Mixed Methods Formative Research and Pilot Testing of a Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
Phase: NA
Conditions: Non Communicable Diseases, HIV
Sponsor: University of North Carolina, Chapel Hill

 
 
Mixed methods formative research and pilot testing of a task-shifted 
adaptation of the WHO-PEN intervention to address cardio-metabolic 
complications in people living with HIV in Zambia 
 
 
NCT number NCT05005130 
Document Date 12/13/2021 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 0 
 
 
Mixed methods formative research and pilot testing of a task-shifted adaptation of the WHO-
PEN intervention to address cardio-metabolic complications in people living with HIV in Zambia 
 
 
 
 
 
 
 
Short title: TASKPEN  
Protocol version: 1.3 dated 13 December, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
                         
                                       
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 1 
Table of Contents 
1. 
Introduction ......................................................................................................................... 7 
a. 
General information on the research topic ......................................................................... 7 
b. 
Overview of the research and research gaps ...................................................................... 7 
c. 
Overall purpose of the research and area where the research will be conducted ............. 8 
2. 
Statement of the Problem ................................................................................................... 9 
a. 
Short summary of the background on the problem ............................................................ 9 
b. 
Importance / relevance of the research .............................................................................. 9 
3. 
Rationale/ Justification ........................................................................................................ 9 
a. 
Contribution of the study to science or body of knowledge ............................................... 9 
b. 
Changes to be made by the study ....................................................................................... 9 
c. 
Evidence supporting the justification ................................................................................ 10 
4. 
Theoretical / Conceptual Framework ................................................................................ 11 
5. 
Literature Review .............................................................................................................. 11 
a. 
Cardio-metabolic complications in people living with HIV ................................................ 11 
b. 
Risk factors for metabolic syndrome in HIV ...................................................................... 13 
c. 
Service delivery models and implementation strategies from LMICs for integrated HIV/NCD Care
 
13 
6. 
Research Question ............................................................................................................. 14 
7. 
Research Aims, General Objectives and Specific Objectives ............................................. 14 
8. 
Methodology ..................................................................................................................... 15 
Study design overview ............................................................................................................... 15 
Intervention Component/ Strategy & Description ....................................................... 16 
a. 
Overview ............................................................................................................................ 18 
b. 
Study design ...................................................................................................................... 18 
c. 
Study site and population / research materials ................................................................ 24 
d. 
Selection of participants, sampling methods, sample size ................................................ 24 
e. 
Specific Objective #1 Outputs: Final TASKPEN Pilot Sites & Package for Pilot Testing ..... 24 
a. 
Overview ............................................................................................................................ 25 
b. 
Study design ...................................................................................................................... 25 
c. 
Study sites and population / research materials ............................................................... 26 
d. 
Selection of participants, sampling methods, sample size, enrolment and follow-up procedures
 
26 
e. 
Data collection plan and tools ....................................................................................... 31 
f. 
Data management and storage ......................................................................................... 40 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 2 
g. 
Data analysis ...................................................................................................................... 42 
9. 
Ethical Considerations ....................................................................................................... 45 
a. 
Overview ............................................................................................................................ 45 
b. 
Non-human subjects research activities ........................................................................... 45 
c. 
Informed consent .............................................................................................................. 45 
d. 
Confidentiality ................................................................................................................... 46 
e. 
Potential risks .................................................................................................................... 46 
f. 
Protection against Risks ..................................................................................................... 47 
g. 
Potential benefits .............................................................................................................. 47 
h. 
Consent process................................................................................................................. 47 
i. 
Physical Risks ..................................................................................................................... 49 
j. 
Psychosocial Risks .............................................................................................................. 49 
k. 
Methods to Minimize Risk ................................................................................................. 49 
l. 
Anticipated Benefits to Participants .................................................................................. 50 
m. Handling of Unexpected or Adverse Events ...................................................................... 50 
10. 
Sponsor Monitoring ........................................................................................................... 51 
11. 
Dissemination of Findings .................................................................................................. 52 
12. 
Timeline ............................................................................................................................. 53 
13. 
References ......................................................................................................................... 54 
14. 
Appendices (Please see attached supporting documents folder) ..................................... 62 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 3 
Investigators & Collaborators   
 Investigator/ Collaborator 
Organization 
Role on Project 
FWA/SEV# 
Funding  
Wilbroad Mutale, MBChB, MPhil, 
PhD 
CIDRZ 
Multiple PI (Lead/ ContaFWA00008541 
 
See below 
Michael Herce, MD, MPH, MSc 
CIDRZ, UNC 
Multiple PI 
FWA00004801 
Samuel Bosomprah, PhD 
CIDRZ 
Co-Investigator, 
Biostatistician 
FWA00008541 
 
Felix Masiye, MSc, PhD 
UNZA 
Co-Investigator 
FWA00000338 
Fastone Goma, MBChB, MSc, PhDUNZA 
Collaborator 
FWA00000338 
Michael Vinikoor, MD 
CIDRZ, UAB 
Co-Investigator 
FWA00005960 
Sharon Kapambwe, MBChB  
MOH, CIDRZ 
Collaborator/ Study A
Treatment & Care 
FWA00000338 
Jessie K. Edwards, MSPH, PhD 
UNC 
Co-Investigator, 
Epidemiologist 
FWA00004801 
John Koethe, MD, MS 
Vanderbilt UniveCollaborator 
FWA00005756 
Oliver Mweemba, MPhil, PhD 
UNZA 
Co-Investigator 
FWA00000338 
Maurice Musheke, MPH, PhD 
CIDRZ 
Co-Investigator 
FWA00008541 
Douglas Heimburger, MD, MS 
Vanderbilt UniveCollaborator 
FWA00005756 
Chilambwe Mwila, MSc 
CIDRZ 
Co-Investigator 
FWA00008541 
Perfect Shankalala, MSc 
UNZA 
Co-Investigator 
FWA00000338 
Peter Mbewe, MSc  
CIDRZ 
Co-Investigator 
FWA00008541 
Mulenga Mukanu, MSc  
UNZA 
Co-Investigator 
FWA00000338 
Tulani Matenga, MSc 
UNZA 
Co-Investigator 
FWA00000338 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 4 
Chomba Mandyata, MSc 
UNZA 
Co-Investigator 
FWA00000338 
Hae-Young Kim, PhD 
NYU 
Co-Investigator 
FWA00006386 
 
Patrick Shabangu 
IHM 
Collaborator 
FWA00000338 
 
 
Funding Information 
This work is supported by the U.S. National Institutes of Health, through funding from the National 
Heart, Lung, and Blood Institute (NHLBI) and Fogarty International Center (FIC) via award 
UG3HL156389.  
• 
Funding type: Grant 
• 
Name of Funding Agencies: NHLBI and FIC of NIH 
• 
Multiple Principal Investigators: Wilbroad Mutale, MBChB, MPhil, PhD (Lead/ Contact) & 
Michael Herce, MD, MPH, MSc 
• 
Grant Number:  UG3HL156389 
 
Ethical reviews by other institutions 
The protocol has been submitted for review to the Institutional Review Boards (IRBs) of the University 
of Zambia and University of North Carolina—Chapel Hill. 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 5 
Acronyms 
 
ART   
Antiretroviral Therapy 
CIDRZ  
Centre for Infectious Disease Research in Zambia 
DM 
 
Diabetes mellitus 
EMR   
Electronic Medical Record 
FGD   
Focus group discussions 
GRZ   
Government of the Republic of Zambia 
HCW   
Health Care Workers 
HTN 
 
Hypertension 
HTS   
HIV testing services 
HIV/AIDS  
Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome 
IDI  
 
In-depth interviews 
KII 
 
Key informant interview 
MOH   
Ministry of Health 
NCD   
Non-communicable disease 
NPHW  
Non-physician health workers 
PEPFAR  
U.S. President’s Emergency Plan for AIDS Relief 
QA/QC  
Quality Assurance/Quality Control 
UNZA   
University of Zambia 
 
 
 
 
 
 
 
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 6 
Key Concepts 
 
Implementation Science 
The scientific study of the use of strategies to adopt and 
integrate evidence-based health interventions into clinical and 
community settings in order to improve patient and population 
outcomes. 
Non Communicable Diseases (NCDDiseases that are not transmissible directly from one person 
to another. They tend to be of long duration and are the result 
of a combination of genetic, physiological, environmental and 
behavioural factors. 
Cardio-metabolic complications of HHealth problems that arise from a combination of metabolic 
dysfunctions mainly characterized by insulin resistance, 
impaired glucose tolerance, dyslipidemia, hypertension, and 
central adiposity. These tend to be more common in people 
living with HIV. 
Non-Physician Health Workers 
Health care workers who are licensed to provide health 
services that complement or supplement those provided by 
a physician.  
WHO 
Package 
of 
Essential 
Communicable 
Disease 
Interve
(WHO PEN) 
An 
innovative 
and 
action-oriented set of 
cost-
effective interventions for the control of NCDs in primary 
health care, that can be delivered to an acceptable quality of 
care, even in resource-poor settings. Also known as “WHO 
PEN” for short. 
TASKPEN 
TASKPEN is the name of the package of implementation stra
proposed by the investigators that are intended to deliver the
PEN intervention in routine HIV clinical practice settings in Z
TASKPEN has five components, which are described in deta
Table 2 (below), and which will be the subject of stake
consultation and adaptation in this formative research protocol. 
Implementation Strategy 
Highly specified, systematic processes used to implement evi
based treatments or interventions, often at the clinic level, into
care settings. 
 
 
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 7 
1. Introduction 
a. General information on the research topic 
Non-communicable diseases pose an urgent global health threat Globally, non-communicable diseases 
(NCDs) pose a significant public health and economic threat due to the associated disability, loss of 
productivity, and premature deaths from conditions like cardiovascular diseases (CVD) and diabetes 1. 
Among the NCDs, cardiovascular conditions are the leading cause of mortality globally. By 2017, 17 
million of the 56 million NCD-related deaths were attributed to CVDs 2. 
b. Overview of the research and research gaps 
Increased burden of   NCDs, particularly  cardiometabolic complications, among PLWH in SSA.  
With the increasing availability and widespread use of antiretroviral medications in SSA, efforts to stem 
the HIV pandemic have transitioned from major focus on preventing early mortality and managing 
opportunistic infections (OI’s) to now also facilitating long-term quality of life, which requires addressing 
chronic complications. Complex interactions between HIV, antiretroviral drugs, nutritional and other 
lifestyle factors, insulin resistance, systemic inflammation, 
dyslipidaemias, and other chronic disease risk factors 
contribute to the development of chronic complications 
involving a number of organ systems (Fig 1). 
Zambia, like many sub-Saharan African countries, is 
experiencing a transition of economic conditions and 
lifestyle, with an expanding middle class, more sedentary 
lifestyle, and increasingly Western-style diets and tobacco 
use 
3. Whereas undernutrition formerly predominated, 
Zambia’s nutrition-related challenges now range from 
malnutrition and undernutrition to obesity, hyperlipidaemias, 
hypertension, 
diabetes, 
cancers, 
and 
other 
chronic 
conditions 4,5. Unhealthy alcohol use is on the rise in Zambia 
and other countries and is a risk factor for multiple NCDs. 
Recent research  has  linked inflammation and other factors to dyslipidaemia, with low high-density 
lipoprotein cholesterol and increased oxidized LDL-C associated with increased innate immune 
activation 6. Insulin resistance and diabetes mellitus  are other cardiometabolic complications 
increasing in HIV patients in Sub-Saharan Africa, with prevalence estimates approaching 26% and 47% 
for diabetes mellitus and prediabetes mellitus, respectively 7. In Zambia, the prevalence of insulin 
resistance was estimated to be at 30% and often associated with virologic failure among PLWH 
enrolled in the national HIV treatment programme 8. Diabetes mellitus has been linked to CVD in HIV 
such that PLWH with diabetes mellitus have a 2.4-fold increased risk of coronary heart disease events 
9. ART regimens complicate CVD risk, with newer drugs in the Zambian treatment arsenal, such as 
dolutegravir, associated with weight gain and others, such as protease inhibitors, with dyslipidaemia 8. 
Changes in body composition associated with some antiretroviral agents, including excess visceral 
adipose tissue, have been linked to increased mortality 10,11.  
Feasibility of HIV/NCD Integration due to common chronic care elements  
HIV/NCD integration requires a focus on evidence and assessment of available resources. This is 
particularly true in the context of overburdened health systems 12. Integrated care systems are more 
convenient for patients, decrease stigma associated with healthcare, and could be more efficient for 
government and non-governmental funders. Several integration approaches within HIV platforms have 
Fig 1: HIV related NCDs and cardiometabo
li
ti

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 8 
been piloted  for NCD screening 13,14 and HIV Care and treatment 15,16. However, most studies have 
mainly focused on cancer and mental health 17. 
 
Task shifting is common and effective in HIV care in SSA, but has not yet been widely extended 
to other chronic conditions 18,19.  In the emergency response to the HIV epidemic, the lack of doctors 
and limited number of nurses was circumvented using task shifting within HIV clinics. Because the 
professional workforce remains limited, task shifting hypertension care to nurses or community health  
workers (CHWs) has the potential to synergize resources and knowledge to support NCD care 18,20. 
Just as non-physicians now have strong capacity to provide HIV care in a public health approach,  
hypertension care can be provided by non-physician health workers (NPHWs), who provide knowledge 
of the benefits of a healthy lifestyle to patients almost as often as physicians 18,21. 
 
WHO-PEN package  for NCDs has potential to be used in HIV/NCD integration in SSA 
The World Health Organization (WHO) has developed a Package of Essential Noncommunicable 
Disease Intervention for Primary Care (WHO-PEN) for LMICs which includes: clinical decision support 
for management of CVD via easy-to-follow algorithms; lifestyle counselling curriculum; and streamlined 
drug treatment protocols delivered by community health nurses 22. Its efficacy at improving blood 
pressure control is well proven in LMICs 23,24. Despite its established evidence base, implementation of 
WHO-PEN is rare in SSA, and its potential to be integrated with HIV services has not been explored. 
This provides an opportunity for using task-shifting and other implementation strategies to adapt and 
introduce WHO-PEN into the existing HIV program in Zambia. If shown to be feasible and effective, 
such an approach may serve as a model for other LMICs in which an adapted version of WHO-PEN 
can be used to train nurses and CHWs to manage hypertension and other CVDs within the HIV service 
delivery platform 25.  
Implementation science theory and strategy can support successful introduction of evidence-
based practices for HIV/NCD integration into routine HIV care settings. 
It is well recognized that most efficacious interventions are not effective when introduced in real-world 
settings, particularly in overburdened health systems or new contexts, without appropriate adaptation 
12. Implementation science theories and strategies can help close the so-called ‘know-do gap’ and 
improve implementation of efficacious interventions, technologies, and approaches to achieve health 
impact at scale 12. The Interactive Systems Framework (ISF) 26, Consolidated Framework for 
Implementation Research (CFIR) 27-29 the Normalisation theory (NPT) 30,31 and RE-AIM (Reach, 
Evaluation, Adoption, Implementation and Maintenance) are all implementation oriented and empirically 
supported frameworks for adapting, introducing, and evaluating evidence-based interventions in routine 
practice settings, such as the PEPFAR-supported HIV program in Zambia. We will use these 
frameworks concurrently in the formative work, WHO-PEN adaptation, and pilot testing proposed here 
to deliver and evaluate our integrated HIV/NCD intervention (i.e., TASKPEN). 
c. Overall purpose of the research and area where the research will be conducted 
The overall purpose of the formative research proposed herein is to adapt the WHO Package of 
Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public 
health system, and to pilot test an adapted, streamlined, and task-shifted package of integrated 
HIV/NCD services collectively called “TASKPEN.” Specifically, this protocol is designed to adapt and 
pilot-test TASKPEN to manage cardiovascular disease risk factors and the cardiometabolic 
complication of HIV among persons living with HIV in Lusaka, Zambia. Using local data and 
implementation science theory, TASKPEN will address challenges faced by HIV patients who have 
cardio-metabolic complications related to HIV or its treatment. TASKPEN will enable productive 
interactions between activated, informed patients and proactive, prepared health care professionals by  

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 9 
task shifting most of the care to NPHWs who will be supported by the additional training and adapted 
screening and treatment protocols  based on WHO-PEN protocols. If successful, TASKPEN’s clinical 
effectiveness and implementation factors in Zambia would then be evaluated in a larger program.  
2. Statement of the Problem 
a. Short summary of the background on the problem 
Despite a high NCD burden in low- and middle-income countries (LMICs), including Zambia, health 
systems in these countries are often tailored towards fighting infectious diseases and have limited 
capacity to address highly morbid cardiometabolic conditions such as hypertension, dyslipidaemia, and 
diabetes 32-37. Although current evidence suggests an urgent need to leverage HIV resources at various 
health system levels to address the growing NCD burden among PLHIV in SSA, there still remains a 
critical  evidence gap to identify a feasible, impactful, and cost-effective model of HIV/NCD integration 
for wide adoption in Zambia.  
b. Importance / relevance of the research  
The proposed research is important because formative evidence is lacking on how best to develop a 
feasible, integrated package of HIV/NCD services for Zambia’s national HIV program. The study will 
also form the basis for a larger follow-on trial that will rigorously test the effects of the TASKPEN 
intervention on important dual clinical and implementation outcomes for NCDs and HIV, including dual 
or individual control of HIV and/or NCDs, linkage to and retention in care for those with a dual HIV/NCD 
diagnosis, and sustainability and cost-effectiveness of the intervention.  
 
