The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building
Phase: NA
Conditions: Depression
Sponsor: University of North Carolina, Chapel Hill

STUDY PROTOCOL 
 
The Sub-Saharan Africa Regional Partnership (SHARP) for Mental 
Health Capacity Building – A Clinic-Randomized Trial of Strategies to 
Integrate Depression Care in Malawi 
 
 
NCT number NCT03711786 
Document Date 11/11/2022 
 

 
 
 
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The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity 
Building – A Clinic-Randomized Trial of Strategies to Integrate Depression Care in Malawi 
Sponsored by:  
National Institute of Mental Health (NIMH) at the National Institutes of Health (NIH) 
 
 
 
US Protocol Chairs: Brian Pence & Mina Hosseinipour 
Malawi Protocol Chair: Jones Masiye 
 
 
 
 
 
 
 
 
Version 1.9  
11 November 2022 
 
 

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ABSTRACT 
Despite the heavy burden of mental illness, the mental health treatment capacity of most sub- 
Saharan African health systems is extremely limited. Although effective mental health treatment 
interventions are well defined in high-income countries, their deployment in low- and middle-
income countries is limited due to lack of implementation science research that addresses the 
challenges of adapting evidence-based interventions to low-resource contexts and few 
researchers and policymakers adequately trained in implementation science. The Sub-Saharan 
Africa Regional Partnership (SHARP) for Mental Health Capacity Building seeks to make a 
meaningful impact on the mental health treatment gap in sub-Saharan Africa. The partnership 
brings together governmental, academic, and non-governmental partners invested in mental 
health research and treatment. SHARP will conduct critical implementation science research 
and build capacity among researchers and policy makers to facilitate scale-up of evidence-
based mental health treatment in Malawi, Tanzania, and sub-Saharan Africa. This protocol 
covers the clinic-randomized trial planned for the second phase (Years 2-5) of the study, which 
will compare two different implementation strategies to facilitate scale-up of depression 
treatment within existing chronic disease clinics in Malawi.  
 
 

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TABLE OF CONTENTS  
ABSTRACT ................................................................................................................................... 2 
TABLE OF CONTENTS ................................................................................................................ 3 
HISTORY OF PROTOCOL CHANGES ........................................................................................ 5 
Version 1.1, 07 November 2018 ................................................................................................... 5 
PROTOCOL TEAM ROSTER ....................................................................................................... 7 
GLOSSARY OF TERMS/ACRONYMS ......................................................................................... 9 
1.0 INTRODUCTION .................................................................................................................. 10 
1.1 Background and Literature Review ............................................................................... 10 
1.2 Study Rationale ............................................................................................................. 11 
2.0 HYPOTHESES AND STUDY OBJECTIVES ........................................................................ 11 
2.1 Hypotheses .................................................................................................................... 11 
2.2 Study Objectives ............................................................................................................ 12 
3.0 METHODOLOGY .................................................................................................................. 12 
3.1 Study Sites .................................................................................................................... 13 
3.2 Population ...................................................................................................................... 14 
3.3 Duration ......................................................................................................................... 14 
3.4 Sample Size .................................................................................................................. 14 
3.5 Data Sources ................................................................................................................. 15 
3.5.1 Record Availability ...................................................................................................... 15 
4.0 STATISTICAL ANALYSIS PLAN .......................................................................................... 15 
5.0 ETHICAL CONCERNS ......................................................................................................... 16 
5.1 Human Subjects ............................................................................................................ 16 
5.1.1 Institutional Review Board .......................................................................................... 16 
5.1.2 Confidentiality, Risks, and Risk Minimization ............................................................. 16 
5.1.3 Benefits to Participants ............................................................................................... 17 
5.1.4 Costs and Compensation ........................................................................................... 17 
5.1.5 Informed Consent ....................................................................................................... 17 
5.2 Adverse Event Reporting ............................................................................................... 18 
5.3 Study Discontinuation .................................................................................................... 18 
6.0 PUBLICATION AND DISSEMINATION OF RESEARCH FINDINGS ................................... 18 
7.0 WORKPLAN ......................................................................................................................... 20 
7.1 Project Management ..................................................................................................... 20 

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8.0 BUDGET ............................................................................................................................... 21 
9.0 REFERENCES ..................................................................................................................... 22 
 
 
 

