PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study
Phase: NA
Conditions: Hypertension, Medication Adherence
Sponsor: NYU Langone Health

Official Title: 
PT4A (Peers and Technology for Adherence, Access, Accountability, 
and Analytics) - A Qualitative Study  
NCT Number:
NCT05051124
Study Number:
20-01579 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
December 23, 2022 

PT4A Protocol 1.4 23rd November, 2022 
Page 1 of 86
PEERS AND TECHNOLOGY FOR ADHERENCE, ACCESS, ACCOUNT-
ABILITY, AND ANALYTICS (PT4A) 
PI
Dr. Rajesh Vedanthan, MD, MPH 
 
 
 
 
CO-Is 
Dr. Benson Njuguna, B. Pharm, MPPM 
Dr. Sonak Pastakia, PharmD, MPH, BCPS 
Dr. Tina Tran, PharmD 
Dr. Jeremiah Laktabai, MD 
Dr. Juddy Wachira, PhD 
Dr. Ann Mwangi, PhD 
Dr. Imran Manji, B. Pharm, MPH 
Dr. Antoinette Schoenthaler, EdD 
Dr. Andrea Troxel, ScD 
Dr. Becky Genberg, PhD 
Dr. Dustin Duncan, ScD 

PT4A Protocol 1.4 23rd November, 2022 
Page 2 of 86
CONTENTS
 
 
 
 
CONTENTS
STATEMENT OF COMPLIANCE………………………………………………………………2
PROTOCOL SYNOPSIS…………………………………………………………………………4 
SIGNIFICANCE…….......................................................................................................................7
INNOVATION………………………………………………………………………………......  9 
APPROACH……………………………………………………………………………………….…………………………………… 9 
Preliminary Data…………………………………………………………………………………10
International Advisory Committee………………………………………………………………11 
Overall Implementation Research Framework…………………………………………………..12 
Aim 1: Identify micro- and macro-level contextual factors that might influence the 
implementation of the PT4A strategySub Aim 2.1: Evaluate The Intervention For Acceptability 
And Appropriateness…………………………………………………………………………….18 
Rigor and Reproducibility……………………………………………………………………….19
Assessment of Potential Risks and Benefits……………………………………………………..20
Milestones……………………………………………………………………………………………………………………………….25 
Table 4: PT4A Milestones……………………………………………………………………….27
Timeline………………………………………………………………………………………….27
REFERENCES…………………………………………………………………………………..28 
APPENDIX A……………………………………………………………………………………37 
PT4A AIM 2 STUDY PROTOCOL……………………………………………………………..37
APPENDIX B……………………………………………………………………………………47
STUDY INTERVIEW QUESTIONNAIRES…………………………………………………...47
APPENDIX C……………………………………………………………………………………59 
STUDY INTERVIEW GUIDES………………………………………………………………...59 
 
 
 
 
 
 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 3 of 86
STATEMENT OF COMPLIANCE
 
The trial will be carried out in accordance with International Council on Harmonization Good Clin-
ical Practice (ICH GCP) and the following:  
 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 
812).  
National Institutes of Health (NIH)-funded investigators and study site staff who are responsible 
for the conduct, management, or oversight of the study have completed Human Subjects Protec-
tion and ICH GCP Training. 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 4 of 86
PROTOCOL SYNOPSIS
Title: 
Peers and Technology for Adherence, Access, Accountability, 
and Analytics (PT4A) – A Qualitative Study 
Grant Number:
1R56HL150036
Study Description:
The overall objective of this project is to utilize the PRECEDE-
PROCEED framework to conduct transdisciplinary, translational 
implementation research focused on improving medication 
adherence for hypertension control. The central hypothesis is 
that peer delivery of medications integrated with HIT (PT4A) will 
be effective in improving hypertension medication adherence, 
contributing to improved blood pressure among patients with 
uncontrolled hypertension in western Kenya. This application 
will focus on the critical formative components of the overall 
implementation research objective, and we propose the 
following specific aims: 
Aim 1 will identify micro- and macro-level contextual factors that 
might influence the implementation of the PT4A strategy 
(individual, family, clinician, health system, and environment), 
using qualitative methods. Aim 2: We will then use a human-
centered design approach to refine the PT4A intervention using 
the findings from Aim 1. Sub-Aim 2.1 will evaluate the 
intervention for acceptability and appropriateness by use of a 
survey tool with patients, peers, and clinical staff. In Sub-Aim 
2.2, we will then conduct a pilot of the intervention and conduct 
a survey questionnaire with patients, peers, and clinical staff to 
evaluate feasibility. We will evaluate impact on systolic blood 
pressure, medication adherence, and fidelity of implementation. 
We will also create a retrospective comparator (control) group 
of CDM patients, through querying AMRS, matched by sex, 
age, location and initial blood pressure level. We will then use 
their recorded blood pressure over a comparable period of upto 
1 year and to allow for comparison to the blood pressure 
changes observed in the patients enrolled in the PT4A program 
to help understand the magnitude and variance of the 
intervention effects. 
 
Objectives*: 
The overall objective of this proposal is to utilize 
transdisciplinary, translational implementation research, guided 
by the PRECEDE-PROCEED framework, to address the 
challenge of hypertension medication non-adherence in low-
resource settings.
Endpoints*: 
The primary adherence outcome is the pill count adherence 
ratio, which is the proportion of prescribed doses taken over a 
1-month time period, assessed at the end of the pilot. The 
primary implementation outcome is fidelity, measured as 
quantity and quality of intervention delivery as intended, 
comprised of three components: confirmed medication delivery 
documented by patient e-signature, peer completion of the HIT 
form, and quality of data entry into the HIT form. 

PT4A Protocol 1.4 23rd November, 2022 
Page 5 of 86
Study Population:
Approximately 146 individuals will participate in this study. The 
number is approximate because for focus group discussions, 
the number of participants can range from 6-10.  
Aim 1: 
 
Focus group discussions (approximately 96 
participants): Participants will be patients with 
hypertension who are currently enrolled in the AMPATH 
CDM program, and at least 18 years of age from the 
counties of Bungoma, Trans Nzoia, and Uasin Gishu in 
Western Kenya. Clinical staff in the AMPATH CDM 
program and community leaders from the counties will 
also participate. (12 total FGDs, 6-10 participants each) 
 
Key informant interviews (4 participants): Participants 
will be County Executive Committee representatives for 
health from the three Counties included in the study and 
the Ministry of Health head for non-communicable 
diseases (NCDs). 
Aim 2: 
 
Human Centered Design Team (20 participants): 
Participants will be individuals representing the following 
stakeholder groups: research team members, clinicians, 
pharmacists, peers, patients with hypertension, 
representatives from the informatics team, and other 
relevant staff members involved in hypertension care 
Aim 2.1: 
 
Use of Survey tools adapted from acceptability and 
appropriateness measures (39 participants): 
 
Participants will be patients (as described above), peer 
navigators, and clinical staff (as described above). 
Aim 2.2: 
 
Pilot (up to 100 participants): Participants will be 
patients who are currently enrolled in the AMPATH 
CDM program, and at least 18 years of age from the 
counties of Bungoma, Trans Nzoia, and Uasin Gishu in 
Western Kenya. 
Retrospective comparator group: AMRS records of up to 
100 patients who will serve as a control group matched 
by sex, age, location and initial blood pressure level
Phase* or Stage: 
N/A  
Description of 
Sites/Facilities Enrolling 
Participants:
AMPATH catchment area in three counties of western Kenya: 
Bungoma, Trans Nzoia, and Uasin Gishu. 

PT4A Protocol 1.4 23rd November, 2022 
Page 6 of 86
Description of Study 
Intervention/Experimental 
Manipulation: 
Peer delivery of medications: We will adopt a novel approach of 
extending beyond the use of peer support in the clinical setting 
and implement door-to-door peer delivery of medications within 
patients’ communities 
Health Information Technology (HIT) Platform: To support peer 
delivery, we will use a HIT platform that performs 4 core 
functions: 1) tailored counseling strategies through decision 
support; 2) teleconsultation support for clinician-peer-patient 
interactions; 3) tracking medication refills to enhance 
accountability of the peer delivery process; and 4) analytics to 
improve medication supply chain by generating patient-level 
drug consumption data. This is an innovative use of HIT to 
accomplish these functions to support medication adherence.
Study Duration*: 
Up to 1 year
Participant Duration: 
Up to 1 year

PT4A Protocol 1.4 23rd November, 2022 
Page 7 of 86
A. SIGNIFICANCE
Hypertension – Global Burden and Unmet Needs.  Elevated blood pressure (BP) is the lead-
ing risk factor of death globally.1,2 The global burden of hypertension is increasing,3,4 dispropor-
tionately so in low- and middle-income countries (LMICs).5-8 While BP control reduces cardio-
vascular disease (CVD) and death,9-11 treatment and control rates remain suboptimal both in the 
U.S. and LMICs.5-7,12 The economic burden of hypertension is staggering, in terms of both direct 
health costs and indirect impact on employment and productivity.13-16 Despite many evidence-
based interventions to manage hypertension, substantial implementation gaps persist.17
Medication Adherence. Adherence is defined as “the process by which patients take their 
medications as prescribed,” and is often divided into three phases: initiation, implementation, 
and persistence.18 Adherence to hypertension medication reduces congestive heart failure,19
CVD risk,20 CVD events,21,22 and mortality.21-24 Despite increased medication costs, adherence 
can lead to net decrease in both health care utilization and cost in hypertensive patients.25
Given the clinical and economic benefits of adherence, improvements in hypertension medica-
tion adherence will improve BP control and reduce CVD risk and mortality.26 However, in low-
resource settings worldwide, nearly 60% of hypertension patients report non-adherence to anti-
hypertensive medications—both suboptimal implementation (i.e. day-to-day medication-taking 
behavior) and non-persistence (i.e. premature discontinuation), leading to poor BP control and 
increased hospitalization and mortality.27-33  
Multi-Level Barriers Impacting Adherence.  Barriers to adherence to hypertension medica-
tions are complex and multi-level.32,34-37 At the macro-level (e.g. health systems and communi-
ties), challenges include reduced medication availability,38 low affordability,38 inadequate insur-
ance coverage,32 transportation,39,40 and distance to health facilities.41,42 At the micro-level (e.g. 
individual patients and providers), barriers include provider training,43 poor patient-provider rela-
tionships,44-46 patient missing doses,40 real and perceived adverse effects,47 and psychological 
factors.40,48 Therefore, there is a need to develop and evaluate rigorous implementation strate-
gies that address the multi-level barriers impacting medication adherence. 
Peer Delivery of Medications. Peers are lay individuals with shared disease experience who 
provide practical, social, emotional, and motivational assistance to patients.49 Peer support can 
improve chronic disease medication adherence; however, most studies have occurred in clinical 
settings.50-52 To date, door-to-door peer delivery of hypertension medications to patients in order 
to improve adherence has not been evaluated.
Health Information Technology (HIT). The use of HIT, such as electronic medical record sys-
tems, mobile health (mHealth) approaches, and electronic prescribing, can enhance medication 
adherence.53-55 In LMICs, HIT has demonstrated beneficial impact on clinical care processes for 
chronic diseases, and can enhance peer support networks for non-communicable disease 
(NCD) care.56-58 However, it is not well known if HIT, combined with peer delivery, can enhance 
adherence to antihypertensive medications and improve BP control.58,59
Rigor of Prior Research. As described above, a large evidence base has clearly documented 
that medication adherence is associated with improved BP and CVD outcomes. However, mi-
cro- and macro-level barriers to hypertension medication adherence lead to suboptimal BP con-
trol and adverse CVD outcomes. While peer support and HIT have separately shown promise 
with respect to improving medication adherence, there remain gaps in the literature that will be 
addressed by our proposed project to combine peer delivery and HIT to address multiple barri-
ers, thereby improving hypertension medication adherence, ultimately contributing to improved 
BP among patients with uncontrolled hypertension in western Kenya. 

