Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use
Phase: NA
Conditions: Substance-Related Disorders, Mental Disorder, Social Stigma, Depression, Treatment Adherence and Compliance, Health Care Utilization, Attitude of Health Personnel, Hiv, Tuberculosis, Mental Health Disorder, Community Health Workers, Health Care Delivery
Sponsor: University of Maryland, College Park

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Study Protocol & Statistical Analysis Plan for ClinicalTrials.gov  
Protocol for NCT05282173 on ClinicalTrials.gov  
 
 
Official Title: 
Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and 
Substance Use 
 
NCT Number: 
NCT05282173 
 
Document Date: 
IRB Protocol Approved April 4, 2023   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SIYAKHANA - C 

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Training CHWs to Support Re-engagement in TB/HIV Care in the Context of 
Depression and Substance Use 
SIYAKHANA – C  
 
South African Medical Research Council Protocol Number: EC039-10/2021 
 
Version 5 
Protocol date: 4 April 2023 
 
 
 
Authorized By: 
Name: Dr Bronwyn Myers 
Role: Principal Investigator 
Signature: 
 
 
 
Date: 
29 August 2021 
Name: Dr Jessica Magidson 
Role: Principal Investigator 
Signature: 
 
 
 
Date: 
29 August 2021 
 
 
Key Words: community health workers, lay health workers, trainings, mental health stigma, 
substance use stigma, depression, substance-related disorders, HIV, tuberculosis  
 
 
 
 

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GENERAL INFORMATION 
 
FUNDER 
National Institute of Mental Health (NIMH), Division of the National Institutes of Health (NIH)  
R34MH122268 
 
AUTHORIZATION 
The study will be authorized by Drs Bronwyn Myers and Jessica Magidson.  
 
STUDY INVESTIGATORS 
Multiple Principal Investigator (South Africa): Bronwyn Myers (PhD)  
Chief Specialist Scientist 
Alcohol Tobacco and Other Drug Research Unit 
South African Medical Research Council 
Email: bmyers@mrc.ac.za 
 
Multiple Principal Investigator (United States): Jessica Magidson (PhD)  
Assistant Professor  
Department of Psychology, University of Maryland 
1121 Biology Psychology Building, 4094 Campus Drive, College Park, MD, USA 20742 
Tel: +1 301-405-5059 
 
 
Email: jmagidso@umd.edu  
 
RESEARCH SUPPORT 
South Africa 
Kim Johnson, MA  
Project Manager  
Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council  
Francie van Zyl Drive, Tygerberg, 7505 
Western Cape, South Africa  
Tel:  +27 21 938 0364/0851 
 
Email: kim.johnson@mrc.ac.za  
 
Sibabalwe Ndamase 
Research Assistant 
Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council  
Francie van Zyl Drive, Tygerberg, 7505 
Western Cape, South Africa  
Tel:  +27 21 938 0213  
Email: sibablwe.ndamase@mrc.ac.za  
 
Nonceba Ciya 
Research Assistant 
Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council  
Francie van Zyl Drive, Tygerberg, 7505 
Western Cape, South Africa  
Tel:  +27 21 938 0213  
Email: Nonceba.ciya@mrc.ac.za  
 
Busisiwe Beko 
Research Assistant 
Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council  
Francie van Zyl Drive, Tygerberg, 7505 
Western Cape, South Africa  
Tel:  +27 21 938 0213  
Email: Busisiwe.Beko@mrc.ac.za 
 
 
United States 

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Kristen Regenauer, MS  
Graduate Research Assistant  
Department of Psychology, University of Maryland  
4094 Campus Drive, College Park, MD, USA 20742  
Tel: +1 301-405-0899 
 
 
Email: kregenau@terpmail.umd.edu  
 
Alexandra Rose, MSc 
Graduate Research Assistant  
Department of Psychology, University of Maryland  
4094 Campus Drive, College Park, MD, USA 20742  
Tel: +1 301-405-0899 
 
 
Email: alrose@umd.edu   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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DECLARATION  
 
We, Bronwyn Myers and Jessica Magidson, have read the Department of Health: Ethics in 
health research: principles, processes and structures, second edition, 2015, the Guidelines for 
Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa, Second 
Edition, 2006, Department of Health, Pretoria, South Africa (where applicable), and the 
Declaration of Helsinki (2013) and have prepared this proposal with due cognizance of its content. 
Furthermore, we will adhere to the principles expressed when conducting this proposed research 
project.  
 
Signed:  
 
 
 
29 August 
2021 
 
Bronwyn Myers, PhD 
 
Date 
 
 
 
 
29 Aug 2022 
 
Jessica Magidson, PhD 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS  
Table of Contents 
GENERAL INFORMATION ....................................................................................................................................... 3 
FUNDER ..................................................................................................................................................................... 3 
AUTHORIZATION ....................................................................................................................................................... 3 
STUDY INVESTIGATORS ............................................................................................................................................. 3 
RESEARCH SUPPORT .................................................................................................................................................. 3 
DECLARATION ........................................................................................................................................................ 5 
TABLE OF CONTENTS .............................................................................................................................................. 6 
LIST OF ABBREVIATIONS ........................................................................................................................................ 8 
1. OVERALL AIM AND SPECIFIC OBJECTIVES ........................................................................................................... 9 
1.1 
OVERALL AIM ................................................................................................................................................... 9 
1.2 SPECIFIC OBJECTIVES ................................................................................................................................................. 9 
1.2.1. Initial Pilot Training ..................................................................................................................................... 9 
1.2.2 Stepped-Wedge Pilot Trial ........................................................................................................................... 9 
2. INTRODUCTION ................................................................................................................................................ 10 
2.1 BACKGROUND AND RATIONALE ................................................................................................................................. 10 
2.2 ADAPTING TRAINING FOR THE INITIAL PILOT TRIAL ........................................................................................................ 11 
2.3 ADAPTING TRAINING FOR THE STEPPED-WEDGE PILOT TRIAL .......................................................................................... 12 
3. RESEARCH WORK PLAN .................................................................................................................................... 13 
3.1 STUDY SITES .......................................................................................................................................................... 13 
3.1.1 Initial Pilot Training .................................................................................................................................... 13 
3.1.2 Stepped-Wedge Trial of the Training ......................................................................................................... 14 
3.2 STUDY DESIGN ....................................................................................................................................................... 14 
3.2.1 Initial Training ............................................................................................................................................ 14 
3.2.2 Stepped-Wedge Trial .................................................................................................................................. 14 
3.3 PARTICIPANTS AND ELIGIBILITY .................................................................................................................................. 14 
3.3.1 Initial Training ............................................................................................................................................ 15 
3.3.1 Stepped-Wedge Trial .................................................................................................................................. 16 
3.4 RECRUITMENT ....................................................................................................................................................... 18 
3.4.1 Initial Training ............................................................................................................................................ 18 
3.4.2 Stepped-Wedge Trial .................................................................................................................................. 19 
3.5 STUDY PROCEDURES ............................................................................................................................................... 20 
3.5.1 Initial Training ............................................................................................................................................ 20 
3.5.2 Stepped Wedge Trial .................................................................................................................................. 22 
3.6 COVID-19 MODIFICATIONS .................................................................................................................................... 24 
3.7 PARTICIPANT REIMBURSEMENT ................................................................................................................................. 25 
4. DATA ANALYSIS................................................................................................................................................ 26 
4.1 TYPE AND PURPOSE OF DATA .................................................................................................................................... 26 
4.1.1 Initial Pilot Training .................................................................................................................................... 26 
4.1.2 Stepped Wedge Trial .................................................................................................................................. 26 
4.2 PRIMARY IMPLEMENTATION OUTCOMES ..................................................................................................................... 26 
4.2.1 –Initial Pilot Training .................................................................................................................................. 26 
4.1.2 Stepped-Wedge Trial .................................................................................................................................. 26 
4.3 PRIMARY PRELIMINARY EFFECTIVENESS OUTCOMES (STEPPED-WEDGE TRIAL ONLY) ........................................................... 27 
4.3.1 –Stepped Wedge Trial ................................................................................................................................ 27 
4.4 SECONDARY PRELMINARY EFFECTIVENESS OUTCOMES (STEPPED-WEDGE TRIAL ONLY) ........................................................ 28 
4.4.1 Stepped-Wedge Trial .................................................................................................................................. 28 
4.5 MISSING DATA (STEPPED WEDGE TRIAL ONLY) ............................................................................................................ 28 
5. ETHICAL CONSIDERATIONS .............................................................................................................................. 29 
5.1 
POTENTIAL RISKS TO PARTICIPANTS .................................................................................................................... 29 

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5.1.1 Breach to Confidentiality............................................................................................................................ 29 
5.1.2 Psychological or Mental Discomfort .......................................................................................................... 29 
5.1.3 COVID-19 Transmission .............................................................................................................................. 29 
5.2 PROTECTIONS AGAINST RISKS ................................................................................................................................... 29 
5.2.1 Informed Consent ....................................................................................................................................... 29 
5.2.2 Preventing Breaches to Confidentiality ...................................................................................................... 30 
5.2.3 Protections against psychological or mental discomfort ........................................................................... 31 
5.2.3 Health and Safety: COVID-19 ..................................................................................................................... 32 
5.3 
POTENTIAL BENEFITS OF PROPOSED RESEARCH TO HUMAN SUBJECTS ....................................................................... 32 
5.3.1 Participants ................................................................................................................................................ 32 
5.3.2 Importance of the Knowledge to be Gained .............................................................................................. 32 
6. DATA MANAGEMENT ....................................................................................................................................... 33 
5.2 
DATA STORAGE............................................................................................................................................... 33 
6.1.1 Data Acquisition and Transmission ............................................................................................................ 33 
6.1.2 Data Entry Methods ................................................................................................................................... 34 
6.1.3 Quality Assurance ...................................................................................................................................... 34 
5.3 
DATA SAFETY AND MONITORING PLAN ............................................................................................................... 34 
6.2.1 Regulatory Issues ....................................................................................................................................... 34 
6.2.2 Amendments .............................................................................................................................................. 34 
6.2.3 Reporting Definitions ................................................................................................................................. 35 
6.2.4 Protocol violations ..................................................................................................................................... 35 
6.2.5 Adverse events and unanticipated problems ............................................................................................. 35 
6.2.6 Additional review bodies ............................................................................................................................ 36 
6.3 RESPONSIBILITY ...................................................................................................................................................... 36 
6.4 DISCLOSURE OF ANY CONFLICT OF INTEREST ................................................................................................................. 37 
7. TIMELINE ......................................................................................................................................................... 37 
8. MANAGEMENT DETAILS ................................................................................................................................... 38 
8.1 MANAGEMENT APPROACH ....................................................................................................................................... 38 
8.1.1 SAMRC ........................................................................................................................................................ 38 
8.1.2 UMD ........................................................................................................................................................... 38 
8.3.1 Both Sites ................................................................................................................................................... 38 
8.2 STAFF AND SCIENTIFIC COLLABORATION ...................................................................................................................... 38 
8.3 
FACILITIES ...................................................................................................................................................... 39 
8.3.1 Field Site ..................................................................................................................................................... 39 
8.3.2 Data Management Site .............................................................................................................................. 39 
9. ADDITIONAL DETAILS ....................................................................................................................................... 40 
9.1 RESEARCH TRANSLATION ......................................................................................................................................... 40 
9.1.1 Manuscripts. .............................................................................................................................................. 40 
9.1.2 Scientific Conferences. ............................................................................................................................... 40 
9.1.3 Training Materials. ..................................................................................................................................... 40 
9.1.4. Data Sharing Plan. .................................................................................................................................... 40 
9.2 SCIENTIFIC VALIDITY ................................................................................................................................................ 40 
REFERENCES ......................................................................................................................................................... 41 
APPENDIX 1: BUDGET DOCUMENTS ..................................................................................................................... 45 
APPENDIX 2: PROCEDURES FOR DISTRESSED PARTICIPANTS................................................................................ 46 
Ask the following questions: ............................................................................................................................... 48 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AE 
Adverse Event 
ART 
Antiretroviral Therapy 
CFIR 
Consolidated Framework for Implementation Research 
CHW 
Community Health Worker 
Co-I 
Co-Investigator  
DoH 
Department of Health 
HREC 
Human Research Ethics Committee 
ID 
Identification 
LMIC 
Low and Middle-Income Countries  
LTFU 
Lost to Follow-Up 
MD 
Maryland 
MDR-TB 
Multidrug-Resistant Tuberculosis  
MH 
Mental Health  
MI 
Motivational Interviewing 
MPI 
Multi-Principal Investigator 
NGO 
Non-Governmental Organization   
NIH 
National Institutes of Health 
NIMH 
National Institutes of Mental Health 
PI 
Principal Investigator  
PLWH 
People Living With HIV 
PST 
Problem Solving Therapy 
SA 
South Africa 
SAMRC 
South African Medical Research Council 
SDS 
Social Distance Scale 
sIMB-CIM 
Situated Information Motivation Behavioral Skills Model of Care Initiation and 
Maintenance 
SSA 
Sub-Saharan Africa  
SU 
Substance Use 
TAU 
Treatment As Usual 
TB 
Tuberculosis 
UMD 
University of Maryland 
US 
United States 

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1. OVERALL AIM AND SPECIFIC OBJECTIVES  
1.1 Overall Aim 
The overall aim of this study is to test the feasibility, acceptability, fidelity, and preliminary 
effectiveness of a community health worker (CHW) training programme. The goal of this program 
is to reduce stigma on the part of CHWs towards patients living with HIV/tuberculosis (TB) and 
with depression or substance use (SU) in order to better help these patients re-engage in TB/HIV 
care. The training we propose to test was informed by formative interviews conducted with CHWs, 
other stakeholders, and patients in South African Medical Research Council (SAMRC) Protocol 
#EC039-9/2020.  
 