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HISTORY OF PROTOCOL CHANGES 
Version 1.0, 9 August 2018 
• 
None to date. 
Version 1.1, 07 November 2018 
• 
Changed titled to: The Sub-Saharan Africa Regional Partnership (SHARP) for Mental 
Health Capacity Building – A Clinic-Randomized Trial of Strategies to Integrate 
Depression Care in Malawi 
• 
Added sample size justification 
• 
Revised objectives 
• 
Updated list of sites 
• 
Discussion of risks related to recording and to blood collection 
• 
Removed “not” from “These recordings will NOT be identified with a code number” on 
pages 14 and 15 
Version 1.3, 04 December  2019 
• 
Changed patient interview follow-up schedule from 3 and 9 months to 3, 6 and 12 
months  
Version 1.4, 20 February, 2020  
• 
Made follow-up schedule consistent across protocol (interviews during Year 3)  
• 
Added to Year 3 qualitative interview population (added 6 Clinical Coordinators, 6 
Friendship Bench counselors, and 6 SHARP research assistants to the existing 
population of 6 clinic directors, 6 providers, and 3 MOH administrators)  
• 
Reduced sample size for patient qualitative interviews from 16 to 8    
Version 1.5, 19 March, 2020 
• 
Amended interview format to include phone calls  
Version 1.6, 30 September, 2020  
• 
Added to Year 3 qualitative interview population (added 6 more providers for a total of 
12)  
Version 1.7, 26 February, 2021  
• 
Added to Year 3 cognitive interviews and structured surveys to evaluate providers’ 
perceptions of stigma and acceptance towards individuals with mental health disorders. 
Version 1.8, 1 September, 2021 
• 
Added Year 4 qualitative interviews with hospital workers and SHARP research 
assistants following results of Year 3 qualitative interviews 
Version 1.9, 11 November 2022 

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• 
Removed Dignitas International personnel from protocol team roster 
• 
Updated statistical analysis plan to replace generalized linear models with generalized 
estimated equation models.   
 

 
 
 
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PROTOCOL TEAM ROSTER 
UNC Principal Investigators 
Brian Pence, PhD, MPH 
UNC School of Public Health 
Department of Epidemiology  
CB# 7435, 2102-E McGavran-Greenberg 
Chapel Hill, NC 27599-7435, USA 
Phone: 1-919-966-7446 
Fax:     1-919-966-2089 
Email: bpence@unc.edu 
 
Mina Hosseinipour, MD, MPH 
UNC Project-Malawi 
Private Bag A-104   
Lilongwe, Malawi 
Phone:  265-1-755-056 
Fax:      265-1-755-954                              
E-mail: mina_hosseinipour@med.unc.edu 
 
Malawi Principal Investigator 
Jones Masiye, MBBS MPH 
Ministry of Health, Malawi 
Deputy Director of Non-communicable 
Diseases and Mental Health Clinical 
Services 
P.O. Box 30377, Lilongwe, Malawi 
Phone: +265 1 789 400 
Email: jkmasiye@yahoo.co.uk  
 
Co-Investigators 
Michael Udedi, MBA MPhil 
Ministry of Health, Malawi 
Assistant Director for Clinical Mental Health 
Services  
P.O. Box 30377     
Lilongwe, Malawi 
Phone: +265 1 789 400  
Email: mphatsoudedi@yahoo.co.uk 
 
Victor Mwapasa, MPH, PhD  
College of Medicine, University of Malawi                  
Blantyre, Malawi 
Phone: +265 888 381 551 
Email: vmwapasa@medcol.mw 
 
Bradley Gaynes, PhD 
UNC School of Medicine 
Department of Psychiatry 
CH# 7160, 130 Mason Farm Rd 
Chapel Hill, NC 27599 USA 
Phone: 919-445-0214 
Fax: 919-445-0234 
Email:  bradley_gaynes@med.unc.edu 
 
Vivian Go, PhD 
UNC School of Public Health 
Department of Health Behavior  
CB# 7440, 361 Rosenau Hall  
Chapel Hill, NC 27599-7440, USA 
Phone: 1-919-966-3908 
Fax:     1-919-966-2921 
Email: vgo@email.unc.edu 
 
Irving Hoffman, PA, MPH 
UNC School of Medicine  
International Director, UNC Project-Malawi 
101 Manning Drive 
Chapel Hill, NC 27514 
Phone: 1-919-966-6324 
Fax:     1-919-966-8536 
Email: irving_hoffman@med.unc.edu 
 
Kazione Kulisewa 
Ministry of Health, Malawi 
Head of Psychiatry Department 
Kamuzu Central Hospital 
Private Bag 149, Lilongwe, Malawi 
Phone: +265 997 210 381 
Email: kkulisewa@yahoo.com  
 