PT4A Protocol 1.4 23rd November, 2022 
Page 8 of 86
Relevance to the U.S. The burden of hypertension in the U.S. is substantial,60 and the chal-
lenges for population subgroups (health facility access, transportation, and opportunity cost of 
lost work) are similar to those in Kenya.61 Despite efforts to improve adherence, gaps remain
leading to morbidity, mortality, and costs.62 Hence, we aim to produce generalizable knowledge 
relevant to the U.S. In fact, our team and colleagues have previously translated research learn-
ings from Kenya into impactful interventions for U.S. communities.63-65
Implementation Science Training and Capacity Building.  Capacity building has been a 
longstanding priority for our team and is fundamental to this project.66-73 We are therefore pur-
posely involving a relatively junior Kenyan sub-award investigator with more experienced U.S.-
based Multiple Principal Investigators. In addition to this experiential learning, we will leverage 
didactic training activities, as we have previously done.74,75 This human resource investment will 
ensure future implementation research related to hypertension and other NCDs. 

PT4A Protocol 1.4 23rd November, 2022 
Page 9 of 86
B. INNOVATION 
Human-Centered Implementation Research. Human-centered design (HCD) is a creative ap-
proach to problem-solving, a process whereby stakeholders are engaged in all phases: inspira-
tion (identify the challenge), ideation (design, test and refine solutions) and implementation 
(maximize impact).76,77 Our team has previously utilized HCD in the context of NCD care and 
prevention, and we have previously proposed an approach termed “human-centered implemen-
tation research”.78-81 Using this approach is pioneering and could provide a model for co-crea-
tion and participatory design that could be relevant worldwide. 
Peer Delivery of Medications. We will adopt a novel approach of extending beyond the use of 
peer support in the clinical setting and implement door-to-door peer delivery of medications 
within patients’ communities. 
Health Information Technology (HIT) Platform. To support peer delivery, we will use a HIT 
platform that performs 4 core functions: 1) tailored counseling strategies through decision sup-
port; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication re-
fills to enhance accountability of the peer delivery process; and 4) analytics to improve medica-
tion supply chain by generating patient-level drug consumption data. This is an innovative use of 
HIT to accomplish these functions to support medication adherence. 
C. APPROACH 
Setting. The proposed study will take place in western Kenya at the Academic Model Providing 
Access to Healthcare (AMPATH) program, an academic partnership between Moi University 
College of Health Sciences (MUCHS), Moi Teaching and Referral Hospital (MTRH), and a con-
sortium of North American universities.82 AMPATH has established an HIV care program that 
has enrolled over 200,000 patients in a catchment population of 4 million.82,83 In 2011, AMPATH 
was designated as a Center of Excellence for Cardiovascular and Pulmonary Disease Research 
by the NHLBI.67,84 At the same time, AMPATH also established a Chronic Disease Management 
(CDM) Program in collaboration with the Ministry of Health (MOH).85 We have a Memorandum 
of Understanding with the Kenya MOH to provide care for NCDs and to develop and evaluate 
innovative approaches to NCD management including hypertension.  
The CDM Program has enrolled over 40,000 patients with hypertension. Our team has con-
ducted several NIH-funded implementation research studies targeting various elements of the 
NCD care delivery system: nurse management of hypertension (K01TW009218), linkage/reten-
tion to hypertension care (U01HL114200), group medical visits and microfinance for NCDs 
(R01HL125487), and strengthening referral networks for hypertension (U01HL138636). In addi-
tion, we have implemented a network of revolving fund pharmacies (RFPs) to ensure a reliable 
supply of medicines for hypertension and other NCDs across all levels of the health system, in-
cluding 60 health facilities where availability of medications for hypertension is now 95-99%.35,86-
88
AMPATH has used the AMPATH Medical Records System (AMRS), a customized version of 
OpenMRS, since 2005.89 In 2016, AMPATH developed a software program called “Point-of-
Care” (AMRS-POC), which we started using in CDM clinics for hypertension management in 
2017. We have developed software modules for the following clinical functions: 1) historical pa-
tient data review (patient dashboard); 2) real-time clinical data entry (customized interactive 
forms with skip logic); 3) decision support tailored to the type and training of clinician (e.g. when 
to escalate hypertension therapy); 4) health facility management (scheduling, follow-up of pa-
tients missing clinic visits, generating administrative reports); and 5) data visualization (quality 
indicators). AMPATH has invested in a Wi-Fi network and solar power system to ensure net-
work access and server connectivity for each health facility. Our current system is being 

PT4A Protocol 1.4 23rd November, 2022
Page 10 of 86
implemented in over 30 health facilities serving a patient population of nearly 100,000 patients, 
and has been used for more than 1 million clinical encounters. We have developed and imple-
mented a HIT-based home glucose monitoring program that has led to significant improvements 
in glycemic control.90 We have also implemented real-time interactive HIT for oncology, enabling 
specialists at the referral hospital to co-manage patients with clinicians from remote health facili-
ties. Finally, we are developing a personal health record platform to support asynchronous tele-
medicine. The proposed HIT component of this study builds upon this established infrastructure.  
Preliminary Data.  
Suboptimal Medication Adherence. Adherence to hypertension medications is suboptimal in 
western Kenya, and there remain gaps to improve patient-level access and medication refill 
rates. Preliminary analysis of data from participants in the BIGPIC trial (R01HL125487) indi-
cates that nearly 50% of patients with hypertension and/or diabetes reported suboptimal adher-
ence, similar to other countries in Africa.37 Due to limited cash supply, patients often choose to 
fill only a part of their prescription on the day of the clinic visit, and are expected to return for re-
fills. AMPATH pharmacy data indicate that as the prescription duration increases, fewer patients 
fill the prescription for the entire period: 43% filled their 60-day prescription, and only 21% filled 
their 90-day prescription. The remaining patients required a return visit to refill their prescrip-
tions. However, missed refills are frequent; in fact, 62% of hypertensive patients in this region
reported having missed or skipped a refill, while 64% reported having run out of medication be-
fore the next refill date. Pharmacy program data confirm this self-report; a recent audit indicated
that only 24% of individuals who were due to return to clinic for a prescription refill actually did 
so. 
Impact of Adherence on BP. Suboptimal adher-
ence in our catchment is associated with worse 
BP outcomes: individuals reporting having missed 
doses of medications had an average systolic BP 
(SBP) of 157 mmHg compared to 134 mmHg 
among those with perfect adherence. Those who 
had run out of medications and missed refills also
had higher SBP levels (unpublished data).  
Factors Impacting Adherence. For hypertension 
patients in Kenya, unaffordability of care, low 
availability of providers, poor access to health 
facilities, and inadequate social support are all 
barriers to hypertension care and medication 
adherence.42,91 Cost of transport and distance to 
the health facility have also been reported as significant barriers. Preliminary analysis of BIGPIC 
trial data indicates that time taken to reach the health facility is significantly associated with a 
missed prescription;79 round-trip estimates average approximately 90-120 minutes. In addition, 
patients spend nearly two hours at the health facility when attending a hypertension clinic, or 
even just for a medication refill. We have previously reported that the clinician-patient encounter 
averages less than 10 minutes,92 indicating long wait times and therefore time lost from work.
To supplement the substantive preliminary data summarized above, we propose to conduct a 
more thorough assessment of the various factors that might impact successful implementation 
of the PT4A strategy.
Results from Peer and HIT Involvement in Care Delivery. We have successfully used peers in 
the AMPATH program to provide adherence counseling and psychosocial support for patients 
with HIV.93,94 We have also delivered portable group-based NCD care, peer support, and medi-
cations in remote, patient-centered locations for several years, with improvements in retention in 
Figure 1. Study sites in western Kenya

PT4A Protocol 1.4 23rd November, 2022 
Page 11 of 86 
care, BP, and A1c.79,95,96 Our 
program of peer delivery of HIV 
medications, begun over one 
year ago, has grown by nearly 
20%, with 97% of medications 
delivered on time. We also have 
implemented a pilot program of 
peer delivery of medications for 
hypertension and diabetes, with 
improvement in adherence and 
a nearly 6-mmHg reduction in 
SBP. We have also shown that 
HIT strategies can integrate and 
coordinate care across the 
health system for HIV, diabetes, and hypertension.85,97-100
Summary of Preliminary Data and Remaining Gaps. As described above, the current proposal is 
an extension of established work, building upon a solid foundation of several years and itera-
tions of peer- and HIT-based strategies. However, there remain implementation gaps, as well as 
gaps in the rigor of prior research, to be addressed. We hypothesize that our proposed strategy, 
peers and technology for adherence, access, accountability, and analytics (PT4A), will help to 
address some of the remaining gaps we have identified in our prior research. As an initial step, 
further formative research is required prior to full-scale implementation and evaluation of this 
strategy to improve medication adherence and blood pressure. We will conduct this project in 
the AMPATH catchment area in three counties of western Kenya: Bungoma, Trans Nzoia, and 
Uasin Gishu (Figure 1).  
Study Team. Our proposal builds upon longstanding institutional partnerships that comprise the 
AMPATH Consortium, which have laid the groundwork for clinical care and research in 
CVD.67,82,84,85,101-103 Both Dr. Vedanthan (contact PI) and Dr. Pastakia (MPI) have success-
fully collaborated for several years with each other and with investigators from MUCHS 
and MTRH, as well as members of the current study team, to establish robust structures 
for chronic disease research and clinical care in western Kenya.67,68,79,85,91,99,104-109 Each 
collaborator adds specific value to this proposal (Table 1). Critically, we have secured strong 
high-level political support from the Head of the Division of NCDs at the MOH. In addition, the 
AMPATH Executive Director of Care is supportive of this application. The head of the AMPATH 
Population Health Program, Dr. Laktabai, as well as the head of the AMPATH RFP program, 
Imran Manji, are co-investigators. This key program and government leadership support provide 
a strong foundation that positions us to successfully carry out our proposed research and pro-
duce lessons and insights that can have impact worldwide.  
International Advisory Committee. Our goal is to make the PT4A strategy relevant for health 
systems in low-resource settings worldwide. We will therefore create an International Advisory 
Committee consisting of peers, researchers, clinicians, administrators, and policy makers from 
around the world. Twice a year, the committee will discuss by teleconference how to tailor the 
strategy for the Kenyan context as well as in other low-resource settings, and how to adapt, im-
plement, and evaluate the PT4A strategy in other contexts.  
Stakeholder Engagement. We will collaborate with key stakeholders throughout the proposed 
project. At the conception stage, we have aligned our proposal to address a key national prior-
ity: curbing NCDs while addressing the shortage of human resources for health.110 We have 
also already secured input and support for this proposal from the MOH NCD leadership. At the 
design phase, we have engaged key program leaders both informally and formally as 

PT4A Protocol 1.4 23rd November, 2022
Page 12 of 86
investigators on this proposal, leveraging their experience with NCD care, peer-based care, and 
NCD medication adherence, thus ensuring our proposed strategy is aligned with program and 
policy priorities.83 We will engage patients, communities, clinicians and health program leaders 
as we conduct our qualitative research and human-centered design-based strategy refinement. 
AMPATH’s Community Strategy Initiative routinely engages existing community-based govern-
ance structures to gather input and feedback on community-based initiatives. In addition, the 
AMPATH research program has a long history of engaging and informing community stakehold-
ers of research interventions.79,108,111-121 finally, we will conduct regular dissemination of our 
program experiences, successes, and challenges to key stakeholders to co-create solutions and 
promote receptivity for future wider implementation.   
Overall Implementation Research Framework. The PRECEDE-PROCEED framework pro-
vides a conceptual framework for assessment of an implementation challenge, design of a re-
sponsive strategy, and implementation and evaluation of that strategy (Figure 2). 122-124 We 
chose to use PRECEDE-PROCEED as our overall implementation research framework be-
cause of its participatory nature, multi-pronged assessment of the multi-level factors that affect 
adherence, and multiple evaluation components. In addition, PRECEDE-PROCEED is appropri-
ate for a hybrid type 2 implementation research trial,125 where we will have a dual focus to as-
sess effectiveness of the strategy in improving medication adherence and BP, while also evalu-
ating the fidelity of our implementation strategy. We are currently using PRECEDE-PROCEED
in another NIH-funded study,126 while others have successfully used this framework to develop 
strategies to promote cardiovascular health in low-income populations.127 Phases 1 and 2 are 
simultaneous with our baseline contextual assessment (Aim 1). Phase 3 aligns with the HCD
Figure 2. PRECEDE-PROCEED Implementation Research Framework

