, maintaining a study timeline, creating reports on study 
projects, handling ethics committee issues, and ensuring clear communication between all study members. 
 
Facilities 
7.1.4 
Field Site 
The present study team will be based on the SAMRC premises in Delft. This site has all the privileges 
of SAMRC office space and is the base for several studies located within the community. Project staff 
will be housed at this facility.  
 
Please note that due to COVID-19, staff may work remotely. If working remotely, staff will still have 
access to SAMRC resources. 

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7.1.5 
Data Management Site 
Data management will primarily occur in the Global Mental Health and Addiction Program (Director: 
Dr Magidson) at UMD. The office space consists of shared office space, a conference room, individual 
offices, and locked file storage rooms. Data files will be saved to a secure network running the PI’s 
laboratory.  
 
Please note that due to COVID-19, staff may work remotely. If working remotely, staff will still have 
access to UMD resources including access to the secure network. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8. ADDITIONAL DETAILS 
Research Translation  
8.1.1 
Manuscripts  
We plan to publish the findings of this study in peer-reviewed journals. At a minimum we hope to 
publish a report of the implementation and preliminary effectiveness findings of this pilot study. 
 
8.1.2 
Scientific Conferences.  
We plan to present findings from this study at scientific conferences, including Addiction Health 
Services Research (AHSR) annual meeting, the Dissemination & Implementation Science Annual 
Conference, and the College of Problems on Drug Dependence (CPDD).  
 
8.1.3 
Training Materials.  
This study will allow for the final adaptation of our PRC model. If at the end of this future study the 
approach proves to be effective, feasible, and acceptable, we will offer capacity-building workshops to 
help the Department of Health scale-up peers and make our initial peer training and supervision 
available to all who would like it.  
 
8.1.4 
Data Sharing Plan.  
We will make de-identified transcripts, codebooks, and quantitative data available to interested 
individuals (with appropriate training and approvals) after publication of the main outcome paper(s). 
Data will be released directly by the investigators providing evidence of their institution’s ethics 
approval for planned analyses of the data. Our team will be available to address queries.  
 
8.1.5 
Clinical Trial Registration  
In line with the requirements of the US National Institutes of Health (NIH), the Pilot PRC Study will 
be registered on ClinicalTrials.gov within 21 days of enrolment of the first participant. 
 
Scientific Validity  
This study has been peer-reviewed and approved by the US National Institute on Drug Abuse (NIDA), a 
division of the US NIH.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES 
 