We wish to extend our initial feasibility test of the training into a larger, stepped-wedge pilot trial. 
Findings will inform future iterations of this training at a larger scale. 
 
1.2 Specific Objectives 
1.2.1. Initial Pilot Training 
To test the feasibility, acceptability, and fidelity of this CHW training program, we will:  
a. Train CHWs in the adapted training program (n = 25)  
b. Conduct assessments with the CHWs (n = 25) to obtain feedback on the 
perceived appropriateness, acceptability, and feasibility of the adapted training. 
We will also assess a representative sample of patients seen by the CHWs 
following the training (n = 75). Patients will be asked about the presence or 
absence of stigmatizing behaviours from each of the CHWs.  
c. Code a subset of audiotaped CHW visits and/or behavioural role plays (n=25) to 
assess fidelity to the training 
d. Adapt the implementation strategy and content (if needed) of the CHW training 
program based on findings from objectives b and c.  
 
1.2.2 Stepped-Wedge Pilot Trial  
To further evaluate the implementation (feasibility, acceptability, fidelity) and preliminary 
effectiveness of this CHW training program to reduce CHW stigma towards depression 
and SU in order to promote re-engagement in TB/HIV care, we will conduct a Type 2, 
hybrid effectiveness-implementation trial.1 This will be guided by Proctor’s implementation 
model.2 Using a stepped-wedge design with multiple NGO/clinic sites (N = 60 CHWs total), 
we will randomly allocate the timing of the CHW training (versus treatment as usual; TAU) 
over six months. The following multi-level outcomes will be evaluated: 
a. Feasibility, acceptability and fidelity of the CHW training (primary implementation 
outcomes). This will be assessed through both quantitative and qualitative 
methods so that qualitative data can add key context to quantitative findings and 
will include both CHWs and stakeholders (e.g., NGO leaders, policymakers 
focused on CHW training, supervisors of CHWs) to identify potential 
organizational barriers and facilitators to implementation of the training beyond 
the course of this study. 
b. CHW stigma towards depression and SU in TB/HIV patients (primary; 
effectiveness outcome)  
c. Patient re-engagement in TB/HIV care over six months via chart review 
(secondary effectiveness outcome)  
 
 
 
 

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2. INTRODUCTION 
2.1 Background and Rationale 
 
Globally, South Africa (SA) is in the top three countries with the highest burdens of HIV 
and TB.3 With approximately 7.7 million people living with HIV (PLWH), SA has the most HIV 
cases in the world,3,4 and PLWH are over 20 times more likely to develop TB than HIV-uninfected 
individuals.5 TB is a leading cause of death in SA, and PLWH have the highest burden of TB.6   
 
Poor engagement in care contributes to HIV and TB morbidity and mortality in SA, and 
depression and SU contribute to poor engagement in TB/HIV care. In SA, 62% of PLWH are 
on HIV medication3 – called antiretroviral therapy (ART) – and over 70% of individuals with TB 
are diagnosed and initiated on treatment.7 However, nearly half of PLWH have not achieved viral 
suppression,3 and only about half of people with TB successfully complete treatment (29% are 
LTFU between TB diagnosis and treatment completion).7 Individuals with depression and/or SU 
are particularly susceptible to poor engagement in TB/HIV care, including missed visits and 
greater likelihood as being LTFU.8,9  Approximately one-third of PLWH have hazardous alcohol 
use,10 over half have elevated depressive symptoms,9,11 and rates are even higher among TB/HIV 
co-infected patients.8,12 In previous studies, our team has shown a 42% lower odds of HIV 
treatment adherence among PLWH with depressive symptoms versus those without elevated 
depressive symptoms, and that depressive symptoms are associated with poorer engagement in 
HIV care.9 Further, our team has also shown that alcohol use is associated with 2 times greater 
odds of poor TB outcomes, including treatment failure and LTFU, and poor HIV adherence.13,14 
 
CHWs are frontline workers in SA who play a central role in re-engaging patients who are 
LTFU in TB/HIV care. As part of SA’s national strategy for HIV and TB care,15 CHWs are deployed 
in communities to provide active support for patients, including finding PLWH and TB-infected 
individuals who have been LTFU. Community-based, CHW-delivered interventions show 
promising outcomes, including improved engagement in care and treatment completion for 
patients with TB/HIV co-infection.16–19 However, barriers continue to remain for TB/HIV re-
engagement.  
 
CHWs need additional support and training to manage patients with depression and/or SU 
in TB/HIV care. Despite the prevalence of depression and SU in TB/HIV co-infected individuals8 
and the impact on engagement in care, CHWs receive little, if any, training on how to respond 
and re-engage people with depression and/or SU in care. In fact, although CHWs form an integral 
part of SA’s response to the HIV epidemic, CHW training programs in SA do not routinely provide 
training in mental health (MH) comorbidities such as depression or SU. In our team’s pilot data 
with CHWs in SA (n=66), 63% reported not having prior training on depression or SU, although 
over 90% were ‘very interested’ in learning how to support these clients.20  
 
High levels of MH and SU stigma exist among CHWs, which is a central barrier to patient 
re-engagement in care. Our team’s pilot data also demonstrated high levels of stigma towards 
SU and depression among CHWs (n=66). Using the Social Distance Scale (SDS), 79% of CHWs 
had moderate to high stigma towards patients with SU, and 53% had moderate to high stigma 
towards patients with depression.20 These findings are aligned with other research on stigma and 
CHWs in sub-Saharan Africa (SSA).21 Additionally, our team has found extensive qualitative 
evidence that CHW SU stigma is a major barrier to care engagement, with patients describing 
feeling “scolded”, “judged” and disrespected for SU,22–24 resulting in reluctance to both access 

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and continue HIV and TB care.25 Other work by our team has also shown that PLWH with 
depression and/or SU26 report lack of respect and stigma from CHWs as a barrier to accessing 
care.27 There is also quantitative evidence that PLWH experience high levels of stigma related to 
MH – and particularly to SU – that contributes to delays in seeking or re-starting care.28 Further, 
there is evidence that when CHWs have negative attitudes towards patients with depression or 
SU, they spend less time with these patients, are less likely to implement evidence-based 
practices, and deliver less patient-centred care.29 At the same time, it is well documented that MH 
and SU stigma lead to negative health outcomes among patients including patient delays in 
seeking treatment, lower treatment continuation rates, and poorer physical health.30–32 In SA 
specifically, patients have been found to stop seeking TB/HIV care or terminate prematurely due 
to stigmatisation of MH-related symptoms.33 Yet, to date, few studies have explored how to reduce 
CHW stigma as a means to improve re-engagement in TB/HIV care.  
 
There is evidence that MH-related stigma reduction interventions in low and middle-
income countries (LMICs) can reduce discrimination and improve patient outcomes. In 
SSA, stigma reduction strategies for TB and HIV stigma have demonstrated efficacy for reducing 
discriminatory practices among health workers and improve patient-level outcomes, including 
engagement in TB and HIV care.34–37 However, compared to TB- and HIV-related stigma, there is 
much less research on how to shift MH and SU-related stigma in LMICs, particularly in the context 
of TB/HIV care. The limited evidence available indicates that the most effective MH-related stigma 
reduction interventions among healthcare workers include social contact with peers or service 
users.36,38 However, this research is still in early phases36,38 with the impact of these interventions 
on patient-level care outcomes rarely examined.36  
 
The proposed training integrates two conceptual models: the Link and Phelan stigma 
framework39 and the Situated Information Motivation Behavioural Skills Model of Care 
Initiation and Maintenance (sIMB-CIM).40 According to the Link and Phelan stigma framework, 
stigma may occur among providers (including lay health workers, such as CHWs) when (1) 
individuals label differences and attach negative stereotypes to others and (2) the ‘us’ and ‘them’ 
are separated leading to status loss, discrimination, and conditional access to care. The sIMB-
CIM model guides the identification of relevant contextual variables that may affect patients’ re-
engagement in care and suggests that engagement and maintenance in care is determined by 
(1) accurate information about one’s illness; (2) intrapersonal and interpersonal motivation; and 
(3) behavioural skills, including systems navigation and organizational/planning skills, all of which 
may be affected by depression and SU.  
 
Guided by the conceptual models, our proposed CHW training integrates two-evidence 
based CHW training approaches that have not previously been integrated with information 
from qualitative interviews in SAMRC Protocol #EC039-9/2020. The proposed training 
integrates:  
(1) a CHW-training developed in SA41 to increase awareness and understanding of depression 
and SU and reduce stigma—which addresses the Information element of sIMB-CIM; and  
(2) evidence-based skills for promoting re-engagement in care (i.e., problem solving therapy; 
PST) and motivational interviewing (MI), previously adapted for CHW delivery in SA42—which 
addresses the Motivation and Behaviour elements of sIMB-CIM.  
 
2.2 Adapting Training for the Initial Pilot Trial 
We previously conducted a rapid analysis of Phase 1 interviews (#EC039-9/2020) to guide 
adaptations to the training in three domains: (1) training content; (2) training structure; and (3) the 
implementation strategy. Through this, we identified the need for ongoing supervision, monitoring, 
and consultation with CHWs; the need to consider how to incorporate cultural beliefs and 

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practices into the training; and the need to consider how to incorporate lived experience into the 
training to reduce stigma.  
 
Based on these qualitative interviews, we determined that:  
- 
The training should be at least three days long 
- 
The training should cover basic information about depression and substance use along 
with information about stigma 
- 
The training should focus on empowering CHWs to work with patients who have 
depression or are struggling with SU, as currently many CHWs feel underprepared to help 
such patients. 
 
2.3 Adapting Training for the Stepped-Wedge Pilot Trial 
Based on the findings of the initial training, we will adapt the training for a larger pilot test. We will 
use a randomized, hybrid Type 2 effectiveness-implementation design1 to compare the adapted 
CHW training to usual CHW training (treatment as usual; TAU) in this setting. This type of design 
builds evidence for the effectiveness of an intervention in a real-world context, while also 
supporting the transition to implementation for subsequent, larger trials, with an equal emphasis 
on effectiveness and implementation. 
 
This hybrid Type 2 effectiveness-implementation study will utilize a stepped wedge design to 
maximize power and ethically ensure that all clinics receive the CHW training, while also including 
a rigorous comparison condition. In this pilot trial, all clinics will receive the CHW training; each 
clinic will be randomized to the timing in which their CHWs receive the training.  
 