3. Rationale/ Justification 
a. Contribution of the study to science or body of knowledge 
We hope that this study will contribute new evidence on how best to integrate NCDs and HIV services 
in African settings with high HIV/NCD burden and limited financial and human resources, and on how 
NPHWs can contribute to service delivery in these settings. While the formative research proposed 
here focuses on adapting and defining an integrated care package for cardio-metabolic co-morbidities 
in PLHIV, the strategies studied will be relevant to other NCDs, like mental health, and can advance the 
field by rigorously documenting implementation outcomes for our strategies of interest. The study will 
also fill critical knowledge gaps on the following: 1) the effects of pilot testing HIV/NCD integration on 
HIV clinical outcomes such as viral suppression and risk of cardio-metabolic complications such as 
myocardial infarction; 2) the health system consequences of integration; and 3) optimal ways to apply 
implementation science theories to develop HIV/NCD service integration models in SSA 12. 
b. Changes to be made by the study 
The overarching objective of this mixed methods formative research study is to define a package of 
integrated HIV/NCD services and the associated implementation strategy for pilot testing, collectively 
referred to as the TASKPEN intervention. We plan to use pilot testing to adapt, improve, and refine 
TASKPEN, as well as the related training curricula and algorithms for nurses, pharmacists, community 
liaison officers, community health workers, treatment supporters, and other non-physician cadres. 
Thus, this formative research is intended to lead to a finalized TASKPEN intervention to be tested in a 
follow-on pragmatic stepped-wedge hybrid effectiveness-implementation  trial. That trial will be 
designed to generate new programmatic insights that enable delivery of high-quality integrated 
HIV/NCD care, which may promote improved long-term outcomes of cardiovascular morbidity 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 10 
reduction, HIV care retention, and viral suppression for PLHIV. Thus, findings from this study will be 
used to make impactful recommendations to improve integrated non-communicable disease care 
undertaken by GRZ and partners in Zambia. 
c. Evidence supporting the justification 
Table 1. Summary of  literature on  WHO-PEN package gaps and strategies to  address them: 
Evidence 
Intervention  
Barrier 
Strategy  
References 
 
 
WHO-PEN pac
1. 
Lack integrated 
guidelines to manage HIV 
and NCDs 38 
Promote 
adaptation 
Adoption 
of 
the 
integrated model in Zamb
International  Association of Pro
of AIDS Care (IAPAC) 39 
Powell, Waltz 40 
2. 
Lack of adequate 
technical skills in NCD 
management 5,41 
Adopt and tailor   the 
skills and  training mater
Zambia  
Powell, Waltz 40 
3. 
Low number of 
doctors 41 
Revise professional rol
Task shifting  NCD manag
to NPHW 
Powell, Waltz 40 
4. 
Lack of decision 
support 41,42 
Develop an integrated d
support tool/ automatic 
using 
SMARTCARE 
platform to remind and s
clinicians 
Powell, Waltz 40 
5. 
Silos: HIV and 
NCDs 43 
Integrate HIV and NCD caInternational  Association of Pro
of AIDS Care (IAPAC) 39 
6. 
Lack of data 
collection tools 5 
Develop and adapt tools f
quality 
mon
SMARTCARE E-First/ 
platform 44 
Powell, Waltz 40 
Munthali, Musonda 45 
Ministry of Health Zambia 46 
7. 
Lack of basic 
diagnostic and vital sign 
equipment 47  
 
Provide basic NCDs diag
laboratory, 
and 
vital 
equipment 
WHO 48 
 
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 11 
 
4. Theoretical / Conceptual 
Framework  
The  Integrated Systems Framework (ISF, 
figure 2) is a theory intended to help 
researchers move research into practice. The 
ISF 
proposes 
and 
organizes 
several 
implementation strategies to achieve evidence-
based 
intervention 
adaptation, 
including 
dissemination, 
implementation 
processes, 
integration, capacity building and scale up. 
Figure 2 shows how this can happen. The three 
large boxes all represent a collection of 
activities, broadly defined, termed “systems”. 
The “Distilling the Information” box reflects the 
importance 
of 
distilling 
information 
about 
innovations down to their essential components 
and preparing them for use by end users such 
as health workers or program managers. It is 
the foundation upon which the other two boxes 
or “systems” are placed. The “Supporting the Work” box notes the importance of supporting the work of 
those end users who will put an innovation into practice, such as health workers or program managers. 
This can be accomplished through strategies like supportive supervision, audit and feedback, and 
coaching. The “Implementing Prevention” box, while focused on prevention for illustrative purposes, is 
about optimizing the individual, organizational, and community-level capacity of practice settings to 
carry out activities necessary to deliver the innovation. Importantly, these systems should optimally 
interact and collaborate to ensure successful dissemination and implementation of an innovation, which 
is reflected by the three double-headed arrows between the systems. These various systems all 
operate within a context that affects implementation of innovations and reflects a combination of 
funding availability (e.g., from government or bilateral donors), the policy environment (e.g. willingness 
of governments to support an intervention), the implementation climate (e.g., readiness of key 
stakeholders to emphasize or support an innovation), and existing research and theory (e.g., 
acceptability of research findings to practitioners and end-users). We will apply this theoretical 
foundation and the strategies revealed by the ISF at different levels of the healthcare system   to 
ensure local adaptation and introduction of TASKPEN into the routine HIV care practice setting in 
Lusaka, Zambia.  
 
5. Literature Review 
a.  Cardio-metabolic complications in people living with HIV 
Cardio-metabolic complications in HIV can occur  in isolation or in combination. One of the  commonly 
observed combination is called metabolic syndrome. The metabolic syndrome comprises a group of 
cardiovascular risk factors that include high blood pressure (hypertension), abdominal obesity, 
dyslipidaemia and insulin resistance 49. In addition to cardiovascular disease, individuals with metabolic 
syndrome are susceptible to a wide variety of conditions such as diabetes 50, cancers 51, polycystic 
Figure 2: The interactive systems framework for disseminat
d i
l
t ti
(Ad
t d W
d
t 2008)

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 12 
ovary syndrome 10, and asthma 52,53. Today, the widely used guideline for diagnosis of metabolic 
syndrome is the harmonized one which was suggested in 2009 by different organizations 54. 
  
In sub-Saharan Africa, the burden of metabolic syndrome has been shown to be highly variable among 
HIV positive individuals who are ART-experienced and -naïve. A cross-sectional study among 
individuals aged ≥ 18 years on ART in Ghana found the prevalence of metabolic syndrome to be at 
24.5%, 48.3% and 42.3% according to WHO, NCEP-ATP III and IDF criteria, respectively 55. The study 
also found that the prevalence of metabolic syndrome in patients on ART was higher than those not on 
ART. Similar conclusion was drawn in a study which was conducted in South-West region of Cameroon 
56. A lower prevalence (18%) of metabolic syndrome was observed in a study conducted in Burkina 
Faso 57. Muyanja, Muzoora 58 revealed that more than half (58%) of study individuals on ART in 
Southwestern Uganda had metabolic syndrome. A meta-analysis by Nguyen, Peer 59 found a wide 
range (13% to 58%) of the prevalence of metabolic syndrome in Africa. In Kenya, the prevalence of 
metabolic syndrome was 19.2% among adults living with HIV, of whom 98.6% of the study population 
were on ART 60. Osoti, Temu 61 in the same country, found no significant difference in the prevalence of 
metabolic syndrome between ART-experienced (16.9%) and ART-naïve (15.2%) groups. In Southern 
Ethiopia, using IDF criteria, metabolic syndrome was diagnosed in 25% and 22.5% of individuals on 
ART and in the ART-naïve group, respectively 62. Further, using ATP criteria, the study found that the 
prevalence of metabolic syndrome in the ART group was 18.1% and 15.6% in the ART-naïve group. 
The authors observed that patients on ART had raised triglycerides, cholesterol, LDL-c and glucose 
levels, making these factors the major contributors to metabolic syndrome 62.  
In a narrative review in Africa, Husain et al. found a wide range of prevalence of metabolic disorders in 
the HIV-positive population: diabetes 2.1% to 26.5%, pre-diabetes 20.2% to 43.5%, metabolic 
syndrome 13% to 58% and dyslipidaemia 13% to 70% 63. In Feleke, Fekade 64 cross-sectional study in 
Ethiopia, the prevalence of hyperlipidaemia was 56.9% in patients on ART for greater ≥ 1 year and 
among these, 38.2%, 54.2% and 17.8% had hypercholesterolemia, high LDL-c and hyperglycaemia, 
respectively. A study in a hospital setting in Cameroon showed that the prevalence of hypertension in 
patients on ART was twice that of ART-naïve patients (38% vs. 19%) 65. A longitudinal study in Senegal 
which had a median follow-up of 9 years for patients on ART found that 28% and 14% of them had 
hypertension and diabetes, respectively 66. In a study which assessed the burden of cardiometabolic 
risk factors among untreated HIV-positive Cameroonians, the prevalence of impaired fasting glucose, 
diabetes and metabolic syndrome was higher in ART-naïve than in healthy individuals (47% vs. 27%, 
26% vs. 1%, and 47% vs. 21%, respectively) 67. However, the prevalence of hypertension was high and 
comparable in both groups (41% vs. 44%). A longitudinal study in South African young women 
following them for 3 years after HIV infection showed that metabolic syndrome was 8.7% and 19.2% at 
HIV diagnosis and over 36 months, respectively 68. These data suggest that on its own, HIV has an 
effect on the metabolic syndrome. 
There are no published estimates of the prevalence of metabolic syndrome among adults living with 
HIV in Zambia. However, in a study where metabolic syndrome was evaluated among patients with 
type 2 diabetes, the burden was 73% using NCEP-ATP III criteria 69, and higher in women as compared 
to men. A population-based survey found that the prevalence of hypertension, impaired glucose 
tolerance, and obesity were 34.8% (Goma et al., 2011), 4% 70 and 14.2% 71, 19% 72 respectively. These 
findings may be different if focused on HIV-positive patients on ART. A cross-sectional survey at the 
Department of Medicine at University Teaching Hospital in 2017-2018 found that 19% of admissions 
involved cardiovascular disease; CVD was a leading cause of hospitalization in people with HIV and 
high CD4 counts during ART. 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 13 
b. Risk factors for metabolic syndrome in HIV 
The occurrence of metabolic syndrome among people living with HIV (PLHIV) has been associated with 
a number of factors. Published studies showed strong associations of changes in fat or adipocyte 
function with metabolic syndrome 73,74. In the US, elevated glycated haemoglobin (HbA1c) and high 
total sugar consumption have been found to be associated with metabolic syndrome, accounting for 
30% of the prevalence 75. Morimoto, Simão 76 revealed that individuals who had metabolic syndrome 
and were using ART had significantly higher CD45(+), CD3(+), and CD4(+) T cell counts compared to 
patients without metabolic syndrome and using ART. In Poland, it was shown that CD4 counts less 
than 350 were a strong predictor of metabolic syndrome 77. PLHIV in Barcelona with metabolic 
syndrome displayed a higher levels of C-reactive protein (CRP) and leptin, and lower adiponectin 78, 
and metabolic syndrome was associated with a substantial increase in the prevalence of type 2 
diabetes. In young South African women, one year after HIV diagnosis, the chance of having metabolic 
syndrome increased by 47% 68. In another study, a log10 increase in HIV-VL was independently 
associated with metabolic syndrome 79. Individuals who had a smoking history, HIV-1 infection, higher 
body mass index (BMI) 80,81 and higher trunk-to-limb fat ratio (Jacobson et al., 2006) had higher 
likelihood of developing metabolic syndrome 82. Lipodystrophy was also shown to be associated with 
metabolic syndrome in adult patients on ART 57. 
Metabolic syndrome was shown to be higher in women than men in Ethiopia 62, Burkina Faso 57 and 
Uganda 58. However, this finding was contrary to that of Rogalska-Płońska, Grzeszczuk 77. In Poland 
where more males had metabolic syndrome compared to females. In Brazil, metabolic syndrome 
among males was associated with physical activity and education status 80. However, in Kenya, 
physical activity and education status were found to be factors associated with metabolic syndrome in 
both males and females 60. Other studies revealed that older age was a strong predictor of metabolic 
syndrome 57,58,77,81,82 . Education status has also been mentioned as a factor that affects the incidence 
of metabolic syndrome. In the US, among HIV-positive adults in the Healthy Living (NFHL) study, it was 
revealed that the incidence of metabolic syndrome was lower among the college-educated persons 74. 
Metabolic syndrome was found to be higher in ART compared with non-ART users in a meta-analysis 
and varied significantly by age, duration of HIV diagnosis, severity of infection and use of Non-
Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 59.  Further, it has been noted that the prolonged 
use of ART, especially protease inhibitors (Pis) 78; 83 such as  lopinavir/ritonavir 57,74,81,83, was 
associated with metabolic syndrome components i.e., dyslipidaemia, insulin resistance (IR), and 
changes in body fat compartmentalization (i.e., peripheral lipoatrophy and central fat accumulation), 
which are all risk factors for CVD 84,85. In Southern Ethiopia, individuals who were taking stavudine-
lamivudine-efavirenz (d4T-3TC-EFV) had increased odds of metabolic syndrome 62. Antiretroviral 
therapy has also been associated with the development of severe metabolic complications which 
includes, lipodystrophy, dyslipidaemia, and insulin resistance 78 In addition, Nguyen et al.’ meta-
analysis showed that use of ART is strongly associated with metabolic syndrome 59. Patients on ART 
have been known to have elevated lipid profile and glucose metabolism disturbances 86 more frequently 
than ART-naïve patients 62. Systematic review and meta-analyses have found hypertension to be 
significantly more prevalent among patients on ART when compared to HIV-positive persons who are 
ART- naïve 87,88.   
c. Service delivery models and implementation strategies from LMICs for integrated 
HIV/NCD Care 
Evidence from both developed and developing countries supports integrating prevention, management 
and surveillance of NCD into other models of chronic care. HIV care platforms have commonly been 
used for integrating NCD management 16,89. This is because decades of funding for HIV programs have 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 14 
resulted in established structures and human resource capacity. In addition, the advent of ART 
treatment has transformed HIV into a chronic condition, and the prevalence of NCDs among the HIV 
positive population has also increased 90. An integrated approach in chronic care is therefore an 
attractive option especially in the LMIC contexts where resources are scarce.  
Provision of integrated care requires a multidisciplinary response with engagement of various cadres of 
health workers. Critical to provision of integrated chronic care in resource constrained environments is 
implementation of a task sharing strategy. Task sharing is premised on the fact that most health 
facilities in LMICs have inadequate numbers of trained health workers (especially doctors) to meet the 
demand of the population. Therefore, uncomplicated aspects of prevention, management and 
surveillance of chronic conditions typically conducted by doctors can be assigned to other non-doctor 
health workers in order to free up the few available doctors for complicated cases. Integrated care of 
NCD with task shifting to nurses, pharmacists and community health workers has been shown to be 
effective across several settings in LMICs. Task shifting approaches for the management of 
hypertension typically involves non-physician health workers like nurses, community health workers 
and pharmacists providing lifestyle modifications through education, home based follow-up care, 
algorithm-based clinical management, non-physician drug prescription, referrals, and organisations of 
care 91.  
Engaging community health workers in cardiovascular disease risk assessment, patient referral to 
physicians and patient follow ups resulted in decreased systolic blood pressure of 8.8mmHg in the 
treatment group in a trial in India 92. Task shifting to nurse care coordinators who generate prescriptions 
using a clinical decision support system on a mobile phone was found to reduce systolic blood pressure 
by 14∙6 mm Hg 93. A multidisciplinary team comprising nurse conducting cardiovascular risk 
management and community health workers making patient follow-ups resulting in a mean reduction of 
27∙2 mm Hg. Nurses providing cardiovascular risk assessment, lifestyle counselling, and 
initiation/titration of antihypertensive medications coupled with health insurance resulted in better 
control of hypertension in Ghana 94. In Nigeria, pharmacy staff were involved in blood pressure 
measurements and lifestyle consultation using an mHealth application and in consulting with a 
cardiologist achieved a mean reduction of 9∙9 mm Hg 95.   
Integrated chronic care should be context specific and conducted systematically if it to be successful. 
WHO has provided guidance on integrating NCD management into other models of chronic care. 
Critical steps in the integration process include stakeholder identification and engagement, review of 
existing status, developments of a service delivery model, capacity building, monitoring and evaluation 
and review 48. 
 
6. Research Question  
The main study question is the following: “Is it feasible, acceptable, and appropriate to task-shift the 
delivery of an evidence-based package of integrated cardio-metabolic health services for PLHIV within 
Zambia’s national HIV program?”  
 
7. Research Aims, General Objectives and Specific Objectives   
The general objective of this research is to adapt WHO-PEN for a task-shifted locally-informed 
intervention for screening and management of cardio-metabolic co-morbidities for Zambian PLHIV, and 
to pilot-test it in preparation for a larger evaluation of clinical effectiveness and implementation 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 15 
outcomes. To facilitate rapid formative evaluation and to initiate the stakeholder conversation on a 
package of integrated HIV/ NCD services for Zambia, we will begin by proposing that the five core 
components/ strategies from Table 2 (below) be considered for TASKPEN. To achieve this general 
objective, we will pursue the following specific objectives: 
 
1. Adapt WHO PEN into a package of integrated HIV/NCD services known as 
“TASKPEN” and prepare TASKPEN for pilot testing in Lusaka. 
i. 
Conduct health facility assessments to: document current HIV infrastructure, laboratory 
capacity, and human resources to support integrated NCD management by NPHWs; 
characterize gaps in existing patient and clinic flows for optimized integrated HIV/NCD service 
delivery; and collect data to support pilot site identification (for objective #2).  
ii. 
Prepare data collection tools and methods to enable TASKPEN outcome ascertainment during 
pilot testing and the follow-on trial, including for the WHO quality of life data collection 
instrument (WHOQOL-HIV BREF) and an NCD module for the SmartCare electronic medical 
record.  
iii. 
Engage key stakeholders through formative research to: align WHO PEN algorithms to national 
NCD guidelines; generate feedback on proposed TASKPEN components, clinic processes and 
patient flows, and training materials; and obtain consensus on pilot sites (for objective #2). 
 
2. Pilot test the TASKPEN intervention and related outcome ascertainment at 
two PEPFAR-supported health facilities in Lusaka, Zambia. 
 
 
8. Methodology    
Study design overview  
Using local data and implementation science theories we will adapt WHO-PEN for Zambia and refine 
the proposed TASKPEN core intervention components. TASKPEN will focus on addressing challenges 
faced by PLHIV who have cardio-metabolic complications related to HIV or its treatment (e.g. 
hypertension, diabetes, dyslipidaemia). TASKPEN aims to improve detection and management of these 
complications. We expect the total impact of this process to result in reduced cardiovascular disease 
risk.  
 