PT4A Protocol 1.4 23rd November, 2022 
Page 13 of 86 
process (Aim 2). Phase 4 aligns with the acceptability, appropriateness, and feasibility testing. 
Phases 5 to 8 will encompass the subsequent planned R01 grant application. Phase 5 will be 
the implementation of the cluster randomized trial comparing the PT4A strategy to usual care. 
Phase 6 will align with our impact and outcome evaluation to determine the overall impact as 
well as the impact of spatial factors on strategy effect, respectively. The Phase 7 process evalu-
ation will be implemented simultaneous with Phase 5, and Phase 8 is our planned scalability 
and adaptability evaluation.  
Conceptual Model for Adherence Behavior. We will use the capability, opportunity, and moti-
vation model for behavior change (COM-B)128 as our conceptual model for medication adher-
ence behavior. The COM-B model provides a solid foundation to comprehensively understand 
the multi-level determinants of adherence, and develop our strategy targeting improved adher-
ence (Table 2). We chose the COM-B model due to its versatility at addressing a variety of be-
havior change challenges, its applicability in low-resource settings, and its comprehensiveness 
in recognizing interactions among multiple determinants of the same problem.106,129-133  
We hypothesize that the PT4A strategy will address determinants of hypertension medication 
adherence at the micro- and macro-levels, leading to changes in patient activation, improve-
ment in adherence, and reduction of BP. Peer-based delivery of medications will reduce both 
direct costs (e.g. transport) and opportunity costs (e.g. time lost, time off economic activity) as-
sociated with acquiring medication refills. Secondly, peer delivery will provide a platform for 
peer-patient interaction that can be leveraged to provide adherence counseling and psychoso-
cial sup-
port. 
Through 
the inter-
action, 
peers 
may help 
address 
medica-
tion-re-
lated con-
cerns 
(e.g. per-
ceived 
and real 
adverse 
effects), 
improve patient activation (e.g. coaching patients to raise concerns and questions with clini-
cians), and provide psychosocial support. HIT will augment peer roles through the decision sup-
port system, teleconsultation functionality, and provision of patient-specific adherence summar-
ies for targeted counseling. The HIT platform will also provide enhanced supply chain analytics 
in order to optimize availability of medications at the rural dispensing facilities.  
Aim 1: Identify micro- and macro-level contextual factors that might influence the imple-
mentation of the PT4A strategy.  
We will use qualitative research methods to conduct a thorough baseline contextual assessment 
of barriers and facilitators for implementing PT4A.  
Participants: We will conduct focus group discussions (FGDs) of 6-10 participants each among 
four different groups in each county 

PT4A Protocol 1.4 23rd November, 2022 
Page 14 of 86 
: individuals with hypertension (men and women separately), clinical staff, and community mem-
bers (12 total FGDs). Purposive sampling will be used to select study participants in order to 
sample a diversity of stakeholders. For individuals with hypertension, diversity of age and dis-
tance from the nearest health facility will be targeted. In addition, we will conduct four key in-
formant interviews (KIIs): one each with the County Executive Committee representative or the 
county health director for medical services in each of the three counties where we will conduct 
our study, and one with the head of the division of NCDs at the MOH.  
Methodology: Focus Group Discussions: Clinical staff will be recruited by identifying staff who
care for patients with hypertension. Patients will be recruited from the health facilities participat-
ing in the study. We will work with the AMPATH leadership to identify local community mem-
bers. FGD guides will be created specific to each target group, based on the COM-B constructs 
listed above (Table 1). Additionally, the FGDs of the clinical staff will assess organizational read-
iness for change (change efficacy, change commitment, and organizational context)134 to imple-
ment a new multi-level strategy. Each guide will be pilot-tested on three individuals (male, fe-
male, and clinician) and revised accordingly. A trained moderator will lead each FGD and facili-
tate the discussion,135 with an observer and a note-taker present. Each FGD will last approxi-
mately 60 to 90 minutes and will be audio-recorded. We will encourage interactions between 
and among group members136 employing participatory techniques that elicit emotional elements 
and promote group interactions.137-139 After each FGD, the facilitators will conduct a debriefing 
session to summarize findings, compare impressions, identify procedural problems, and de-
velop plans for future FGDs 
Key Informant Interviews (KIIs): The four key informants will be approached and recruited in col-
laboration with AMPATH CDM who have existing relationships with policymakers at both the na-
tional and county level. A trained research assistant will conduct each of the KIIs. Each KII will 
last approximately 30-45 minutes and will be audio-recorded. We will prepare and pilot-test an 
interview guide in a similar manner as above and revise it accordingly. In addition to asking 
about facilitators, barriers and contextual factors that may impact the strategy, the KIIs will also 
assess governmental readiness for change to implementing a new multi-level strategy.134 For all 
qualitative sessions, a transport allowance and refreshments will be provided to participants.  
Focus Group Discussions and Key Informant Interviews will be conducted in-person by the Prin-
cipal Investigator (PI), Dr. Rajesh Vedanthan, or designated research team members, assisted 
by an interpreter. The study team will adhere to the COVID-19 regulations during the interviews 
including social distancing, wearing masks throughout the interviews, as well as sanitize and en-
suring proper aeration. During the interview, the investigators will ask questions regarding incor-
porating health IT and peer delivery for improving medication adherence and control of blood 
pressure among hypertensive patients in PT4A participating communities.  
Outcomes and Analysis: All FGDs and KII audio-recordings will be transcribed and translated 
into English by the research team, and all translated interviews will be double-checked for accu-
racy. We will perform content analysis of the transcripts and notes using NVIVO software.140
Specific quotations, group interactions, and observations will be assigned codes based on con-
tent. Two co-Is will code two transcripts independently, after which they will compare codes, ar-
rive at consensus, and develop a coding list with definitions for the remaining transcripts. In or-
der to assess inter-coder reliability, we will randomly select 10% of transcribed pages to be 
coded by two co-Is, and the Kappa-statistic will be calculated. Discrepancies will be adjudicated 
by a third qualitative research co-I. We will then search the remaining transcripts for the follow-
ing deductive (a priori) codes: (a) perception of adherence to hypertension medication; (b) per-
ception of HIT; (c) perceptions regarding the role of social support; (d) perception of peer deliv-
ery; and (e) factors that may impact the success of the PT4A strategy. Significant inductive 

PT4A Protocol 1.4 23rd November, 2022 
Page 15 of 86 
(emerging) codes will also be identified, assessing for differences by sex. Coded items will be 
grouped into a hierarchical, branching structure in which broad concepts are first identified. 
Then themes and interpretive ideas emerging from those constructs are labeled using constant 
comparison techniques, and subsequently synthesized using matrices structured by the main 
themes of the analysis.141,142 Findings from the FGDs and KIIs will inform the HCD strategy re-
finement (Sub-Aim 1.1). 
Limitations and Alternative Strategies: We may have trouble recruiting for the FGDs. To mitigate 
this, we will adhere to the principles of community engagement as described above, and hold 
sensitization sessions among potential participants. Given our success recruiting for similar re-
search recently,91,109 we do not anticipate that this will be a significant issue. It is also possible to 
assess for these factors using a more quantitative approach. However, using the proposed type 
of qualitative methods, our team has successfully uncovered novel factors that have informed 
and impacted the implementation of previous strategies.91,143,144 It is possible that we will identify 
factors that are not aligned with the planned components of the PT4A strategy; in this scenario, 
we will incorporate those factors into the human-centered design approach described in Aim 2. 
Aim 2: Use a human-centered design approach to refine and adapt the PT4A strategy (to 
be implemented following completion of Aim 1 activities) 
We will pursue a participatory, iterative design process122,123,145 and assemble a human centered 
design (HCD) team consisting of individuals representing stakeholder groups: research team, 
clinicians, pharmacists, peers, and patients with hypertension, informatics staff, and other pro-
viders involved in hypertension care. The design process will involve three phases: brainstorm-
ing, conceptualization, and creation. During brainstorming, the facilitator will review relevant in-
formation on adherence to hypertension medications, findings from Aim 1, and the PT4A proto-
type core principles and characteristics. In the conceptualization phase, the team will evaluate 
advantages and disadvantages of ideas resulting from brainstorming, and arrive at consensus 
regarding importance, feasibility, and congruence to the PT4A strategy goals,146,147 in order to 
more concretely refine the strategy. In the creation phase, we will develop the refined PT4A 
strategy. Educational (for patients) and training (for peers) materials will be developed in Eng-
lish, Kiswahili, and other local languages as appropriate, using standard approaches to transla-
tion and back-translation.  
Core components of the PT4A strategy will include a HIT component and a peer delivery com-
ponent. Prototype characteristics of each are described as follows (Figure 3). 
Health Information Technology: All of the HIT components will build upon, and be aligned with, 
the AMPATH Informatics infrastructure that has been established. We are working with leadership 
of the AMPATH Informatics program to ensure full alignment. Our PT4A intervention will augment 
AMRS to support peer-based delivery in four ways: 1) decision support and tailored adherence 
counselling: provide a patient-level and historical adherence summary that includes pill count, 
self-report, and clinical data synced with AMRS to generate tailored adherence counselling; 2) 
teleconsultation: facilitate teleconsultation via text or phone call between peers and clinicians; 3) 
tracking and accountability: provide timely prompts to peers when refills are near due, and capture 
participant signature to confirm receipt of medications to improve accountability; and 4) analytics: 

PT4A Protocol 1.4 23rd November, 2022
Page 16 of 86
patient-level medication use 
analytics to predict future 
stock requirements for phar-
macy supply chain. The 
specific design and imple-
mentation of the above will 
be iteratively improved via 
the participatory design pro-
cess, as described in Sub-
Aim 1.1. Each peer will be 
equipped 
with 
a 
tablet 
loaded with the AMRS-POC 
software and specific en-
counter forms and other fea-
tures associated with the 
HIT component of the PT4A 
intervention. A Programmer 
will be hired as part of the 
Research staff, in coordina-
tion with the AMPATH infor-
matics Program and ap-
proval by the Moi Research 
and Sponsored Projects Of-
fice and they will provide 
technical support and training for the peers. 
Peer Delivery: This component will involve trained and paid peer-delivery agents who will cover 
a prescribed catchment area associated with each health facility in the intervention arm. Peers 
will play three roles: 1) Drug delivery: peers will deliver medication refills to the patient at a con-
venient location and time. Upon enrollment, clinical data from the AMRS, including the partici-
pant’s current prescription and the next refill date, will be sent by AMRS to the pharmacy staff, 
in order for them to package the medication. Each patient’s prescriptions will be individually 
packed in standard manufacturer-issued blister packs, which will be packaged in single-seal 
bags to prevent pilferage. A prompt will also be sent by AMRS to the peer, who will confirm with 
the patient delivery details (which drugs, quantity, location, date, and time for delivery). The peer 
will pick up the medication package from the pharmacy at the health facility and then deliver the 
medication to the patient, who will confirm receipt by digitally signing on the HIT tool. The peer 
will then request the next installment of medications from the pharmacy (via AMRS), accounting 
for any pills that the patient did not consume and are remaining in the blister pack. The peer will 
continue this cycle of medication delivery until the patient returns to the health facility for a fol-
low-up clinic visit, when a new prescription will be issued by the clinician to the patient. The peer 
will then start a new prescription refill cycle for the patient. 2) Psychosocial support and adher-
ence counseling: leveraging the peer-patient relationship,148 and using the HIT-generated ad-
herence data, the peer will provide adherence counseling and psychosocial support to patients 
at the time of medication delivery to address individual-level adherence barriers and any new 
issues that may have been discovered during Aim 1 activities. Peers will be trained in motiva-
tional interviewing, health coaching, and psychosocial support.149 3) Enhance patient activation: 
peers will use health coaching strategies to address concerns regarding medications, hyperten-
sion and other NCDs, and relationship with clinicians, thereby enhancing patient activation. 
Training, mentorship, supervision and monitoring of clinicians and peers on clinical content will 
be performed by the clinician investigators on the study who are qualified to do so, 
Figure 3. Summary of the PT4A components

PT4A Protocol 1.4 23rd November, 2022 
Page 17 of 86 
complemented by the standard CDM training that is organized by CDM leadership and clini-
cians. Research assistant led training and supervision of peers will be limited to research re-
lated SOPs and other research content. 