Stephanie Wheeler, PhD 
UNC School of Public Health 
Department of Health Policy and 
Management   
CB# 7411, 1103-C McGavran-Greenberg  
Chapel Hill, NC 27599-7411, USA 
Phone: 1-919-966-7374 
Fax:     1-919-966-3671 
Email: wqstepha@email.unc.edu 
 
Mia Crampin, PhD 
Malawi Epidemiology and Intervention 
Research Unit (MEIRU) 
Box 46  
Chilumba, Malawi  
Phone: +265 99 937 3980 
Email: mia.crampin@lshtm.ac.uk 

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GLOSSARY OF TERMS/ACRONYMS 
 
ABCD  
Algorithm-Based Care for Depression  
DALY  
Disability-adjusted life year 
EC 
 
Ethics committee 
IRB 
 
Institutional Review Board 
LMIC  
Low- and middle-income country 
MoH 
 
Ministry of Health 
NCD 
 
Non-communicable disease 
NHSRC 
National Health Sciences Review Committee 
RCT 
 
Randomized controlled trial  
SHARP 
Sub-Saharan Africa Regional Partnership for Mental Health Capacity 
Building 
YLD 
Years lived with disability 
 
 

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1.0 INTRODUCTION 
Despite the heavy burden of mental illness, the mental health treatment capacity of most 
sub- Saharan African health systems is extremely limited. Although effective mental health 
treatment interventions are well defined in high-income countries, their deployment in low- 
and middle-income countries is limited due to lack of implementation science research that 
addresses the challenges of adapting evidence-based interventions to low-resource 
contexts and few researchers and policymakers adequately trained in implementation 
science. The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity 
Building seeks to make a meaningful impact on the mental health treatment gap in sub-
Saharan Africa. The partnership brings together governmental, academic, and non-
governmental partners invested in mental health research and treatment. SHARP will 
conduct critical implementation science research and build capacity among researchers and 
policy makers to facilitate scale-up of evidence-based mental health treatment in Malawi, 
Tanzania, and sub-Saharan Africa. 
1.1 Background and Literature Review 
Mental health disorders, including depression, contribute substantially to global disease 
burden, disability and mortality. Mental health disorders are the leading cause of years lived 
with disability (YLD) (31.7%) and the fifth leading cause of global disability-adjusted life 
years (DALYs) (7.4%).[1, 2] Depression contributes more to this burden than any other 
mental health condition. A recent review indicates that mental disorders are associated with 
significantly increased mortality; a median of 10 years of potential life is lost due to mental 
disorders, and 14.3% of deaths worldwide (approximately 8 million) can be attributed to 
mental disorders.[3] Globally, more than 2.2 million excess deaths annually can be 
attributed to depression.[4] Across regions, sub-Saharan Africa suffers from the highest cost 
of years of life lost due to mental disorders.[1] At the same time, the capacity of many low- 
and middle-income countries (LMICs), and especially many sub-Saharan African countries, 
to respond to this mental health burden is severely limited.[5] The median number of mental 
health professionals per 100,000 population among sub-Saharan African nations is less 
than one-fiftieth of that found in the United States.[6, 7] 
 
Given the limited human resources, most of the efforts to respond to the burden of mental 
health disorders in LMICs have focused on task-shifting strategies to expand treatment 
capacity. Such initiatives give community members or general medical providers the skills 
and support to deliver evidence-based depression treatment interventions.[8-10] Some 
efforts have trained lay health workers or non-specialist clinicians to deliver counseling 
interventions in, for example, Uganda, Tanzania, South Africa, Pakistan, and India.[11-18] 
Others have trained non-specialist clinicians, e.g. HIV clinicians or general care providers, to 
prescribe and manage antidepressant treatment in the context of regular medical care.[15, 
19-21] [18] Both counseling and medication-based task-shifting approaches have 
demonstrated feasibility, acceptability, and efficacy in improving mental health outcomes in 
LMICs generally and sub-Saharan Africa specifically.   
 
Despite the growing evidence base of task-shifting mental health interventions, rates of 
treatment for mental health disorders in LMICs are low. The proportion of individuals with a 
mental health disorder in LMICs who are not receiving treatment is estimated to be as high 
as 90%; the treatment gap for depression is even higher in many settings.[5] Several key 
factors are currently limiting the translation of this growing evidence base into actual health 