We will engage stakeholders at all levels of the Zambian health system, including front-line nurses and 
community health workers who will lead the intervention. Using data from stakeholders, we will adapt 
and finalize the TASPKEN intervention, and pilot test it at two high-volume health facilities in Lusaka, 
Zambia using a “mini” stepped-wedge trial design that will mimic the approach for the future larger trial. 
As the individual components of TASKPEN are already recommended by Zambia national guidelines, 
the pilot study will be done as an integral part of routine HIV care. Therefore, the TASKPEN 
intervention is evidence-based and not investigational. 
 
In Table 2 below, we summarise the core intervention components/ strategies that we will assess, 
integrate, and adapt under this protocol to constitute the TASKPEN intervention, including the expected 
outputs from each activity. 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 16 
 
 
 
Table 2.  TASKPEN intervention components/ strategies proposed for adaptation and expected outputs. 
Intervention Component/ Strategy & Description 
Actors  
Outputs 
i. 
Adaptation of protocols, training 
materials, and management algorithms to the 
national context 
Review the current treatment guidelines in NCDs  and 
other cardiometabolic diseases in Zambia and align these 
to the TASKPEN  training materials and content, including 
the WHO HEARTS technical package for cardiovascular 
disease management in primary health care. This 
process  will ensure consistency with MOH guidelines, 
culture and availability of resources of the health system. 
We will also ensure training materials feature an 
emphasis on client-centred care, which is increasingly 
being identified as key driver of patient retention in HIV 
care.  
Hypertension protocol: 
Adapt WHO PEN/ HEARTS therapy recommend
based on national hypertension guidelines
availability of medical supplies.  
Diabetes and other co-morbidities protocol: 
Adapt to the Zambian diabetes guidelines and
practices to  manage diabetes. 
Algorithms made suitable for NPHW to use, with
guidelines when to consult or refer patien
specialist physicians  
 
Project 
Technical 
A
Committee (TAC). 
 
Ministry 
of 
Health 
directorate of clinical ser
Health workers 
Local experts 
&Patient groups 
 
  
Adapted Training manual; 
Adapted 
clinical 
protocols
algorithms 
for 
hyperte
diabetes and other cardiome
complications 
to 
the 
Za
settings. 
 
ii. 
Strengthened diagnostic capacity for 
decentralized monitoring of haemoglobin A1c, 
cholesterol, and albumin:creatinine ratio  
Integrate POC diagnostics or other streamlined 
at health facility level to enable decentralized an
shifted monitoring of NCDs/ cardiovascular risk fa
Project TAC. 
MOH directorate of 
services 
Health workers 
Local experts 
Patient groups 
Introduction of point-of-care
monitoring 
or 
other 
strea
diagnostics at pilot sites 
Zambia 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 17 
iii. 
Adapt local electronic NCD clinical data 
collection and decision support tool 
We will adapt the local EMR  (SMARTCARE), a fully 
integrated electronic health record system,  but mainly 
used for HIV care. We will adapt SMARTCARE to include 
data collection fields and clinical decision support prompts 
for 
NPHWs 
NCDs 
and 
other 
cardiometabolic 
complications. 
Project TAC. 
MOH directorate of 
services 
Health workers 
Local experts 
Patient groups 
SMARTCARE 
Module 
integrates HIV and NCDs and
cardiometabolic complications
iv. 
Adapt and leverage HIV infrastructure 
and systems to support NCD integration 
 
We will evaluate the current configurations and 
as needed, the physical structure and/or equ
(e.g., changing the layout of a room, adding equi
to best accommodate the targeted  integration o
and NCDs including patient flow, laboratory c
and human resources. This will include creating 
stop shop” for HIV/ NCD co-management in th
or OPD clinics.  
 
We will also harmonize NCD care to take advantage of 
existing innovations in the health system for HIV care, 
including for medication distribution, fast-tracked clinical 
evaluation, and integrated adherence support and back-to-
care services. 
 
Local clinicians, 
Nurses 
Laboratory specialists 
Patients groups 
Agreed patient and laborato
that integrates HIV and NCDs
v. 
Task shift and task share responsibilities 
 
CHWs based at the facility will conduct blood pr
screening, height and weight measurement
random blood glucose monitoring. CHWs will s
health education, including delivery of brief med
adherence and smoking cessation counselling. 
will also support community tracing and back t
activities for PLHIV with cardio-metabolic compli
who are late or disengagement from care. 
 
Nurses will be trained on the aforementioned pr
and will be enabled to prescribe medicatio
hypertension, diabetes, and dyslipidaemia. 
Nurses 
Community health worke
Patients groups 
Guidelines for nurse prescribi
 
Agreed CHW work flow 
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 18 
Specific Objective #1:  
a. Overview  
The activities described below involve a combination of programmatic activities (i.e., “non-human 
subjects research” or “NHSR” under i. & ii. below) and formative mixed methods research (iii. below). 
Where applicable, we have explicitly indicated activities that are NHSR below. Specific objective #1  will 
yield the following outputs in preparation for specific objective #2: Treatment guidelines and algorithms 
(both in SmartCare and on paper); Defined service delivery package and patient flow; Training 
materials and work flow for NPHW; Agreed sites where we will pilot test;  Data collection tools both for 
MOH/program and the study (e.g. the WHOQOL-HIV instrument); Agreed indicators that if achieved will 
provide sufficient evidence to move to a larger program. 
b. Study design 
i. 
Health facility assessments (Non-human subjects research) 
Health facility assessments will follow WHO recommendations for data collection and a previously 
adapted version of the WHO PEN site readiness assessment tool. Health facility assessments will take 
place at approximately 15 sites selected purposively from among health facilities in Lusaka, Zambia 
with high-volume (i.e., more than 3,000 HIV-positive patients in care) and that have CDC/PEPFAR-
supported ART clinics. Sites include: 
1 
Matero Reference 
2 
Kanyama 1st Level Hospital 
3 
Chipata 1st Level Hospital 
4 
Chawama 1st Level hospita 
5 
Chelstone Urban Health Center 
6 
George urban health center 
7 
Chilenje 1st level hospital 
8 
Kalingalinga Urban Health 
9 
Matero Main Urban Health 
10 
Kamwala Urban Health Center 
11 
Makeni Urban Health Center 
12 
Mtendere health center 
13 
Railway Urban Health Center 
14 
Kabwata Urban Health Center 
15 
Ng'ombe Urban Health Center 
 
At a subset of sites—Chawama 1st Level hospital, Chilenje 1st level hospital, George urban health 
center and Mtendere health center—we will conduct a more comprehensive assessment using a 
structured observation. Criteria for selecting these 4 sites include: 1) Patient volume— at least 3,000 
patients on ART in the past 12 months so we have increased opportunity to encounter recipients of HIV 
care who also have cardio-metabolic co-morbidities; 2) Health facility level—we aimed to include 
facilities representing both primary health care level and higher level (level I hospital) heath services in 
order to capture heterogeneity in the health system and a variety of contextual implementation 
challenges; 3) Models of NCD integration—we aimed to include facilities that had either nonintegrated 
ART and outpatient/ NCD services and sites that were already working towards integration; 4) 
Catchment population socioeconomic status—we targeted sites with a mix of low, middle, and higher 
socio-economic status for the Lusaka catchment population; and 5) Data Quality—we selected a 
combination of sites with both high and low data non-missingness (defined as above or below 60% 
non-missingness) for variables of interest (i.e., at least one documented blood pressure measurement 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 19 
and BMI in the past 12 months). These 4 sites will include the 2 sites where we will pilot our 
intervention pending stakeholder agreement. 
Structured observations will describe how NCDs for PLHIV are being managed, who are managing 
them, which cardio-metabolic complications are being addressed, what medications, equipment, and 
lab tests are available and which are not, and how patients are being managed, communicated with, 
and referred across departments within the same facility and between various levels of the health 
system to coordinate care. Structured observations will generally consist of: directly observing 
encounters between patients and healthcare workers or lay cadres (i.e. treatment supporters and 
community health workers); reviewing facility and program registers and records; and generally 
observing the flow, wait times, and dynamics for NCD and integrated HIV/NCD service delivery 
activities in selected facilities. The data will be formalized into research memos and will contribute to 
building a picture—alongside other data collection activities for Specific Objective #1—of services 
supporting or impeding integration of HIV/NCD care and management of cardio-metabolic risk factors 
and co-morbidities for PLHIV in Lusaka, Zambia.  
 
Structured observations will involve a trained study team member as a passive observer in public 
observable zones within health facilities, such as waiting areas, departmental registry rooms and vitals 
measurement stations. In all instances, permission to be based in these areas will be established with 
the overall-in charges (for facilities) prior to the commencement of study activities.  Informed consent 
will not be sought out for structured observations since they will take place in open publicly available 
areas and will not collect any protected or identifying health information, and will not create 
generalizable knowledge. This activity is simply intended to document existing service delivery for 
integrated HIV/NCD care in the local Lusaka context. Based on a list of themes outlined in a Structured 
Observation tool (Appendix B), the trained observer will sit or stand in an unobtrusive location to 
observe client flow, one-on-one and group interactions involving HCWs, and other elements of day-to-
day operations. Each ‘block’ of observation will last 1-2 hours.  As far as possible, the observer will not 
participate in conversations or activities although where necessary may answer direct questions.  
Observations will be conducted over approximately 2–3 days per facility and will be scheduled to occur 
on different days of the week and at different times of the day to better reflect the timing and variation of 
services and practices affecting NCD care and HIV/NCD integration. Structured observations will 
incorporate time spent in facility departments that affect patient and NPHW flow for management of 
NCDs in PLHIV, particularly the ART clinic, the Outpatient Department (OPD), the laboratory, and 
pharmacy. The study observer(s) will introduce themselves to all HCWs and staff, accompanied by the 
facility in-charge, in a general round of introductions at the beginning of the observation-period, and 
subsequently sit in a single space (as much as possible) in departments of interest, making shorthand 
notes related to their observations of health facility operations, healthcare worker interactions, patient-
provider interactions and informal conversations. Notes will be structured under general thematic 
headings, including environment and workflow for NCD care, NCD patient care services, Equipment 
and Lab services, Medications, HCW work patterns & behaviours, with a particular focus on NPHWs, 
and communication and rapport-building patterns, among others. Short hand notes will be recorded on 
sub-thematic areas, including the following: operations; equipment and medication availability; waiting 
times; record keeping; communication patterns; referral systems; and interactions among healthcare 
workers and patients. Notes will be expanded in full at the end of the day (or as soon as possible 
thereafter), and formalized into a summary memo, which will be stored in an electronic log for later 
analysis. No personal identifying information such as names will be documented in notes or reports to 
protect confidentiality of staff and patients. 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 20 
 
ii. 
Preparation of data collection tools (Non-human subjects research) 
Piloting of WHOQOL-HIV Brief 
WHOQOL-HIV BREF is an essential tool to assess quality of life, considered the ‘4th’ 95-95-95 HIV 
indicator (i.e., beyond viral suppression), which will be a secondary outcome for the pilot and the later 
follow-on trial. As such, under this sub-aim, we will use the WHOQOL-HIV instrument previously 
adapted to the Zambian context, and pilot the WHOQOL-HIV BREF items focusing on ensuring 
semantic equivalence and assessing known group validity.  
To confirm semantic equivalence, two trilingual (English, Bemba, Nyanja) study staff will back translate 
WHOQOL-HIV BREF items into English from Nyanja and Bemba. A consensus discussion will then be 
held between the translators and the MPIs to discuss difficult items with questionable clarity, which will 
then be resolved by consensus and the WHOQOL-HIV BREF revised accordingly. The final version for 
assessing known group validity will be called “WHOQOL-HIV-BREF-Zam.”  
 
Preparation of the SmartCare NCD module 
We will work with a CIDRZ program developer hired by the study team, and with the stewards of the 
national EMR, SmartCare, which comprise CIDRZ, MOH, CDC/PEPFAR, and BroadReach, to adapt 
SmartCare to include an NCD module and automatic decision-support prompts for non-physician health 
workers. We envision that this may include a rather simple adaptation of an existing “outpatient 
department” module already available in SmartCare. 
We will test this adapted version of SmartCare using an innovative approach known as “theatre 
testing”. Theatre testing is a visual consultative process for obtaining rapid feedback on a new service 
or product from end-users. For this non-human subjects research component, we will use a voluntary 
sign-up sheet posted at health facility-level to invite ~10-15 adapted NCD SmartCare module end 
users, including a mix of NPHWs, from CIDRZ-supported sites to observe a demonstration of the 
module in action and/or use the module themselves. As this will be a convenience sample of 
SmartCare end users, we cannot exclude the possibility of selection bias among volunteers who agree 
to participate in theatre testing. However, since the intention of theatre testing is to improve the quality 
of the NCD module for local implementation, and not to create generalizable knowledge, we do not 
consider this a substantive methodological limitation. Following the theatre testing, a brief questionnaire 
(Appendix D. ii) will be administered to obtain feedback on the module that will feature the simple 12-
item implementation survey (incorporating empirically supported measures for acceptability, feasibility, 
and appropriateness) mentioned above, among other implementation-relevant items 98. Data from the 
theatre testing surveys will be summarized using descriptive statistics, and the results used to further 
refine and finalize the SmartCare module in advance of the pilot in objective #2. 
While theatre testing will involve brief interactions with human volunteers to administer a 12-item 
survey, no identifiable private information or biospecimens will be obtained, used, studied, analysed, or 
generated during theatre testing. Moreover, the information obtained from the surveys will be recorded 
in such a manner that the identity of the volunteers cannot readily be ascertained, directly or through 
identifiers linked to the volunteers, and the investigators will not try to re-identify or contact the 
volunteers. Finally, any disclosure of the volunteers’ responses outside theatre testing would not 
reasonably place the volunteers at risk of criminal or civil liability or be damaging to their financial 
standing, employability, educational advancement, or reputation. As such, theatre testing is considered 
to be research exempt from U.S. federal regulations, category 2 (exemption 2). 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 21 
 