Before CHWs receive this adapted training, they will receive TAU. In TAU, a CHW is typically 
deployed to a patient’s home who has TB/HIV and has been LTFU for TB and/or HIV treatment 
with the central goal for supporting re-engagement in TB/HIV care. The CHW Typically goes to 
the patient’s home twice per week for one month, or until the patient has re-engaged in care (if 
less than one month). CHWs typically meet with supervisors weekly for monitoring, which is 
limited to target review and does not include additional skills training or psychosocial debriefing. 
CHWs typically routinely document their visits to facilitate supervision and monitoring, and as part 
of efforts to roll out screening for depression and SU.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. RESEARCH WORK PLAN  
 
Aims: The aims of this study are to test the implementation (feasibility, acceptability, fidelity) and 
preliminary effectiveness of a CHW training programme. The goal of this program is to reduce 
stigma on the part of CHWs towards patients living with TB/HIV and with depression or substance 
use (SU) in order to better help these patients re-engage in TB/HIV care. We have adapted this 
training first based on interviews with patients and stakeholders in SAMRC Protocol #EC039-
9/2020.  
 
We are initially piloting this training with a small group (up to n=25) CHWs. Based on the feedback 
from these CHWs and our study team running the training, we are making small adaptations to 
the training. We will pilot this updated training with a larger group of CHWs (n=60) using a 
stepped-wedge design.   
 
 
3.1 Study Sites  
3.1.1 Initial Pilot Training 
For the initial training, we are recruiting CHWs from NGOs employing CHWs at clinics in 
the Western Cape, for instance TB/HIV Care, ANOVA, Kheth’Impilo, and Courage to 
Care. More information about these sites is detailed in the table below.  
 
NGO 
Description of Work 
Locations 
Contact Info 
TB/HIV Care 
TB HIV Care is a registered non-profit organisation 
that puts integrated care at the heart of responding to 
TB, HIV and other major diseases. They work to 
prevent, find and treat TB and HIV in South Africa as 
well as targeting interventions to address the needs of 
populations at risk, such as inmates, sex workers and 
people who inject drugs. 
 
Atlantis 
DuNoon 
Hout Bay 
Khayelitsha 
Philippi 
Head Office 
7th Floor, 11th Adderly St 
Cape Town City Centre 
Cape Town  
800 
#: 021 424 0500 
 
Wynberg Office 
Wynberg Main Road 
Cape Town 
#: 021 699 8866 
ANOVA (APACE 
Western Cape) 
The Anova Health Institute is an NGO that empowers 
people and changes lives. With a specific focus on 
HIV, their work is built on a foundation of research to 
ensure that funds are focused where they can make 
the most difference. They have teams throughout 
South Africa that are also actively involved in 
community outreach, support, engagement and 
awareness, and educational campaigns. 
 
Khayelitsha 
Head Office 
3rd Floor, Tijger Park 2, 
Bellville 
Cape Town  
#: 012 824 0052 / 
    083 253 7161 
Kheth’Impilo 
Kheth’Impilo is an NGO that has provided innovative 
approaches to clinical care and treatment services, 
health and community systems strengthening with 
social facilitation through program implementation at 
all levels of health and social service delivery. 
 
Gugulethu  
Khayelitsha 
Phillipi 
Head Office 
Uitvlugt, 20 Howard 
Drive, Pinelands 
7405 
#: 021 410 4300 
Courage to Care 
Courage to Care offers community development and 
set out to establish additional programmes funded by 
the Department of Health, Western Cape. Courage to 
Care’s Community Wellness Centres opened in the 
Eersteriver and Kuilsriver area, serving both 
communities with Intergraded Home and Community 
Based Care Services. This include but not limited to 
family planning; support groups, wound care; 
bereavement counselling and child health, TB 
Eersteriver 
Kuilsriver 
Mfuleni 
Head Office 
Unit 15 Tainan Centre, 
Gordon St,  
Eerste River  
Cape Town 
#: 072 599 7063 

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screening, HIV/AIDS testing, and medication 
distribution. 
 
 
3.1.2 Stepped-Wedge Trial of the Training  
We will recruit CHWs employed by our partner NGOs (see above) who work at one of 
the clinics this study has partnered with. The exact clinics will be determined based on 
ongoing conversations with the Western Cape Department of Health, the City of Cape 
Town, and the NGO’s. We expect the majority of clinics – if not all – to be based in 
Khayelitsha. 
 
3.2 Study Design  
3.2.1 Initial Training 
We will invite up to 25 CHWs to participate in a pilot training. As the purpose of this 
activity is to gather feedback from the CHWs about their experiences with the brief 
training—rather than to test the effectiveness of the training—all enrolled CHWs will 
receive the training.  
 
3.2.2 Stepped-Wedge Trial  
We will use a stepped-wedge design.  
 
CHWs will be clustered based on the site at which they work. When recruiting participants, 
we will aim to recruit approximately 20 CHWs per cluster.  
 
CHWs across all clusters will be recruited and complete a baseline assessment at 
approximately the same time. In stepped-wedge trials, all groups have different intervals 
of a baseline period in which they are not exposed to an intervention (which we refer to as 
“treatment as usual” or “TAU”). Following this, at measurable intervals (steps), one group 
at a time will receive the training intervention. This process continues until all clusters have 
received the intervention. Then, at least one more follow-up assessment occurs after all 
clusters have received the intervention.  
 
In this study, when a cluster receives the intervention (versus continues TAU) depends on 
whether they are randomized to Training Time #1, Training Time #2, or Training Time #3. 
Each training time will occur at a measurable intervention (compared to when the baseline 
assessment was conducted) so that the doses of TAU are discernable.  
 
During data analysis, outcome variables will be compared between people before taking 
the intervention (TAU only; timepoints are baseline assessment (t1) and pre-training 
assessment (t2)) and with the same group of people after the intervention (TAU+Training; 
additional timepoints are 3-month follow-up (t3) and 6-month follow-up (t4)) after adjusting 
for individual random effect and time effect.  
 
Randomization will not affect any other TB/HIV-related clinic services or mental health 
training.  
 
3.3 Participants and Eligibility  
The below table shows who will be recruited and consented.  
 
Participants in study 
 
CHWs 
Patients 

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Initial Pilot Training 
Up to n = 25 
Up to n = 75 
Stepped-Wedge Trial 
Approximately n = 60 
0 
 
3.3.1 Initial Training 
3.3.1a CHW Participants  
CHW participants will be 25 CHWs from TB/HIV Care, Kheth’Impilo, Courage to 
Care, and ANOVA. CHWs from any of these NGOs will be eligible.  
 
 
Rationale for enrolment numbers.  
Based on previous trainings and interventions our team has piloted, we believe 
25 CHWs will allow us to get a good sense of the preliminary acceptability, 
feasibility, and fidelity of the intervention and provide enough information to help 
us refine the training programme for future implementation. 
 
 
Eligibility.  
To be eligible for the training, CHWs must meet all of the following eligibility criteria: 
(1) be at least 18 years old; (2) previously completed CHW training approved by 
the Western Cape Department of Health; (3) be employed by one of the NGOs 
listed above as a CHW; (4) work with patients who have HIV and TB and struggle 
with depression or SU, or supervise CHWs who work with such patients; (5) be 
able to complete informed consent and study procedures in English, Afrikaans or 
isiXhosa; (6) be able to complete training in English.  
 
3.3.1b Patient Participants  
Patient participants will be up to 75 patients (up to three patients/ CHW) who 
receive care from a CHW who attended the training. 
 
 
Rationale for enrolment numbers.  
The number of patients (n = 75) was based on the number of CHWs in the study; 
each CHW will be asked to try to identify at least one and up to three patient who 
may be eligible for the study. 
 
 
Eligibility.  
To be eligible for the study, patients must meet the eligibility criteria below. These 
criteria were chosen to reflect patients with life experiences that are relevant to 
the content of the training programme.  These criteria are identical to those used 
in our formative work.  
 
Please note that the purpose of this pilot study is to focus on CHWs learning 
skills taught in the training/ the feasibility of the training, and not patient 
outcomes.  
 
Patient Eligibility Criteria  
Inclusion 
Exclusion 
1. 
Be a patient of one of the CHWs enrolled in the study  
1. Currently pregnant (due to receiving 
more intensive adherence support and 
treatment plan) 
2. 
Have or have had a history of TB/HIV co-infection  
3. 
The CHW believes the patient is struggling with substance 
use (alcohol or other drug use) or depression 
2. Having multi-drug resistant TB 
(MDR- TB; due to receiving more 
intensive adherence support and 
treatment plan) 
4. 
Age 18 or older 
5. 
Able to complete informed consent and study procedures in a 
language spoken by research team (isiXhosa, Afrikaans, or 
English)   

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3.3.1 Stepped-Wedge Trial 
3.3.2a CHW Participants  
Participants will be 60 CHWs who are employed by one of the NGOs listed 
above. Please see Section 3.1.2 (above) for more information on these NGOs.  
 
 
Rationale for enrolment numbers. 
The number of CHWs to enroll (N=60) was determined through power 
calculations based on the primary effectiveness outcome (i.e., CHW stigma 
measured with the SDS.20,43,44  
 
A linear mixed model will be used for the primary outcome, considering both the 
within clinic correlation (i.e., multiple CHWs working at the same clinic) and the 
within person correlation (i.e., repeated measures on CHW stigma over time). In 
the power analysis, anticipated standardized effect sizes were defined from (1) a 
meta-analysis of 13 randomized clinical trials of mental health stigma reduction 
interventions that shows a standardized effect size of 0.63 on measures of stigma 
[121], and (2) prior work in sub-Saharan Africa using the SDS to test changes in 
mental health stigma among community mental health volunteers that had an 
effect size of 0.75.44 Assuming similar baseline characteristics from a prior study 
using SDS among community health workers,44 and an intra-class correlation of 
0.1 within clinic and 0.3 within person, with 60 CHWs, our study can achieve a 
power of 86% at a significance level of 0.05 and a CHW training effect of 0.63, and 
96% power at a training effect of 0.75.  
 
A subset of these CHWs (up to n=20) will then participate in qualitative 
interviews. We will select CHWs for these further interviews by classifying CHWs 
based on level of change in stigma during the training. We intend to include 
CHWs who had reduced stigma following the training, no change in stigma 
following the training, and increased stigma following the training. We will also 
ensure that recruited CHWs represent the multiple NGOs that participated in the 
training. Only CHWs who attended the training will be eligible. We anticipate that 
this number of participants will allow us to reach theoretical saturation for 
qualitative analysis.47  
 
Eligibility. 
To be eligible, CHWs must meet all of the criteria in the below table.  
 
CHW Eligibility Criteria 
Inclusion 
Exclusion 
1. At least 18 years old 
1. Unable to complete informed 
consent or study procedures in 
English or isiXhosa 
 
2. Be employed as a CHW through a 
partner NGO that provides HIV/TB CHW 
services  
2. Unable to complete training in 
English 
3. Work with patients who have HIV and TB 
and struggling with depression or SU 
3. Participated in the initial 
trial(s) of this training.  

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3.3.2b Stakeholder participants 
Participants will be up to n=28 NGO leaders as well as policymakers and other 
stakeholders working with these NGOs. Please see Section 3.1.2 (above) for 
more information on these NGOs.  
 
Rationale for enrolment numbers. 
This number of participants will allow us to represent a wide range of 
perspectives. As in Phase I of this study, we will identify stakeholders by asking 
health care system leadership to refer us to stakeholders involved in NGO-
managed CHW services. NGO stakeholders that participated in formative work 
for this stepped-wedge training will be also be recruited. We anticipate this 
number will also allow us to reach theoretical saturation for qualitative analysis.47  
 
Eligibility  
To be eligible, stakeholders must meet all of the criteria in the below table. 
Stakeholders that participated in formative work for this stepped-wedge training 
will be eligible to be enrolled, however prior participation is not required.  
 
Stakeholder Eligibility Criteria 
Inclusion 
Exclusion 
4. At least 18 years old 
1. Unable to complete informed 
consent or study procedures in 
English or isiXhosa 
 
5. Be employed by or referred by a partner 
NGO 
that 
provides 
HIV/TB 
CHW 
services  
2. Unable to complete training in 
English 
6. Work with patients who have HIV and TB 
and struggling with depression or SU 
 
  
 

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3.4 Recruitment  
3.4.1 Initial Training  
3.4.1a CHW Recruitment  
CHWs (n = 25) will be recruited from the NGOs we are working with (please see 
above). Specifically, study team members will consult with supervisors at these 
NGOs to determine which CHWs may be able to participate in the training and 
incorporate the training content into their current job. Trained study team members 
will approach these CHWs, tell them about the training and study procedures, and 
ask if they would be interested in participating in the training. Participation (or lack 
thereof) will not affect the 
CHW’s employment. 
 