PT4A Protocol 1.4 23rd November, 2022 
Page 18 of 86 
Sub Aim 2.1: Evaluate The Intervention For Acceptability And Appropriateness. 
This will be implemented following completion of Aim 2 activities and analysis 
Sub Aim 2.2: Conduct A Pilot of the Intervention and Evaluate Feasibility.  
We will also conduct a pilot of the strategy for up to 1-year and conduct further FGDs to evalu-
ate feasibility. We will select three pilot health facilities, one from each county. We will hire one 
peer delivery agent per facility, train them in core roles and responsibilities, and equip them with 
tablets. Each peer will be 
stationed at a specific 
health facility and will be 
able to communicate di-
rectly with the clinicians, 
pharmacy staff, and pa-
tients. To maintain patient 
confidentiality, all research 
staff and peers will receive study specific training on the need to at all times maintain participant 
confidentiality, in addition to receiving training in good clinical practice (GCP) and human sub-
jects’ protection (HSP) training. The HIT platform builds on the AMPATH OpenMRS system 
which encompasses patient data protection measures such as restricted access to authorized 
users only, which will further maintain patient confidentiality. We will recruit up to 100 patients 
from among these three facilities, targeting an equal number per county. In case there is a re-
port of an adverse reaction to medications or new symptom by the participant to the peer during 
the pilot phase of the study, all peer navigators will be guided by a decision support system built 
into the HIT that will require the prompt notification of one of the two local pharmacist investiga-
tors in the study, as well as the patient’s clinician. The peer will contact directly both the phar-
macist investigator(s) and the appropriate clinician. Swift action will be taken based on the ad-
visement of the clinician. Inclusion criteria will include age greater than 18 years, and currently 
enrolled in the AMPATH CDM program. Exclusion criteria will include acute illness requiring im-
mediate medical attention, terminal illness, or inability to provide informed consent. 
We will collect data through a survey on process and implementation measures such as com-
pleteness of the peer delivery, satisfaction of the patients, patient activation, and fidelity of deliv-
ery strategy. We will conduct FGDs with patients and clinicians then conduct KII (Key informant 
interviews) with the peer delivery agents, focusing on contextual issues impacting implementa-
tion, suggestions for modifications, and concepts of feasibility (Table 3).The target group size for 
the FGDs is 6-10 participants but If there are insufficient numbers, we will accommodate a 
smaller size. FGD transcripts, data management, and analysis will be performed as described 
above. We have used this approach previously with success.80,91,112,150  
We will evaluate the impact of the pilot on absolute mean change in SBP and medication adher-
ence from baseline to up to 1 year. The primary adherence outcome is the pill count adherence 
ratio,151 which is the proportion of prescribed doses taken over a 1-month time period, assessed 
at the end of the pilot. The primary implementation outcome is fidelity, measured as quantity 
and quality of intervention delivery as intended,152 comprised of three components: confirmed 
medication delivery documented by patient e-signature, peer completion of the HIT form, and 
quality of data entry into the HIT form. 
We will also create a retrospective comparator group of CDM patients, by querying AMRS, 
matched by sex, age, location and by initial blood pressure level. We will use their recorded 
blood pressure over time and compare the 3, month, 6 month and 1 year change in blood 
pressure to those of the patients receiving the PT4A intervention to evaluate the magnitude and 
variance of the intervention effects. 

PT4A Protocol 1.4 23rd November, 2022 
Page 19 of 86 
Rigor and Reproducibility 
In addition to the rigorous study design described above, as well as the consideration of rele-
vant biological variables including sex, we will create a data archive that will contain raw study 
data (no personal identifiers). This will be available to other investigators upon formal request 
made to the AMPATH Research Manager, following the publication of the primary analyses of 
the project, and after the data have been appropriately checked, cleaned and de-identified. The 
archive will reside on a server for which appropriate firewalls and other forms of data protection 
will be installed for maximum security. Prospective users will complete an application for use of 
the data, which will include queries about the users’ project hypotheses and proposed analyses. 
All NIH regulations and restrictions as well as HIPAA Security Rules regarding personal health 
information will be observed. 
Study Procedures, Materials, and Potential Risks
Aim 1: Qualitative data will not contain any patient identifiers. These data include transcripts of 
FGDs and KIIs, and observation notes. FGDs and KIIs will be digitally audio-recorded and up-
loaded with a coded identification number (no identifying names) as an audio file to an electroni-
cally secure database on a password-protected computer. These research data will be stored in 
a password-protected electronically secure database on a password-protected computer that 
will be known only to key research team members and the Study Coordinator. Once uploaded to 
the electronically secure database, the data will be deleted from the digital recording device. 
Any documents containing identifying information and consent documentation will be separated 
and added to the site’s secure storage locker. Electronically captured data will transfer to the re-
search database at the time of entry into the handheld device through a secure connection tun-
nel. All data on mobile devices will be encrypted and stored on the device’s internal memory. All 
paper data collection forms will be reviewed by the Study Coordinator and Data Manager for 
completeness. Once validated, any sheets containing directly identifiable information and con-
sent documentation will be separated and added to the site’s secure storage locker. The re-
maining, de-identified pages will then be placed in a separate storage locker prior to data entry. 
Only key investigators and study personnel will have access to individually identifiable private 
information about human subjects. Transcription of the audio files will occur in Kenya. These 
transcripts will also be stored in an electronically secure database on a password-protected 
computer.  
 
Aim 2, Sub-Aim 2.1 and Sub-Aim 2.2: All clinical patient-level data will be entered into the AM-
PATH Medical Record System (AMRS) as per AMPATH’s standard operating procedures. A 
separate, password-protected research database will retrieve data from AMRS via access that 
will be controlled through user authentication. All data collected on paper forms will be trans-
ferred to the password-protected REDCap research database hosted by Moi University, using 
double data entry. Electronically captured data will be collected using the REDCap Mobile App, 
which enables offline data collection, then transferred to the password-protected REDCap re-
search database through a secure connection tunnel. All data on mobile devices will be en-
crypted and stored on the device’s internal memory. All paper data collection forms will be re-
viewed by the Study Coordinator and Data Manager for completeness and the presence of pre-
specified “danger” values. Once validated, any sheets containing directly identifiable information 
and consent documentation will be separated and added to the site’s secure storage locker. The 
remaining, de-identified pages will then be placed in a separate storage locker prior to data en-
try. Only key investigators and study personnel will have access to individually identifiable 

PT4A Protocol 1.4 23rd November, 2022 
Page 20 of 86 
private information about human subjects. Qualitative data will be collected and handled in the 
same manner as Aim 1 above. 
All research activities will be performed by CITI-certified research staff members. All data will be 
stored on dedicated, password-protected computers. Any data stored on portable media will be 
PGP-encrypted, in order to ensure security of the data. Paper forms will be stored for the dura-
tion of the study, and for one year following in order to allow verification of any data as needed 
for reporting and publication purposes. The paper forms will then be shredded. The electronic 
data with a coded identification number only (and no identifying names) may be kept indefinitely, 
in a secure manner as described above. Many of the questions used in this study carry a mini-
mal risk of harm. Some of the questions in the focus group discussions, and interviews may be 
personal and may be considered sensitive or embarrassing. However, the project personnel will 
take measures to ensure that each subject’s confidential information is secure and cannot be 
linked back to one’s identity by anyone not involved in the study. Furthermore, there could be 
personal psychological stress related to a newly diagnosed health condition.  
Known Potential Benefits  
The benefits to the study participants are two-fold. First, the information and data collected in Aim 
1 will impact the implementation of strategies which enhance the adherence to hypertension med-
ications and we will be able to modify its implementation based on the results of the research. 
Thus, the results of the research have the potential to decrease the cardiovascular risk, morbidity 
and mortality associated with elevated blood pressure. In addition, the cluster randomized trial, 
multiple-criteria decision analysis, and spatial analysis results will reveal important information 
that will benefit the stakeholders and subjects involved in the research, as well as to other indi-
viduals not directly involved in the research. We feel strongly that the benefits of such knowledge 
and the potential impact on the implementation of AMPATH’s chronic disease management pro-
gram greatly outweigh the minimal risks of the research procedures as described in the Research 
Strategy. 
 
The knowledge gained from this study will also yield a direct benefit to the communities residing 
in Bungoma, Trans Nzoia, and Uasin Gishu Counties due to the direct applicability of the results 
to program implementation. In addition, other clinical sites within the AMPATH network will also 
benefit from the results of this research. Finally, other resource-poor communities in low-, middle-
, and high-income countries may benefit from the results and insights generated from this project. 
 
In sum, we believe that this project involves minimal to low risk to the research subjects. Research 
subjects themselves stand to benefit substantially from the research activities. In addition, the 
benefit of the information obtained and disseminated to the study population as well as the greater 
population of Kenya, and its use to design scalable medication adherence interventions for 
chronic disease management, far outweigh the risks associated with this study. The projects ex-
pected benefits far exceed the expected risks, and therefore has a very low risk-benefit ratio. 
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Adequacy of Protection Against Risks 
A. Informed Consent and Assent 
The study team will consist of local personnel and individuals from western Kenya who are familiar 
with the region. With the support of AMPATH and community leadership, the key investigators 
and Study Coordinator from MTRH will approach the subjects involved in Aim 1 in-person. Written 

PT4A Protocol 1.4 23rd November, 2022 
Page 21 of 86 
consent will be obtained from each individual. Consent forms will standardize the description of 
the study and will be given to each subject. For Aim 1, activities requiring a consent form are the 
key informant interviews and focus group discussions. At the end of the subject’s reading, the 
interpreter will ask the subject if s/he has any questions. Study candidates will be provided infor-
mation in terms that they can fully understand, not exerting any overt or covert coercion. A consent 
document will be used that is written and explained in the language that the potential subject 
understands (Kiswahili or English). Extreme care will be taken to fully explain the benefits and 
risks of the research before consent is obtained. The consent forms will be written in lay terminol-
ogy at approximately 6th grade level. For Aim 1, the study subjects will provide written informed 
consent prior to any focus group discussion or key informant interview. 
 
For Aim 2, the clinician will invite AMPATH CDM Program patients with uncontrolled hypertension 
and who are eligible for the study from the health facility to enroll in the study on the day of their 
routine clinic visit. On that day, research team members will describe the research study and the 
study protocol, and ensure the patient meets eligibility criteria. For patients randomized to the 
PT4A intervention arm, participants of will be informed the Health Information Technology (HIT) 
functionality and the availability of peer delivery agents who can deliver the medications to them. 
As above, extreme care will be taken to fully explain the benefits and risks of the research study, 
before consent is obtained. Written informed consent will be obtained from all participants. For 
Aim 2, activities requiring a consent form are the human-centered design FGD and the human-
centered design survey. For Aim 2.1, a consent form will be developed and implemented to obtain 
written informed consent to participate in the FGD. Finally, for Aim 2.2, consent forms will be 
developed and implemented to obtain written informed consent in the Aim 2.2 FGD and partici-
pation in the pilot study. The consent forms will be written in lay terminology at approximately 6th 
grade level. For FGDs, written informed consent will be obtained in the same manner as above. 
 