iii. 
Engage key stakeholders (Formative research) 
All the formative research activities described under this sub-section are intended to generate 
generalizable knowledge about how diverse stakeholders in settings heavily burdened by HIV and 
cardio-metabolic NCDs perceive the need and urgency for HIV/NCD service integration, as well as the 
changes to the health system and implementation context necessary to realize integration. 
Focus group discussions 
We will prepare the strategies described in Table 2 for pilot implementation through consultative focus 
group discussions (FGDs) and brief surveys to create generalizable knowledge. These data collection 
activities will be guided generally by phases of the ADAPT-ITT approach 96 In order to get views from 
relevant stakeholders about the acceptability, appropriateness, and applicability of the strategies 
described in table 1 above, we will conduct the following 9 consultative focus group discussions (FGDs) 
within each of the following levels of the health system, including: Provincial and District Health Offices 
(x1) involving senior program managers, technical staff and coordinators; Health facilities (x 4) with 
high-volume ART clinics meeting WHO PEN criteria for becoming a demonstration site (i.e. have district 
and provincial government approval) involving front-line non-physician health workers (e.g. nurses, 
clinical officers, and pharmacists); and community level (x4) involving CHWs/ lay health providers and 
treatment supporters from the 4 purposively selected facilities for collection of formative data. 
Consultative FGDs will involve 4-8 participants each (i.e., 36-72 total), during which we will present the 
training materials, management algorithms, and patient and clinic flows, as appropriate, using vignette-
style semi-structured guides to depict the core components of the proposed TASKPEN intervention. We 
will invite participants (Appendix A. i) to discuss how these do or do not fit with the local implementation 
context, and provide feedback for improvement.  
Sampling for participation in consultative FGDs will be purposive for MOH headquarters (such as MoH 
staff already dedicated to cardiometabolic NCD issues) and provincial and district health offices staff 
and opportunistic for non-physician health workers and CHWs and lay health providers based on an 
open invitation. A few screening criteria will be applied for FGDs with NPHWs and CHWs/ lay health 
providers, which will be verified using a brief screening and eligibility case reporting form to confirm that 
participants are: ≥18 years of age; a non-physician professional or lay/ peer HCW involved with HIV 
and/or NCD service delivery at one of the study sites; and generally familiar with health services and 
operations at their facility. 
A small team of trained FGD moderators will conduct all FGDs using semi-structured discussion guides 
(Appendix C. i, ii and iii) that will explore domains adapted from the Consolidated Framework for 
Implementation Research 97, including: complexity (i.e. the perceived difficulty of implementing 
TASKPEN intervention components in terms of time required, the disruptiveness of TASKPEN activities 
to average HCW work flow, the number of steps required to complete steps along the patient care 
pathway, and preferences for models of facility-level service integration of varying complexity, etc.); 
perceived patient needs and resources (i.e. the extent to which perceived patient needs, as well as 
factors that enable or hinder satisfying those needs are known to FGD participants and prioritized by 
their respective organizations); perceived  HCWs challenges (i.e. perceived individual and system-level 
challenges and their context that may hinder delivery of TASKPEN); structural characteristics (i.e. the 
number and scope of professional NPHW and lay/ peer HCWs tasked with or otherwise organized into 
units that can support the TASKPEN intervention): knowledge and beliefs (i.e. individual attitudes 
regarding and value placed on supporting integrated HIV/NCD services, as well as familiarity with 
evidence and other facts surrounding the importance of integrated HIV/NCD services for improving the 
health of PLHIV); planning (i.e. the extent to which established procedures or strategies are in place to 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 22 
manage cardio-metabolic risk factors and co-morbidities among PLHIV); engaging (i.e. the types of 
leaders among MOH management and frontline HCWs, including facility-level physicians, focused on 
NCD and/or cardio-metabolic complication management); and executing (i.e. the extent to which plans 
exist to support NCD and/or cardio-metabolic complication management for PLHIV); among others. 
Within this thematic framework, questions will be open-ended to allow the moderator to probe for 
emerging major and minor themes. The discussion guides will include a standard opening statement for 
use by the moderator to clarify FGD processes and participant roles, will present a description of the 
proposed TASKPEN intervention, and will be structured such that participants are encouraged to 
respond mostly to the moderators and not one another. FGDs will last approximately 1 to 2 hours each. 
FGDs will be conducted in a private room in the health care facility or other neutral setting. 
Implementation surveys 
At the conclusion of each consultative FGD, we will administer a simple 12-item survey (Appendix D. i) 
incorporating 
three 
empirically 
supported 
measures 
for 
the 
acceptability, 
feasibility, 
and 
appropriateness of the final package of proposed TASKPEN training materials, protocols, standard 
operating procedures, and processes 98. Each measure will contain 4 questions that are scored on a 
Likert scale from 1 (completely disagree) to 5 (completely agree) that ask respondents to rate the 
TASKPEN intervention on the aforementioned implementation domains. Guided by the Integration and 
Training Phases of ADAPT-ITT, we will use results from the surveys and consultative FGDs to refine 
and finalize TASKPEN implementation strategies and related outputs in readiness for the pilot testing in 
specific objective #2. 
Key informant interviews 
We will engage senior MOH stakeholders and policy makers through key informant interviews (KIIs). KII 
participants will be identified and contacted by phone, email, or in-person by the MPIs or one of the co-
investigators and will be given detailed information regarding the purpose of the KIIs, and will then be 
asked if they would be willing to participate (Appendix A. ii). KII interview guides (Appendix C. iv.) will 
be semi-structured and follow the same Consolidated Framework for Implementation Research9 
domains described for the FGDs. 
Patient in-depth interviews 
We will engage patients as our final key stakeholder group through in-depth interviews (IDIs) (Appendix 
C. v.). For IDIs, we will purposively select approximately 20 PLHIV with cardio-metabolic NCDs (i.e., 
diabetes, hypertension, dyslipidaemia, etc.) from the 4 sites where structured observations will be done. 
IDIs will examine patient experiences accessing both HIV and NCD services. We believe this number 
will be sufficient to identify major and minor themes, and achieve saturation on patient thoughts on 
ways to adapt and introduce the TASKPEN intervention for the pilot sites in specific objective #2. To 
ensure balanced representation across sex, age band, and major NCDs of interest, study staff will 
purposively select IDI participants by manually reviewing existing clinic registers and SmartCare 
records. For all potential IDI participants, study staff will approach them in person to see if they might 
be interested in learning more about the study using a recruitment script (Appendix E). If interested, 
study staff will then speak with the potential participant to sensitize them about the study and ask if they 
might be willing to participate in the interview (Appendix A. iii). Where a potential participant declines to 
learn more about the study or to provide consent, we will identify a replacement from among other 
potential participants until we achieve the enrolment targets summarized below.  
Table 3. Mixed methods data collection summary for Specific Objective #1 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 23 
Method 
Activity TypeActivity Description 
Total ParticipantApproxim
Time for
activity 
Health 
facility 
asses
Structured Observations  
Non-human 
s
research 
~15 
observations—1 
at 
each 
purposively selected health faci
Lusaka Province 
n/a 
1–2 hours  
Theatre testing 
Non-human 
s
research 
End users participate in theatre te
adapted SmartCare NCD module 
n/a 
~1 hour 
Key Informant Interviews 
Research 
~5-10 central MOH senior policy ma
technocrats 
~5-10 
~1 hour 
Focus Group Discussions & 
Implementation survey 
Research 
1 FGD involving senior provincia
office (PHO) and district health offic
program managers, technical st
coordinators 
~4 – 8 
~2 hours 
Research 
~4 FGDs (i.e. 1 at each of 4 pur
selected high-volume ART clinics in
Zambia) involving frontline non-p
health workers (NPHWs) such as nu
~16 – 32 
~2 hours 
Research 
~4 FGDs at community level (i.e. 1
of the 4 selected facilities above) 
CHWs/ lay health providers and tr
supporters  
~16 – 32 
~2 hours 
Research 
Implementation survey done for 
participants at end of FGD 
~36 – 72 
~20 minut
In-depth Interviews 
Research 
~20 IDIs will be done with PLH
cardio-metabolic co-morbidities (i.e
each of 4 purposively selected high
ART clinics in Lusaka, Zambia) 
~20 
~1 hour 
Key Informant Interviews 
Research  
~8 KIIs (i.e. 2 at each of the 4 pur
selected 
high-volume 
sites) 
w
conducted with clinicians at each fac
~8 
~1 hour 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 24 
 
c. Study site and population / research materials 
Formative research activities will be conducted in MOH administrative settings at central, provincial and 
district levels in Lusaka, as well as 15 high-volume, PEPFAR-supported facilities and their surrounding 
catchment areas in Lusaka District (henceforth referred to as “sites”). These sites will be selected in 
consultation with our TAC. The study population will include a mix of MOH policy makers, program 
managers, non-physician health workers (e.g., nurses and clinical officers) community health workers 
(CHWs)/ lay health providers, and adult patients living with HIV and related NCD co-morbidities. 
d. Selection of participants, sampling methods, sample size  
i. 
Description and source of population and catchment area 
For the mixed methods formative outcome evaluation, we will conduct: 1) In-Depth Interviews (IDIs) 
with patients; 2) Focus Group Discussions (FGDs) with Provincial Health Office (PHO) and District 
Health Office (DHO) program managers, technical staff and coordinators, NPHWs and community 
health workers participating in the delivery of the TASKPEN; 3) Key Informant Interviews (KII) with key 
stakeholders, such as policy makers from the Ministry of Health (MOH) and clinicians, critical to 
implementation of the TASKPEN intervention.  
ii. 
Participant inclusion criteria 
IDI participants must be emancipated HIV-infected adults ≥18 years of age who have a documented 
cardio-metabolic condition. 
FGD participants must be:  ≥18 years of age; a NPHW or community health worker / lay provider 
involved with HIV and/or NCD service delivery; or a PHO and DHO program managers, technical staff 
and coordinators generally familiar with HIV and/or NCD service delivery at their facility. 
Implementation survey participants must be:  ≥18 years of age; a NPHW involved with HIV and/or NCD 
service delivery; and coordinators generally familiar with HIV and/or NCD service delivery at their 
facility. 
KII participants must be:  ≥18 years of age; a senior MOH policy maker or health official working at 
national level in Zambia involved in managing, coordinating, and/or overseeing health services for non-
communicable diseases in Zambia. 
iii. 
Participant exclusion criteria 
We will exclude any potential IDI, FGD/ implementation survey, or KII participant if they are unwilling or 
unable to provide informed consent.  
e. Specific Objective #1 Outputs: Final TASKPEN Pilot Sites & Package for Pilot Testing 
After all objective #1 data collection and analysis, we will review the data and may modify the 
implementation strategies and peripheral elements necessary to introduce the  TASKPEN intervention,  
but not the evidence-based core elements detailed in Table 1. These will then be circulated to 
stakeholders on our Technical Advisory Committee (TAC) to get their final feedback. This will be done 
via email or Zoom video-conference meeting depending on TAC member availability. The outputs from 
Specific Objective #1 following TAC consultation will be: 1) consensus on the final TASKPEN package, 
including the core strategies/ components, training materials and 2) finalization of the two pilot sites for 
proceeding to pilot testing in specific objective #2. 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 25 
Specific Objective #2: Pilot test TASKPEN at two PEPFAR-supported health 
facilities in Lusaka, Zambia. 
a. Overview  
By completing specific objective #1, we will be fully prepared for TASKPEN pilot testing, having ready 
an adapted version of TASKPEN that includes all the essential implementation strategies necessary to 
overcome barriers to HIV-NCD integration in routine care settings. While the peripheral elements and 
implementation strategies used to introduce TASKPEN may undergo adaptation under specific 
objective #1, it is important to note that the 5 core, evidence-based components outlined in Table 1 and 
proposed for this pilot will not substantively change. Under specific objective #2, we will launch the 
TASKPEN pilot and fully task-shift our intervention to NPHWs and integrate it within the PEPFAR-
supported HIV service delivery platform. Concurrently with implementation, during the pilot we will 
identify facilitators and barriers to TASKPEN introduction, assess preliminary implementation outcomes 
and patient and provider preferences related to integrated management of cardio-metabolic 
complications for PLHIV, ascertain early clinical outcomes for patients before and after TASKPEN 
piloting, and collect formative costing data.  
 
b. Study design 
For this objective, we will conduct a quasi-
experimental “mini” cross-sectional stepped-wedge 
study at the 2 pilot sites employing a mixed methods 
approach. First, at the two pilot sites (i.e. A and B), 
we will conduct a baseline assessment of select 
outcomes for PLHIV receiving the existing standard 
of care. This will involve conducting a brief bio-
behavioural survey or “patient survey” among a 
consecutive sample of ~376 adult PLHIV presenting 
for routine HIV services at the two sites (i.e., ~188 
PLHIV per site, see Sample Size and Statistical 
Power below). After this first patient survey, one 
randomly selected facility (i.e. cluster) will be 
switched to the full TASKPEN intervention. The 
patient survey will be repeated again with another 
~376 adult PLHIV after ~3 months at both sites 
before switching the second site to the full 
TASKPEN intervention. After switching the second 
site,  both pilot sites A and B will implement the full TASKPEN intervention for another ~3 months after 
which time a third and final “end line” patient survey will be conducted. Survey data will be used to 
estimate the pilot effect size of the TASKPEN intervention to aid in planning a future larger trial and to 
measure WHO PEN process indicators for all PLHIV in care who accessed routine health services 
during the pilot period.  
 
 
Complementing the baseline, midline, and endline patient surveys will be a “nested cohort” of PLHIV 
with cardio-metabolic comorbidities enrolled at both sites beginning at baseline. At each site, we will 
enrol a subset of ~100 baseline survey participants (i.e., ~200 total) found to have at least one cardio-
metabolic complication or risk factor (see below) on the baseline survey. We will then follow these 
nested cohort participants longitudinally for ~9 months at site A and site B. A nested cohort sample size 
Figure: Study schematic with “mini” stepped 
wedge and nested cohort. 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 26 
of 200 PLHIV was selected to represent about 50% of all baseline survey participants who are 
estimated to have a cardiometabolic co-morbidity at each site (i.e., ~188 PLHIV in care per site who 
complete a baseline survey x ~50% of survey participants with hypertension, diabetes, and/or 
dyslipidaemia = ~100 participants per site), consistent with estimates for the prevalence of cardio-
metabolic comorbidities among PLHIV in Lusaka, Zambia. Moreover, the nested cohort sample size of 
~200 total participants (~100 per site) is intended to assess the feasibility of the intervention and 
longitudinal follow up of study participants to inform a future larger trial; it is not intended to test a 
hypothesis a priori.  By enrolling a nested cohort, we can use their data to enrich inferences made from 
the cross-sectional surveys and will be able to make more granular comparisons between and within 
sites (i.e. with an external and internal comparator group, respectively).  
The “mini” stepped-wedge approach is appropriate because individual randomization is not feasible 
since TASKPEN is a facility-level program, and because it will help us anticipate operational challenges 
for the future larger trial (i.e., a stepped-wedge cluster randomized trial planned for 2023 with NIH 
funding). The nested cohort will also leverage existing routine data sources, including the SmartCare 
electronic medical record (EMR) and CIDRZ Laboratory Information Management Systems (LIMS). The 
MOH/CIDRZ teams implementing HIV program activities routinely collect individual-level clinical data, 
which as a line-listed resource can provide insights into individual outcomes for the nested cohorts. 
Nested cohort data collection will include a patient quality of life questionnaire and a patient discrete 
choice experiment (DCE). The DCE will require patient completion of a questionnaire to elicit 
preferences for the different features of integrated HIV and NCD services. Stated preference methods 
such as DCEs have been increasingly used to quantify the relative importance and trade-offs among 
HIV service delivery and treatment programs. For example, recent DCEs from Zambia have examined 
how patients stable on ART would make trade-offs among the features of differentiated service delivery 
programs, including the location of service delivery and frequency of medication pick-up. In order to 
ensure successful uptake of integrated services for HIV and non-communicable diseases (NCDs), it is 
critical to incorporate patient preferences into the service design and delivery. 
We will also conduct a mix of IDIs, FGDs, key informant interviews, and implementation surveys with 
patients and providers to evaluate feasibility, acceptability, and other implementation outcomes.   
 
c. Study sites and population / research materials 
Evaluation activities will be conducted in 2 high-volume, ACHIEVE-supported facilities and their 
surrounding catchment areas, henceforth referred to as the “pilot study sites” in Lusaka Province. 
These sites will be selected from among the 4 sites undergoing in-depth formative assessment under 
Objective #1. Tentatively, the pilot sites will be Chilenje 1st level hospital and George urban health 
centre, subject to approval by our TAC and findings from our formative assessment. The “mini” stepped 
wedge pilot will include all HIV-infected adults aged 18 years and older seeking care at the two pilot 
sites. Inclusion in the nested cohort will require documented HIV infection, age  ≥ 18 years and one or 
more cardio-metabolic conditions or risk factors of interest described below (i.e., hypertension, 
diabetes/ pre-diabetes, and/or dyslipidaemia).  
d. Selection of participants, sampling methods, sample size, enrolment and follow-up 
procedures  
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 27 
i. 
Description and source of population and catchment area 
Based on existing PLHIV volumes at high-volume ACHIEVE supported sites in Lusaka, we expect to 
survey at least ~188 PLHIV meeting patient survey eligibility criteria at each site at baseline, midline, 
and endline (i.e., ~564 at each site or ~1128 participants in total) and to recruit approximately 100 
baseline survey participants into the nested cohort at each site (i.e., ~200 total). For outcome 
ascertainment in the surveys, we will check vital signs, anthropomorphic measurements, and 
biomarkers. For outcome ascertainment in the nested cohort, we will review SmartCare, LIMS, and 
other MOH and CIDRZ registers and augment the abstraction of these routine data with study-driven 
primary data collection. Study-driven primary data collection in the nested cohort will include 
administration of the adapted WHOQOL-HIV-BREF-Zam and discrete choice experiment (DCE) 
questionnaire to these ~200 participants.  
For the implementation outcome evaluation, we will conduct: 1) In-Depth Interviews (IDIs) with patients; 
2) Focus Group Discussions (FGDs) with NPHWs and community health workers participating in the 
delivery of the TASKPEN; and 3) Key Informant Interviews (KII) with key stakeholders, such as policy 
makers from the Ministry of Health (MOH) and Clinic In-Charges, critical to implementation of the 
TASKPEN intervention. A brief implementation survey will be conducted with FGD participants at the 
end of each FGD.  
ii. 
Participant inclusion criteria 
For the cross-sectional patient surveys, we will include all adult males and females ≥18 years of age 
seeking routine HIV care at the two pilot sites during the pilot period.  
For the nested cohort, the participant will need to be eligible and included in the patient survey done at 
baseline plus they will also need to have one or more of the following cardio-metabolic conditions or 
risk factors: 1) any current tobacco smoking; 2) hypertension as defined by WHO PEN (i.e., systolic 
blood pressure [SBP] ≥140 mmHg and/or diastolic blood pressure [DBP] ≥90 mmHg; 3) diabetes 
mellitus as defined by WHO PEN (i.e. random plasma glucose ≥ 11.1 mmol/L, fasting plasma glucose  
≥ 7 mmol/L, and/or haemoglobin A1c  ≥ 48 mmol/mol / ≥6.5%); 4) prediabetes (defined as having 
impaired fasting glucose of 6.1 to 6.9 mmol/L, impaired glucose tolerance with a two-hour, post-oral 
glucose tolerance test glucose ≥7.8 mmol/L but <11.1 mmol/L and a fasting plasma glucose <7.0 
mmol/L, and/or haemoglobin A1c 42 to 48 mmol/mol or between 6.0–6.4%); and/or 5) dyslipidaemia 
(defined as total cholesterol >5.2 mmol/L or low density lipoprotein ≥3.4 mmol/L).  
IDI participants must be emancipated HIV-infected adults ≥18 years of age who were enrolled in the 
nested cohort and had documented exposure to the TASKPEN intervention at a pilot site. 
FGD / implementation survey participants must be:  ≥18 years of age; a NPHW or community health 
worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery; and 
generally familiar with HIV and/or NCD service delivery at their facility. 
KII participants must be:  ≥18 years of age; a facility-level ART or OPD clinic manager/ in-charge or 
policy maker at district, provincial, or national level in Zambia; and generally familiar with HIV and/or 
NCD-related issues in their community. 
iii. 
Participant exclusion criteria 
For the cross-sectional patient surveys, we will exclude adults who do not have documented evidence 
of HIV infection or who have not established HIV care at a study site. We will also exclude people 
unwilling or unable to provide written informed consent. 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 28 
For the nested cohort component, we will exclude adults who have no documented evidence of HIV 
infection or a NCD of interest. We will also exclude people who did not participate in the baseline 
patient survey, are not likely to remain at the site for their care through the end of cohort follow-up, or 
unwilling/ unable to provide written informed consent.  
We will exclude any potential IDI, FGD/ implementation survey, or KII participant if they are unwilling or 
unable to provide written informed consent.  
iv. 
Justification of exclusion of any sub-segment of the population 
We will not exclude any sub-segment of the adult population for the cross-sectional patient surveys. We 
have chosen to exclude infants, children, and adolescents under 18 years of age from this analysis as 
the mechanisms and systems built to support their care are unique, and because this population has a 
lower risk of cardio-metabolic complications of HIV. 
v. 
Site sampling and randomization, including sample size and statistical power 
The pilot sites for the formative evaluation will be selected based on their feasibility to deliver 
TASKPEN and to reflect different levels of the health system. For the mini stepped wedge study, the 
pilot sites will be Chilenje 1st level hospital and George urban health centre, subject to approval by our 
TAC and findings from our formative assessment. We will use a computer-generated allocation 
algorithm to randomize the time at which Chilenje and George will switch from standard of care to the 
TASKPEN intervention. This timing will be concealed from clusters and the trial team until ~4 weeks 
before the switch date. 
 