1.  
Haroz EE, Bolton P, Nguyen AJ, et al. Measuring implementation in global mental health: 
validation of a pragmatic implementation science measure in eastern Ukraine using an experimental 
vignette design. BMC Health Serv Res. 2019;19(1):262. doi:10.1186/s12913-019-4097-y 
2.  
Adewuya AO, Makanjuola ROA. Social distance towards people with mental illness in 
southwestern Nigeria. Aust N Z J Psychiatry. 2008;42(5):389-395. 
doi:https://doi.org/10.1080/00048670801961115 
3.  
Meyers B, Sibeko G, Rose, Belus J, Regenauer K, Magidson J. Piloting the Social Distance Scale 
among CHWs in Two Sites in South Africa.; Unpublished Data. 
4.  
Bogardus ES. Measuring social distance. J Appl Sociol. 1925;9:299-308. 
5.  
Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: Reliability and 
validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 
2016;162:34-43. doi:10.1016/j.drugalcdep.2016.02.019 
6.  
UNAIDS. UNAIDS Data 2019. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2019. 
https://www.unaids.org/sites/default/files/media_asset/2019-UNAIDS-data_en.pdf 
7.  
Johnson LF, Dorrington RE, Moolla H. Progress towards the 2020 targets for HIV diagnosis and 
antiretroviral treatment in South Africa. South Afr J HIV Med. 2017;18(1). 
8.  
Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 Infection with Early Antiretroviral 
Therapy. N Engl J Med. 2011;365(6):493-505. doi:10.1056/NEJMoa1105243 
9.  
Kader R, Seedat S, Govender R, Koch JR, Parry CD. Hazardous and harmful use of alcohol and/or 
other drugs and health status among South African patients attending HIV clinics. AIDS Behav. 
2014;18(3):525-534. 
10.  Kalichman SC, Simbayi LC, Kaufman M, Cain D, Jooste S. Alcohol use and sexual risks for 
HIV/AIDS in sub-Saharan Africa: Systematic review of empirical findings. Prev Sci. 
2007;8(2):141. 
11.  Simbayi L, Zuma K, Moyo S, et al. South African National HIV Prevalence, Incidence, Behaviour 
and Communication Survey, 2017. Published online 2018. 
doi:http://hdl.handle.net/20.500.11910/13760 
12.  Shield KD, Rylett M, Gmel G, Gmel G, Kehoe-Chan TA, Rehm J. Global alcohol exposure 
estimates by country, territory and region for 2005—a contribution to the Comparative Risk 
Assessment for the 2010 Global Burden of Disease Study. Addiction. 2013;108(5):912-922. 
13.  Magidson JF, Fatch R, Orrell C, et al. Biomarker-Measured Unhealthy Alcohol Use in Relation to 
CD4 Count Among Individuals Starting ART in Sub-Saharan Africa. AIDS Behav. 
2019;23(6):1656-1667. doi:10.1007/s10461-018-2364-2 
14.  Wechsberg WM, van der Horst C, Ndirangu J, et al. Seek, test, treat: substance-using women in the 
HIV treatment cascade in South Africa. Addict Sci Clin Pract. 2017;12(1):12. 

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       Uploaded September 2024 
 
 
31 
15.  Patterson TL, Semple SJ, Zians JK, Strathdee SA. Methamphetamine-using HIV-positive men who 
have sex with men: correlates of polydrug use. J Urban Health. 2005;82(1):i120-i126. 
16.  Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J. Problem drinking and 
medication adherence among persons with HIV infection. J Gen Intern Med. 2001;16(2):83-88. 
doi:10.1111/j.1525-1497.2001.00122.x 
17.  Naidoo N, Railton J, Jobson G, et al. Making ward-based outreach teams an effective component of 
human immunodeficiency virus programmes in South Africa. South Afr J HIV Med. 2018;19(1). 
18.  Naledi T, Schneider H, Barron P. Primary health care in SA since 1994 and implications of the new 
vision for PHC re-engineering. South Afr Health Rev. 2011;2011(1):17-28. 
19.  Magidson JF, Joska JA, Regenauer KS, et al. “Someone who is in this thing that I am suffering 
from”: The role of peers and other facilitators for task sharing substance use treatment in South 
African HIV care. Int J Drug Policy. 2019;70:61-69. doi:10.1016/j.drugpo.2018.11.004 
20.  Van Boekel LC, Brouwers EP, Van Weeghel J, Garretsen HF. Stigma among health professionals 
towards patients with substance use disorders and its consequences for healthcare delivery: 
Systematic review. Drug Alcohol Depend. 2013;131(1-2):23-35. 
doi:https://doi.org/10.1016/j.drugalcdep.2013.02.018 
21.  Myers B, Joska JA, Lund C, et al. Patient preferences for the integration of mental health counseling 
and chronic disease care in South Africa. Patient Prefer Adherence. 2018;12:1797-1803. 
22.  Bogart LM, Chetty S, Giddy J, et al. Barriers to Care among People Living with HIV in South 
Africa: Contrasts between Patient and Healthcare Provider Perspectives. AIDS Care. 
2013;25(7):843-853. doi:10.1080/09540121.2012.729808 
23.  Earnshaw VA, Smith LR, Cunningham CO, Copenhaver MM. Intersectionality of internalized HIV 
stigma and internalized substance use stigma: Implications for depressive symptoms. J Health 
Psychol. 2015;20(8):1083-1089. doi:10.1177/1359105313507964 
24.  Stringer KL, Marotta P, Baker E, et al. Substance use stigma and antiretroviral therapy adherence 
among a drug-using population living with HIV. AIDS Patient Care STDs. 2019;33(6):282-293. 
doi:10.1089/apc.2018.0311 
25.  Calabrese SK, Burke SE, Dovidio JF, et al. Internalized HIV and drug stigmas: interacting forces 
threatening health status and health service utilization among people with HIV who inject drugs in 
St. Petersburg, Russia. AIDS Behav. 2016;20(1):85-97. 
26.  Thornicroft G, Mehta N, Clement S, et al. Evidence for effective interventions to reduce mental-
health-related stigma and discrimination. The Lancet. 2016;387(10023):1123-1132. 
doi:https://doi.org/10.1016/S0140-6736(15)00298-6 
27.  Nyblade L. Disentangling stigma to find entry points for intervention. Sex Health Exch. 2004;(2):5. 
28.  Nyblade L, Stangl A, Weiss E, Ashburn K. Combating HIV stigma in health care settings: What 
works? J Int AIDS Soc. 2009;12(1):15. doi:https://doi.org/10.1186/1758-2652-12-15 