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system change.  First, implementation science research is needed to close the knowledge 
gaps that policy makers face in trying to translate research to policy, for example what sorts 
of staffing and supervision structures are needed to sustain an evidence-based mental 
health intervention at scale? Relatedly, capacity to conduct implementation science 
research must be expanded among LMIC researchers.  Finally, capacity among policy 
makers to interpret and apply implementation science research findings must be increased 
so that research can be efficiently used to inform health system redesign. 
1.2 Study Rationale 
Mental health disorders are among the leading causes of disease burden and disability 
worldwide. Globally, mental health disorders account for nearly a third of years lived with 
disability and are the fifth-leading cause of disability-adjusted life years.[1, 2] The global 
economic burden due to mental health conditions and related death and disability is 
expected to result in productivity losses of USD 16.1 trillion from 2010-2030.[22]  
Both Malawi and Tanzania are currently in the process of revising their Mental Health Action 
Plans, and the potential for large impact from this project is high. In Malawi, the Non-
Communicable Diseases and Mental Health Unit of the Ministry of Health was recently 
successful in expanding access to fluoxetine, a key antidepressant, across the country, 
based on the leadership of SHARP co-investigator Dr. Udedi. The unit has also recently 
expanded non-communicable diseases clinics to treat hypertension and diabetes across the 
country under the leadership of SHARP Malawi PI Dr. Masiye, and a current high priority is 
the integration and expansion of mental health services within those clinics. The leadership 
in both Ministries of Health is eager to see the proposed scale-up study and capacity-
building activities take place. Given the Mental Health Action Plans in place in both countries 
and the demonstrated commitment by the Ministries of Health to using research to guide 
efficient and meaningful expansion of services, the proposed activities will have a large and 
sustainable impact on mental health care.  
The aims and objective of SHARP are significant because they directly address the 
knowledge and capacity gaps that are currently hampering broader scale-up of mental 
health services in Malawi and Tanzania. SHARP will build critical bridges between 
governmental, academic, and non-governmental actors involved in mental health service 
delivery and planning, provide key evidence to guide expansion of mental health services, 
and expand capacity to conduct, interpret, and utilize mental health-related implementation 
science research to address the mental health treatment gap in Malawi, Tanzania, and the 
broader region. 
 
2.0 HYPOTHESES AND STUDY OBJECTIVES 
2.1 Hypotheses 
Our primary objective is to compare two different implementation strategies to facilitate 
ongoing MOH efforts to scale up evidence-based depression treatment within NCD care. 
Specifically, we hypothesize that: 
H1. Compared to providers at clinics receiving the basic implementation package, 
providers at clinics receiving the enhanced implementation package will deliver 
depression treatment with greater fidelity.   

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H2. Compared to patients receiving care at clinics with the basic implementation 
package, patients receiving care at clinics with the enhanced implementation 
package will be more likely to achieve depression remission at 6 and 12 months.   
H3. Compared to patients receiving care at clinics with the basic implementation 
package, patients receiving care at clinics with the enhanced implementation 
package will be more likely to have well controlled hypertension and diabetes at 6 
and 12 months.   
2.2 Study Objectives  
Phase I (formative studies, not covered in this protocol) 
Results from Phase I will inform the implementation of the Phase II research study 
comparing two different implementation strategies.  
• 
We conducted in-depth interviews with providers, clinic directors, and Ministry of 
Health representatives to adapt the intervention to the NCD care context in Malawi. 
• 
We conducted site visits to assess key contextual and structural characteristics of 
each clinic including organizational readiness for change, management support, 
patient panel size and demographics, number and training level of staff, staff-to-
patient ratio, typical daily patient volume, hours of operation, and storage facilities for 
medications. 
Phase II (Randomized Trial) 
• 
Compare providers’ fidelity of depression treatment between clinics receiving the 
basic implementation package vs. clinics receiving the enhanced implementation 
package. 
• 
Compare patients’ depression remission at 6 and 12 months between those 
receiving care at clinics with the basic implementation package vs. those receiving 
care at clinics with the enhanced implementation package.    
• 
Compare patients’ well controlled hypertension and diabetes at 6 and 12 months 
between those receiving care at clinics with the basic implementation package vs. 
those receiving care at clinics with the enhanced implementation package.     
3.0 METHODOLOGY 
We will conduct a clinic-randomized trial (RCT) to determine the best way to integrate 
evidence-based depression treatment into non-communicable disease (NCD) clinics in 
Malawi. We will compare implementation of depression treatment using (1) a basic 
implementation package vs. (2) an enhanced implementation package.  
 
The basic implementation package will involve identifying an internal coordinator who is one 
of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to 
peers and support to leadership in implementing the treatment program and aligning it with 
clinic priorities.  
 
The enhanced implementation package will combine the internal coordinator with an 
external quality assurance committee.  This committee will complete quarterly audits at the 
facility to evaluate compliance with the depression treatment protocol as well as providing 

13 
 
high-level support in implementing the treatment program through clinical expertise and 
limited on-site presence.  
 