3.4.1b Patient Recruitment 
At the training, CHWs will be 
asked to identify at least one 
and up to three patients with a 
history of HIV/TB co-infection 
who they suspect is depressed 
or struggling with substance 
use. CHWs will be asked to 
follow the scripts below with 
such patients:  
1. Before the visit: Is it okay with 
you 
if 
I 
audio-record 
this 
session? This recording will be 
used by researchers at the 
SAMRC to help assess how I 
am doing my job, not to collect 
information  about you. You may 
say yes or no—it will not affect 
your care. If the patient says 
yes, the CHW will audio-record 
his/her 
interaction 
with 
the 
patient. If the patient says no, 
the CHW will continue with the 
session as usual. The patient 
will continue to receive their usual care from the CHW. 
2. At the end of the visit: Would you be willing to talk to a researcher from the SAMRC 
about your experience with this visit? This researcher will contact you and you will 
be compensated for your time spent answering these questions. If the patient says 
no, the CHW will end the session as usual. If the patient says yes, the CHW will 
ask: Can I give the researcher your contact information? If the patient says yes, 
the CHW will pass on any relevant contact information (e.g., a phone number) to 
the study team. If the patient says no they do not want to have their details passed 
on but is willing to participate in the study, a researcher and the CHW will arrange 
to visit this patient together.  
 
Patients who agree to be contacted by a researcher and have a phone number, 
will be called by a researcher in the team. During this call, the researcher will 
Patient Recruitment Figure 

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perform informed consent procedures with the patient and ask them some brief 
questions about themselves and the CHW visit.  
 
For patients who agree to be asked questions by a researcher but do not agree for 
their contact details to be passed on or do not have a phone number to allow them 
to be interviewed telephonically, we will ask the CHW to arrange a suitable date 
and place for the researcher to meet the patient for a follow up interview. This will 
be a place where the patient feels comfortable and that can maintain 
confidentiality. If COVID-19 permits, we will offer patients the option of being 
transported to our project site in Delft where they can complete the interview. All 
procedures will follow usual CHW care processes and ways of engaging with 
particular patients so that their HIV status is not inadvertently disclosed to family 
members or others. Before the researcher meets the patient, the CHW will ask the 
patient if they are still interested in talking to the researcher and if now is a good 
time. If it is, the researcher will complete informed consent processes with the 
patient and ask them questions about themselves and the CHW visit. The CHW 
will be waiting away from the researcher and patient at this time so they cannot 
overhear what the patient says. If it is not a good time to complete these questions, 
the researcher will set a suitable time directly with the patient (should they still wish 
to participate in the study). 
 
The patient recruitment process is illustrated in the Patient Recruitment figure. 
 
3.4.2 Stepped-Wedge Trial  
3.4.1. CHW Recruitment.  
CHWs (n=60) will be recruited from the NGOs we are working with (please see 
Section 3.1.2 above). Specifically, study team members will consult with 
supervisors at our partner NGOs—who employ the CHWs—to determine which 
CHWs may be eligible to participate in the training and incorporate the training 
content into their current job (i.e., CHWs to see patients living with HIV/TB and 
may be struggling with depression and/or substance use). Trained study team 
members will approach these CHWs, tell them about the training and study 
procedures, and ask if they would be interested in participating in training. 
Participation (or lack thereof) will not affect the CHW’s employment. 
 
For qualitative interviews, a subset of CHWs (up to n=20) will be contacted from 
the organizations that participated in the training. Only CHWs who attended the 
training will be recruited for these interviews. CHW will be recruited across 
organizations and across change in stigma levels (improvement in stigma, no 
change in stigma, increase in stigma). Trained study team members will approach 
CHWs, tell them about the further study procedures, and ask if they would be 
interested in participating in the interview. Participation (or lack thereof) will not 
affect the CHW’s employment. 
 
3.4.2. Stakeholder recruitment 
NGO leaders, policy makers and other stakeholders (up to n=28) will also be 
recruited. These stakeholders will be recruited after referral from health system 
leadership. Additionally, stakeholders who participated in Phase 1 interviews may 
be re-enrolled to participate in these follow-up interviews. Trained study team 

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members will approach stakeholders, tell them about the study procedures, and 
ask if they would be interested in participating.  
 
3.5 Study Procedures             
3.5.1 Initial Training 
3.5.1a CHW Screening and Consent 
Potentially eligible CHWs—referred to us by staff at partner NGOs—will be 
screened for eligibility. If they are 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 study. 
Participants will be reminded that participation is voluntary, that they can decline 
to answer questions they are not comfortable answering, they are able to leave the 
study at any point, and that their decision to participate in the study will not impact 
their job. As part of signing the consent form, they will also consent to the 
Protection of Personal Information Act 4 of 2013. Upon giving willing, informed 
consent, they will then be invited to attend the training.    
 
3.5.1b Training 
Eligible and interested CHWs (n = 25) will be invited to attend a training on mental 
health and substance use. This training was adapted for this setting based on 
qualitative feedback collected from providers, stakeholders, and patients in our 
formative work, described in SAMRC Protocol #EC039-9/2020. It integrates two 
evidence-based training approaches: (1) information, defined as training to 
increase awareness and understanding of depression and SU in order to reduce 
stigma; and (2) motivation and behavior, defined as problem-solving therapy and 
motivational-interviewing for promoting re-engagement in care. More information 
on the specific training is provided in the training outline.  
 
Training will be conducted in English, as the business language of the healthcare 
system.  All CHW trainings offered by the Western Cape Department of Health that 
are required as part of their certification occur in English.  Our training team, 
however, consist of isiXhosa and Afrikaans mother-tongue speakers and therefore 
will be able to address questions in these languages and facilitate roleplays in 
multiple languages should the need arise. 
 
3.5.1c CHW Assessments 
Pre-Assessment. Before the training begins, CHWs will complete a brief 
assessment. This assessment will include questions around demographics and 
stigma. It will also contain a brief roleplay vignette (approximately 10 minutes long) 
to assess pre-training competencies in psychological care, based on the ENACT 
stigma training,45–47 which will give us an estimate of how CHWs currently  work 
with patients before attending our training. Finally, the assessment will include 
some questions to assess what CHWs already know about HIV, TB, depression, 
SU and stigma. We anticipate that this assessment will take about 40 minutes to 
complete. 
 
Post-Assessment. On the last day of training, CHWs will complete another 
assessment with questions around stigma and knowledge of HIV, TB, depression, 
SU, and stigma. They will also complete another roleplay vignette based on the 
ENACT45,46 to assess competencies in psychological care and how they will work 

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with their patients after the training. Finally, they will self-complete surveys48 to 
assess the training’s feasibility and acceptability.  
 
1-Month Follow-Up. Approximately one-month after the training—and one-month 
into receiving supervision—the CHWs will be asked to complete a final brief 
assessment. This assessment will contain the same questions around stigma, 
knowledge of HIV, TB, depression, SU, and stigma. It will also contain questions 
to assess the feasibility and acceptability of the supervision component of the 
training package.  
 
3.5.1d Patient Recruitment 
After the training, CHWs will return to their normal jobs and will be provided with 
the patient study eligibility criteria. CHWs will be asked to identify at least one 
patient and up to three patients who they believe fit eligibility criteria and that they 
think might be interested in (1) having their normal session audio-recorded and (2) 
if they would be interested in talking to a researcher at the MRC about the visit (for 
which they will be compensated). CHWs will be reminded of this in ongoing 
supervision. Please see the Patient Recruitment section for more details on this 
process.  
 
3.5.1e Patient Assessment 
Patients who agree to be contacted by a researcher and complete informed 
consent will be given a brief assessment where they are asked about demographic 
information, their HIV and/or TB, depression, and substance use. They will also be 
asked about their thoughts on their most recent CHW visit. Please note that 
informed consent will including consenting to the Protection of Personal 
Information Act 4 of 2013.  
 
3.5.1f CHW Fidelity 
CHW fidelity to the training will be measured in either or both of the following ways: 
through audio-recordings with real patients and through role-playing after the 
training.  
a) Audio-recordings with patients. Audio-recordings obtained by the CHWs will be 
assessed for fidelity to the training (i.e., skills taught that the CHW uses, correct 
information, and non-judgmental language). If a CHW obtains multiple audio-
recordings, one audio-recording will be randomly selected to be assessed for 
fidelity.  
b) Roleplays. The roleplays in the post-assessment training will be videorecorded 
and will also be rated for fidelity to the training (i.e., skills taught that the CHW 
uses, correct information, and non-judgmental language, including non-
judgmental nonverbal communication). Using roleplay information will (1) allow 
us to assess fidelity immediately after the training and (2) allow us to assess 
fidelity to the training even if CHWs are unable to later obtain audio-recordings 
of their actual sessions with patients. 
 
3.5.1g CHW Supervision 
Once a week for about a month, each CHW will have the opportunity to receive 
weekly small group supervision (n=5) with a registered psychological counselor. 
Supervision sessions will include feedback from fidelity checks, reminders from 
the three-day training, and role-playing of challenging patient interactions. There 

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will also be opportunities for clinical debriefing and psychosocial support for 
challenging patient interactions with a focus on problem solving. Role-plays may 
also be recorded at the end of some supervision sessions. 
 
3.5.2 Stepped Wedge Trial  
3.5.2a CHW Screening & Consent  
Potentially eligible CHWs—referred to us by NGO staff 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 study. Participants will be reminded 
that participation is voluntary, that they can decline to answer any questions they 
are not comfortable answering, they can leave the study at any point, and their 
decision to participate in the study will not impact their job. As part of signing the 
consent form, they will also consent to the Protection of Personal Information Act 
4 of 2013. 
 
3.5.2b CHW Baseline and Pre-Training Assessments  
Baseline Assessment. Upon giving willing, informed consent, CHWs will complete 
a baseline assessment with study staff. The baseline assessment will consist of 
self-report questions around CHWs’ demographic characteristics and job, personal 
mental health questions, questions around knowledge of HIV, TB, depression and 
substance use, and questions around stigma.  
 
Pre-Treatment Assessment. Immediately before their training, participants will 
complete a pre-training assessment. At this visit, participants will be asked to 
answer the same self-report questionnaires and as they did at baseline (with the 
exception of demographic and job information, which will not be asked again). All 
CHWs will also complete a brief (~10 minutes) role-play vignette with a staff 
member who is minimally involved in delivering the training, which will be 
videotaped and later coded for stigma using the ENACT.  
 
3.5.2c CHW Training  
After the baseline assessment all groups will receive at least one dose of TAU. 
Based on the training time to which their cluster was randomized, CHWs will then 
be invited to participate in a training on mental health and substance use. 
Clusters randomized to Training Time #1 will receive the training first (while the 
other training times continue to receive TAU), followed by Training Time #2 
(while the final training time continues to receive TAU), and finally, Training Time 
#3.  
 
The training in the stepped-wedge trial will be the as the initial training, with minimal 
adaptations based on participant feedback (e.g., potentially an additional day, 
allocating more or less time to specific concepts, etc.). It will still be conducted in 
English, as all CHW trainings offered by the Western Cape Department of Health 
are required as part of the CHW certification occur in English. Roleplays will be 
conducted in English (training language) or isiXhosa (patients’ language). 
Additionally, our training team consists of English, isiXhosa, and Afrikaans mother-
tongue speakers; therefore, our team will be able to address questions and further 
explain concepts in these languages if needed. 
 

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3.5.2d CHW Post-Training Assessments 
In addition to the Baseline and Pre-Treatment Assessments (which both occur 
before the training, and therefore, measure TAU), CHWs will also be required to 
complete two additional assessments after the training:  
 
3-Month Follow-Up Assessment (3MFU): All participants will be invited to complete 
a follow-up assessment approximately 3-months after their training (3MFU). At this 
visit, participants will answer the same self-report questions they answered at the 
Pre-Training Assessment, answer additional questions about their perceived 
feasibility/acceptability of the training, and complete a roleplay for later ENACT 
coding.  
 