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       Uploaded September 2024 
 
 
32 
29.  Oanh KTH, Ashburn K, Pulerwitz J, Ogden J, Nyblade L. Improving hospital-based quality of care 
in Vietnam by reducing HIV-related stigma and discrimination. Published online 2008. 
30.  Kohrt BA, Jordans MJ, Turner EL, et al. Reducing stigma among healthcare providers to improve 
mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a 
stigma reduction intervention for training primary healthcare workers in Nepal. Pilot Feasibility 
Stud. 2018;4(1):36. 
31.  Thornicroft G, Bakolis I, Evans-Lacko S, et al. Key lessons learned from the indigo global network 
on mental health related stigma and discrimination. World Psychiatry. 2019;18(2):229-230. 
32.  Kohrt BA, Mutamba BB, Luitel NP, et al. How competent are non-specialists trained to integrate 
mental health services in primary care? Global health perspectives from Uganda, Liberia, and 
Nepal. Int Rev Psychiatry. 2018;30(6):182-198. 
33.  Magidson JF, Regan S, Jack H, Wakeman S. Reduced hospitalizations and increased abstinence six 
months after recovery coach contact. In: Poster Presented (with Distinction as the Early 
Investigator Award) At. ; 2018. 
34.  Jack HE, Oller D, Kelly J, Magidson JF, Wakeman SE. Addressing substance use disorder in 
primary care: The role, integration, and impact of recovery coaches. Subst Abuse. 2018;39(3):307-
314. 
35.  Kleinman MB, Doran K, Felton JW, et al. Extending the reach: Implementing a community-based 
peer recovery coach model to reach underserved, minority individuals not engaged in care in 
Baltimore City. Oral presentation presented at: Addiction Health Services Research Annual 
Conference; October 2019; Park City, Utah. 
36.  Sorsdahl K, Morojele NK, Parry CD, et al. ‘What will it take’: addressing alcohol use among people 
living with HIV in South Africa. Int J STD AIDS. Published online 2019:0956462419862899. 
37.  Myers B, Carney T, Browne FA, Wechsberg WM. A trauma-informed substance use and sexual risk 
reduction intervention for young South African women: a mixed-methods feasibility study. BMJ 
Open. 2019;9(2):bmjopen-2018. 
38.  Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation Hybrid 
Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance 
Public Health Impact. Med Care. 2012;50(3):217-226. doi:10.1097/MLR.0b013e3182408812 
39.  Hickey MD, Omollo D, Salmen CR, et al. Movement between facilities for HIV care among a 
mobile population in Kenya: transfer, loss to follow-up, and reengagement. AIDS Care. 
2016;28(11):1386-1393. doi:10.1080/09540121.2016.1179253 
40.  Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption 
questions (AUDIT-C): An effective brief screening test for problem drinking. Arch Intern Med. 
1998;158(16):1789-1795. doi:10.1001/archinte.158.16.1789 
41.  Basedow LA, Kuitunen-Paul S, Eichler A, Roessner V, Golub Y. Diagnostic Accuracy of the Drug 
Use Disorder Identification Test and Its Short Form, the DUDIT-C, in German Adolescent 
Psychiatric Patients. Front Psychol. 2021;12. Accessed June 27, 2022. 
https://www.frontiersin.org/article/10.3389/fpsyg.2021.678819 