Individuals will be free to refuse to participate in the study at any time during the period of the 
study. A refusal will not impact the health care available to the individual in any manner. Access 
to care will not be impacted in any manner by an individual’s decision to opt out of this research 
project. 
 
AMPATH’s Chronic Disease Management program in western Kenya provides clinical care for 
diabetes and hypertension using a robust and evidence-based clinical protocol, and is available 
at the rural health facilities (all government of Kenya primary care facilities) in this region. This 
care program includes facility-based testing and counseling, referral to the nearest appropriate 
health facility, clinical care at the health facility, and follow-up as required. All of the nurses and 
clinical officers who staff the chronic disease management program at the health centers and 
rural dispensaries have been trained in hypertension management according to the AMPATH 
protocol. Both the management protocol and the chronic disease management trainings have 
been developed jointly with the Ministry of Health and the District Health Management Team 
(DHMT) (Government of Kenya). In addition to an initial training workshop, continuing medical 
education sessions are organized every quarter during which hypertension and other topics are 
covered. Refresher trainings are also planned on an annual basis in order to update and assess 
nurses’ knowledge and practices regarding hypertension management. Finally, AMPATH has 
used novel and innovative smartphone technology to create a clinical decision support and rec-
ord-keeping system for the clinicians at the health facilities, in order to ensure that the 
standard-of-care AMPATH hypertension management protocol is adhered to by the practitioners. 
All individuals with hypertension or suspected hypertension are provided care in these clinical 
settings. In addition to AMPATH CDM Program described above, clinical care is available at mis-
sion hospitals, private clinics, and referral hospitals, and every individual will be informed of 

PT4A Protocol 1.4 23rd November, 2022 
Page 22 of 86 
his/her option to receive care at any of these health facilities. All individuals will be able to attend 
any of these health facilities for care, and this will not be impacted in any manner by an individual’s 
decision to opt out of this research project. This will be made clear during the informed consent 
process. 
B. Protections Against Risk 
The following principles and procedures for data collection will be followed at the research site in 
order to minimize risk and protect confidentiality:  
 
Data will be collected on coded forms, which do not include other personal identifiers. 
 
Only the tracking form will have the participant’s name and identifiable information. 
 
Study records will be stored in locked cabinets in a locked room only accessible by key 
staff at MTRH in Eldoret, Kenya. 
 
Only the study personnel will have access to the data and the codes. 
 
All computerized information will be protected by access codes known only to key inves-
tigators and certain designated staff members. 
 
No data will be published with participant names. 
 
Data that are contained on a digital audio recording device will be PGP-encrypted and the 
only identifying information captured during the recording will be the recording of the par-
ticipants’ voices. 
 
 
 
All staff members will be trained to keep participants' information confidential, and will be 
informed of the penalty for breach of confidentiality. 
 
Any data accessed by NYUGSoM study personnel will be viewed and stored only on 
MCIT-approved computers and software. 
 
The consent form signed by the participant will provide written assurance that all individual data 
collected in the study will be kept confidential to the extent provided by the Privacy Act of 1974. 
AMPATH will provide file security so that confidential data are not released. Specifically, partici-
pants will be informed that: (1) the only people who will know that they are research participants 
are members of the research team and, if appropriate, their physicians or health care providers; 
(2) no individual identifying information about them will be disclosed to others, except if required 
by law; and (3) when the results of the study are published or discussed in 
conferences, no information will be included that would reveal their identity. Any material that is 
digitally audio-recorded will be uploaded with a coded identification number (no identifying names) 
as an audio file to an electronically secure database  The only identifying information captured 
during the recording will be the recording of the participants’ voices. These research data will be 
stored in an electronically secure database protected by password that will be known only to the 
Principal Investigator and the Study Coordinator. Once uploaded to the electronically secure da-
tabase on a password-protected computer, the data will be deleted from the digital recording 
device to protect confidentiality and minimize the risk of breach of confidentiality. Transcription of 
the audio files will occur in Kenya by trained research team members who have undergone human 
subjects research training certification. Transcripts will not be shared with anyone outside of the 
study team. 
 
All clinical patient-level data will be entered into the AMRS as per AMPATH’s standard operating 
procedures. A separate, password-protected research database will retrieve data from AMRS via 
access that will be controlled through user authentication. All data collected on paper forms will 
be transferred to the research database using double data entry. Electronically captured data will 
transfer to the research database at the time of entry into the handheld device through a secure 

PT4A Protocol 1.4 23rd November, 2022 
Page 23 of 86 
connection tunnel. All data on mobile devices will be encrypted and stored on the device’s internal 
memory. 
All data management will be carried out by CITI-certified research staff members, and all data will 
be stored on dedicated, password-protected computers. Paper forms will be stored for the dura-
tion of the study, and for one year following in order to allow verification of any data as needed 
for reporting and publication purposes. The paper forms will then be shredded. The electronic 
data with a coded identification number only 
(and no identifying names) may be kept indefinitely, in a secure manner as described above. Data 
containing residential locations/addresses (person-identifiers) are considered highly sensitive 
 
To prevent inadvertent disclosures and ensure subject confidentiality, data entry and document 
storage for materials containing directly identifiable information (i.e., coversheets) will be handled 
by key investigators or the Study Coordinator. The Study Coordinator will be responsible for the 
secure handling and storage of survey documents for the duration of research activity at the study 
site. Once activities have been completed, coversheets will be collected and forwarded to the 
AMPATH research office, where they will be stored in a secure, locked cabinet within a secure, 
locked room. To minimize the number of people with access to the 
coversheet data, all data entry will be conducted under the direct supervision of the Study Coor-
dinator. Once identifiable data has been entered as described, paper-based documents will be 
returned to secure storage. Data collected in the study will be used for research purposes only. 
The results of this research project will be summarized for reports and may be summarized for 
presentation at meetings or in publications. No individual identities will be disclosed in any of 
these reports or presentations. Furthermore, No data will be reported on an individual basis; all 
findings will be presented in aggregate form.  
 
We recognize that “macro-level” structural and environmental factors such as cost of medicines 
and poorly equipped health facilities may be more important than the peer delivery and HIT inter-
vention. However, addressing these macro-level factors is integral to the AMPATH CDM Pro-
gram’s operations, which have already been universally applied to all of the rural health facilities 
throughout the research catchment area. For instance, AMPATH has established community-
based revolving fund pharmacies to ensure that there is adequate stock of the required medica-
tions in every rural health facility. The rural health facility committees described above are inti-
mately involved with the establishment of these revolving fund pharmacies, in order to ensure 
community participation, ownership, and empowerment. The AMPATH pharmacy team has a 
pharmacy technician designated to supervise these revolving fund pharmacies and ensure ac-
countability, proper storage and record-keeping. Likewise, the AMPATH CDM Program has 
equipped the rural health facilities with blood pressure machines, filing cabinets, desks, and other 
infrastructure to facilitate the clinical care program. In addition, the CDM program has consciously 
chosen to implement the clinical care program in the rural health facilities precisely because of 
proximity to the local communities, villages, and households. Moreover, as described above, AM-
PATH has developed a training curriculum jointly with the MOH and the DHMT that addresses 
both the theoretical and practical aspects of diabetes and hypertension management. Combined 
with the clinical decision support, AMRS, mentorship, and supervision described above, AMPATH 
is implementing comprehensive strategies to optimize the human resources dedicated to hyper-
tension management in this region. Finally, the AMPATH Safety Net Program is actively engaged 
in income-generating and financial security activities for the communities of western Kenya, in 
order to address the economic situation confronted by those populations. We feel that AMPATH’s 
efforts to address these macro-level factors will both address human subjects concerns, as well 
as support the implementation of the intervention strategy described in the grant application. 

PT4A Protocol 1.4 23rd November, 2022 
Page 24 of 86 

PT4A Protocol 1.4 23rd November, 2022 
Page 25 of 86 
MILESTONES
The milestones to be achieved for this portion of the project are listed in Table 4, along with details 
of each milestone’s objectives, activity, target completion date, performance goal and metric, and 
anticipated challenges and mitigation strategies. 