Clinics will be randomized 1:1 to receive either the basic or the enhanced implementation 
package.  Clinics will then implement depression treatment as part of standard care at their 
NCD clinics.  All patients at each clinic will receive that clinic’s standard care.   
 
To evaluate patient health outcomes, we will enroll a cohort of patients from each NCD 
clinic.  (Sample size and inclusion criteria are below.)  Participants will complete 
assessments at baseline and 6 and 12 months. Assessments will measure 
sociodemographics, depressive severity, self-reported health, and key medical, structural, 
and psychosocial factors including trauma history, intimate partner violence, other violence 
in the home, socioeconomic measures, coping, social support, self-efficacy, experiences of 
stigma related to mental health, medical and psychiatric comorbidity, and risk factors for 
hypertension and diabetes. Medical appointment attendance data will be abstracted from 
clinic records.  
 
We will conduct qualitative interviews to provide context for the primary study findings. In 
year 3, we will interview a subsample of 8 patients (4 in each arm: 2 with depression 
remission and 2 who remained depressed) to understand their experiences with each 
intervention. We will ask about satisfaction with and engagement in each intervention 
component and barriers and facilitators to retention in care. At 3 higher and 3 lower 
performing clinics (6 clinics total), we will interview clinic directors (District Medical Officers), 
Clinical Coordinators, NCD providers, Friendship Bench counselors, and SHARP research 
assistants (n = 6 clinic directors, 6 Clinical Coordinators, 12 NCD providers, 6 Friendship 
Bench counselors, and 6 SHARP research assistants) to contextualize implementation 
strategy and intervention acceptability and fidelity. We will also assess implementation 
climate and intervention-values fit. Finally, we will interview key MOH representatives (n=3) 
to understand the facilitators and barriers to future scale up. In year 4, we will interview 3 
hospital staff and 1 SHARP research assistant from each of the 10 study sites (n=40). 
These interviews expand upon the findings of the year 3 qualitative interviews and will add 
further depth to the study’s primary findings.  
3.1 Study Sites 
Study activities will take place at 11 non-communicable disease clinics distributed across the 
three regions of Malawi. These clinics include: 
1) Bwaila Hospital (Lilongwe District) 
2) Chilumba Rural Hospital 
3) Karonga District Hospital 
4) Kasungu District Hospital 
5) Machinga District Hospital  
6) Mchinji District Hospital 
7) Mulanje District Hospital 
8) Phalombe Rural Hospital 
9) Salima District Hospital 
10) Zomba Central Hospital  

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3.2 Population 
Patients at the participating NCD clinics who meet the following eligibility criteria will be 
invited to participate. 
Inclusion criteria 
1. Ages 18-65 years (antidepressant treatment considerations differ for those <18 
or >65 years, and these age groups are expected to be very rare in the target 
clinics),  
2. Current or new patient receiving care for either hypertension or diabetes from the 
NCD clinic at a study site listed in Section 3.1, and 
3. Elevated depressive symptoms (PHQ-9 score ≥5). 
 
Exclusion criteria 
Patients will be excluded if they have a history of bipolar or psychotic disorder, or 
show emergent threat of self-harm. 
3.3 Duration  
The Phase II RCT will occur during project years 2-4 (November 2018-October 2021). We will 
complete training for providers and staff in the two arms. We will initiate the two implementation 
strategies at all clinics and spend 24 months recruiting participants. Follow-up monitoring will 
extend an additional 12 months, through year 4.  
3.4 Sample Size 
A total of 116 patients will be enrolled from each clinic to measure clinical outcomes over 
time, for a total sample of 1,160 patients recruited over a two-year period.   
 
Sample size and power: Assumptions. Statistical power analyses are based on these 
assumptions: (1) two-sided statistical significance tests; (2) Type I error α=0.05; (3) power 
(1-β) of 80%; (4) intraclass correlation coefficient (ICC) of 0.02 for the mental health 
outcome. For behavioral interventions, clinic-level ICCs normally range from <<0.01 to 0.04.  
For effect size, up to 30% of depressive episodes may remit without treatment. We assume 
that the basic implementation package may improve depression treatment, so we assume 
the incidence of depression remission to be 40% with the basic package. A difference of 15 
percentage points or more in depression remission in the enhanced arm relative to the basic 
arm would be clinically meaningful and worth detecting.  Therefore the study is powered to 
detect this difference.  Based on extremely high retention success in prior studies and the 
short time frame of the primary outcome (3 months), 90% retention is assumed.  Given 
these assumptions, we will enroll 116 participants per clinic from 10 clinics, or 1,160 
participants overall.  Fewer clinics would require a prohibitive sample size  
 
We will also complete qualitative interviews with 8 patients, 6 clinic directors, 6 Clinical 
Coordinators, 12 providers, 6 Friendship Bench counselors, 6 SHARP research assistants, 
and 3 MOH officials.  These interviews will take place in Year 3 of the study.  Given standard 
sample size guidelines for qualitative data collection, this sample size is expected to be 
sufficient for theme saturation in each group.   
 