6-Month Follow-Up Assessment (6MFU): All participants will also be invited to 
complete another follow-up assessment approximately 6-months after their 
training (6MFU). At this visit, participants will answer the same self-report 
questions they answered at the 3MFU and complete a roleplay for later ENACT 
coding. A subset of CHWs will also participate in semi-structured individual 
interviews in which they answer open-ended questions about their perceived 
feasibility/acceptability of the training. 
 
3.5.2e Additional CHW Self-Report Measures  
CHWs will complete the same measures during the stepped-wedge trial as they 
did in the initial training. In addition, they will also complete an integrated measure 
that assesses stigmas related to HIV and TB, which has been previously validated 
among health workers in South Africa.49,50 Additionally, the personal questions 
around personal mental health/ substance use will be slightly expanded upon (i.e., 
asking about self and friends in addition to family). Although there is not an 
immediate post-training assessment, participants will additionally do another 
roleplay on their last day of training, which will be rated using the ENACT.45,46 
Please see Initial Training Procedures (above) for more information on the 
roleplay.  
 
Based on feedback from the initial training, measures used in the initial training 
may also be shortened or slightly reframed (e.g., only asking the feasibility and 
acceptability subscales of the D&I measure).  
 
3.5.2f Stakeholder Screening and Consent 
Potentially eligible NGO leaders and 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 study. Participants will be reminded that 
participation is voluntary, that they can decline to answer any questions they are 
not comfortable answering, they can leave the study at any point, and their 
decision to participate in the study will not impact their job. As part of signing the 
consent form, they will also consent to the Protection of Personal Information Act 
4 of 2013. 
 
 
 
3.5.2g Additional Measurements  
 

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Training Feasibility. CHW attendance in the training (less than one-week) and will 
be assessed as one measure of training feasibility. Over 75% of training sessions 
attending across all CHWs will be used as a benchmark for assessing whether the 
training is feasible.2 
 
CHW Fidelity. To assess the fidelity of CHW delivery of training components (e.g., 
using non-judgmental communication, implementing MI/PST skills), 20% of the 
3MFU roleplays will be randomly selected and rated using a fidelity assessment 
rating form in addition to being rated on the ENACT. A fidelity score will be 
calculated based on the proportion of key intervention components delivered as 
intended across the interactions based on these ratings.  
 
NGO leader and stakeholder perceptions of feasibility and acceptability: Following 
the 6MFU assessment timepoint and collection of mixed-methods feasibility and 
acceptability data from CHWs, we will conduct qualitative interviews with 
leadership staff from NGOs, as well as policymakers and other stakeholders. 
These interviews will explore their perceptions of the feasibility and acceptability 
of the stepped-wedge training and aid in interpretation of data from CHWs 
themselves. Further, understanding organizational and systems barriers and 
facilitators to this training has important implications for longer term sustainment.  
 
Patient Re-Engagement. 
Chart Extraction. Chart extraction will be used to examine the rate of patient re-
engagement in TB/HIV care. Specifically, data will be extracted from a centralized 
database of routinely collected data (the Western Cape Province’s Health Data 
Center), which is hosted within the Western Cape Department of Health. The 
database includes information pertaining to demographic information, TB and HIV 
status, including whether TB and/or HIV treatment was initiated, date of initial 
diagnosis, lost-to-follow-up for TB and/or HIV care (i.e., missed treatment for two 
consecutive months), and date of TB and/or HIV treatment visits. This data is 
available by site and by unique patient health identification number (PHIN).  
 
Around the time of a group’s training, trained study researchers will receive a list 
of PHINs assigned to each CHW in the group in the past six-months from CHW 
supervisors/ workers overseeing CHWs. Aggregating data by CHW, and only 
viewing patients’ PHIN and TB/HIV attendance data, we will extract whether 
patients re-engage, the time to re-engagement among those who return to care, 
and where patient re-engage in the six-months before the training.  
 
Approximately six-months after a group’s training, trained study researchers will 
receive a list of PHINs assigned to each CHW in the group since the training. 
Aggregating data by CHW, and only viewing patients’ PHIN and TB/HIV 
attendance data, we will extract whether patients re-engage, the time to re-
engagement among those who return to care, and where patient re-engage in the 
six-months before the training. 
 
As only aggregate, de-identified data will be extracted from a centralized database, 
patients will not need to give informed consent.  
 
3.6 COVID-19 Modifications 
If any assessments or participant contacts take place over the phone: 

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- 
The informed consent process will occur over the phone or virtual platform. The study 
staff will offer to email the informed consent form to the participant so that they can follow 
along/ have the form for their records. Documented verbal informed consent will be 
received before any study procedures can occur.  
- 
All survey questions will be read to participants over the phone by a study team member. 
The study team member will enter the answers to these questions on REDCap on behalf 
of the participant. 
- 
Training may occur over video platforms, such as Microsoft Teams- this is aligned with 
current strategies being used to train CHWs during COVID, delivered through the 
Western Cape Department of Health’s People Development Centre. 
- 
At the beginning and the end of the training we will set up a secure video call so that we 
may complete the pre-training and post-training role-play vignettes and adjust our 
scoring of these vignettes to account for this modality using an approach used in other 
studies using this measure and conducted during the pandemic. 
- 
Qualitative interviews may take place in person or remotely over video platform such as 
Microsoft teams. Likewise, they may take place individually or in group formats to align 
with current guidance on social distancing.  
 
3.7 Participant Reimbursement  
3.6.1a CHW Reimbursement (Initial Pilot & Stepped-Wedge Training)  
CHWs will not receive monetary compensation for the training because 
participation in trainings are normal and required part of their professional 
development for CHWs. Participation in this training as part of usual working hours 
will be negotiated with their NGO employers. However, attendees will be provided 
with meals during training and will receive reimbursement for travel when training 
is in-person.  
 
The subset of CHWs participating in semi-structured qualitative interviews will 
receive a 150 Rand gift voucher for being consented and completing questions 
about their perceptions of the feasibility and acceptability of the stepped-wedge 
training with researchers conducted during a separate study visit with members of 
the research team. 
 
3.6.1b Patient Reimbursement (Initial Pilot Only) 
Patients will not receive monetary compensation for the recording of their sessions 
with the CHW, as these sessions are part of their normal care and evaluation of 
the training. Further the purpose of these recordings is for quality improvement of 
training rather than data collection. Patient participants will receive a 150 Rand gift 
voucher for being consented and completing questions about themselves and their 
visit with the CHW with researchers conducted during a separate study visit with 
members of the research team. No data will be directly collected from participants 
in the stepped-wedge pilot trial of the training. 
 
3.6.1c Stakeholder Reimbursement (Stepped-Wedge Trial only) 
Stakeholder participants will receive a 150 Rand gift voucher for being consented 
and completing questions about their perceptions of the feasibility and 
acceptability of the stepped-wedge training with researchers conducted during a 
separate study visit with members of the research team. 
 

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4. Data Analysis  
 
4.1 Type and purpose of Data 
4.1.1 Initial Pilot Training 
As this is a pilot of our training, the main purpose of data collection is for us to collect 
sufficient information that will allow us to adapt the training for the next phase 
(implementation of training across six clinics). The aim of the study is not to generate effect 
sizes or statistical significance but rather pilot procedures including data collection 
procedures with patients who interact with CHWs) and gather feedback on how well these 
procedures worked and how they might need to be refined for the future.   
 
This study will collect quantitative and video data from assessments with CHWs (n = 25) 
and brief assessments with their patients (n = 75). CHW fidelity to training will also be 
generated by having an independent team member listen to a subset of sessions and/or 
roleplays and rate the sessions on a pre-determined fidelity checklist.    
 
Conducting roleplays both at the assessments before and after the training will also allow 
us to measure improvements in competencies we teach in the training (i.e., non-
judgmental communication, confidentiality). If the roleplay is conducted in English, the 
independent rater will rate the video as they watch the video. If the session is not 
conducted in English, it will be translated into English and then rated along with the non-
verbal communication from the video. A final competency score45,46 will be calculated for 
both pre-training and post-training roleplays for comparison.   
 
4.1.2 Stepped Wedge Trial  
The purpose of this stepped wedge trial is to examine the preliminary effectiveness and 
implementation of the proposed training. This study will collect the same quantitative and 
video data from assessments with CHWs (n = 60). An independent team member will 
rate the roleplays for both fidelity to the training using a predetermined fidelity checklist, 
and for stigma using the ENACT45,46 checklist. The fidelity rating will yield a final fidelity 
score, and the ENACT checklist will yield a final stigma score.   
 
4.2 Primary Implementation Outcomes 
4.2.1 –Initial Pilot Training 
Fidelity. At least one session or roleplay per CHW (n = 25) will be rated for fidelity using 
the fidelity monitoring tool. If a CHW recorded more than one session with a patient, the 
recording to be assessed for fidelity will be randomly selected. If the session or roleplay 
to be rated is conducted in English, the independent fidelity rater will rate the session as 
they listen to the audio. If the session is not conducted in English, it will be translated into 
English and then rated for fidelity using the checklist. Fidelity monitoring will focus on the 
presence of stigmatizing language and behaviors, adherence and competence in 
delivering skills learned in training, correct information, and the presence of positive, 
supportive interactions (i.e., use of positive affirmations in steps towards change). A final 
fidelity score will be calculated for each rated session/roleplay based on the proportion of 
key intervention components delivered as attended across interactions based upon these 
ratings.  
 
4.1.2 Stepped-Wedge Trial  
Fidelity. ENACT roleplays at the 3MFU will be rated for fidelity using a predetermined 
fidelity checklist. If the roleplay to be rated is conducted in English, an English-speaking 

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independent fidelity rater will rate the session as they listen to the audio. If the session is 
conducted in isiXhosa, an isiXhosa-speaking independent fidelity rater will rate the session 
using the same checklist (translated into isiXhosa). Fidelity monitoring will focus on the 
presence of stigmatizing language and behaviors, adherence and competence in 
delivering skills learned in training, correct information, and the presence of positive, 
supportive interactions (i.e., use of positive affirmations in steps towards change). A final 
fidelity score will be calculated for each rated session/roleplay based on the proportion of 
key intervention components delivered as attended across interactions based upon these 
ratings.  
 
Feasibility. Feasibility will be assessed by assessing CHW attendance in the training. 
Over 75% of training sessions attended across all CHWs will be used a threshold for 
determining feasibility based on our prior work. Feasibility will additionally be assessed 
using the Feasibility subscale of the D&I tool.48 CHWs will complete this measure at the 
3MFU (primary) and 6MFU (secondary). Further, we will convergently analyze the 
quantitative measure of feasibility collected from CHWs with the qualitative exploration of 
feasibility among CHWs. The coding process will be aided by the CFIR codebook and 
coding tool (available at http://cfirguide.org). After coding the individual transcripts, we 
will create case memos, which summarize, aggregate, and prioritize the barriers by 
CFIR construct and implementation outcomes for each participant. This will identify the 
most prevalent implementation barriers that require implementation strategy 
prioritization. Key themes from qualitative interviews with CHWs will then be compared 
for discrepancies and areas of alignment with the quantitative measure from CHWs. 
Lastly, key themes from qualitative interviews with stakeholders will also be compared to 
findings from CHWs for areas of discrepancy and alignment and for further 
organizational context.  
 
Acceptability. Acceptability will be assessed using the Acceptability subscale of the D&I 
Tool,48 
which 
measures 
the 
perceived 
satisfaction, 
relevance, 
usefulness, 
comprehension, and comfort level of the training to the CHWs. Acceptability will be 
assessed at both the 3MFU (primary) and 6MFU (secondary). We will also convergently 
analyze the quantitative acceptability measure collected from CHWs with qualitative data 
on acceptability from CHWs, using the same methods as for feasibility. Again, we will also 
compare and contextualize the mixed-methods data from CHWs with qualitative data from 
stakeholders.  
 