PT4A Protocol 1.4 23rd November, 2022 
Page 26 of 86 
 
Aim
Milestone
Objective
Activity
Completion Date
(Month)
Performance Goal
Performance 
Metric
Data Source
Anticipated Challenges and Potential Mitigation
Develop study 
protocols and 
standard operating 
procedures 
M2
100% of SOPs 
completed 
# of SOPs started, 
% finalized
Completed SOP 
document 
Challenge: Delays in coordinating SOPs across multiple 
regions
Mitigation:  Regular conference calls among 
investigators and research team members, clear and 
enforced deadlines
Develop data 
collection tools
M2
100% of data 
collection tools 
finalized by completion 
date
# of data collection 
tools initiated, % 
successfully 
completed
Data collection tools 
records
Challenge:  Delays in creating uniform data collection 
tools across multiple regions
Mitigation:  Regular conference calls among 
investigators and research team members, rigorous pilot 
testing, consensus-building activities
Receive IRB 
approval
M2
100% protocol 
approved by all parties 
by completion date
% approval 
received from 
required parties
Finalized protocol 
and supporting 
documents
Challenge: Delays in receiving approval for all updated 
study material
Mitigation:  team will work with the IRBs to streamline 
approval process and will create a strategic plan to 
ensure content quality and completeness
Hire and training of 
staff
M3
(and ongoing as 
new staff are hired)
100% of staff hired 
and trained by the 
target completion date
# of new staff hired 
and trained on 
relevant study 
methods
Sign-in sheets from 
trainings
Challenge:  Unforeseen barriers related to HR hiring 
policies and procedures at individual institutions
Mitigation:  Incorporate additional time for any additional 
unforeseen time barriers/institutions requirements that 
may delay onboarding and training of new staff, and 
adjust training schedule as necessary
Obtain human 
subjects training 
certification
M3
(and ongoing as 
new staff are hired)
100% of staff have 
completed human 
subjects certification 
by target completion 
date
# staff that have 
successfully 
completed human 
subjects training
Training record log 
and documented 
CITI certifications
Challenge :   Human subjects research may take longer 
than anticipated.
Mitigation:  Research coordinator will create and review 
a training record log on a weekly  basis of all research 
staff, and report to PI.
Develop  and 
conduct pre-tests of 
qualitative interviews 
and discussion 
guides 
M2
100% of all interview 
and discussion guides 
developed; & 100% of 
all pre-tests conducted 
# of interviews and 
discussion guides 
completed 
Finalized interview 
and discussion 
guides 
Challenge:  Delays in creating uniform interview and 
discussion guides across multiple regions and countries 
Mitigation:  Regular conference calls among 
investigators and research team members, rigorous pilot 
testing, consensus-building activities
Conduct in-depth key 
informant interviews 
and FDG's
M5
100% of all interviews 
conducted 
# of interviews 
conducted
Interviews 
Challenge: All interviewees may not be available to be 
interviewed at scheduled times 
Mitigation:  Research coordinator and research 
assistants to schedule all participants with backup times 
scheduled as necessary 
Transcribe and 
translate interview 
recordings 
M5
100% of all interview 
recordings transcribe 
and translated 
# of interviews 
conducted, 
translated, and 
transcribed
Interview transcripts 
Challenges:  Lengthy interview recordings; multiple 
language translation required
Mitigation:  Allocate more time for transcription and 
translation 
Create data analysis 
code book 
M5
100% of code books 
developed 
# of code books 
developed by 
research team
Code books 
Challenge:  Difficulties in creating uniform coding 
scheme across multiple regions
Mitigation: Regular conference calls among qualitative 
investigators and analysts; Kappa statistic threshold
Code and analyze 
qualitative data 
M6
100% of transcripts 
coded and analyzed
# transcripts coded 
and analyzed
NVivo database 
Challenge:  Difficulties in harmonizing qualitative data 
analysis across multiple regions 
Mitigation:  Documenting context-specific differences 
that arise from the transcripts; ensure that qualitative 
analytic team consists of individuals representing all 
regions and countries
1. Human-
centered design 
process
Conduct human-
centered design 
process
M8
100% of 
brainstorming, 
conceptualization, and 
creation of process 
completed
# of HCD sessions 
completed
Sign-in sheets from 
sessions
Challenge: Difficulty assembling HCD team with 
addequate representation of all key stakeholders, and 
difficulty scheduling sufficient sessions based on 
stakeholder and project staff availability
Mitigation:  Incorporate additional time for any additional 
unforeseen time barriers/institutions requirements that 
may delay recruitment and implementations, and adjust 
schedule as necessary
Conduct FGDs with 
patients, peers and 
clinical staff
M9
100% of all interviews 
conducted 
# of interviews 
conducted
Interviews 
Code and analyze 
qualitative data 
M9
100% of transcripts 
coded and analyzed
# transcripts coded 
and analyzed
NVivo database 
Pilot implementation
M11
100% of pilot activities 
implemented
# of patients who 
were recruited and 
received pilot 
intervention
REDCap database
Challenges: Unforeseen delays in county engagement; 
lower-than-anticipated enrollment
Mitigation:  Community-based screening events, 
community entry, clinician engagement, approval from 
clinic and regional administrators 
Feasibility Testing
M12
100% of testing 
activities completed
# of FGDs 
completed
Interviews 
Challenge: All challenges from qualitative data collection 
from Aim 1 above will apply
Mitigation:  All mitigation from qualitative data collection 
from Aim 1 above will apply, as appropriate
Analysis
M12
100% completion of 
pilot data analysis
% of pilot data 
analysis completed
Pilot data collected 
on REDCap and 
Nvivo
Challenge: Incomplete data from implementation phase 
Mitigation: An algorithm that factors in missing data will 
be developed prior to data collection
Publications and 
abstracts related to 
the aims
1. Complete 
publications and 
abstracts related 
for Aims 1 and 2
Prepare and submit 
publications and 
abstracts for peer 
review to relevant 
journals
M8, M12
100% of planned 
publications and 
abstracts submitted for 
review
# of abstracts and 
publications 
submitted
All data collected 
and analyzed from 
Aim 1&2
Challenge:  delay in data collection and subsequent 
analysis, thus preventing writing initiation and completion
Mitigation: incorporate additional time for completion of 
writing of publications 
1. Identify target 
study population 
for subsequent 
R01
Rank potential study 
regions according to 
MCDA results and 
other factors
M7
100% of study sites 
selected
# of clusters and 
health facilities 
selected
MCDA results; Aim 
1 results
Challenges:  All challenges from Aim 1 and Aim 2 
Milestone activates below will apply; in addition, ranking 
might be subject to differential weighting. 
Mitigation: All mitigation strategies from Aim 1 and Aim 
2 Milestone activities will apply; in addition, all 
investigators and relevant stakeholders if appropriate, will 
discuss and ultimately arrive at consensus for all study 
regions, study sites, and health facilities to be included in 
the subsequent R01
Reach out to and 
meet with key 
stakeholders for 
collaboration 
(community 
members, healthcare 
workforce, and policy 
makers)
M7
100% stakeholder 
representation 
reached from 
community members 
and leadership, 
healthcare workforce, 
and policy makers 
across all enrollment 
institutions
# of stakeholders 
engaged at each 
enrollment 
institutions 
Stakeholder 
meetings and 
signed letters of 
engagement 
agreements
Recruit and establish 
collaboration with 
baseline facilities
M7
100% of facilities 
recruited as baseline 
study sites
# of facilities 
recruited for 
qualitative activities
Stakeholder 
meetings and 
signed letters of 
engagement 
agreement from 
medical 
superintendents 
3. Submit R01 Grant 
Application
Prepare and submit 
R01 grant application
M7
100% of grant 
submission activites 
completed by 
appropriate NIH 
deadline
1 R01 submitted 
grant
Analysis results from 
Aim 1 and 2 as 
available
Challenge: delay in data collection and subsequent analysis, 
thus preventing possibility of completion of R01 application
Mitigation:  incorporate additional time for R01 grant 
application submission, based on NIH deadlines, if necessary
2. Hire and train 
research team
2. Analyze 
qualitative data 
Preparatory Phase
1. Conduct 
qualitative 
interviews (Focus 
Group 
Discussions and 
Key Informant 
Interviews)
1. Develop  
standard 
operating 
procedures and 
study protocols 
Aim 1
Identify micro- and 
macro-level contextual 
factors that might 
influence the 
implementation of the 
PT4A strategy
Conduct a thorough 
baseline contextual 
assessment of 
barriers and 
facilitators for 
implementing PT4A
Refine the peer 
delivery and HIT 
components
Aim 2
Use a human-centered 
design approach to 
refine and adapt the 
PT4A strategy 
3. Conduct a pilot 
of the 
intervention and 
evaluate 
feasibility. 
2. Establish 
collaborative 
partners for 
subsequent R01
Challenge:  Difficulty of access due to the geographical 
location of facilities may be underestimated; stakeholders 
might be hesitant to collaborate
Mitigation:  A two-week buffer period will be provided for 
qualitative interviews with unforeseen access challenges; 
engage in community entry activities; attempt to align 
project objectives with interests of all stakeholder parties.
Subsequent R01 
grant submission
Research Products
2. Acceptability 
and 
appropriateness 
testing
Challenge: All challenges from qualitative data collection 
from Aim 1 above will apply
Mitigation:  All mitigation from qualitative data collection 
from Aim 1 above will apply, as appropriate

PT4A Protocol 1.4 23rd November, 2022 
Page 27 of 86 
TABLE 4: PT4A MILESTONES1 
Timeline  
 
 
M1
M2
M3
M4
M5
M6
M7
M8
M9
M10
M11
M12
Finalize protocol manuals
Finalize standard operating procedures
Develop data collection tools
IRB approval
Hire and train staff
Focus Group Discussions
Key Informant Interviews
Analysis
Human-Centered Design Process
Sub-Aim 2.1
Acceptability and Appropriateness Testing
Sub-Aim 2.2
Pilot Implementation
Feasibility Testing
Analysis
Community dialogue and input
*
*
*
*
*
*
*
International Advisory Committee Meetings
x
x
International Conferences
§
§
Publications
‡
‡
R01 Grant Application
Research Products
Aim 1
Preparatory Phase
Aim 2

PT4A Protocol 1.4 23rd November, 2022 
Page 28 of 86 
REFERENCES
1. GBD 2017: a fragile world. Lancet 2018;392:1683. 
2. Global, regional, and national comparative risk assessment of 84 behavioural, environmental 
and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-
2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 
2018;392:1923-94. 
3. Forouzanfar MH, Liu P, Roth GA, et al. Global Burden of Hypertension and Systolic Blood 
Pressure of at Least 110 to 115 mm Hg, 1990-2015. JAMA : the journal of the American Medical 
Association 2017;317:165-82. 
4. Huffman MD, Lloyd-Jones DM. Global burden of raised blood pressure: Coming into focus. 
JAMA : the journal of the American Medical Association 2017;317:142-3. 
5. Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control of 
hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA 
2013;310:959-68. 
6. Irazola VE, Gutierrez L, Bloomfield G, et al. Hypertension Prevalence, Awareness, 
Treatment, and Control in Selected LMIC Communities: Results From the NHLBI/UHG Network 
of Centers of Excellence for Chronic Diseases. Global Heart 2016;11:47-59. 
7. Mills KT, Bundy JD, Kelly TN, et al. Global Disparities of Hypertension Prevalence and 
Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation 
2016;134:441-50. 
8. Roth GA, Abate D, Abate KH, et al. Global, regional, and national age-sex-specific mortality 
for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for 
the Global Burden of Disease Study 2017. The Lancet 2018;392:1736-88. 
9. Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of 
cardiovascular disease and death: a systematic review and meta-analysis. Lancet (London, 
England) 2016;387:957-67. 
10. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome 
incidence in hypertension. 1. Overview, meta-analyses, and meta-regression analyses of 
randomized trials. Journal of hypertension 2014;32:2285-95. 
11. Bundy JD, Li C, Stuchlik P, et al. Systolic Blood Pressure Reduction and Risk of 
Cardiovascular Disease and Mortality: A Systematic Review and Network Meta-analysis. JAMA 
Cardiol 2017;2:775-81. 
12. Whelton PK. The elusiveness of population-wide high blood pressure control. Annual 
review of public health 2015;36:109-30. 
13. Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics-2017 
Update: A Report From the American Heart Association. Circulation 2017;135:e146-e603. 
14. Stevens B, Verdian L, Pezzullo L, Tomlinson J, Zegenhagen S. The Economic Burden of 
Hypertension in Latin America. Value in Health 2016;19:A647-A8. 
15. Wang G, Fang J, Ayala C. Hypertension-associated hospitalizations and costs in the United 
States, 1979-2006. Blood pressure 2014;23:126-33. 
16. Gheorghe A, Griffiths U, Murphy A, Legido-Quigley H, Lamptey P, Perel P. The economic 
burden of cardiovascular disease and hypertension in low- and middle-income countries: a 
systematic review. BMC public health 2018;18:975. 
17. Owolabi M, Olowoyo P, Miranda JJ, et al. Gaps in Hypertension Guidelines in Low- and 
Middle Income Versus High Income Countries: a Systematic Review. Hypertension (Dallas, Tex 
: 1979) 2016;68:1328-37. 
18. De Geest S, Zullig LL, Dunbar-Jacob J, et al. ESPACOMP Medication Adherence 
Reporting Guideline (EMERGE). Annals of Internal Medicine 2018;169:30-5. 