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       Uploaded September 2024 
 
 
33 
42.  Kader R, Seedat S, Koch JR, Parry CD. A preliminary investigation of the AUDIT and DUDIT in 
comparison to biomarkers for alcohol and drug use among HIV-infected clinic attendees in Cape 
Town, South Africa. Afr J Psychiatry. 2012;15(5):346-351. 
43.  Pape H, Lobmaier P, Bukten A. An evaluation of eight short versions of the Drug Use Disorder 
Identification Test (DUDIT). A prison population study. Drug Alcohol Depend Rep. 2022;3:100043. 
doi:10.1016/j.dadr.2022.100043 
44.  Magidson JF, Joska JA, Belus JM, et al. Project Khanya: Results from a pilot randomized type 1 
hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART 
adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021;24(S2):e25720. 
doi:10.1002/jia2.25720 
45.  Magidson JF, Joska JA, Myers B, et al. Project Khanya: a randomized, hybrid effectiveness-
implementation trial of a peer-delivered behavioral intervention for ART adherence and substance 
use in Cape Town, South Africa. Implement Sci Commun. 2020;1(1):1-12. 
46.  Satinsky EN, Doran K, Felton JW, Kleinman M, Dean D, Magidson JF. Adapting a peer recovery 
coach-delivered behavioral activation intervention for problematic substance use in a medically 
underserved community in Baltimore City. Plos One. 2020;15(1):e0228084. 
47.  Kleinman MB, Doran K, Felton JW, et al. Implementing a peer recovery coach model to reach low-
income, minority individuals not engaged in substance use treatment. Subst Abuse. 2021;42(4):726-
734. doi:10.1080/08897077.2020.1846663 
48.  Kohrt BA, Jordans MJD, Rai S, et al. Therapist competence in global mental health: Development 
of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res 
Ther. 2015;69:11-21. doi:10.1016/j.brat.2015.03.009 
49.  Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MD. Development of a scoring system for 
non-specialist ratings of clinical competence in global mental health: a qualitative process 
evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob 
Ment Health. 2015;2. 
50.  Pope C, Mays N, eds. Qualitative Research in Health Care. 3rd ed. Blackwell Pub/BMJ Books 
51.  Weller SC, Vickers B, Bernard HR, et al. Open-ended interview questions and saturation. PLOS 
ONE. 2018;13(6):e0198606. doi:10.1371/journal.pone.0198606 
52.  Silverman D. Doing Qualitative Research: A Practical Handbook. SAGE publications limited; 
2013. 
53.  NVivo [Program]. 11th Version.; 2015. 
54.  Abayomi O, Adelufosi AO, Olajide A. Changing attitude to mental illness among community 
mental health volunteers in south-western Nigeria. Int J Soc Psychiatry. 2013;59(6):609-612. 
55.  Regenauer KS, Kleinman MB, Belus JM, Myers B, Joska JA, Magidson JF. Effects of intersecting 
internalized stigmas and avoidance on HIV and alcohol-related outcomes among people living with 
HIV in South Africa. Drug Alcohol Depend. 2022;233:109364. 
doi:10.1016/j.drugalcdep.2022.109364 

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