We will additionally conduct of 16 cognitive interviews and 200 structured surveys with 
nurses, clinicians and peer friendship bench counsellors to evaluate providers’ perceptions 
of stigma and acceptance towards individuals with mental health disorders. These 

15 
 
interviews and surveys will take place in Year 3 of the study. The desired sample size for 
cognitive interviewing, while adequate for the inclusion of variety of staff, reflects the 
expectation that data saturation will be reached with a relatively small number of 
participants. The desired sample size for structure interview is reflective of the expectation 
that approximately 10 participants are needed for every survey item in the measure. 
 
We will also complete Year 4 end point qualitative interviews with a similar group of health 
workers and SHARP staff interviewed during Year 3. In Year 4, these interviews will take 
place at each of SHARP’s 10 study sites, specifically: 10 clinic directors, 10 Clinical 
Coordinators, 10 providers, and 10 SHARP research assistants (n=40).  
3.5 Data Sources 
Data will come from the following sources: 
1. Patient participants: The 1,160 patients will complete structured interviews, either in-
person or via phone, with trained interviewers at baseline, 3, 6 and 12  months.  
Research interviewers will also measure blood pressure, blood glucose, height, and 
weight.   
2. Qualitative interviews with patients: Additional information on acceptability of the 
depression treatment program will be gathered via in-depth interviews with a subset 
of patients (n=8).   
3. Clinical records: Information on depression treatment delivery and fidelity will be 
abstracted from clinical records. 
4. Clinic director, Clinical Coordinator, provider, Friendship Bench counselor, SHARP 
research assistant, and MOH interviews: Information about implementation strategy 
and intervention acceptability and fidelity from in-depth interviews with clinic directors 
(n=6), Clinical Coordinators (n=6), providers (n=12), Friendship Bench counselors 
(n=6), SHARP research assistants (n=6), and MOH officials (n=3). Cognitive 
interviews will be conducted with providers (n=8) and Friendship Bench counselors 
(n=4). Structured surveys will be conducted with providers, friendship bench 
counselors, and clinic leadership (n=200). 
5. End point qualitative interviews at each of SHARP’s study sites will focus on 
additional factors affecting implementation strategy fidelity like organization climate, 
organizational change, and barriers and facilitators to strategy implementation. 
Specifically, this information will be gathered from clinic directors (n=10), Clinical 
Coordinators (n=10), providers (n=10), and SHARP research assistants (n=10).  
3.5.1 Record Availability 
The site investigator will make all data abstraction documents and records readily available 
for inspection by the local IRB and the Office for Human Research Protections (OHRP) as 
requested. 
4.0 STATISTICAL ANALYSIS PLAN 
Analysis of implementation and effectiveness outcomes will be intent-to-treat comparisons 
between arms. Comparisons will be made using generalized estimating equation models 
with a log link and binomial error distribution to compare proportions. The design effect 
introduced by clinic-level randomization will be addressed using the bias-corrected robust 
variance estimate for GEE models recommended given the small number of clusters. A 
secondary, as-treated analysis will restrict the analysis to those who received a minimum 