Table 4. Study sites for the TASKPEN formative assessment. 
Facility 
Annual 
PLHIV i
(TX_CUR
% 
of 
TX_
clients 
with
documented 
(within last 6 m
% of TX_CURR 
with a document
pressure measur
(within 
the 
la
months) 
Avg. 
No. 
o
PLHIV enterin
(TX_NEW) 
Health 
Level 
 
Integration of NCD a
care 
Mtendere 
6138 
727 (11.84%) 
719 (11.71%) 
833 
First 
Partial integration 
(ART services 
available in outpatient 
department) 
Chawama 
10161 
5599 (55.10%) 
4485 (44.14%) 
1353 
Secondary 
No integration 
Chilenje 
8083 
7225 (89%) 
6484 (80%) 
1045 
First 
No integration 
George 
8785 
1103 (13%) 
38 (0.4) 
1345 
Primary 
No integration 
 
For the cross-sectional patient surveys, we will survey a consecutive sample of 188 eligible patients in 
care at each clinic at each of the 3-time points (i.e., baseline, midline, and end-line) using a stepped-
wedge cluster-randomized design. Applying this design with a sample of 2 clusters (i.e., sites), 3 survey 
time points, 2 steps, 1 cluster switching from control to intervention at each step, and an average of 564 
subjects per cluster (i.e., 188 participants per cluster per period) achieves 80% power to detect a risk 
ratio of 1.25 (for the risk of dual HIV/NCD control during the intervention period compared to the control 
period) at the 0.05 significance level with an inter-class correlation coefficient of 0.25. We assumed that 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 29 
the proportion of participants achieving dual  HIV/NCD control is 0.75 under the alternative hypothesis, 
and 0.6 under the null hypothesis, and used the two-sided Wald Z-Test as the test statistic. Based on 
the above calculation, we will survey 564 eligible patients at each clinic across the 3-time points (i.e., 
3*188=564 eligible patients) to achieve a total sample size of 1128 participants for the mini stepped-
wedge. It is important to note that participants previously surveyed will not be eligible for subsequent 
surveys—i.e., once interviewed, a patient should not be eligible for interview in subsequent surveys 
unless they are part of the nestd cohort. Finally, as part of the baseline, midline, and endline cross-
sectional surveys, we will review de-identified routine data for all PLHIV in care at the study sites during 
the study period to estimate HIV viral load completeness, NCD-variable data completeness (e.g., 
routine weight and blood pressure measurements), and performance on WHO PEN indicators in the 
routine medical record. 
 
For the nested cohort component, the total sample size of ~200 participants was selected for 
operational feasibility and to assess our ability to collect longitudinal cardio-metabolic data, but does not 
involve a priori hypothesis testing.  
The suggested sample size for DCE surveys is estimated by the method of Orme and Johnson as N 
>500c/(t x a), where c is the number of analysis cells (i.e., the largest number of levels for any 
attribute), t is the number of choice tasks, and a is the number of options. Assuming maximum 4 levels 
per attribute, 10 choice tasks, and 3 options, the minimum required sample size is 67 to examine the 
effects in the overall study population. However, a larger sample size is necessary to measure 
preference heterogeneity among patients participants. Thus, administering the DCE questionnaire to all 
nested cohort participants is being proposed to fully assess preference heterogeneity in the patient 
population. 
 
For our qualitative and costing components, we have not calculated sample sizes a priori, as we will not 
be conducting statistical hypothesis testing. The total participants listed in Table 5 (below) are meant to 
serve as a guide only. Additional IDIs, FGDs/ implementation surveys, KIIs, and structured 
observations may be added until thematic saturation is reached and no new themes are elicited from 
participants. 
 
vi. 
Recruitment & Enrolment 
For the cross-sectional patient surveys, we will coordinate with facility staff to approach, in person, 
consecutive PLHIV accessing routine health services at the clinic about the study. We will sensitize 
patients about the study at the clinic appointment desk, triage, and other waiting areas to take 
advantage of times when patients are queueing or otherwise awaiting health services. We will seek to 
conduct study activities after patients have received most of their clinic services so as not interrupt 
routine work and patients flows. After written informed consent procedures are completed, we will 
request basic locator information (e.g. phone number) to follow up with participants and administer a 
brief, one-time bio-behavioral survey.  
For the nested cohort component, we will contact a consecutive sample of survey participants who we 
identify with a cardio-metabolic NCD through the survey and invite them to be followed in the cohort. 
For consenting participants, we will prospectively collect individual-level data, using existing routine 
data systems and study-specific case reporting forms, at the selected sites during the pilot period. 
Study staff will mention during baseline survey consent procedures that we may contact, by phone or in 
person, participants found to have a cardio-metabolic NCD via the survey and invite them to learn more 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 30 
about the cohort at their next clinic visit. Phone recruitment for the nested cohort will be done using a 
recruitment script (Appendix D.i). For those interested, study staff working closely with facility staff will 
speak with potential cohort participants during their next clinic visit to sensitize them about the study 
and proceed with informed consent procedures if eligible and interested. The study procedures, risks, 
and benefits will be discussed in detail in Nyanja, Bemba, or English based on potential participant 
preference. The potential participant will have the opportunity to ask questions and deliberate before 
they decide whether or not they consent to participate.  
 
For IDIs, potential participants identified to be eligible from among nested cohort participants will be 
contacted by phone or in person by study staff using study locator information. Study staff will ask if the 
potential participant might be interested in volunteering for the IDIs. IDI risks and benefits will be 
discussed in detail. The potential participant will have the opportunity to ask questions and deliberate 
before they decide whether or not they consent to the IDI. Where a potential participant declines to 
learn more about an IDI or to provide consent, we will identify a replacement from among other nested 
cohort participants until we achieve our IDI enrolment target.   
For KIIs, participants identified to be eligible will be contacted by phone, email, or in-person by the MPIs 
or one of the co-investigators and will be given detailed information regarding the purpose of the KIIs, 
and will then be asked if they would be willing to participate. Because using a structured screening 
script may undermine the trust and personal rapport necessary to ensure key informant enrolment and 
honest responses to interview questions, a screening script will not be implemented for KIIs.  
Enrolment of FGD/ implementation survey participants in all cases will be achieved by issuing an open 
invitation to all eligible non-physician health care workers (NPHWs) and community health workers 
(CHWs) / lay health providers. For NPHWs and CHWs, the study coordinator or co-investigator will 
communicate the open invitation using a recruitment script during the regularly scheduled (usually 
monthly) “all staff” or similar team meeting, which is scheduled in advance by the facility in-charge 
during the lunch hour and held in a conference room or other relatively private space at the facility. 
Enrolment will be on a first come, first served basis. We will coordinate scheduling of all FGDs/ 
implementation surveys with facility in-charges and will seek to conduct them at study sites on a 
weekend day or, if not feasible, during the lunch hour or late in the day on a weekday when clinical 
activities have wrapped up or are winding down so as to minimally impact patient care activities. For 
example, in many health facilities, ART clinic is only offered on certain days, or if offered daily, one day 
is dedicated to a specialized population (e.g. Paediatric ART Clinic) with the clinical encounters ending 
before lunch due to lower patient volume and workload. The investigators have experience collecting 
data from professional and lay healthcare workers in this way, which has enabled implementation 
science studies to achieve their enrolment targets without adversely affecting patient care activities. We 
will undertake all possible measures so as not to remove healthcare providers from their clinical duties. 
vii. 
Nested cohort follow-up procedures 
Nested cohort participants will be the only study participants having more than one encounter with the 
study team. As such, we will schedule study follow-up visits approximately every 3 months over a ~9-
month period starting at 2 weeks from the time of the baseline patient survey. Thus, their total 
engagement with the study will amount to about 4 follow-up visits (at ~2 weeks and then around 3 and 
6 months from the baseline survey plus one study exit visit at around 9 months). Study visits will be 
largely aligned with the schedule of routine clinic visits stipulated in the Zambia national HIV guidelines 
(i.e., every 3-6 months for established ART patients and more frequently during the first month of 
treatment for new ART patients) and will be scheduled mostly for times when the study teams are 
conducting the midline and endline surveys at the study sites. Study research assistants, who are not 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 31 
providing any interventions as part of TASKPEN, will contact the participants in the nested cohort via 
phone call every month to check vital and clinic status (still in care at original site) and ascertain any 
changes in household location. If the participant is unreachable, community tracing will be done to 
verify whereabouts leveraging existing CIDRZ community tracing platforms in Lusaka. At the next time 
a survey assessment is done at the site, and before the clinic is switched from control to intervention, 
the nested cohort participants will be re-assessed by the team. 
 
Study follow-up procedures will be designed so as not to disrupt routine care delivery and will include: 
determination of retention in integrated HIV/NCD care and referral for routinely available adherence and 
psychosocial counselling and back-to-care services, as appropriate; lab monitoring for cardio-metabolic 
NCDs (see laboratory procedures below) if not already done by the government health workers during 
their routine health visits; brief survey administration to assess adherence, nutritional status, tobacco 
and alcohol use, and other NCD-related health parameters; and completion of the quality of life and 
DCE questionnaires. 
 
e.  Data collection plan and tools  
i. 
Data collection overview 
As in specific objective #1, data collection activities for specific objective #2 will involve a combination 
of NHSR and implementation research activities detailed below. 
 
ii. 
Non-human subjects research activities 
Two NHSR activities will take place under specific objective #2. The first will be structured observations 
of TASKPEN implementation at two pilot sites once the intervention reaches steady state. For 
structured observations, a study observer(s) will introduce themselves and the study to all lay and 
professional healthcare providers, treatment supporters, and other MOH staff in the relevant ART clinic, 
pharmacy, or other service delivery setting where HIV/NCD services are being provided. Observers will 
then position themselves in an unobtrusive location within that setting in preparation for starting the 
observation and will take field notes using a structured observation guide. 
 
The second NHSR data collection activity will involve a costing exercise. The costing work will focus on 
identifying the full range of costs involved in delivering integrated HIV/ NCD care. At the two pilot health 
facilities, we will collect data through a mix of reviewing patient and administrative records, as well as 
conducting pilot costing surveys involving ~10 MOH staff as informants. No demographic or health 
information will be collected directly from informants. Informants will be identified based on their 
knowledge of managerial and administrative issues at MOH and will be contacted by phone, email, or 
in-person by one of the co-investigators or study staff. Patient charts and administrative records will be 
reviewed for the purpose of identifying input data necessary for costing in those records. The data 
gathered will inform the design, adaptation and implementation plan of the full costing module for the 
follow-on larger study. 
We will start our costing data collection activities by reviewing relevant local and regional literature on 
input and price data using the following sources for service delivery costs: 
1. Unit costs for service delivery (cost per visit and admission) 
2. Unit costs for diagnostic tests (blood test, radiography test, etc.) 
3. Prices of all inputs, including salaries, allowances, per diem, medicine process, prices of medical 
supplies, etc. 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 32 
We will then review patient charts (electronic and paper) at the two pilot sites to ascertain patient 
service use, frequency of visits, treatment protocols implemented for each patient, and to facilitate 
determination of associated costs including staff costs, costs of medications, diagnostic tests, and other 
costs. No identifying patient information will be collected. We will also extract cost data from routinely 
available MOH and project administrative records to examine the following: 
1. Determine the availability and quality of cost input data in order to inform design of instruments for 
the future larger evaluation. 
2. The material inputs and costs utilized in implementation of the TASKPEN intervention. 
3. The proportion of human resource requiring training to perform the various TASKPEN intervention 
components. 
Finally, we will administer our pilot costing survey. The survey data to be collected include: 
1. What components of NCD services are offered at facilities 
2. Human resources required and/or available to deliver NCD treatment and care services, and 
training requirements or gaps 
3. Determine distribution of overheads across various centres through interviews 
4. Salaries of all cadres of staff 
5. Time spent by patients waiting, preparing for, or receiving integrated HIV/NCD services 
6. Time spent  by health care workers preparing for, and directly providing health services to, patients 
7. Administrative cost data 
 
iii. 
Quantitative research data collection 
At both sites, during a ~1-month “run in period,” we will establish basic study infrastructure to enable 
quantitative data collection during the patient surveys. This will involve fully equipping study offices at 
the sites and ensuring information technology connectivity and available computer hardware. Then, 
study staff will begin data collection on cardio-metabolic and implementation outcomes of interest using 
three cross-sectional patient surveys. The first two surveys (at baseline [0 months] and midline [3 
months] will be done immediately prior to a site switching to the intervention; a final survey will be done 
at 6 months and serve as the “endline” assessment. The surveys will ask questions about participant 
socio-demographics, HIV and cardio-metabolic NCD history, and health behaviours. It will involve 
trained study staff administering a tablet-based questionnaire to participants, as well as taking 
participants’ anthropomorphic measurements (e.g., height, weight, and waste circumference), vital 
signs (e.g., pulse and blood pressure), and a small blood sample to measure random/ fasting blood 
glucose, haemoglobin A1c, cholesterol levels, and other biomarkers. These laboratory tests will follow 
MOH recommendations and may include new point-of-care diagnostic technologies (see laboratory 
procedures section), and the results will be reported to patients and the clinic for clinical management. 
Any participant found to have newly diagnosed hypertension, diabetes/ pre-diabetes, and/or 
dyslipidaemia will be linked to care at the study sites. In addition, the study QA/QC nurse and study 
clinical scientist/ doctor will be available to act immediately on any vital sign or laboratory abnormality, 
including to offer patient counselling, provide warm “handoffs” to clinical staff, refer patients for acute 
care at the study sites, and prescribe appropriate outpatient treatment for non-acute issues in cases 
where MOH staff are not available (e.g., after business hours). Finally, we will ask participants to 
provide a phone number so we can invite those identified with hypertension, diabetes/ pre-diabetes, 
and/or dyslipidaemia through the survey to be followed in the nested cohort.  
For nested cohort participants, study staff will ask them to provide locator information and to complete 
the midline and endline surveys (shortly after their routine HIV care visits) as part of their ~4 scheduled 
study follow up visits. Similar handling of abnormal vitals signs and lab testing values will be offered to 
nested cohort participants as patient survey participants. In addition, we will administer the brief 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 33 
WHOQOL-HIV-BREF-Zam instrument and the discrete choice experiment questionnaire one time each 
during one of their ~4 follow up visits. Cohort enrolment will stop when the target number is reached. 
Finally, we will review cohort participants’ HIV and NCD clinical data using a minimally sufficient set of 
identifying variables (i.e. first name, surname, date of birth, and SmartCare ART number) to follow them 
longitudinally in the routine medical record. To this end, we will abstract data from existing paper-based 
patient charts and MOH registers, as well as the electronic SmartCare EMR and LMIS systems to: 1) 
assess HIV and NCD outcomes (e.g., viral load); 2) evaluate WHO PEN outcome indicators of interest 
(e.g. proportion of PLHIV routinely screened for hypertension); and 3) monitor for efficient collection of 
routine data, including routine laboratory test results (e.g. viral load).  
Under routine program conditions, and as a part of standard monitoring & evaluation (M&E), CIDRZ 
and MOH staff manually collect data from clinical and program registers and other paper-based routine 
records available in departments providing HIV, NCD, and other health services. These departments 
include the out-patient department (OPD) where some NCD services (such as hypertension 
management) are provided, the ART clinic and Differentiated Service Delivery Centres (where ART and 
HIV care is provided), and the laboratory department, among others. Paper-based records stored in 
these departments contain identifying information, including names, dates of birth, and addresses, and, 
as such, are maintained in locked rooms per MOH standard operating procedures. Trained and 
experienced study staff will confidentially handle these paper-based records following MOH standard 
operating procedures and will ensure they do not leave the secure locations where they are stored and 
are only accessible to authorized study and facility staff during working hours. For the purposes of this 
protocol, study staff will abstract existing health information from these routine paper-based data 
sources, including height, weight, ART start date, viral load sample collection data and results, among 
others, and enter them into a secure, password-protected database in REDCap, eClinical or similar 
web-based system stored securely on the encrypted CIDRZ server. Authorized study staff will also 
extract patient-level electronic data from existing electronic SmartCare and LIMS records already 
housed on the CIDRZ network at the CIDRZ Head Office into the secure, password-protected, web-
based database. The database will be backed up automatically at regular intervals (i.e. at least once 
weekly) onto an encrypted password-protected CIDRZ back-up server for data security purposes. 
Whenever possible, electronic SmartCare and LIMS data will be linked at facility-level with data 
abstracted from paper-based records using the SmartCare ART number.  
For nested cohort participants, we will supplement the aforementioned routinely collected data with 
study-specific data collected through survey and CRF administration to assess medication adherence, 
quality of life, nutritional status, tobacco and alcohol use, and other NCD-related health parameters. 
The WHOQOL-HIV-BREF-Zam (Appendix G) will be administered in Nyanja or Bemba to nested cohort 
participants at our pilot sites to investigate the ability of the instrument items to discriminate between 
those with and without active symptoms related to HIV and co-morbid NCDs, as determined by 
differences in mean scores. A p-value less than 0.05 will be considered significant; items with non-
significant differences between the two groups may be removed from a future iteration of the 
instrument.  
 