PT4A Protocol 1.4 23rd November, 2022 
Page 29 of 86 
19. Perreault S, Dragomir A, White M, Lalonde L, Blais L, Bérard A. Better adherence to 
antihypertensive agents and risk reduction of chronic heart failure. Journal of internal medicine 
2009;266:207-18. 
20. Lowy A, Munk VC, Ong SH, et al. Effects on blood pressure and cardiovascular risk of 
variations in patients’ adherence to prescribed antihypertensive drugs: role of duration of drug 
action. International journal of clinical practice 2011;65:41-53. 
21. Du L, Cheng Z, Zhang Y, Li Y, Mei D. The impact of medication adherence on clinical 
outcomes of coronary artery disease: A meta-analysis. European journal of preventive 
cardiology 2017;24:962-70. 
22. Simpson SH, Eurich DT, Majumdar SR, et al. A meta-analysis of the association between 
adherence to drug therapy and mortality. BMJ (Clinical research ed) 2006;333:15. 
23. Kim S, Shin DW, Yun JM, et al. Medication Adherence and the Risk of Cardiovascular 
Mortality and Hospitalization Among Patients With Newly Prescribed Antihypertensive 
Medications. Hypertension 2016;67:506-12. 
24. Chowdhury R, Khan H, Heydon E, et al. Adherence to cardiovascular therapy: a meta-
analysis of prevalence and clinical consequences. European heart journal 2013;34:2940-8. 
25. Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA. Medication adherence leads 
to lower health care use and costs despite increased drug spending. Health Affairs (Project 
Hope) 2011;30:91-9. 
26. Peacock E, Krousel-Wood M. Adherence to Antihypertensive Therapy. The Medical clinics 
of North America 2017;101:229-45. 
27. Vrijens B, Antoniou S, Burnier M, de la Sierra A, Volpe M. Current Situation of Medication 
Adherence in Hypertension. Front Pharmacol 2017;8. 
28. De Geest S, Ruppar T, Berben L, Schönfeld S, Hill MN. Medication non-adherence as a 
critical factor in the management of presumed resistant hypertension: a narrative review. 
EuroIntervention 2014;9:1102-9. 
29. Erdine S, Arslan E. Monitoring treatment adherence in hypertension. Curr Hypertens Rep 
2013;15:269-72. 
30. Kim S, Shin DW, Yun JM, et al. Medication Adherence and the Risk of Cardiovascular 
Mortality and Hospitalization Among Patients With Newly Prescribed Antihypertensive 
Medications. Hypertension (Dallas, Tex: 1979) 2016;67:506-12. 
31. Whelton PK, Carey RM, Aronow WS, et al. 2017 
ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, 
Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the 
American College of Cardiology/American Heart Association Task Force on Clinical Practice 
Guidelines. Journal of the American College of Cardiology 2018;71:e127-e248. 
32. World Health O. WHO | ADHERENCE TO LONG-TERM THERAPIES: EVIDENCE FOR 
ACTION. WHO. 
33. Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA. Nonadherence 
to antihypertensive drugs: A systematic review and meta-analysis. Medicine 2017;96:e5641. 
34. Njuguna B, Vedanthan R. Find and Plug the Leak: Improving Adherence to Anti-
Hypertensive Medicines : Editorial to: "Assessing Adherence to Antihypertensive Therapy in 
Primary Health Care in Namibia: Findings and Implications" by M.M. Nashilongo et al. 
Cardiovasc Drugs Ther 2017;31:485-7. 
35. Tran DN, Njuguna B, Mercer T, et al. Ensuring Patient-Centered Access to Cardiovascular 
Disease Medicines in Low-Income and Middle-Income Countries Through Health-System 
Strengthening. Cardiology clinics 2017;35:125-34. 
36. Burnier M, Egan BM. Adherence in Hypertension. Circulation research 2019;124:1124-40. 

PT4A Protocol 1.4 23rd November, 2022 
Page 30 of 86 
37. Macquart de Terline D, Kane A, Kramoh KE, et al. Factors associated with poor adherence 
to medication among hypertensive patients in twelve low and middle income Sub-Saharan 
countries. PLOS ONE 2019;14:e0219266. 
38. Attaei MW, Khatib R, McKee M, et al. Availability and affordability of blood pressure-
lowering medicines and the effect on blood pressure control in high-income, middle-income, and 
low-income countries: an analysis of the PURE study data. Lancet Public Health 2017;2:e411-
e9. 
39. Ambaw AD, Alemie GA, W/Yohannes SM, Mengesha ZB. Adherence to antihypertensive 
treatment and associated factors among patients on follow up at University of Gondar Hospital, 
Northwest Ethiopia. BMC public health 2012;12:282. 
40. Khatib R, Schwalm J-D, Yusuf S, et al. Patient and Healthcare Provider Barriers to 
Hypertension Awareness, Treatment and Follow Up: A Systematic Review and Meta-Analysis of 
Qualitative and Quantitative Studies. PLoS One 2014;9. 
41. Naanyu V, Vedanthan R, Kamano JH, et al. Barriers Influencing Linkage to Hypertension 
Care in Kenya: Qualitative Analysis from the LARK Hypertension Study. J Gen Intern Med 
2016;31:304-14. 
42. Rachlis B, Naanyu V, Wachira J, et al. Identifying common barriers and facilitators to 
linkage and retention in chronic disease care in western Kenya. BMC public health 2016;16:741. 
43. Tamblyn R, Abrahamowicz M, Dauphinee D, et al. Influence of physicians' management 
and communication ability on patients' persistence with antihypertensive medication. Archives of 
internal medicine 2010;170:1064-72. 
44. Schoenthaler A, Knafl GJ, Fiscella K, Ogedegbe G. Addressing the Social Needs of 
Hypertensive Patients: The Role of Patient-Provider Communication as a Predictor of 
Medication Adherence. Circulation Cardiovascular quality and outcomes 2017;10. 
45. Schoenthaler A, Allegrante JP, Chaplin W, Ogedegbe G. The effect of patient-provider 
communication on medication adherence in hypertensive black patients: does race 
concordance matter? Ann Behav Med 2012;43:372-82. 
46. Schoenthaler A, Montague E, Baier Manwell L, Brown R, Schwartz MD, Linzer M. Patient-
physician racial/ethnic concordance and blood pressure control: the role of trust and medication 
adherence. Ethn Health 2014;19:565-78. 
47. Berhe DF, Taxis K, Haaijer-Ruskamp FM, et al. Impact of adverse drug events and 
treatment satisfaction on patient adherence with antihypertensive medication - a study in 
ambulatory patients. British journal of clinical pharmacology 2017;83:2107-17. 
48. Lewis LM, Schoenthaler AM, Ogedegbe G. Patient factors, but not provider and health care 
system factors, predict medication adherence in hypertensive black men. J Clin Hypertens 
(Greenwich) 2012;14:250-5. 
49. Fisher EB, Ballesteros J, Bhushan N, et al. Key Features Of Peer Support In Chronic 
Disease Prevention And Management. Health Affairs 2015;34:1523-30. 
50. Enriquez M, Conn VS. Peers as Facilitators of Medication Adherence Interventions: A 
Review. J Prim Care Community Health 2016;7:44-55. 
51. Haidari A, Moeini M, Khosravi A. The Impact of Peer Support Program on Adherence to the 
Treatment Regimen in Patients with Hypertension: A Randomized Clinical Trial Study. Iran J 
Nurs Midwifery Res 2017;22:427-30. 
52. Nieuwlaat R, Wilczynski N, Navarro T, et al. Interventions for enhancing medication 
adherence. The Cochrane Database of Systematic Reviews 2014:CD000011. 
53. Bosworth HB, Zullig LL, Mendys P, et al. Health Information Technology: Meaningful Use 
and Next Steps to Improving Electronic Facilitation of Medication Adherence. JMIR Med Inform 
2016;4. 

PT4A Protocol 1.4 23rd November, 2022 
Page 31 of 86 
54. Dixon BE, Alzeer AH, Phillips EOK, Marrero DG. Integration of Provider, Pharmacy, and 
Patient-Reported Data to Improve Medication Adherence for Type 2 Diabetes: A Controlled 
Before-After Pilot Study. JMIR Med Inform 2016;4. 
55. Dixon BE, Jabour AM, Phillips EOK, Marrero DG. An informatics approach to medication 
adherence assessment and improvement using clinical, billing, and patient-entered data. 
Journal of the American Medical Informatics Association: JAMIA 2014;21:517-21. 
56. Bloomfield GS, Vedanthan R, Vasudevan L, Kithei A, Were M, Velazquez EJ. Mobile health 
for non-communicable diseases in Sub-Saharan Africa: a systematic review of the literature and 
strategic framework for research. Globalization and Health 2014;10:49. 
57. Vedanthan R, Bernabe-Ortiz A, Herasme OI, et al. Innovative Approaches to Hypertension 
Control in Low- and Middle-Income Countries. Cardiology Clinics 2017;35:99-115. 
58. World Health O. WHO | Impacts of e-health on the outcomes of care in low- and middle-
income countries: where do we go from here? WHO. 
59. Martin MY, Kim YI, Kratt P, et al. Medication adherence among rural, low-income 
hypertensive adults: a randomized trial of a multimedia community-based intervention. Am J 
Health Promot 2011;25:372-8. 
60. Collaborators USBoD, Mokdad AH, Ballestros K, et al. The State of US Health, 1990-2016: 
Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA : the journal of the 
American Medical Association 2018;319:1444-72. 
61. Mainous AG, 3rd, King DE, Garr DR, Pearson WS. Race, rural residence, and control of 
diabetes and hypertension. Ann Fam Med 2004;2:563-8. 
62. Kini V, Ho PM. Interventions to Improve Medication Adherence: A Review. JAMA : the 
journal of the American Medical Association 2018;320:2461-73. 
63. Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, 
and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis 
for the Global Burden of Disease Study 2015. Lancet 2016;388:1545-602. 
64. Zimmermann C, Swami N, Krzyzanowska M, et al. Perceptions of palliative care among 
patients with advanced cancer and their caregivers. CMAJ : Canadian Medical Association 
journal = journal de l'Association medicale canadienne 2016;188:E217-27. 
65. Pino M, Parry R, Land V, Faull C, Feathers L, Seymour J. Engaging Terminally Ill Patients 
in End of Life Talk: How Experienced Palliative Medicine Doctors Navigate the Dilemma of 
Promoting Discussions about Dying. PLoS One 2016;11:e0156174. 
66. Barasa FA, Vedanthan R, Pastakia SD, et al. Approaches to Sustainable Capacity Building 
for Cardiovascular Disease Care in Kenya. Cardiol Clin 2017;35:145-52. 
67. Binanay CA, Akwanalo CO, Aruasa W, et al. Building Sustainable Capacity for 
Cardiovascular Care at a Public Hospital in Western Kenya. J Am Coll Cardiol 2015;66:2550-60. 
68. Bloomfield GS, Xavier D, Belis D, et al. Training and Capacity Building in LMIC for 
Research in Heart and Lung Diseases: The NHLBI-UnitedHealth Global Health Centers of 
Excellence Program. Glob Heart 2016;11:17-25. 
69. Truglio J, Graziano M, Vedanthan R, et al. Global health and primary care: increasing 
burden of chronic diseases and need for integrated training. Mt Sinai J Med 2012;79:464-74. 
70. Miller ML, Karwa R, Schellhase EM, et al. Meeting the Needs of Underserved Patients in 
Western Kenya by Creating the Next Generation of Global Health Pharmacists. Am J Pharm 
Educ 2016;80:22. 
71. Dodd R, Ramanathan S, Angell B, et al. Strengthening and measuring research impact in 
global health: lessons from applying the FAIT framework. Health Research Policy and Systems 
2019;17:48. 
72. Pastakia SD, Schellhase EM, Jakait B. Collaborative partnership for clinical pharmacy 
services in Kenya. American journal of health-system pharmacy : AJHP : official journal of the 
American Society of Health-System Pharmacists 2009;66:1386-90. 