4.3 Primary Preliminary Effectiveness Outcomes (Stepped-Wedge Trial Only) 
4.3.1 –Stepped Wedge Trial 
CHW Stigma. The primary measure of CHW stigma is the Social Distance Scale 
(SDS),20,43,44 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 CHW stigma 
towards the target population at each timepoint, with high 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). To account for the stepped wedge study design, we will fit a linear mixed model 
(LMM). This analytic approach will allow us to account for both random effects of the clinic 
and CHW, and fixed effects of time and the effect of the training. We will analyze the 
within- and between-group effects. Specifically, the within group effect will evaluate 
changes in stigma before and after receiving the training with CHWs from the same clinic, 

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and the between group effect will compare the CHW training to assessments before the 
CHW training. An F-test will be used to test the between and within clinic intervention 
effects. Covariates (i.e, CHW demographic and job-related characteristics) will be included 
in the model. The model accounts for any baseline differences in CHW stigma between 
clinics and individual CHWs. Secondary measures of CHW stigma will include behavioral 
coding to stigmatizing responses in a role play based on vignettes using the ENACT scale. 
45,46,51 Specifically, we will examine whether specific ENACT items (interpersonal skills 
sub-scale) at the pre-training timepoint predict other ENACT items (clinical skills sub-
scale) at the later timepoints using multivariate linear models. This will allow us to begin 
to explore whether pre-training ENACT roleplays could be helpful for pre-training 
screening of CHWs in future research. We will also examine improvement in individual 
ENACT items across the data collection timepoints to examine the effect of the training 
and supervision on CHW helping skills and the durability of CHW helping skills over time. 
Additionally, analyses will be conducted on the an integrated HIV and TB stigma scale to 
measure intersectional HIV and TB stigmas. This scale has previously been validated 
among health workers in SA.49,50  
 
4.4 Secondary Prelminary Effectiveness Outcomes (Stepped-Wedge Trial Only) 
4.4.1 Stepped-Wedge Trial 
Re-engagement in TB/HIV care. The rate of patient re-engagement at the CHW level 
and time to re-engagement in TB/HIV care at the patient level in the six months prior to 
the CHW training compared to six-months following the CHW training will be evaluated 
using chart extraction. We will apply a Poisson regression model to compare rates of 
patient re-engagement at the CHW level, accounting for both clinic random effect and the 
fixed effect of time in the stepped wedge design. Pre-intervention patient re-engagement 
rates will be collected during the TAU phase for each clinic over the six months prior to 
the first CHW training, and post-intervention rates will be collected six months after the 
CHW training is complete via chart review. A Wald test will be used to test the effect of the 
CHW training intervention on the rates of patient re-engagement.  
 
Time to re-engagement. To further investigate whether the CHW training intervention 
decreases patient time to re-engagement in TB/HIV care over six months, we will use a 
Cox Proportional Hazard survival model to model the patient-level outcome of time of re-
engagement. Right censoring (those who do not re-engage within six months) is handled 
in the Cox model. A frailty model includes the random effect of clinics to account for 
unobserved heterogeneity. If the proportional hazard assumption is not met, the 
parametric accelerated failure time model can be used instead. We will control for amount 
of CHW contact with the patient (i.e., whether the CHW makes contact with the patient 
and the number of times the CHW visits the patient before the patient re-engages) and 
the patient’s screening results (i.e., whether they screen positive for depression, 
hazardous alcohol use, and/or other drug use).  
 
4.5 Missing Data (Stepped Wedge Trial Only) 
Intent-to-treat (ITT) analysis will be conducted so all participants are analyzed based on 
their initial randomization assignments. All data will be included, regardless of 
subsequent participant dropout or missing data. For observed missing data, we will 
follow guidelines for handling clinical trial missing data. Specifically, data are assumed 
missing at random (MAR) for ITT analysis, but subsequent sensitivity analyses will be 
conducted where data are assumed not missing at random (MNAR) using multiple 
imputation to assess the robustness of the MAR assumption. 
 

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5. Ethical Considerations  
 
5.1 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 the 
interviews. For instance, patient participants may feel uncomfortable discussing their SU, 
feelings of depression, or experiences feeling stigmatised, and CHW participants may feel 
uncomfortable talking about their stigmatising behaviours.   
 
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. 
 
5.2 Protections Against Risks  
Every effort will be made to minimize all study-related risks. These efforts include:  
 
5.2.1 Informed Consent  
All CHWs and patients who are asked questions will complete informed consent 
procedures. To join the study, these participants must fully understand and sign the 
consent. 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 has depression or uses substances. 
Depression is considered a common mental disorder, and unlike severe mental illnesses 
such as schizophrenia, is unlikely to impact on a person’s capacity to provide consent. 
The majority of people who screen positive on the screening tools we propose using will 
have mild to moderate psychological distress. In and of itself, this is unlikely to impact on 
capacity to provide consent. 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. We include a question about alcohol and other 
drug use in the past four hours, which would cause acute intoxication. Individuals who 
respond positively to this question will not be enrolled. Likewise, individuals who respond 
positively to this question before the interview will not be interviewed at that time. The 

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study team will also 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 capacity to provide consent  in our consent 
form, that has been used in other studies with populations of patients who use alcohol and 
local studies with people with severe mental illness. These procedures were approved 
and used in the formative work to develop the training programme (#EC039-9/2020). 
 
5.2.2 Preventing Breaches to Confidentiality  
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 research staff in South 
Africa. 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.  
 
Roleplays (and patient sessions in the Initial Pilot Training) will be recorded for analysis. 
The purpose of recording roleplays will be explained to all CHW participants in the 
informed consent process and authorization for recording will be obtained. Digital 
recordings will be uploaded to a secure database using the study computer immediately 
following the session and the audio file will be deleted from the digital recorder. Computer 
audio and video files will be saved in a secure location that only study-staff can access 
(i.e., UMD Box) and saved with a study ID. Any potentially identifying information will be 
removed or anonymized in the body of the written transcripts (e.g., the names of people). 
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. We will keep recordings even after transcription has occurred as a back-up and to 
allow for more nuanced coding if needed (e.g., of tone in addition to language). The ethics 
committee will review study procedures at least annually to review procedures pertaining 
to participant confidentiality. 
 
English audio files may be transcribed to written text using Otter.ai by AISense. All audio 
files sent to Otter.ai will be de-identified and saved only using participant ID numbers in 
order to protect participants’ confidentiality. Team members will only use Otter.ai for 
assistance; they will still check and correct any errors in the transcripts from the service. 
Otter.ai uses artificial intelligence technology and syncs data over an encrypted 

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connection and stores it in a secure data centre that has both physical and electronic 
security. When the user deletes the recording, there will be no record retained by AISense. 
 
5.2.3 Protections against psychological or mental discomfort  
All interviewers will be trained to recognize signs of discomfort, distress, or anxiety. 
Interviewers will carefully monitor the participant’s response, which will allow the 
interviews to be completed with minimum discomfort. 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.  At the end of the interview, participants will be offered referrals to local 
mental health and substance use services.  We have a network of referral resources in 
Khayelitsha, established through previous studies in this area. 
 
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 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 debriefing and Dr Myers will be available to provide 
supervision and guidance. 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.  Again, it is important to note that our patient participants are unlikely to 
require medical management of depression. 
 
For both distressed participants and other participants with known difficulties relating to 
possible depression and substance use, we will provide individuals with active referrals to 
mental health and substance use (or other health services) on request. Active referral 
involves a discussion with the individual about the benefits of additional services, obtaining 
the participant’s consent for release of information, identifying a suitable service to which 
the individual can be referred, allowing the individual to use a telephone to contact the 
service (or contacting the service on the individual’s behalf) to make an appointment, 
writing a formal referral letter and providing this to the individual, and in some instances, 
transporting the individual to the service for their first appointment.  As part of managing 
this process, we follow up with participants to see whether they were able to access the 
service, and if there were barriers to help them address these. We also follow up to assess 
whether there has been any improvement to their mental health status.  
 

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5.2.3 Health and Safety: COVID-19  
To reduce the likelihood of COVID-19 transmission, the following precautions will be 
taken.   
 
Vaccines. First, all study staff who are eligible to receive the COVID-19 vaccine will be 
encouraged to do so. All of our research staff currently working on this project are 
vaccinated and have agreed to share their vaccination status in this protocol.  
 
Telephonic Interviews. To reduce contact with study participants, if possible, assessments 
with patient participants be conducted telephonically. Depending on the status of COVID-
19, ongoing supervision and parts of the training may be held in-person or telephonically/ 
over video.  
 
In-Person Procedures. All staff members will be trained in COVID-19 safety protocols and 
the SAMRC standard operation procedures for the conduct of research during COVID-19. 
Staff members will have access to personal protective equipment (PPE) which will include 
sanitiser, masks, gloves, and face shield and Perspex dividers. Social distancing between 
staff member and the participant will be practiced, and all surfaces used will be disinfected 
before and after any interviews are held.  
 
Assessments with patients will be conducted at the patient’s home or over the phone. 
Assessments with CHWs will be conducted over the phone, at the location or the training, 
or where CHWs already work, so transportation should not be an issue for participation in 
assessments. However, we are aware that transport may be an issue for CHWs attending 
the training. If CHWs need to utilize public transport for the training, we will make sure that 
they feel safe to travel using this method, that it is their usual mode of transport for daily 
activities, and we will advise them to use masks while on public transport.  
 
5.3 Potential Benefits of Proposed Research to Human Subjects 
5.3.1 Participants 
It is possible that participants will not directly benefit from this study. However, CHWs may 
find that they benefit from the additional information and skills that they learn in the training. 
Their patients also may benefit from them utilizing these new skills. CHW (in the initial and 
stepped-wedge trial), and patient participants (in the initial training), may also enjoy the 
opportunity to share their feedback on the CHW training.  
 
5.3.2 Importance of the Knowledge to be Gained  
From a broader perspective, the current study will likely have important implications for 
identifying how to optimally adapt and implement this CHW training program to promote 
re-engagement in care for patients co-infected with HIV and TB.  
 
Initial Pilot Training 
Findings from this formative study will inform the next iteration of this CHW training 
program, that we will implement in several clinics. We will seek approval for this 
next phase of the research in a separate submission.  
Stepped Wedge Trial 
CHWs are employed at every community health centre in South Africa, either 
through NGOs or the Department of Health. If this training program proves 
successful in reducing CHW stigma towards depression and substance use and 
promoting patient re-engagement in TB/HIV Care, it offers the potential for scale-

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up. This research will also allow us to further understand barriers and facilitators 
to such scale-up.  
6. Data Management 
5.2 Data Storage  
6.1.1 Data Acquisition and Transmission  
Data collection occurs in South Africa 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 interviews, measures, and observation notes will be conducted by a 
trained member of the study staff who will be supervised throughout the study.  
 
Recordings. With the permission patients, some CHW sessions will be audio recorded for 
analysis. Please note that because CHWs—not patients—are the focus of these 
recordings, patients will not be enrolled in the study if their session is audio recorded. They 
will only be enrolled in the study if they choose to participate in a brief assessment about 
themselves and their CHW’s visit. Roleplays with CHWs and either another CHW or staff 
member will be videorecorded. Qualitative interviews will be audio-recorded. If a roleplay, 
interview, or session is translated (e.g., because it is conducted in a non-English 
language), the translator will be a member of the study team and will leave out any 
potentially identifying data (e.g., names, locations). Roleplays will be recorded at the time 
of the training and saved in a secure location that only study-staff can access (i.e., UMD 
Box) and saved with the CHW’s study ID. Qualitative interview recordings will also be 
stored in a secure location that only study-staff can access (i.e., UMD Box) and saved with 
the participant’s study ID. CHWs will receive verbal consent from their patients before 
recording a normal session. If the patient does not want their session recorded, the visit 
will continue as usual. During training and supervision we will stress to CHWs that it is 
okay if none of their patients want to be recorded. If a session is recorded, the CHW will 
be asked to let the study team know. The study team will pick up the recording device as 
soon as possible and upload it to a secure database using the study computer. The audio 
file will then be deleted from the digital recorder. Computer audio files will be saved in a 
secure location that only study-staff can access (i.e., UMD Box) and saved with the CHW’s 
study ID. 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. 
 
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. 
 

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6.1.2 Data Entry Methods  
 
Fidelity Analysis. Roleplays and sessions with patients and roleplays will be analysed for 
fidelity. If done in English, team members will review the recording in English on UMD box. 
If not done in English, study team members who speak isiXhosa will review the recording 
in isiXhosa on UMD box and complete the rating using an isiXhosa version of the measure.  
 
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 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. Data from all participants will be identified 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.’ 
 
5.3 Data Safety and Monitoring Plan 
6.2.1 Regulatory Issues  
The procedures laid out in this document will be followed, in compliance with 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. 
 