All DCE questionnaires will be conducted one-on-one in private by a trained interviewer with consenting 
patient and provider participants. Each DCE will be explained verbally to participants. Each 
questionnaire is expected to last approximately 30 minutes. Before the DCE, the interviewer will 
conduct a brief review of each participant’s clinic file to confirm HIV status, ART regimen, most recent 
CD4 cell count, most recent viral load, and cardio-metabolic conditions. The DCE questionnaire will be 
developed in English and translated into Bemba and Nyanja and then translated back to English to 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 34 
validate the translation. The DCE questionnaire will be administered using the secure REDCap Mobile 
App on Android tablets, which can be used offline, and later uploaded to a secure database. The DCE 
starts with a simple vision and literacy test to ensure internal validity and facilitate quality control as 
sight is necessary for full comprehension of DCE choice tasks. The DCE then proceeds to provide an 
introduction of each attribute and its levels. Participants will be asked to rank the levels of each attribute 
based on their individual preferences. Each participant will receive 8-10 choice tasks on the tablet, and 
will be asked to choose between three hypothetical HIV/NCD integrated service delivery programs/ 
scenarios with different levels of attributes per choice task. 
 
iv. 
Qualitative and mixed methods data collection 
We anticipate needing to complete the following number of qualitative data collection activities (Table 5, 
below) with the following number of participants: 1) For IDIs, ~20 cohort participants will be interviewed 
to explore their experiences with both usual practice and TASKPEN (~10 IDIs per facility). These 
participants will be purposively selected to ensure balance in gender, age band, and NCD co-
morbidities; 2) For FGDs, ~4 total FGDs (or ~2 FDG per site) involving ~4-8 non-physician health 
workers OR ~4-8 community health workers/ lay health providers per FGD following TASKPEN 
implementation (or ~16-32 total participants); and 3) For KIIs, interviews with ~10 key stakeholders will 
be performed, including ART and OPD clinic managers/ in-charges or designee and policy makers at 
provincial and national MOH levels, selected purposively based on their  involvement and familiarity 
with TASKPEN implementation and/or the NCD policy setting in Zambia. For all the above-mentioned 
qualitative data collection activities, we will adapt the semi-structured tools from specific objective #1 
based on the CFIR and formative research findings from that objective to create the tools for specific 
objective #2.  Finally, we will administer the same implementation survey used in objective #1 (with the 
addition of a clinical sustainability assessment) to FGD participants to assess measures of 
acceptability, appropriateness, feasibility, and sustainability. We anticipate conducting qualitative and 
mixed methods data assessment after both sites are exposed to the TASKPEN intervention in the mini 
stepped wedge pilot. 
IDIs, KIIs, and FGDs will be tape-recorded with participant permission for subsequent transcription. An 
interviewer/ facilitator will guide the IDIs, KIIs, and FGDs, and a note-taker will document non-verbal 
cues and main points. The note-taker will also take notes to ensure no loss of information in the event 
of a technological failure and to provide contextual information. For FGD and KII participants, basic 
demographic background information about each respondent (such as title/role, age, gender, and 
education level) will be audio-recorded at the start of the FGD or KII, but no responses will be traced to 
specific individuals during analysis and reporting. At the end of all completed IDIs, KIIs, and FGDs, 
study staff will review all recordings to ensure they are audible and all notes for legible handwriting. 
Ambiguous information from interviews or FGDs will be clarified with the source. As far as practical, the 
field team will transcribe audio-recordings, with support from other qualitative data analysts and coders. 
Interviewers/facilitators will read the transcripts for completeness and fill in gaps using their interview 
and field notes. Transcribed interviews will be stored in password-protected files.  
Table 5. Summary of mixed methods data collection activities for completing Specific Objective #2. 
Method 
Activity Ty Number 
Total Particip Approxim
Time for
activity 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 35 
Structured Observat Non-human s
research 
~2 observations—1 at each site included in the “mini” 
wedge trial 
0 (Non-participato1–2 hours  
Costing survey 
Non-human s
research 
Reviewing administrative records with assistance o
informants 
0 (Non-participato~1 hour 
Focus group 
discussions 
Research 
~2 FGDs total— ~1 FGD with NPHW at each site 
~8 – 16 
~2 hours 
Research  
~2 FGDs total with CHWs/lay health providers – ~1 FGD
each site 
~8 – 16 
~2 hours 
 
Research 
Brief implementation survey done with all FGD participants 
FGD 
~16 – 32 
~15 minutes
In-depth interviews Research 
~20 total from among nested cohort participants— ~10 per s~20 
~1 hour 
Key informant interv Research  
~5 - 10 in each pilot site with key stakeholders 
~10-20 
~1 hour 
WHOQOL-HIV-BRE
survey  
Research 
~200 nested cohort participants (~100 per pilot site from
cohort) 
~200 
~30 minutes
Discrete Choice Ex
(DCE) survey 
Research 
~200 nested cohort participants 
~200 
~30 minutes
 
v. 
Study instruments, questionnaires, lab instruments, and analytic tests 
Data collection tools and instruments are included in the Appendix.  All patient surveys and cohort 
questionnaires will be programmed in REDCap and will be administered by trained study staff directly 
to participants using encrypted, pass-word protected tablets. The same patient survey instrument will 
be administered at baseline, midline, and endline.  
For the DCE, we will develop a questionnaire for patients to elicit their unique preferences for integrated 
HIV and NCD services. Questionnaires will contain a brief section on demographic information 
including age, gender, education level, and average monthly income. DCEs will ask participants to 
choose from among three scenarios of HIV and NCD integrated service provision. Each scenario will 
have a set of attributes that are varied across 2 to 4 levels. The attributes and levels will be developed 
and refined based on the results of formative data collected under Objective #1 (above). For the DCE 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 36 
questionnaire, the following attributes and levels for delivering integrated services will be explored, with 
modifications to be made based on the final results of qualitative analyses under Objective #1: 
1. 
Type of clinical venue  
a. 
Integrated ART Clinic 
b. 
Integrated Outpatient Department 
c. 
Dedicated “Chronic Care Clinic” 
2. 
Type of clinical provider 
a. 
Clinical officer 
b. 
Nurse 
c. 
Lay health worker 
3. 
Type of visit frequency 
a. 
Monthly  
b. 
Every 3 months 
c. 
Every 6 months 
4. 
Type of community psychosocial support 
a. 
Community adherence/ support groups 
b. 
Community health worker/ peer navigator visits 
 
 The DCE survey will be developed with Ngene software using a fractional factorial, balanced and 
orthogonal design. The balanced design indicates that each level per attribute appears for the same 
number of times across the choice tasks, while the orthogonal design indicates that each pair of levels 
appears equally often across all pairs of attributes in the survey.  
Structured observation guides and costing surveys will not be used for research purposes and will be 
developed in English for use by professional study staff only. 
All qualitative data collection activities for specific objective #2, will be adapted from the semi-structured 
tools used in specific objective #1 that are based on the CFIR and formative research findings from that 
objective. IDI guides, as well as the WHOQOL-HIV-BREF-Zam, will be developed in English and 
translated into Bemba and Nyanja, the two other languages that are commonly spoken in Lusaka. FGD 
and KII guides will be developed and administered in English since these participants speak and write 
fluently in English, which is the official language of health training in Zambia.  IDI, FGD and KII guides 
may undergo minor adaptation over the life of the study to optimize participant comprehension and 
thematic elicitation, and to minimize any risk of psychosocial distress posed by the wording of questions 
and probes. Audio recording will also be used with the consent of participants. Verbatim transcripts will 
be transcribed and translated into English (as needed). Field guides will be piloted before data 
collection begins, and the tools will be further refined to improve their clarity, completeness, overall 
usability. Electronic devices used for data collection will be password-protected, with access restricted 
to authorized and trained study staff only. For sharing and analysis purposes, individual identifying 
information will be removed and where necessary, codes will be used. Standard operating procedures 
will be developed to guide and inform the usage of the developed tools. 
At the conclusion of each FGD, we will administer an implementation survey incorporating three 
empirically supported measures for the acceptability, feasibility, and appropriateness of the final 
TASKPEN intervention.98 Each measure contains 4 questions (i.e., 12 total) that are scored on a Likert 
scale from 1 (completely disagree) to 5 (completely agree) that ask respondents to rate the TASKPEN 
intervention on the aforementioned implementation domains. We will also incorporate the Clinical 
Sustainability Assessment Tool, which contains 35 items on 1 (To little or no extent) to 7 (To a very 
great extent) Likert scale to assess perceived sustainability of the TASKPEN intervention.  

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 37 
vi. Laboratory procedures  
All patients receiving integrated HIV/NCD care at the pilot sites will receive standard laboratory tests 
free of charge as part of MOH-recommended routine care. This includes viral load, serum creatinine, 
full blood count, ALT/SGPT, Hepatitis B Surface Ag, CD4 count, urine pregnancy test, rapid syphilis 
testing, and random plasma glucose. The current MOH-guidelines also recommend testing total 
cholesterol and triglycerides in PLHIV and haemoglobin A1c in PLHIV with suspected or known 
diabetes. However, because of resource limitations and limited laboratory infrastructure, these latter 
cardio-metabolic tests are not typically available under usual practice. As such, as part of the patient 
surveys conducted at baseline, midline, and endline at study sites, trained study staff will directly test all 
PLHIV who enrol in the survey for random/ fasting glucose, haemoglobin A1c, and total cholesterol, low 
density lipoprotein (LDL), and high-density lipoprotein (HDL). To conduct this testing, we will equip each 
site with capacity to measure glycosylated haemoglobin A1c (HgbA1c), low density lipoprotein (LDL), 
high-density lipoprotein (HDL), total cholesterol, and/or urine albumin to creatinine ratio. For testing 
through the survey of haemoglobin A1c, low density lipoprotein (LDL), high-density lipoprotein (HDL), 
and total cholesterol, we will collection blood, which will be no more than ~5-10 mL. If possible and 
feasible, a point-of-care (POC) platform (e.g., Afinion™ 2 multi-assay analyser) will be used to ensure 
more rapid result reporting. In this case, the volume of the blood draw will be less at approximately 3 
drops of whole blood (about 20 microL). For urine, 1 mL is required for testing. Results of all testing 
done through the study will be given to participants and healthcare providers for clinical management 
and recorded in study and routine medical records to enable pilot outcome ascertainment. 
vii. 
Outcomes  
Outcomes measurement 
The primary measures for the pilot are adoption, acceptability, feasibility, appropriateness, as well as 
the preliminary effect of the TASKPEN intervention. We will assess implementation outcomes 
principally using a handful of theoretical frameworks. A brief questionnaire will be administered that will 
feature the simple 12-item implementation survey (incorporating empirically supported measures for 
acceptability, feasibility, and appropriateness) mentioned above, among other implementation-relevant 
items98. We will further examine acceptability in our qualitative data as a construct comprising multiple 
dimensions99. We will include open-ended questions guided by established implementation science 
frameworks such as the CFIR to elaborate on what makes the intervention appropriate or not and 
acceptable or not. We will further evaluate feasibility in our qualitative data by applying the theoretical 
basis of ‘‘compatibility’’ from Rogers’ “Diffusion of Innovation” theory, among other theories100.  
We will describe implementation outcomes of adoption and reach according to RE-AIM. We will also 
calculate retention as the proportion of participants enrolled in the nested cohort and considered to be 
engaged in care at ~6 months. We will measure adherence in the nested cohort by reviewing 
pharmacy records at ~6 months to determine consistent access to anti-hypertensive, diabetes, and 
dyslipidaemia medications, as appropriate, as well as antiretroviral therapy. For the patient surveys, we 
will ask participants about adherence and review pharmacy records to examine medication adherence 
overall at the study sites.  
Finally, we will pilot the feasibility, applicability, and completeness of the following measures in the 
cross-sectional assessments and nested cohort for adoption in the future follow-on trial: 
1. 
Dual HIV and NCD disease control, defined as: 
a. 
HIV RNA level of <200 copies per milliliter on the most recent measure; AND 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 38 
b. 
The absence of the following NCD conditions as defined by the nested cohort eligibility criteria: 
1) uncontrolled systolic hypertension; 2) uncontrolled diabetes mellitus; and 3) uncontrolled 
dyslipidaemia. 
2. 
10-year ASCVD risk score (based on American College of Cardiology/ American Heart Society 
guidelines) 
3. 
The HIV-specific D.A.D. CVD risk score: (The Data-collection on Adverse Effects of Anti-HIV 
Drugs) score.  
4. 
Quality of life as measured by WHOQOL-HIV-BREF 101. 
5. 
Number and % of patients with HIV RNA suppression (defined as <1,000 copies/ml) 
6. 
Number and % of patients who are currently smoking (defined as smoking of any tobacco 
product in the last 30 days) 
7. 
Number and % of patients with normal systolic blood pressure (<140 mmHg) among persons 
with HTN 
8. 
Number and % of patients with stage III hypertension (i.e., BP >180/110) among persons with 
HTN 
9. 
Number and % of patients with normal fasting blood sugar among persons with DM  
10. 
Number and % of patients with haemoglobin A1c <7% among persons with DM 
 
 
 
Implementation outcomes measurement 
We will evaluate implementation outcomes as defined by Proctor, Silmere,28 adapting CFIR constructs 
as described by Warner G et al29 and Damschroder and Lowery 102, and using the RE-AIM framework. 
 
Table 6. Primary implementation outcomes. 
Implementation outDescription 
Theoretical BMeasurement 
Time points 
(Months) 
Reach  
No. of people and 
percentage of the target 
population affected and the 
extent to which the 
individuals reached are 
representative and include 
those most at risk for NCD-
related poor outcomes/ 
complications. 
RE-AIM 
% of PLHIV with HTN who are 
recruited and receive/participate in 
intervention at ~6 months; 
 
~6 months 
Appropriateness 
The 
extent 
to 
which 
p
interventions can be deliv
health facilities 
Theory of Diffus Individual interviews, Focus group dis
Key informant interviews. 
We also use measures of appropriate
Weiner, Lewis 98; WHO PEN Health
Assessment questionnaire 
~6 months 
Perceived fit, relevan
compatibility 
of 
TAS
among providers and 
and/or 
perceived 
Proctor et al. 
2011; Weiner 
et al., 2017 
Intervention Appropriateness M
(IAM) 
~6 months  

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 39 
TASKPEN to the lack o
integration 
Referrals for task sharing/ sh  
Administrative records 
~6 months  
Acceptability 
User and provider feedback CFIR 
IDIs, Focus group discussions guid
informants 
~6 months  
Extent 
to 
implementation stakeh
perceive TASKPEN 
agreeable, 
palatable
satisfactory  
Proctor et al
Weiner et al.,
Acceptability Implementation Measure ( ~6 months  
Adoption 
No. and percentage of 
participating, and the extent 
the 
settings 
selected
representative of settings 
target population will use or v
CFIR; 
RE-AIM 
Focus group discussions and Key in
interviews of implementation challeng
barriers; 
% of facilities and providers that 
intervention at ~6 months  
~6 months  
Feasibility 
Extent to which the TAS
intervention 
can 
successfully used or 
out within a practice set
CFIR, ISF; Wein
2017 
Data 
extraction 
checklist 
(Daily 
conducted 
related 
to 
the 
e
interventions e.g. counselling, no. of
profiled, followed up, etc.); 
Feasibility of Intervention M
(FIM) 
~6 months  
Fidelity 
The extent to which provid
delivering TASKPEN packag
the protocol/guidelines 
CFIR 
 
Structured 
observations 
of 
NPHW
community health activities during cons
with clients 
~6 months  
Cost 
Resources, inputs, and H
necessary to implement TA
pilot 
 
Administrative surveys 
~6 months 
 
viii. 
Training for all study personnel  
All study staff will be certified in human subjects’ protection and trained on data abstraction/collection 
and qualitative research procedures, including for FGDs, IDIs and KIIs. This training will include 
methods for the informed consent process, stressing the importance of participant privacy and 
confidentiality, voluntary participation, and risk mitigation. Intensive training sessions will use a mixture 
of methods, both didactic and case-based, including lectures, case-based learning and practice with 
field guides and data abstraction tools. All involved personnel will be trained to respect persons, 
participants’ organization cultures and regulations from initial contact to dissemination. Respect for 
persons and organizations, which constitutes the need to respect persons and their privacy, will be 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 40 
emphasized in Standard Operating Procedures. All study personnel will also be required to sign a 
confidentiality agreement to further promote protection of participants’ data. 
Patient chart, registers, LIMS and SmartCare reviews are part of routine patient monitoring systems. 
Study staff will be trained on research ethics and management before data is abstracted from patient 
charts, records or registers. They will assure confidentiality and privacy of data processed in this study. 
All hard copy and electronic records will be kept in a secured and locked area. All electronic data 
collection devices and computers storing study data will be encrypted and password protected and 
access restricted to authorized study staff only.  
The study clinical scientist/ doctor, QA/QC nurse, and research assistants will be trained on sterile, 
safe, and proper finger pricking for the purposes of checking random/ fasting glucose during patient 
surveys. We will also train these research staff on operations of the point-of-care Afinion™ 2 multi-
assay analyser platform and performing finger pricks to load a few drops of blood (~20 micoL) into the 
platform’s testing cartridges.  
All study staff, including study clinicians and mentors, interviewers, facilitators and note-takers will be 
trained on recruitment, consenting processes, enrolment and the conduct of their duties. In addition, 
qualitative research will be trained on how to set up rooms to ensure a non-coercive atmosphere 
conducive to dialogue and discussion, use of digital recorders, note-taking techniques and techniques 
for eliciting participant response. They will be trained on writing field notes and in managing, 
transcribing and analysing data. Finally, interviewers and facilitators will receive basic training on how 
to actively refer back to care those participants wishing to re-engage in care, including who to contact at 
the relevant facilities to arrange follow-up and how to document such interactions. 
f. Data management and storage  
i. 
Information management and analysis software  
Under current programmatic conditions already in place at the study sites, SmartCare EMR data, which 
includes routinely collected patient identifying and health information, are stored in secure Microsoft 
SQL Server databases at each facility and merged into a central server located at CIDRZ head office in 
Lusaka at least once monthly, but often weekly, depending on the patient volume at the facility.  
ii. 
Data entry, editing and management, including handling of data collection forms, 
different versions of data, and data storage, security, and disposition  
For the patient surveys and nested cohort, study-specific data will be entered by study staff onto secure 
REDCap study forms using the REDCap application and encrypted, password-protected study tablets. 
REDCap has built in data logic and security functionalities to ensure high quality data collection.  
For the purposes of routine data review, SmartCare and LIMS EMR data will be abstracted and merged 
with information from study-specific CRFs/ surveys and facility paper-based registers and records, such 
as NCD laboratory result registers and routine program viral load and anthropomorphic data available 
at the study sites. The above data will then be merged to create a final, comprehensive, and secure 
database in REDCap or similar system. Data in the pilot database will be organized by study number 
assigned to each participant that will then serve as the lone and overarching study identifier. The study 
number will be formatted similar to the following CIDRZ approach: SC—XXXXX—CD with “SC” serving 
as the 2-digit site code, “XXXXX” the participant number, and “CD” representing the 2-digit check digit. 
Immediately upon exportation of data from the database to create the analytical dataset, all patient 
identifying information will be purged from all records for the purposes of protecting patient 
confidentiality. We will accomplish this by programming code to automatically drop all variables that 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 41 
include identifying information from the analytical dataset and recoding all identifying information in the 
final database to “0” or missing value. 
The DCE for each participants will be identified by the aforementioned study ID. REDCap is specifically 
geared to support online or offline data capture for research studies and operations. After returning to 
the study office, study staff will upload DCE data from the REDCap Mobile App to a secure server 
(likely the REDCap server). The DCE data will then be merged into the study database using the 
REDCap API via a secure, encrypted transmission (SSL/HTTPS).  
The final study database comprised of study-specific data and abstracted routine data for all study sites 
will be stored on a secure, encrypted SQL server and will be updated with new data at least once 
weekly. The final database will be backed up daily onto a secure study account housed on a separate, 
encrypted CIDRZ server. To ensure data security and integrity, the database will be programmed to 
automatically back up daily to One Drive without user prompting. We will conduct regular database 
queries of extreme and missing values. Quality assurance and quality control procedures will be in 
place throughout the project, with regular assessment of missing or inconsistent records. The analytical 
dataset will be created as a comma-separated variable file or stored as one of the available analysis 
software package formats, including SAS, Stata or R.  The analytical dataset will be encrypted and 
password protected at all times for analysis purposes. Quantitative analyses will be performed using 
Stata (Statacorp LLC, College Station, TX) or other comparable statistical software.  
For qualitative data specifically, digital audio-files will be transferred to password-protected, encrypted 
study computers accessible only to trained study staff responsible for transcription. All transcriptions will 
be done in one translation and transcription step. Microsoft word will be used to create transcripts and 
Nvivo QSR™ (or comparable qualitative analytical software) will be used to manage documents and 
code sets for complex qualitative data derived from structured observation notes and IDI, FGD, and KII 
transcripts. All transcripts and research memos (from structured observations) will be stripped of any 
and all identifying information and will be saved as password-protected files on an encrypted CIDRZ 
One Drive account housed on the secure CIDRZ local area network. After completion of transcription 
and validation, all electronic audio-files will be immediately destroyed. Transcripts and research memos 
will be backed up daily and automatically to a separate location on an encrypted CIDRZ server to 
ensure data security and integrity. 
Any study-specific paper forms, such as demographic forms, will be stored securely at study sites in 
locked filing cabinets in a locked room identified in coordination with the MOH department or overall in-
charge. In all cases of study-specific form management, personal identifying information and study data 
collected during the course of IDIs, KIIs, FGDs, or structured observations will be stored separately and 
will only be linkable through the use of a link log kept in a separate, secure location. 
At study closeout, evaluation data will be stored/ archived until at least the final analysis and reporting 
on the project are complete.  CIDRZ will follow the recommendations of the Zambia MOH for archiving 
of all hard copy and electronic records (tentatively for 3 years after the completion of the analysis), as 
well as for the method of eventual destruction of data including the shredding of any original paper-
based information and systematic deletion of original data files from CIDRZ’s servers. CIDRZ will defer 
to Zambia MOH guidance on the handling and management of all data to be used as part of this 
evaluation protocol. The MPIs will be ultimately responsible for all data security issues. All data will be 
stored per National Health Research Authority, UNC IRB, and University of Zambia Biomedical 
Research Ethics Committee guidelines and guidance.   