16 
 
dose of the depression treatment program (e.g., at least three depression care management 
appointments).  
5.0 ETHICAL CONCERNS 
5.1 Human Subjects 
5.1.1 Institutional Review Board 
Prior to implementation of this RCT, all protocol materials will be approved, as appropriate, 
by local institutional review boards (IRB) / ethics committees (EC) responsible for oversight 
of the evaluation including the National Health Sciences Research Committee of Malawi 
(NHSRC) and the Biomedical Institutional Review Board of the University of North Carolina 
at Chapel Hill. All research will adhere to Malawian and US ethical standards for research in 
human subjects.  
5.1.2 Confidentiality, Risks, and Risk Minimization  
Breach of confidentiality: There is always the possibility of a breach of confidentiality when 
conducting research. Disclosure of medical or other personal information about participants, 
particularly mental health status may result in negative stigma being associated with the 
individual and/or family. Our research team is very aware of the need for absolute 
confidentiality and has extensive experience in dealing with highly sensitive personal 
medical and family information. While we acknowledge that a breach of confidentiality is 
possible, we anticipate that the likelihood is very low because of the precautions that will be 
taken to protect confidentiality. Research data will be coded (with identifiers removed). The 
linking file that connects the codes to individual identities will be securely stored by the study 
team. Research data will be stored securely on password-protected machines or servers or 
in locked cabinets, with access restricted to study staff. 
Mental health counseling sessions may be recorded so that supervisors can provide 
feedback to the counselors about the quality of their counseling.  These recordings will be 
identified with a code number only and will not be shared with anyone outside the research 
team.  If participants do not want their counseling sessions recorded, they can choose not to 
participate in the study.  This information is included in the informed consent form.   
Qualitative and cognitive interviews will also be recorded.  These recordings will be 
identified with a code number only and will not be shared with anyone outside the research 
team.  If participants do not want to be recorded, they can choose not to participate in the 
qualitative component of the study.  This information is included in the informed consent 
form.   
Psychological distress from interview questions pertaining to mental health: To expose 
participants to as little psychological distress as possible and to ensure protection of 
participant identities and confidentiality, all questions will be asked in a private place at the 
health facility or a private place of the participant’s choosing. Interviews will be conducted by 
trained interviewers in a language in which the participant is comfortable responding.    
Discomfort: Patients may experience discomfort from the collection of a small amount of 
blood for blood glucose monitoring.  This risk will be minimized by using trained clinical staff 
for blood collection.   
 
Indication of threat of harm to self or others reported in response to interview questions: 
Patients indicating such threat of harm during interviews will be referred to existing clinical 

17 
 
response pathways as defined by each clinic.  For participants with indication of acute risk of 
self harm, research staff will ensure handoff to a clinical team member.   
 
Protection from COVID-19: As of March 2020 the likelihood of Malawi experiencing initial 
cases and rapid escalation of COVID-19 is high, therefor we are adding the option of phone 
interviews in case there is a need to minimize exposure to the novel coronavirus to 
participants and staff.   
5.1.3 Benefits to Participants  
Participants will not receive any direct benefit from participating in the study.  Whether or not 
they participate in the research component, all patients at the participating sites will receive 
that site’s standard care.   
The study will raise awareness about the diagnosis of depression, a condition that has 
received little research attention in sub-Saharan Africa. The study will also provide essential 
information about the potential reciprocal relationships between depression and NCD 
infection. This information will inform an appropriate intervention for depression in the future.  
While this study has some risks associated with participation, we anticipate that few 
participants will experience negative events as a result of taking part in the study. The risk to 
individual participants is small and the potential benefit to society is substantial. Therefore, 
the risk/benefit ratio is favorable. 
5.1.4 Costs and Compensation  
Patients, providers, directors, and MOH officials invited to participate will received a travel 
reimbursement equivalent to 10 USD for each research interview in which they participate. 
Participants will not assume any extra costs as part of this study.  
5.1.5 Informed Consent 
This protocol and the informed consent documents and any subsequent modifications will 
be reviewed and approved by the IRB and ethics committees responsible for oversight of 
the study: the Biomedical Institutional Review Board of the University of North Carolina at 
Chapel Hill and the National Health Sciences Research Committee of Malawi (NHSRC). All 
procedures conform to US and Malawian ethical standards regarding research involving 
human subjects. 
Written informed consent will be obtained. Informed consent will clearly explain the purpose 
of the research, what will be required of the individual, and the risks and benefits of 
participation. For providers and clinic directors, the informed consent process will emphasize 
that the provider is free to participate or not; a decision not to participate will have no 
negative impact on his or her employment, evaluation, or anything else related to the 
workplace; and the provider is free to end participation at any time. For patients, the 
informed consent process will emphasize that the patient is free to participate or not; a 
decision not to participate will have no negative impact on any aspect of his or her clinical 
care; and the patient is free to end participation at any time. The informed consent process 
and all documents will be in the provider’s or patient’s preferred language (likely English for 
providers and Chichewa or Chitumbuka for patients). Participants will be presented an 
informed consent form with the above information and contact information for the PI, study 
personnel, and IRB. Illiterate participants will be asked to put their mark (in lieu of a 
signature) as a written sign of consent. 

18 
 
The investigators have experience obtaining informed consent for trials in Malawi and thus 
the informed consent process has been designed to maximize understanding of potential 
risks.  
5.2 Adverse Event Reporting 
We do not anticipate any adverse events occurring given the nature of the minimal risks 
associated with this research. However, in the case that a breach of confidentiality does 
occur, the study team will immediately inform the IRBs.  
 