6.2.2 Amendments 
Any changes to the protocol or amendments will be submitted to the SAMRC ethics 
committee before they are implemented.  

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6.2.3 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.  
Likelihood. 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”.  
 
6.2.4 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.   
 
6.2.5 Adverse events and unanticipated problems 
As this study consists of low-risk one-time visits, we do not anticipate having any AEs, 
SAEs, or unanticipated problems. However, the plan for monitoring and reporting AEs, 
SAEs, and unanticipated problems is below.  
 
Monitoring. Participants in semi-structured interviews will be monitored for AEs, SAEs, 
and unanticipated problems during the one-time interview session.  
 
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 SAMRC HREC within 48 hours of the team 
discovering the SAE, regardless of whether or not the SAE is related.  
 

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6.2.6 Additional review bodies 
US National Institute of Mental Health (NIMH). The following events will be reported to the 
NIMH, this study’s sponsor, as follows:  
 
Event 
Details 
Reported By 
IRB Suspension or 
Termination 
If ethics approval is suspended 
or termination, a statement of 
reason(s) for the action must 
be reported to the NIMH 
Program Officer (PO) within 3 
business days of 
suspension/ termination 
receipt.  
 
PIs and SAMRC 
ethics board 
Deaths related to study 
participation 
Within 48 hours of PIs 
becoming aware of death. 
 
PIs 
Unexpected SAEs related 
to study participation 
 
Reported to the NIMH PO 
within 10 business days of 
the study team becoming 
aware of the SAE. 
 
PIs 
Unanticipated Problems 
involving risks to subjects 
or others 
 
Reported to the NIMH PO 
within 10 business days of 
the PI becoming aware of 
event.  
 
PIs 
Serious or Continuing 
Noncompliance 
Reported to the NIMH PO 
within 10 business days of 
ethics determination. 
 
SAMRC ethics board 
AEs and SAEs 
A summary of all AEs and 
SAEs that are deemed 
expected and/or unrelated to 
the study should be submitted 
to the NIMH PO and the 
SAMRC ethics board with the 
annual progress report. 
 
PIs 
Protocol Violations 
Annual progress report. 
PIs  
 
 
6.3 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.  
 

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6.4 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. 
 
 
 
7. Timeline 
 
 
Initial Training: 
Week 
Task 
Amount of Time 
Week 1 
Finalize training manual, set training date, and recruit CHWs 
 
1 month 
Week 2 
Week 3 
Week 4 
Week 5 
Training (including pre-training and post-training assessment) 
3 – 5 days 
Week 6 
Weekly supervision, roleplays, audio-recordings, and patient 
consents/ assessments 
1-month 
Week 7 
Week 8 
Week 9 
Week 10 
1-Month Follow-Up Assessment 
~30min per CHW 
 
 
Upon receiving ethics approval for stepped-wedge trial, approximate timeline: 
Month 
Group 1 
~20 CHWs 
Group 2 
~20 CHWs 
Group 3 
~20 CHWs 
1 
Finalize minor adaptions to training manual, work with NGOs and Western Cape Department of 
Health, recruit CHWs 
2 
3 
Baseline Assessment  
+ TAU 
Baseline Assessment  
+ TAU 
Baseline Assessment  
+ TAU 
4 
TAU 
TAU 
TAU 
5 
Pre-Treatment Assessment  
+ Training  
+ Supervision 
TAU 
TAU 
6 
Supervision 
Pre-Treatment Assessment  
+ Training  
+ Supervision 
TAU 
7 
Supervision 
Supervision 
Pre-Treatment Assessment  
+ Training  
+ Supervision 
9 
3MFU 
Supervision 
Supervision 
10 
 
3MFU 
Supervision 
11 
 
 
3MFU 
12 
6MFU 
 
 
13 
Stakeholder (CHW and 
providers) interviews 
6MFU 
 
14 
 
Stakeholder (CHW and 
providers) interviews 
6MFU 
15 
 
 
Stakeholder (CHW and 
providers) interviews 
TAU = treatment as usual 
 
 
 

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8. Management Details 
 
8.1 Management Approach 
The present study will be led by the two PIs: Dr Bronwyn Myers and Dr Jessica Magidson.  
8.1.1 SAMRC 
Dr Myers (MPI) will take primary responsibility for SAMRC ethics protocols, training 
materials, staff training and management, and quality assurance. They will also oversee 
data collection.  
 
8.1.2 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.  
 
8.3.1 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), team 
members who are not located in South Africa 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.  
 
8.2 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 (United States 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. 
 
 

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8.3 Facilities 
8.3.1 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. 
 
8.3.2 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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9. Additional Details 
 
9.1 Research Translation 
9.1.1 Manuscripts.  
We plan to publish the findings of this study in peer-reviewed journals. At a minimum we 
hope to publish a mixed-methods report of the implementation (i.e., acceptability and 
feasibility) findings of this pilot study. At a minimum we will publish a report of the 
implementation and preliminary effectiveness findings of the study. 
 
9.1.2 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).  
 
9.1.3 Training Materials.  
This study will allow for the final adaptation of our training program for CHWs. We will use 
this final adaption in the next phase of the study with more CHWs (for which we will receive 
separate ethics approval). If at the end of this future study the approach proves to be 
effective, feasible, and acceptable, we will offer capacity-building workshops to train 
CHWs in the adapted manual, using a version that incorporates stakeholder feedback of 
feasibility and acceptability.  
 
9.1.4. 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.  
 
9.1.5. Clinical Trial Registration  
In line with the requirements of the US National Institutes of Health (NIH), Part II of this 
study (Stepped Wedge Design) will be registered on ClinicalTrials.gov within 21 days of 
enrolment of the first participant. 
 
9.2 Scientific Validity  
This study has been peer-reviewed and approved by the US National Institute of Mental Health, 
a division of the United States’ NIH.  
 
 
 
 
 
 
 
 
 
 
 
 
 

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14. Nakimuli-Mpungu E, Bass JK, Alexandre P, et al. Depression, alcohol use and adherence 
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perfection: reflections on harm reduction engagement in South Africa. Crit Public Health. 
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25. Versfeld A. Reimagining the problem: Substance use in tuberculosis patients in Cape 
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counseling and chronic disease care in South Africa. Patient Prefer Adherence. 
2018;12:1797-1803. 

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27. Bogart LM, Chetty S, Giddy J, et al. Barriers to Care among People Living with HIV in 
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31. Knaak S, Mantler E, Szeto A. Mental illness-related stigma in healthcare: Barriers to 
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32. Zewdu S, Hanlon C, Fekadu A, Medhin G, Teferra S. Treatment gap, help-seeking, stigma 
and magnitude of alcohol use disorder in rural Ethiopia. Subst Abuse Treat Prev Policy. 
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33. Clement S, Schauman O, Graham T, et al. What is the impact of mental health-related 
stigma on help-seeking? A systematic review of quantitative and qualitative studies. 
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34. Nyblade L. Disentangling stigma to find entry points for intervention. Sex Health Exch. 
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What works? J Int AIDS Soc. 2009;12(1):15. doi:https://doi.org/10.1186/1758-2652-12-15 
36. 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. 
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37. 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 
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38. Kohrt BA, Jordans MJ, Turner EL, et al. Reducing stigma among healthcare providers to 
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39. Link BG, Phelan JC. Conceptualizing stigma. Annu Rev Sociol. 2001;27(1):363-385. 
40. Rivet Amico K. A situated-Information Motivation Behavioral Skills Model of Care Initiation 
and Maintenance (sIMB-CIM): an IMB model based approach to understanding and 

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intervening in engagement in care for chronic medical conditions. J Health Psychol. 
2011;16(7):1071-1081. 
41. Sibeko G, Milligan PD, Roelofse M, et al. Piloting a mental health training programme for 
community health workers in South Africa: an exploration of changes in knowledge, 
confidence and attitudes. BMC Psychiatry. 2018;18(1):191. 
42. Myers B, Petersen-Williams P, van der Westhuizen C, et al. Community health worker-
delivered counselling for common mental disorders among chronic disease patients in 
South Africa: a feasibility study. BMJ Open. 2019;9(1):e024277. 
43. Adewuya AO, Makanjuola ROA. Social distance towards people with mental illness in 
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44. 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. 
45. Kohrt BA, Jordans MJD, Rai S, et al. Therapist competence in global mental health: 
Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) 
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46. 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. 
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review of empirical tests. Soc Sci Med. 2022;292:114523. 
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48. Haroz EE, Bolton P, Nguyen AJ, et al. Measuring implementation in global mental health: 
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019-4097-y 
49. Wouters E, Rau A, Engelbrecht M, et al. The development and piloting of parallel scales 
measuring external and internal HIV and tuberculosis stigma among healthcare workers in 
the Free State Province, South Africa. Clin Infect Dis. 2016;62(suppl_3):S244-S254. 
50. Wouters E, Masquillier C, Sommerland N, et al. Measuring HIV-and TB-related stigma 
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51. Silverman D. Doing Qualitative Research: A Practical Handbook. SAGE publications 
limited; 2013. 
 
 
 

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Appendix 1: Budget Documents 
 
Please see attached budget documents.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2: Procedures for Distressed Participants  
 
Procedures for Distressed Participants and Mandatory Reporting 
Given the nature of this study, there may be instances, where you as a researcher are faced with 
a distressed participant who you are concerned needs additional or immediate mental health 
support. For the most part, you can address this by talking to the participant and providing them 
with a referral to see the mental health nurse or for additional substance abuse services. 
 
1. 
What is a distressed participant? 
By “distressed” we mean that a participant shows signs of experiencing negative emotions and 
by his/her words, expressions, or other nonverbal behaviors or body language indicates that s/he 
is emotionally upset.   
 
Possible signs or indications of distress: 
• 
A participant who is tearful and/or reports that s/he feels badly or is sad 
• 
A participant who shows signs of being considerably more nervous or anxious (e.g., very 
nervous speech, increased sweating, difficulty sitting still during the appointment) than would 
be expected during an appointment. 
• 
A participant who seems agitated or aggressive and that you cannot easily calm down. 
 
1.1 Steps to follow with mildly distressed participants who need additional services 
In most cases of distress, participants may talk about feeling badly but you will be able to manage 
or contain these feelings and continue with the appointment.  They may however, need additional 
services or support once the counselling intervention has been completed.   
In these cases, complete the following steps at the end of the study appointment: 
• 
Indicate to the person that they seem upset or anxious 
• 
Discuss with the participant the importance of additional support 
• 
Ask if they would like to receive additional services to talk more about feelings that came 
up during the course of the study 
• 
If the participant indicates s/he would like to talk with someone further, ask if they would 
like you to refer them to an organization 
• 
Complete the referral and release form 
• 
With the participant’s permission, call the agency or the clinic nurse to make an 
appointment 
• 
Provide the patient with a copy of the referral letter in an envelope and keep one in the 
participant’s file 
• 
Provide the participant with a copy of the resource guide for additional services 
• 
If the participant indicates that s/he does not want you to make a direct referral, suggest 
various organizations for him/her to contact on her own and give them a copy of the 
resource guide.  
• 
At the end of the appointment, document this referral in the Participant’s file 
 

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These steps should only be followed if the participant shows signs of distress or expresses a need 
for more counselling- but no suicidal intent or imminent harm is disclosed or suspected.   
If the person expresses any desire to end their life or hurt themselves or others, follow the 
steps described in 1.2 and the mandatory reporting procedures described in section 2. 
 
1.2 Steps to follow with very distressed participants 
There may be instances where participants are so distressed that you are concerned for their 
safety and may not be able to continue with the appointment. Remember that we have made it 
clear in the consent form that there are exceptions to our promise of confidentiality. If participants 
express the intent to harm themselves or others, or ongoing abuse and/or neglect of children, 
then we have a duty to report this matter to the proper authorities, e.g. the police, courts or social 
workers. Field staff will provide information on toll-free hotlines that people can call to talk to 
someone and seek assistance, as well as local resource information.  
If during the course of the study you are concerned that a participant intends to harm him/herself 
or others, then mandatory reporting procedures need to be followed on completion of the 
appointment. Immediately inform the project manager and the principal investigator (PI) who will 
report the incident to the various ethics committees and our project officer within 72 hours.     
In these instances, please follow the following steps: 
• 
As far as possible, complete the study appointment 
• 
Indicate to the person that they seem upset or anxious 
• 
Remind the person of the limits of confidentiality as expressed in the consent form, and 
your duty to report 
• 
Follow the mandatory reporting procedures described below 
• 
Complete the referral and release form  
• 
Call the agency to make an immediate appointment 
• 
Provide the patients with a copy of the referral letter in an envelope and keep one in the 
participants folder 
• 
Provide the patient with a copy of the resource guide for additional services 
• 
At the end of the appointment, document this referral in the Participant’s file 
• 
Complete an incident report form and immediately send to the project manager and PI 
who will both keep copies on file and will report the incident to the relevant regulatory 
bodies. 
 