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 42 
iii. 
Quality control/ assurance 
As a part of routine monitoring activities, data audits are performed to verify the quality of routine 
clinical, laboratory, and pharmacy data collected at CIDRZ-support facilities, including the facilities 
included for this study. CIDRZ conducts data quality monitoring activities at specific times (daily, 
weekly, monthly, quarterly, semi-annually and annually). Data quality audits (DQA) are conducted with 
reference to standard SOPs. Sites are sampled in the following fashion: (i) randomly, when conducting 
routine audits; (ii) targeted (objectively), when poor performance is observed; and (iii) purposively, 
when data manipulation is suspected. Lay Counsellors assist in manual checks of patient records 
during DQAs. Data Associates primarily enter data into SmartCare from patient charts, ensure data 
completeness, and run facility-level performance reports. Data Coordinators run validation checks, 
compare indicator cascades, ensure that data associates follow the laid down standard operating 
procedures, run data aggregations and proactively identify potentially missing data. M&E Coordinators 
analyse data submitted and participate in Facility and District Data Review meetings. Data Managers 
develop data collections tools and provide first-level data quality analysis of aggregated data. The M&E 
Manager coordinates SIMS and feedback to program teams (data reviews). Additionally, through its 
PEPFAR-funded projects, CIDRZ provides facility-level mentorship to health workers and supports 
collaborative quality improvement (CQI) activities.  
For quantitative and mixed methods study activities, we will leverage the aforementioned data QC 
systems to ensure accurate and efficient data collection. The study SmartCare Developer, will run 
aggregate reports on the percentage of patients at study sites with missing vital signs, 
anthropomorphic, and laboratory data and feed this back to the site. The study Data Manager will run 
data logic, completeness, and consistency checks on data in the study database using programmed 
REDCap functionalities and feedback QC queries to the study sites for clarification and resolution. 
For qualitative data, final qualitative transcripts will be reviewed for accuracy against original notes and 
recordings, for at least 5% of the transcripts. Any errors will be corrected by the person who conducted 
the interview using good clinical practice (GCP) correction procedures. Monitoring visits will be 
conducted on an ad hoc basis to ensure that data collection is being done well.  Any retraining will be 
done on-site on an as-needed basis, to ensure that collected data are of high quality. 
iv. 
Data ownership, sharing and governance 
All study data will be owned by the Zambia Ministry of Health (MOH) as the stewards of the national 
HIV program. As the owners of the data, the Zambia MOH will ultimately be responsible for oversight of 
all data governance issues. Qualitative data will not be shared due to the small sample size involved 
and the potential for deduction. All decisions regarding data dissemination, for example at the request 
of a journal at the time of publication, will be made by the Zambia MOH as the owners of the data. 
 
g. Data analysis   
i. 
Quantitative data analysis 
We will summarize background characteristics (for participants and facility) by the intervention periods 
(control, intervention). The preliminary effect of the TASKPEN intervention will be estimated by 
comparisons of the percentage of participants in the patient surveys with dual HIV/NCD control during 
the control period and the intervention period. We will also calculate CVD risk score based on the 
ASCVD, D.A.D, or similar and compare this outcome between the control and intervention periods. 
Binary outcomes will be analysed using generalized linear mixed logistic model with margins to 
estimate risk ratio and risk difference adjusted for key potential confounders. Health facilities will be 
specified as random effects while time will be specified as fixed effect in the model. Continuous 
outcomes will be analysed using linear models to estimate mean score difference in an analogous way. 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 43 
Quality of life score will be analysed in a similar way. P-values less than 0.05 will be considered 
statistically significant. We do not plan to impute missing values. All analyses will be performed using 
Stata 16 MP4 (StataCorp, College Station, TX, USA).  
Using baseline, midline, and endline patient survey data and routine EMR data, we will assess the 
implementation outcomes described in Table 6. We will calculate standardized scores for validated 
instruments in our implementation survey. Comparisons of proportions for the aforementioned 
implementation outcomes will be done by calculating prevalence ratios and associated 95% confidence 
intervals as appropriate. Comparisons of continuous outcomes will be done by the Z-test/ 2-sample T-
test or the Wilcoxon Rank-Sum test as appropriate.  
To understand patient-level outcome measures of disease control, retention, adherence, and viral 
suppression, we will analyse data from the patient surveys. We will estimate dual disease control as 
the proportion of participants in the intervention and control periods who have a HIV viral load <200 
copies/ml and do not have uncontrolled systolic hypertension, diabetes,  and/or dyslipidaemia. We will 
calculate retention as the proportion of participants considered to be consistently engaged in care at 6 
months according to the national HIV treatment program definition (e.g., without evidence of death, 
default, or loss to follow up defined as ≥30 days having elapsed since a missed pharmacy refill/ clinic 
visit). We will measure adherence in the nested cohort by reviewing pharmacy records at 6 months to 
calculate the medication possession ratio (MPR) over that time frame for anti-hypertensive, diabetes, 
and dyslipidaemia medications, as well as antiretroviral therapy. We will calculate viral suppression as 
the proportion of survey participants meeting established thresholds of suppression (e.g., viral load 
<1,000 copies/ml or <200 copies/ml) at 6 months following ART initiation and/or study enrolment. To 
compare outcome measures, we will report differences and ratios with accompanying 95% confidence 
intervals. We will compute variance for differences and ratios using the sandwich variance estimator or 
appropriate resampling approaches to account for the clustered nature of the data by site.  
We will leverage the rich data from the nested cohort on cardiometabolic outcomes and covariates to 
make more accurate inferences about the distributions of these outcomes, and their trends over time, 
among all survey participants, as well as the target population of all PLHIV routinely in care at the study 
sites. Specifically, we will use outcomes measured in the nested cohort to account for measurement 
error (e.g., failure to capture a NCD diagnosis) or missing data (e.g., no record of a component of a 
given risk score) in the survey data and routinely collected medical record data. Rather than simply 
excluding records with missing data, considering those without a recorded diagnosis or biomarker value 
to be “outcome free,” or using potentially mismeasured versions of the outcomes, we will address both 
measurement error and missing data  using imputation approaches. These approaches fit models for 
the outcome of interest conditional on covariates among the nested cohort and use results to predict 
outcomes in the study population (i.e., survey participants) and the target population (i.e., all PLHIV in 
care at the study sites). We will report results from the nested cohort alone and after the imputation 
described above. To better understand the ability of the SmartCare EMR to capture routine NCD 
covariats and outcomes over time, we will also report the sensitivity and specificity of various measures 
obtained using the routine data only (assessed using data from the nested cohort as the gold standard) 
and the distribution of study-collected outcomes in the nested cohort among those with missing routine 
measurements. 
DCE analysis: DCE questionnaire results will be analyzed by the mixed-effects logit model, which is 
commonly used to analyze DCE data and identify potential preference heterogeneity by the patients’ 
key characteristics. The mixed-effects logit model calculates the relative mean preference weights per 
attribute. We will compare models with different random parameters using the Akaike information 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 44 
criterion (AIC), Bayesian information criterion (BIC), and likelihood ratio tests for goodness-fit-test and 
select the final model. 
 
Cost analysis: A micro-costing approach will be conducted from a provider perspective. The costing 
analysis will include the following items: (i) Staff and patient time in clinical settings, (ii) medical supplies 
and nonmedical consumables per procedure, (iii) type and number of laboratory and other medical 
investigations, (iv) capital allowance (equipment and buildings) overheads, and (v) administration 
(including management, M&E). In terms of calculating costs, for staff costs, data from interviews and 
structured questionnaires will be used to estimate average time input per consultation or procedure 
type per staff cadre will be used. Appropriate salary data will be used to calculate staff cost for each 
procedure or intervention. Personnel costs will be drawn from public sector salary scales. Staff time for 
non-clinical work such as administration, management, M&E shall be calculated using time allocation 
and staff salaries. Drugs and medical costs shall be based on prescriptions filled out and prices. 
Names, dosages and quantities of drugs prescribed will be multiplied by respective unit prices to obtain 
costs of the drug regimen. Where applicable, cost per laboratory test or other diagnostic test and 
number of tests will be used to calculate the costs of medical investigations for each case. Secondary 
data on cost per test will also be used where possible. For equipment and buildings, the share of cases 
in total patient volumes per year will be used. We shall apply standard recommendations on 
annualization of capital costs in order to obtain the equivalent annual cost using a discount rate of 3% 
and depreciation periods of 3-5 years for equipment and 30 years for buildings/ construction. All cost 
items will be aggregated into total costs. Using the outcomes estimated in the study, the average cost 
per case will be calculated for each intervention and the standard of care.   
 
ii. 
Qualitative data analysis 
We will use content analysis with a deductive directed approach guided by the CFIR and other 
implementation science frameworks to code, analyse, and interpret our data104. Nvivo (QSR 
International, Melbourne, Australia, version 12) will be used to support data management, coding and 
analysis. The first step in the analysis, after reading all transcripts, will be to develop initial coding 
nodes and sub nodes based on the domains and constructs of the CFIR framework, Proctor et al. 
implementation outcomes,28 and possibly other frameworks104. In the second step, units of analysis, 
such as sentences or longer semantic units, will be deductively coded into the nodes and sub nodes. 
Third, the coded text will then be subjected to a rating process based on the recommended method 
described by the authors of CFIR 102. A deliberated consensus process will be used to assign a rating to 
each construct obtained from TASKPEN. The ratings will reflect the valence (positive or negative 
influence) and the magnitude or strength of each construct that emerged in each Group based on the 
coded text. When all constructs are obtained from all groups, they will be rated, we will compare ratings 
for each construct across health facility and patient groups. We will use criteria described by CFIR 
developers and adapted by Gee, P.104 
The participation of one versus multiple coders in the qualitative analysis process will depend on the 
volume and complexity of the data. All audio-recordings from IDIs and FGDs will be translated and 
transcribed directly into English in one step (in Microsoft Word) incorporating expanded field notes. The 
note-taker fluent in all three languages will compare transcripts to audio-recordings and assess them 
for accuracy, completeness and compliance with formatting requirements. Any anomalies will be 
addressed by the interviewer or facilitator supported by field notes. Transcripts will be transformed into 
projects for coding in Nvivo QSR™, which will be used to sort and organise the data to enable 
Framework analysis and subsequent interpretation. A thematic framework will be developed for data 
analysis using both inductive reasoning based on emerging themes and deductive reasoning based on 
a priori themes to capture factors that facilitate and hinder linkage to care. For IDIs and FGDs, two 

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independent coders (interviewer and facilitator) will code two transcripts each to refine and validate the 
codes and then another three transcripts each to achieve consistency in coding. They will code the 
remaining transcripts independently. All qualitative data will be indexed by themes as well as cases 
(type of respondent, gender, urban/rural, district). The analysis team will also apply a modified 
grounded theory perspective and will note contradictions and points of convergence in analytic memos. 
Indexed data will be put into matrices embedded with Nvivo corresponding to the a priori program 
inquiries on facilitators and barriers, clearly identifying the source of the data. These matrices will help 
identify links between theme, patterns and inherent evidence in extracted quotes. Such mapping will 
provide explanations that are used to develop recommendations that reflect participants’ lived 
experiences, and perceived needs and preferences for linkage to care. Triangulation and use of 
multiple analysts will minimize bias in the qualitative inquiry.  
 
9. Ethical Considerations     
a. 
Overview 
As we propose to implement MOH-recommended HIV/NCD integrated services, the risks incurred with 
the study activities described herein are minimal. The principal risk involved is the possibility of an 
inadvertent disclosure of confidential patient health information, which could include HIV status, or a 
minimal risk of bruising or infection from blood draws that are no different than what is encountered in 
routine clinical practice. At all steps of the study, we will protect participant privacy and confidentiality to 
reduce this risk. 
This protocol will obtain ethical and regulatory approvals from the University of Zambia Biomedical 
Research Ethics Committee (UNZABREC) and the University of North Carolina Internal Review Board 
(UNC IRB).  The study team will also receive an approval letter from the Ministry of Health, National 
Health Research Authority.  All staff who have contact with participants will receive training on the 
protection of human research participants prior to participating in the study.  
b. 
Non-human subjects research activities 
A number of data collection activities do not involve direct interactions with participants and are not 
intended to generate generalizable knowledge, namely: health facility assessments/ structured 
observations, costing surveys, and theatre testing. Rather, these data collection activities are intended 
to refine the TASKPEN package or understand its implementation in a specific, local implementation 
context to inform routine healthcare services.  
For structured observations, since they seek to understand the scope and manner in which services are 
provided in a specific local context and no direct participant interactions or data collections will occur, 
we are seeking a non-human subjects research determination. Similarly, for costing surveys, since the 
goal is to collect information about the commodities, staffing, and other programmatic inputs into NCD 
care and services in the public sector, and no personal or otherwise identifying information will be 
sought or recorded, we are seeking a non-human subjects research determination. Finally, for theatre 
testing, since this seeks to collect information about the feasibility, acceptability, and appropriateness of 
modification of modules of the national SmartCare EMR, and no personal or otherwise identifying 
information will be sought or recorded from participants, we are seeking a non-human subjects 
research determination.  
c. 
Informed consent 
Discussions with prospective participants and informed consent procedures will be conducted in private 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 46 
to protect confidentiality.  Data collection team members will obtain written informed consent from all 
participants prior to completing research activities.  The procedures, risks, and benefits will be 
discussed and the research team swill answer all questions prior to obtaining consent.  Consent forms 
for patients (e.g., nested cohort and IDI participants) will be translated into the two most common local 
languages in Lusaka (Bemba, Chinyanja,) and back-translated into English to assure accurate 
translation.  All versions of the consent forms will be approved by the relevant ethics committees prior 
to study initiation.  For illiterate participants, a literate, impartial witness will be present during the entire 
consent process to ensure that all of the relevant information has been provided and the participant 
voluntarily gives consent.  A comprehension question checklist will be used for all informed consent 
discussions involving nested cohort participants to evaluate and document understanding of study 
procedures and risks and benefits. 
d. 
Confidentiality 
Measures will be taken to ensure safety of data and confidentiality of all our study participants.  The 
tablets together with audio tapes, field notes, and all other materials will be kept in a locked, fireproof 
safe cabinet at study clinics and CIDRZ headquarters. No participants nor health facility will be 
identified in any report or publication about this study.  However, for quality control and safety 
purposes, collected data may be reviewed by the sponsor of this study, the ethical and regulatory 
committees at the University of North Carolina at Chapel Hill or the University of Zambia.  Data will be 
stored on the CIDRZ secure server in Lusaka.   
e. 
Potential risks 
Since what we propose is consistent with recommended routine health services, just implemented with 
improved efficiency and fidelity, we do not expect major risks from the study participants beyond what 
patients experience during routine care or normal service provision. The principal risk to study 
participants is the possibility of an inadvertent disclosure of confidential health information. This risk will 
be minimized through training and supervision of all study staff. The confidentiality of all study records 
will be safeguarded to the maximum extent possible. To provide protection to all study participants, 
data security measures will be strictly adhered to, including the de-identification of data for analysis 
purposes and the storage of data on secure, password-protected and encrypted computers. All data 
analyses will be done on datasets that include the study number as the only unique identifier. We 
expect these procedures to adequately protect the confidentiality of participants’ health information.  
Phlebotomy conducted during patient surveys carries a small risk of pain, bleeding, bruising, and 
infection. The magnitude and likelihood of phlebotomy risk is consistent with those normally 
encountered during the course of routine medical care for healthy persons. 
The topics covered in the interviews, FGDs/ implementation surveys, KIIs, and DCEs pertain to 
participants’ experiences providing or receiving services, their experiences implementing interventions, 
or their preferences surrounding services, but some participants may feel uncomfortable with some 
questions.  All participants will be informed during the consent process, and again during data collection 
activities, that they can refuse to answer any question they do not wish to answer or to end the 
interview at any time without penalty. 
Coming into close contact with study team members can put participants at risk for COVID-19.  All 
participants will be informed of this risk during the recruitment and consent processes. When 
appropriate and necessary, qualitative data collection for FGDs and KIIs may be done over a secure 
HIPAA-compliant Zoom web conferencing line to minimize direct participant contact, particularly during 
times when local COVID-19 public health restrictions are in place. 