• 
Deaths related to study participation shall be reported by the PI to the NIMH and 
IRBs immediately and no later than within 5 business days of the PI first learning of 
the death 
• 
Unexpected Serious Adverse Events related to study participation shall be reported 
by the PI to the NIMH and IRBs within 10 business days of the study team becoming 
aware of the SAE 
• 
Unanticipated Problems Involving Risks to Subjects or Others shall be reported by 
the PI to the NIMH and IRBs within 10 business days of the study team becoming 
aware of the problem 
• 
Adverse events and SAEs, including deaths, that are deemed expected and/or 
unrelated to the study shall be submitted in summary form to the NIMH and IRBs 
with the annual progress report 
• 
Protocol violations shall be submitted in summary form to the NIMH and IRBs with 
the annual progress report 
5.3 Study Discontinuation 
The study may be discontinued at any time by the UNC IRB, the NHSRC, the Office for 
Human Research Protections (OHRP), or other government agencies as part of their duties 
to ensure that research participants are protected.  
 
6.0 PUBLICATION AND DISSEMINATION OF RESEARCH FINDINGS 
Local dissemination of evaluation results is critical to the success of this project. We will 
conduct a data interpretation workshop during which we will work with stakeholders to 
present preliminary findings. This workshop will serve as a platform for discussion of 
involved staff, stakeholders, and ministry officials through which we will frame the 
implications of the evaluation results. Subsequent dissemination meetings after the data are 
fully analyzed will emphasize development of a data use plan from which stakeholders, staff, 
and ministry officials will help to guide the local dissemination agenda and target audiences. 
Given the scope of this proposal and its intended audience, we have identified some venues 
that are likely to be a suitable target for dissemination. A venue of particular interest is the 
Annual Malawi Mental Health Research and Practice Conference sponsored by the 
Department of Mental Health at the College of Medicine.  Where possible we will also submit 
abstracts to regional and international venues. Publication of the findings is expected in peer 
reviewed scientific journals.  The results of this evaluation will be published and will be 
integral to understanding the role of depression treatment in NCD clinics in Malawi. 
However, any presentation, abstract, or manuscript will be made available for review to 
the NCDs and Mental Health unit at the Ministry of Health and the NHSRC.  

19 
 
In addition to presentation at local and regional conferences, all involved clinics will receive 
a formal presentation regarding program outcomes and proposed next steps. In coordination 
with our stakeholders and partners in the Ministry of Health, we will also develop 
presentations that are geared specifically to local clinics that were not involved in the 
program, transferring relevant information and “lessons learned” from on-the-ground 
healthcare workers. Our goal of result dissemination is directly relevant to our capacity 
building objectives with stakeholders – stakeholders, including clinical staff involved in the 
implementation of the proposed intervention, will be actively involved in the framing and 
contextualization of results prior to presentation or publication. 
 
 

20 
 
7.0 WORKPLAN 
Table 1. Timeline and activities 
 
 
August 2018 –  
July 2019 
August 2019 –  
July 2020 
August 2020 –  
July 2021 
Aug-Oct 
2021 
Activity 
 
 
 
 
Creation of protocol and consent forms 
 
 
 
 
 
 
 
 
 
IRB approval 
 
 
 
 
 
 
 
 
 
Training (both arms) 
 
 
 
 
 
 
 
 
 
Intervention: Recruitment 
 
 
 
 
 
 
 
 
 
 
Intervention: Follow-up 
 
 
 
 
 
 
 
 
 
Fidelity monitoring 
 
 
 
 
 
 
 
 
 
Assessment of satisfaction 
 
 
 
 
 
 
 
 
 
Cost measurement and analysis 
 
 
 
 
 
 
 
 
 
 
7.1 Project Management 
The overall direction of the project will be provided by Jones Masiye, Mina Hosseinipour, 
and Brian Pence, the PIs for this study, in collaboration with the other co-investigators. Dr. 
Hosseinipour will provide training and on-site supervision of the evaluation data abstraction 
and management activities. Vivian Go, co-investigator and qualitative analysis expert, will 
oversee the analysis of any qualitative data. Jones Masiye will oversee dissemination 
activities. 
 
 

21 
 
 
8.0 BUDGET 
 
 

22 
 
 
9.0 REFERENCES 
 
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Whiteford, H.A., et al., The global burden of mental, neurological and substance use 
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Chibanda, D., et al., Group problem-solving therapy for postnatal depression among 
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Measurement-Based Care Depression Treatment for HIV Patients in Bamenda, 
Cameroon. AIDS Behav, 2014. 
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