2. 
Mandatory reporting procedures 
It is possible that a participant will indicate during the course of a discussion that s/he is in 
immediate danger of harm or poses a threat to the safety of others. We want you to feel that you 
can handle this situation with confidence.  
There are essentially three situations in which there may be immediate danger of harm: 
1) Suicidal Intent: The participant expresses a desire to hurt or kill themselves. 
2) Hurtful Intent to Others: The participant expresses an interest in hurting or killing 
someone else (not necessarily someone living in the household).  
3) Child Abuse and Neglect: Ongoing abuse and/or neglect of children. 

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The rest of this protocol describes what to do in each of these cases. For each of these cases, 
you must follow compulsory or mandatory reporting procedures.  
These procedures are important to follow because they take away the responsibility of you having 
to decide what to do. These procedures are in your best interest and in the best interest of the 
participant- they are to keep the participant safe and unharmed.  
 
2.1 Suicidal Intent 
If a participant expresses an interest in harming or killing him/herself, assess whether the risk is 
immediate or not immediate by following this procedure: 
 
Ask the following questions: 
 
In The Past 
Month 
Answer Questions 1 and 2 
YES 
NO 
1) Have you wished you were dead or wished you could go to sleep 
and not wake up? 
 
 
2) Have you actually had any thoughts about killing yourself?  
 
 
If YES to 2, answer questions 3, 4, 5, and 6.  If NO to 2, go directly to question 6 
3) Have you thought about how you might do this?  
 
 
4) Have you had any intention of acting on these thoughts of killing 
yourself, as opposed to you have the thoughts but you definitely 
would not act on them?  
 
 
5) Have you started to work out or worked out the details of how to 
kill yourself?  
Do you intend to carry out this plan?  
 
 
 
In the Past 
3 Months 
6) Have you done anything, started to do anything, or prepared to do 
anything to end your life? 
 
Examples: Collected pills, obtained a gun, gave away valuables, wrote a 
will or suicide note, took out pills but didn’t swallow any, held a gun but 
changed your mind or it was grabbed from your hand, went to the roof but 
 
 

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In The Past 
Month 
didn’t jump; or actually took pills, tried to shoot yourself, cut yourself, tried 
to hang yourself, etc. 
 
In your entire lifetime, how many times have you done any of 
these things? 
 
If the person answers YES to either questions 4, 5, or 6, this is a red flag and you should consider 
them at high risk for suicide.  Risk is not immediate if the person is expressing some suicidal 
thoughts to describe how badly they feel but they do not have a plan.  In the instance of high risk, 
follow the script below:  
 
2.1.1 Procedure: IMMEDIATE or HIGH RISK of SUICIDE 
 
If you assess that the participant is at immediate risk to him/herself, read the following script to 
the participant: 

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Script: Risk of participant suicide or self-injury (immediate danger of harm)  
Team member reads: 
 “When you agreed to participate in this study, I promised that I would tell someone what you told 
me only if it was necessary to protect you or other people.  You told me earlier that you were 
thinking of harming yourself.  I suggest we contact an organization called LifeLine or SADAG and 
let them know so they can talk to you about how you feel. LifeLine and SADAG offers counseling. 
You can discuss your problem with one of their counsellors and they may be able to help you. Do 
you want to call them or should I call them for you?” 
 
Willing participant: 
• If the participant agrees to contact Lifeline or SADAG, use the project phone to make the call 
for the participant, hand them the phone and go to another room to give them privacy during 
the call.  
• If the participant asks you to make the call on their behalf, use the project phone to make the 
call for the participant, and follow the script when speaking to the counsellor 
• After the script has been read, hand the phone to the participant and go to another room to 
give them privacy in the call. 
Script: Risk of participant suicide or self-injury (immediate danger of harm) 
 
Team member reads to telephone counsellor 
“We are conducting a research study and during an appointment, the participant expressed s/he 
was thinking of killing or harming him/herself.  The participant has requested that we make this 
call for him/her.   
 
Please note that this information was obtained through their participation in this research study.  
We went through appropriate informed consent, including telling the participant that a report might 
be made if the information s/he provided raised concerns about his/her well-being. I can give you 
additional information about the research study, if you would like. I can also provide you with the 
participant’s name.” Would you talk with him/her? 
 
Unwilling participant 
• 
If the participant is unwilling to contact the crisis hotline and doesn’t want you to contact 
them, then you should immediately contact the project manager who should immediately 
contact a registered psychological counsellor who can assess the situation (e.g., 
determine reasons why the participant is unwilling to contact the hotline so these issues 
can be addressed) and who can contact one of the psychologists or the medical doctor in 
the investigative team for further inputs.  
• 
In the meantime, do not leave the participant by him/herself nor let them leave on their 
own, as they pose a risk to themselves.  
• 
Ask the participant if s/he has a close family member or friend who can come to sit with 
them until you receive clear instructions about what to do.  
• 
If the participant remains unwilling to contact the hotline, provide the participant with the 
referral guide as well as the counselling hotline numbers. 

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• 
Make sure you document who you spoke to and the advice provided on the incident form 
Script: Risk of participant suicide or self-injury (immediate danger of harm - unwilling to 
contact hotline)  
 
Read to participant 
“You told me earlier that you had thought about harming yourself, and this concerns me.  I have 
to report this information to the appropriate authorities. I can also take you to the mental health 
nurse, refer you to the family physician or call LifeLine or SADAG on your behalf. I strongly 
suggest that you contact LifeLine or SADAG or go and speak to a  doctor. Here is information 
about the telephone hotline that you could call to discuss your problem with a counselor. If you 
feel that this is an emergency now or later, you should go to a hospital emergency room right 
away. If you are unable to get to an emergency room without help, you should call the police for 
assistance." 
After giving  this information to the participant, immediately contact the hotline and adhere to the 
following script.  The hotline will advise you on next steps. 
Script: Risk of participant suicide or self-injury– to hotline 
 
“During an appointment for a research project project, a participant expressed s/he was thinking 
of killing or harming themselves.  The participant was encouraged to call LifeLine or SADAG and 
seek further professional assistance, but we also informed the participant that we have to report 
the situation. The participant was unwilling to contact anyone for help nor allow us to contact 
anyone on his/her behalf. S/he is with us now, but we are concerned about her safety.   
 
Please note that this information was obtained through their participation in the study. We went 
through appropriate informed consent procedures, including telling the participant that a report 
might be made if the information s/he provided raised concerns about his/her well-being. I can 
provide you with the participant’s name and residential area. Please can you advise us as to next 
steps to follow. 
 
2.2. Hurtful Intent to Others 
It is unlikely, but someone may spontaneously tell you that they are planning to seriously hurt or 
kill someone else. If a participant expresses an interest in harming or killing someone else, you 
should take the following steps. 
• 
As far as possible, complete the study appointment 
• 
Indicate to the person that they seem upset  
• 
If they are expressing a desire to hurt someone else, explore whether there is an 
immediate risk (i.e. they have a plan and the means to do it)  
• 
If there is immediacy and a plan, remind the person of the limits of confidentiality as 
expressed in the consent form, and your duty to report. 
• 
Follow the mandatory reporting procedures described below 
• 
Follow the reporting procedures - complete an incident report form and immediately send 
to the project manager and PI who will both keep copies on file. 

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2.2.1 NO IMMEDIATE RISK 
If no immediate danger is perceived, advise the project manager and the PI immediately who will 
evaluate the seriousness of the issue and give advice on what to do. If the danger of harm is 
definitely credible, then the authorities will be called to report the incident. If the danger of harm 
is believed to definitely be credible, you may be advised to contact the police. In this case, please 
follow the script below. 
 
Script: Risk of someone being harmed or killed revealed by participant 
 
Team member to read to police 
“We are conducting a research study, and during an appointment, a participant expressed an 
interest in harming or killing someone.  I have discussed this situation with my supervisors and 
we have decided that this person might pose a real threat, so we are alerting you.  
Please note that this information was obtained during an appointment that was conducted for this 
research study. We went through appropriate informed consent procedures, including telling the 
participant that a report might be made if the information s/he provided indicated that s/he might 
harm him/herself or others.  I can give you additional information about this research study, if you 
would like.  I can also provide you with the contact information for the participant.” 
 
2.2.2 IMMEDIATE RISK 
If immediate danger is perceived please alert the project manager and the PI immediately and 
they will report the incident to the authorities. Do not let the participant leave before you have 
instructions from the police or the trial manager as to next steps to take. Please follow each of 
these steps.   
Script: Risk of someone being harmed or killed revealed by participant during the 
appointment 
 
Project manager or PI to read to the authorities 
 
“We are conducting a research study, and during an appointment, a participant expressed that 
s/he intended to harm or kill someone, so we are alerting you.  
 
Please note that this information was obtained during an appointment that was conducted for this 
research study.  We went through appropriate informed consent procedures, including telling the 
participant that a report might be made if the information s/he provided indicated that s/he might 
harm themselves or others.   I can give you additional information about the research study, if you 
would like.  The participant is here at the moment.” 
It is unlikely that you will be faced with this situation! 
 

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2.3 Child Abuse/Neglect 
 
Someone may tell you that s/he has abused or neglected a child or has been/is being abused, if 
a minor. If a participant reports this, you must report the incident to the authorities i.e Police (if 
sexual abuse) and Social Services/Childline (if any other type of abuse) after completing the 
appointment.  
Note that, if an adult or even a person over the age of sixteen (in some cases where the age gap 
is more than two years above the other minor1) is having sex with a minor aged 12 to 15 years, 
even if it is consensual, it must be reported to the police.  
Follow these steps: 
• 
As far as possible, complete the study appointment 
• 
Indicate to the person that they seem upset  
• 
If they are reporting abusing a child or is a minor reporting that they or another minor a 
being abused, remind the person of the limits of confidentiality as expressed in the consent 
form, and your duty to report 
• 
Follow the mandatory reporting procedures described below 
• 
Follow the reporting procedures - complete an incident report form and immediately send 
to the project manager and PI who will both keep copies on file. 
 
2.3.1. PARTICIPANT (UNDER 18) BEING ABUSED OR NEGLECTED 
 
 
 
1   A person aged 12 can consent to sex with someone who is 14 years old, but not someone who is 16. A minor 
below the age of 16 having sex with a minor below the age of 12 is also a reportable offence. 

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Protocol: NCT05282173                                                                             Approved: 4 April 2023  
 
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• 
 
Script: Minor participant being abused or neglected revealed during the 
appointment  
 
Team member to read to authorities: 
 
“We are conducting a research study, and during an appointment with a participant, who 
is a minor, certain indications were made that the participant has possibly been physically 
or sexually abused or neglected. This led us to conclude that it was necessary to contact 
you to alert you of our concerns. 
 
Please note that this information was obtained through the participant’s participation in 
this research study, with appropriate informed consent procedures which included telling 
the participant that a report might be made if the data raised concerns about a her well-
being. I can give you additional information about this research study, if you would like. I 
can also provide you with the contact information for the participant.” 
 
 
2.3.2. PARTICIPANT ABUSING OR NEGLECTING A CHILD 
  
Script: Child being abused or neglected by participant revealed  
 
Read to authorities: 
 
“We are conducting a research study, and during an appointment with a participant, certain 
indications were made that the participant has possibly physically or sexually abused or neglected 
a minor.  This led us to conclude that it was necessary to contact you to alert you of our concerns. 
  
Please note that this information was obtained through the participant’s participation in this 
research study, with appropriate informed consent procedures which included telling the 
participant that a report might be made if the data raised concerns about a child’s well-being. I 
can give you additional information about this research study, if you would like. I can also provide 
you with the contact information for the participant.”