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f. 
Protection against Risks 
Discussions with potential participants, including informed consent procedures, will be conducted in 
private to protect confidentiality.  Trained data collection staff will obtain written informed consent from 
eligible participants where needed.  The procedures, risks, and benefits of participation will be 
discussed and all questions will be answered prior to obtaining consent.   
 
To minimize phlebotomy risks, the following measures will be taken: (1) finger pricks will be used 
whenever possible; (2) only clinically trained study nurses and/or clinicians will perform or support 
phlebotomy activities, and only trained research staff supervised by the study QA/QC nurse will perform 
finger pricks; (3) the MPIs will review with study staff how to properly conduct study procedures 
involving blood sampling; (4) sterile technique will be used for all blood sampling; and (5) we will seek 
to obtain specimens at the fewest number of time points and with the smallest volumes possible. 
 
Risks to the participant will be minimized by thorough training and supervision of all team members.  All 
study data and forms will only be identified by a coded number to maintain participant confidentiality.  
All databases and digital audio files will be secured with password-protected access systems, and 
computer entries will be identified by coded number only.  Forms, lists, appointment books, audio-
recordings, and any other listings or data forms that link participant ID numbers to other identifying 
information will be stored in a separate, locked cabinet.  All data analysis will be done on a de-identified 
data set or interview transcripts, which have only the participant number as a unique identifier and have 
removed any identifying information.  It is expected that these procedures will adequately protect 
participant confidentiality.  All study procedures carry minimal risks. 
 
In light of COVID-19, the study team will follow MOH guidelines to protect study participants from 
COVID-19.105  This includes providing and using personal protective equipment and following the 
procedures described above. A COVID-19 information sheet will be added to the consent process to 
ensure that participants are aware of potential risks and how to protect themselves.  Participants will be 
reminded that their participation is voluntary. 
g. 
Potential benefits  
Participation carries the possibility of direct benefit to participants, including receiving free screening 
and diagnostic testing, and linkage to care and treatment, for highly morbid cardio-metabolic NCDs 
during patient surveys.  Nested cohort participants who have disengaged from care who are contacted 
by trained study staff may decide to re-engage in HIV and/or NCD care and will receive support from 
study staff to do so. Future patients, and in some cases the individuals providing data themselves, may 
benefit if the study reveals ways to improve NCD/HIV care integration and the management of cardio-
metabolic complications of HIV. 
Knowledge gained from the research may serve to improve the health status of HIV patients living with 
NCDs. The knowledge gained from the research may also provide the government and its partners the 
necessary information for improving multi-sectoral NCD programs, resulting in a healthier, more 
productive population. 
h. 
Consent process  
For the patient surveys, study personnel will only have a one-time contact with participants, unless 
those participants are recruited for, and enrol in, the nested cohort and thus undergo longitudinal follow 
up in the study. For the nested cohort component, study personnel will have contact with individuals at 
the time of the baseline patient survey, and then again at about 2 weeks and about 3-, 6- and 9-months 

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later. For both the patient survey and nested cohort, informed consent procedures will take place as 
detailed under section c “informed consent” above.  
For review of existing, de-identified routine NCD- and HIV-relevant data at the pilot sites, we believe a 
waiver of written informed consent for this component is justifiable for the following reasons: 1) the 
proposed review of existing, routinely collected and de-identified aggregate health data involves no 
greater than minimal risk, with the principal risk being potential harm from an inadvertent breach of 
confidentiality, for which we will institute multiple confidentiality protections to safeguard the data; 2) 
omitting the consent form would prevent creation of the only study-specific document that could link the 
participant to the research; 3) waiving written informed consents will not adversely affect the rights and 
welfare of individuals who have their data reviewed; and 4) conducting the quantitative component 
could not practically be carried out without the waiver. Permission to review individual patient data will 
be sought from the relevant local and international IRBs, and the MOH through protocol review 
procedures under the National Health Research Authority.  
 
For FGDs and the ensuing implementation survey, participation will be completely voluntary and 
subject to verbal informed consent (see Appendix). During the informed consent process, we will make 
sure that NPHWs such as nurses and community health workers/ peer health educators who may be 
employed by MOH or a study partner know that they do not have to participate if they don’t want to and 
that their decision to join the study or not will in no way affect their employment or status with their 
employer. We will also emphasize to all NPHW participants that we will safeguard and anonymize their 
individual responses to minimize the risk that what they say becomes known to their employer or 
colleagues. Study staff will make it clear that participants do not need to answer questions that make 
them feel uncomfortable. All consenting participants will be provided an information sheet. No signature 
page will be collected from FGD participants to avoid creating documentation that connects the 
participants to the research. 
For IDIs and KIIs, participation will be completely voluntary and subject to written informed consent in 
the participant’s choice of English, Nyanja, or Bemba. During the informed consent process for IDIs, 
study staff will review and verify with potential participants their routinely collected locator information 
already on file with their health facility. In addition, study staff will explain to potential IDI and KII 
participants during the consenting process that the interview will be audio-recorded, and that individuals 
who do not wish to have their voice recorded during the IDI will be ineligible to participate.  Staff will 
also explain that participants do not need to answer any question that makes them feel uncomfortable. 
(see Appendix). 
All participant information sheets for the patient surveys, nested cohort, patient IDIs, and FGDs 
involving lay health providers/ community health workers will be prepared in simple English then 
translated into Bemba and Nyanja by a professional translator who is a native speaker of the target 
language. The translated information sheets will then undergo back translation to ensure accuracy, 
consistency, and understandability of the translations. The participant information sheet will explain the 
purpose of the specific study procedures, its processes, inclusion and exclusion criteria, risks, benefits 
if any, and provide assurance of privacy and confidentiality. Further the participant information form will 
explain the meaning of participation; that participation is completely voluntary, and that participants 
have the right to withdraw at any time and with no penalty.  
At encounters for the patient survey, nested cohort, patient IDIs, and lay health provider/ community 
health worker FGDs, staff will provide participants with the information sheet in the language of their 

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choice (Bemba, English, Nyanja), reading the form to those who are unable to read. After this process, 
they will paraphrase each paragraph for all participants to ensure that main points are understood. 
They will invite and answer questions and ask if the participant is willing to participate. If willing, study 
staff will obtain their signature as required. Participants will be asked for permission to be audio-
recorded during IDIs, KIIs, and FGDs, as appropriate, for later transcription and analysis. Participants 
will receive a nominal reimbursement (ZMK 100, equivalent to ~$USD 5) after completing study 
activities/ visits. No reimbursement will be offered for structured observation as these will take place 
during the course of routine service delivery and will not require additional activities on the part of 
participants.   
i. 
Physical Risks 
Phlebotomy conducted during the patient surveys carries a small risk of pain, bleeding, bruising, and 
infection. The magnitude and likelihood of phlebotomy risk is consistent with those normally 
encountered during the course of routine medical care for healthy persons. 
j. 
Psychosocial Risks 
Participants may become embarrassed, worried, anxious, or uncomfortable when discussing sensitive 
topics during FGDs, IDIs, or KIIs. Study staff will be trained how to identify and mitigate issues that may 
cause psychosocial distress, and how to refer to free counselling services available at MOH health 
facilities and in the community.  
There may be a small risk of social harm involved with contacting study participants by phone or in-
person or approaching potential patient participants for procedures at the health facility. For example, if 
a member of staff were to inadvertently disclose confidential health information when speaking to a 
friend or relative who answered the phone for the number listed for a participant, this could cause 
stigma, discrimination, or social harm to the potential participant. These issues notwithstanding, we will 
take several steps to minimize these risks.  
k. 
Methods to Minimize Risk 
To ensure that confidential health information is not inadvertently disclosed during phone or in person 
contacts with potential participants, we will train all staff on the use of a standardized recruitment script 
(Appendix D.i).  
All participants will be instructed during the informed consent process that they may discontinue any 
study procedure, including procedures for the patient surveys, nested cohort, IDIs, FGDs, DCEs, and 
KIIs at any time for any reason, such as experiencing psychosocial stress related to any question(s). 
Risks relating to psychological discomfort will be further minimized by: 1) reducing respondent burden 
through streamlining of IDI and FGD guides; and 2) referring participants to appropriate counselling, as 
necessary. We do not anticipate that focus group discussions, and KIIs will pose any risk of 
psychological discomfort to stakeholders beyond that encountered in the course of everyday 
professional conversations. However, with FGDs, since they will be in a discussion with several of their 
co-workers, there is a chance that what they say could get back to their co-workers, and potentially 
even their supervisors. Thus, due to the presence of work colleagues in FGDs and the potentially 
sensitive nature of questions surrounding perceptions of the functionality of the health system, we will 
ensure through a comprehensive written informed consent process that participants are aware of: 1) 
their right to withdraw; 2) their right to not respond to any question(s) they do not wish to answer; 3) the 
fact that their responses will not be linked back to them in any way or shared with their employers or 
supervisors; 4) the fact that FGD participants will be encouraged to not share anything said outside the 
focus group; and 5) the fact that their decision to participate or not participate in the study will in no 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 50 
affect their standing or employment with the study site/ health facility, their employer, MOH, or CIDRZ.  
We will strive to minimize the risk of unintended confidentiality breeches involving study-related 
information by: 1) conducting all study procedures in private settings that are conveniently located for 
participants such that all information is kept strictly confidential and not inadvertently disclosed to 
anyone not involved in the study activity; and 2) engaging existing MOH and CIDRZ program providers 
to continue offering routine stigma mitigation messaging. 
All electronic and paper information reviewed or collected during the course of this study will be kept 
securely and confidentially and will only be handled by designated study personnel appropriately 
trained in the management of these data. Information entered into the study database will be kept 
separately from participant identifying details and protected by a password.   Indeed, data security 
measures will be strictly adhered to, including the immediate de-identification of all data prior to 
analysis but after linking disparate data source across time in the final database. All data will be stored 
on secure, password-protected servers and encrypted computers and tablets.  
Participant information will remain confidential at all times, unless we are required by law to release 
information. Reports about the study and results that may be published in scientific journals will not 
include any identifying information that would allow participants identities to be revealed or deduced.  
l. 
Anticipated Benefits to Participants 
There may be no benefit to individuals who participate in this study. However, participation in the 
patient survey carries the possibility of newly diagnosing undetected cardio-metabolic NCDs such as 
hypertension, diabetes, and dyslipidaemia, and linking these individuals to treatment and care at the 
study sites.  If the study reveals ways to improve NCD/HIV care integration and the management of 
cardio-metabolic complication of HIV, then future patients, and in some cases the individuals providing 
data themselves, may benefit. 
 
m. 
Handling of Unexpected or Adverse Events 
i. 
Response to new or unexpected findings and to changes in the study environment 
Any new, unexpected finding or change to the HIV programme operational environmental will be 
resolved in consultation with MOH.  
ii. 
Identifying, managing, and reporting adverse events 
Adverse events related to implementation of the TASKPEN pilot will be minimized through study 
mentors and facility-based champions who are experienced in providing integrated services. Study 
team members will report any unfavourable or adverse findings, especially in regard to quality of care, 
immediately to the MOH for consideration of remedial action. All health-related emergencies will be 
handled as per clinic guidelines, including management of abnormal vital signs and laboratory values 
identified through the patient surveys. The study QA/QC nurse and study clinical scientist/ doctor will be 
available to act immediately on these abnormalities, including to offer patient counselling, provide warm 
“handoffs” to clinical staff, refer patients for acute care at the study sites, and prescribe appropriate 
outpatient treatment for non-acute issues in cases where MOH staff are not available (e.g., after 
business hours). 
No adverse events are anticipated as part of this study, as we are not testing any investigational 
interventions, pharmaceutical products, or medical devices.  The most serious—but unlikely—adverse 
event would be related to inadvertent disclosure of confidential information. However, several measures 

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will be taken to safeguard against this risk, including the de-identification of analytical datasets, strict 
adherence to confidentiality procedures, and safeguarding study participant privacy at all times.  
Any adverse events associated with the study will be handled by the MPIs and senior study staff and 
will be reported immediately to all regulatory authorities overseeing the study. We will utilize the HLB-
SIMPLe project-wide Data Safety Monitoring Board (DSMB) led by the Research Coordinating Center 
(RCC) at Washington University in St. Louis, USA, and supported by NIH, for reporting purposes on 
general AEs, serious AEs (i.e., SAEs), unanticipated problems involving risks to subjects or others 
(UPIRSOs), protocol violations and non-compliance and social harm information.  We will use the 
following procedures in the event of an AE, SAE, UPIRSO, protocol violation, or instance of non-
compliance or social harm. In the case of any of these instances, the research team will alert the MPIs 
immediately (same day). Subsequently, the MPIs will report all SAEs or suspected UPIRSOs by an 
expedited written report sent via email to NHLBI and the DSMB chair or designee/ representative within 
24hrs of the MPI’s awareness of the event. The DSMB chair or representative, when necessary in 
conjunction with the full DSMB, will review reports and decide whether the event meets the definition of 
an unanticipated problem increasing risks to subjects or others.  Events that meet these criteria will be 
considered unanticipated problems involving risks to participants or others, and will be reviewed by the 
convened, full DSMB. Copies of the written report will also be sent to UNZA BREC and the UNC IRB 
within 10 working days (with one exception) of events that meet the definition of an unanticipated 
problem involving risks to subjects or others. The exception is if the SAE involved death and indicates 
that participants or others are at increased risk of harm. In such a case, the MPIs will be required to 
submit a report to UNZA BREC and the UNC IRB within 3 working days. Any suspension or termination 
of IRB approval will include a statement of the reason(s) for the action and will be reported promptly to 
the NIH PO within 3 business days of receipt. In cases of protocol violations, staff re-trainings and other 
remedial actions will be taken by the MPIs in coordination with the RCC, CIDRZ Research Operations 
Department, and NIH, as appropriate.  
CIDRZ holds organizational policies and procedures for the safety and security of its personnel and of 
the clientele with which CIDRZ employees interact during professional activities.  Since the evaluation 
falls within the scope of CIDRZ’s typical professional activities, these organizational policies and 
procedures will be relevant. 
10. 
Sponsor Monitoring 
The U.S. National Institutes of Health (NIH) is the primary sponsor for the study. As the sponsor, NIH 
may conduct monitoring or auditing of any study activity to ensure the scientific integrity of the study 
and to ensure the rights and protection of study participants.  Monitoring and auditing activities may be 
conducted by any of the following individuals and parties: NIH staff (“internal”); Authorized 
representatives of NIH (e.g., a contracted party considered to be external”); Both internal and external 
parties. 
 
Monitoring or auditing may be performed by on-site visit carried out at CIDRZ or study facilities or 
through other means of communications such as telephone calls or written correspondence. During the 
visit, any study-related materials may be reviewed and the MPIs, and other investigators, along with the 
study staff should be available for discussion of findings. 
To ensure good clinical practice and compliance with national and international regulatory guidelines, 
the study may also be subject to inspection or review by authorized Zambian or international regulatory 
authorities, including the UNZA BREC, NHRA, UNC IRB, and UAB IRB. 

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11. 
Dissemination of Findings 
All reports and publications of collected data will be presented in aggregate form only. The names or 
other identifiers of participating individuals will not be presented in any publication.  Reports will be 
written so that no person may be individually identified, even indirectly. Results will be disseminated 
locally to the participating clinics, key stakeholders, including US government partners, and the Ministry 
of Health. Results from this study will also be presented at national, regional, and international 
meetings, and submitted to international peer-reviewed journals. 
Study findings will be made available through appropriate local and international channels, including 
academic and public health research symposia. One or more publications will also be submitted to a 
peer-reviewed 
journal

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 53 
 
12. 
Timeline      
Milestone Plan for the TASKPEN Stu
  
Year 1 
Year 2 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Sub-award and contracts  
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol development 
 
X X X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethical review 
 
 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment & Hiring  
 
X X X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Establishing Technical Advisory Co
(TAC) 
 
 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Team orientation and training 
 
 
X X X X X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adaptation consultation with stake
National 
NCD 
Working 
Group, 
Scientists, global actors & Others  
 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Validation and consolidation of  the
tools and guidelines 
 
 
 
 
 
X 
X X X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop SOPs based on guidelines 
 
 
 
 
 
x 
x x X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline assessment 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X  
 
 
 
 
 
 
 
 
 
 
Pilot implementation 
 
 
 
 
 
 
 
 
 
 
X 
X 
X X X X 
X X X 
X X 
X 
 
 
Final evaluation of pilot 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X 
X 
X 
Dissemination & Consultative process
planning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 

TASKPEN Study              v1.3 13 December 2021                                                                   Page | 54 
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62 
TASKPEN  2020 
14. Appendices (Please see attached supporting documents folder)