PT4A Protocol 1.4 23rd November, 2022 
Page 32 of 86 
73. . (Accessed July 3, 2019, at http://www.incap.int/ciipec/index.php/en/ciipecenglishv.)
74. Webster R, Parker G, Heritier S, et al. Strategic, Successful, and Sustained Synergy: The 
Global Alliance for Chronic Diseases Hypertension Program. Glob Heart 2019;14:391-4. 
75. Yan LL, Vedanthan R, Mensah GA, et al. Developing the Core Pillars of Training Global 
Cardiovascular Health Researchers: Companionship, Light, and Fuel. Glob Heart 2019;14:387-
9. 
76. Bazzano AN, Martin J, Hicks E, Faughnan M, Murphy L. Human-centred design in global 
health: A scoping review of applications and contexts. PLOS ONE 2017;12:e0186744. 
77. Ideo. Design Kit. 
78. Vedanthan R, Kamano JH, Horowitz CR, et al. Nurse management of hypertension in rural 
western Kenya: implementation research to optimize delivery. Ann Glob Health 2014;80:5-12. 
79. Vedanthan R, Kamano JH, Lee H, et al. Bridging Income Generation with Group Integrated 
Care for cardiovascular risk reduction: Rationale and design of the BIGPIC study. Am Heart J 
2017;188:175-85. 
80. Leung C, Naert M, Andama B, et al. A Human-Centered Design Approach to Develop a 
Microfinance and Group Medical Visit Model for Cardiovascular Risk Reduction in Western 
Kenya (BIGPIC Study) American Heart Association Annual Scientific Sessions; 2017 
November; Anaheim, USA 
81. Pillsbury MM, Mwangi E, Andesia J, et al. Human-centered design for global health 
implementation science: Lessons from the STRENGTHS study in western Kenya.  Consortium 
of Universities for Global Health; 2020; Washington, DC. 
82. Einterz RM, Kimaiyo S, Mengech HN, et al. Responding to the HIV pandemic: the power of 
an academic medical partnership. Acad Med 2007;82:812-8. 
83. Mercer T, Gardner A, Andama B, et al. Leveraging the power of partnerships: spreading the 
vision for a population health care delivery model in western Kenya. Globalization and health 
2018;14:44-. 
84. Bloomfield GS, Kimaiyo S, Carter EJ, et al. Chronic noncommunicable cardiovascular and 
pulmonary disease in sub-Saharan Africa: an academic model for countering the epidemic. 
American heart journal 2011;161:842-7. 
85. Vedanthan R, Kamano JH, Bloomfield GS, Manji I, Pastakia S, Kimaiyo SN. Engaging the 
Entire Care Cascade in Western Kenya: A Model to Achieve the Cardiovascular Disease 
Secondary Prevention Roadmap Goals. Glob Heart 2015;10:313-7. 
86. Manji I, Manyara SM, Jakait B, et al. The Revolving Fund Pharmacy Model: backing up the 
Ministry of Health supply chain in western Kenya. International Journal of Pharmacy Practice 
2016;24:358-66. 
87. Pastakia S, Manji I, Mercer T. Noncommunicable Diseases And Essential Medicines. 
Health Affairs 2015;34:2003. 
88. Tran DN, Manji I, Njuguna B, et al. Solving the problem of access to cardiovascular 
medicines: Revolving fund pharmacy models in rural western Kenya. BMJ Global Health 
2020;In press. 
89. Mamlin BW, Biondich PG, Wolfe BA, et al. Cooking Up An Open Source EMR For 
Developing Countries: OpenMRS – A Recipe For Successful Collaboration. AMIA Annual 
Symposium Proceedings 2006;2006:529-33. 
90. Pastakia SD, Karwa R, Kahn CB, Nyabundi JS. The evolution of diabetes care in the rural, 
resource-constrained setting of western Kenya. Ann Pharmacother 2011;45:721-6. 
91. Naanyu V, Vedanthan R, Kamano JH, et al. Barriers Influencing Linkage to Hypertension 
Care in Kenya: Qualitative Analysis from the LARK Hypertension Study. Journal of general 
internal medicine 2016;31:304-14. 

PT4A Protocol 1.4 23rd November, 2022 
Page 33 of 86 
92. Lee DJ, Kamano JH, Tulienge D, et al. Estimating the Health Workforce Requirements for 
Hypertension Management in Rural Western Kenya.  American Heart Association Annual 
Scientific Sessions. Orlando, USA2015. 
93. Rachlis B, Karwa R, Chema C, et al. Targeted Spontaneous Reporting: Assessing 
Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an 
International Scale. Drug safety 2016;39:959-76. 
94. Karwa R, Maina M, Mercer T, et al. Leveraging peer-based support to facilitate HIV care in 
Kenya. PLoS Med 2017;14:e1002355. 
95. Inui TS, Sidle JE, Nyandiko WM, et al. 'Triangulating' AMPATH: demonstration of a multi-
perspective strategic programme evaluation method. SAHARA J 2009;6:105-14. 
96. Park PH, Wambui CK, Atieno S, et al. Improving Diabetes Management and Cardiovascular 
Risk Factors Through Peer-Led Self-management Support Groups in Western Kenya. Diabetes 
care 2015;38:e110-1. 
97. Pastakia SD, Karwa R, Kahn CB, Nyabundi JS. The evolution of diabetes care in the rural, 
resource-constrained setting of western Kenya. The Annals of pharmacotherapy 2011;45:721-6. 
98. Rajput ZA, Mbugua S, Amadi D, et al. Evaluation of an Android-based mHealth system for 
population surveillance in developing countries. J Am Med Inform Assoc 2012;19:655-9. 
99. Vedanthan R, Blank E, Tuikong N, et al. Usability and feasibility of a tablet-based Decision-
Support and Integrated Record-keeping (DESIRE) tool in the nurse management of 
hypertension in rural western Kenya. Int J Med Inform 2015;84:207-19. 
100. Were MC, Kamano JH, Vedanthan R. Leveraging Digital Health for Global Chronic 
Diseases. Glob Heart 2016;11:459-62. 
101. Engelgau MM, Sampson UK, Rabadan-Diehl C, et al. Tackling NCD in LMIC: Achievements 
and Lessons Learned From the NHLBI-UnitedHealth Global Health Centers of Excellence 
Program. Glob Heart 2016;11:5-15. 
102. Siika AM, Rotich JK, Simiyu CJ, et al. An electronic medical record system for ambulatory 
care of HIV-infected patients in Kenya. Int J Med Inform 2005;74:345-55. 
103. Tierney WM, Achieng M, Baker E, et al. Experience implementing electronic health records 
in three East African countries. Studies in health technology and informatics 2010;160:371-5. 
104. Pastakia SD, Ali SM, Kamano JH, et al. Screening for diabetes and hypertension in a rural 
low income setting in western Kenya utilizing home-based and community-based strategies. 
Globalization and health 2013;9:21. 
105. Pastakia SD, Manyara SM, Vedanthan R, et al. Impact of Bridging Income Generation with 
Group Integrated Care (BIGPIC) on Hypertension and Diabetes in Rural Western Kenya. 
Journal of general internal medicine 2017;32:540-8. 
106. Peiris D, Thompson SR, Beratarrechea A, et al. Behaviour change strategies for reducing 
blood pressure-related disease burden: findings from a global implementation research 
programme. Implementation science : IS 2015;10:158. 
107. Vedanthan R, Kamano JH, Horowitz CR, et al. Nurse management of hypertension in rural 
western Kenya: implementation research to optimize delivery. Annals of global health 
2014;80:5-12. 
108. Vedanthan R, Kamano JH, Naanyu V, et al. Optimizing linkage and retention to 
hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized 
controlled trial. Trials 2014;15:143. 
109. Vedanthan R, Tuikong N, Kofler C, et al. Barriers and Facilitators to Nurse Management of 
Hypertension: A Qualitative Analysis from Western Kenya. Ethn Dis 2016;26:315-22. 
110. Schwalm JD, McKee M, Huffman MD, Yusuf S. Resource Effective Strategies to Prevent 
and Treat Cardiovascular Disease. Circulation 2016;133:742-55. 

PT4A Protocol 1.4 23rd November, 2022 
Page 34 of 86 
111.Embleton L, Wachira J, Kamanda A, Naanyu V, Ayuku D, Braitstein P. Eating sweets 
without the wrapper: perceptions of HIV and sexually transmitted infections among street youth 
in western Kenya. Culture, health & sexuality 2016;18:337-48. 
112. Embleton L, Ott MA, Wachira J, et al. Adapting ethical guidelines for adolescent health 
research to street-connected children and youth in low- and middle-income countries: a case 
study from western Kenya. BMC medical ethics 2015;16:89. 
113. Wachira J, Kamanda A, Embleton L, et al. Initiation to street life: a qualitative examination 
of the physical, social, and psychological practices in becoming an accepted member of the 
street youth community in Western Kenya. BMC public health 2015;15:569. 
114. Wachira J, Kamanda A, Embleton L, Naanyu V, Ayuku D, Braitstein P. 'Pregnancy Has Its 
Advantages': The Voices of Street Connected Children and Youth in Eldoret, Kenya. PLoS One 
2016;11:e0150814. 
115. Embleton L, Wachira J, Kamanda A, et al. "Once you join the streets you will have to do it": 
sexual practices of street children and youth in Uasin Gishu County, Kenya. Reproductive 
health 2015;12:106. 
116. Naanyu V, Sidle JE, Frankel RM, Ayuku D, Nyandiko WM, Inui TS. Rooting inquiry in 
tradition: the health baraza as a tool for social research in Kenya. Qual Health Res 2011;21:14-
26. 
117. Naanyu V, Asirwa CF, Wachira J, et al. Lay perceptions of breast cancer in Western Kenya. 
World journal of clinical oncology 2015;6:147-55. 
118. Naanyu V, Baliddawa J, Peca E, Karfakis J, Nyagoha N, Koech B. An examination of 
postpartum family planning in western Kenya: "I want to use contraception but I have not been 
told how to do so". African journal of reproductive health 2013;17:44-53. 
119. Leatherman S, Metcalfe M, Geissler K, Dunford C. Integrating microfinance and health 
strategies: examining the evidence to inform policy and practice. Health policy and planning 
2012;27:85-101. 
120. Kamanda A, Embleton L, Ayuku D, et al. Harnessing the power of the grassroots to conduct 
public health research in sub-Saharan Africa: a case study from western Kenya in the 
adaptation of community-based participatory research (CBPR) approaches. BMC public health 
2013;13:91. 
121. Vreeman R, Kamaara E, Kamanda A, et al. A qualitative study using traditional community 
assemblies to investigate community perspectives on informed consent and research 
participation in western Kenya. BMC medical ethics 2012;13:23. 
122. Amin R, St Pierre M, Ahmed A, Haq R. Integration of an Essential Services Package (ESP) 
in child and reproductive health and family planning with a micro-credit program for poor 
women: experience from a pilot project in rural Bangladesh. World Development 2001;29:1611-
21. 
123. Pronyk PM, Hargreaves JR, Kim JC, et al. Effect of a structural intervention for the 
prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. 
Lancet 2006;368:1973-83. 
124. Porter CM. Revisiting Precede–Proceed: A leading model for ecological and ethical health 
promotion. Health Education Journal 2016;75:753-64. 
125. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid 
designs: combining elements of clinical effectiveness and implementation research to enhance 
public health impact. Medical care 2012;50:217-26. 
126. Mercer T, Njuguna B, Bloomfield GS, et al. Strengthening Referral Networks for 
Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a 
study protocol of a cluster randomized trial.  5th Global Symposium on Health Systems 
Research. Liverpool, UK2018. 

PT4A Protocol 1.4 23rd November, 2022 
Page 35 of 86 
127.Paradis G, O'Loughlin J, Elliott M, et al. Coeur en sante St-Henri--a heart health promotion 
programme in a low income, low education neighbourhood in Montreal, Canada: theoretical 
model and early field experience. Journal of epidemiology and community health 1995;49:503-
12. 
128. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for 
characterising and designing behaviour change interventions. Implement Sci 2011;6:42. 
129. Jackson C, Eliasson L, Barber N, Weinman J. Applying COM-B to medication adherence: a 
suggested framework for research and interventions. The European Health Psychologist 
2014;16. 
130. McEvoy CT, Moore SE, Appleton KM, et al. Development of a peer support intervention to 
encourage dietary behaviour change towards a Mediterranean diet in adults at high 
cardiovascular risk. BMC public health 2018;18:1194. 
131. Phillips R, Copeland L, Grant A, et al. Development of a novel motivational interviewing (MI) 
informed peer-support intervention to support mothers to breastfeed for longer. BMC Pregnancy 
Childbirth 2018;18:90. 
132. Crayton E, Wright AJ, Ashworth M. Improving medication adherence in stroke survivors: the 
intervention development process. BMC health services research 2018;18:772. 
133. Aseyo RE, Mumma J, Scott K, et al. Realities and experiences of community health 
volunteers as agents for behaviour change: evidence from an informal urban settlement in 
Kisumu, Kenya. Hum Resour Health 2018;16:53. 
134. Weiner BJ. A theory of organizational readiness for change. Implement Sci 2009;4:67. 
135. Fedder DO, Chang RJ, Curry S, Nichols G. The effectiveness of a community health worker 
outreach program on healthcare utilization of west Baltimore City Medicaid patients with 
diabetes, with or without hypertension. Ethn Dis 2003;13:22-7. 
136. Hill MN, Bone LR, Hilton SC, Roary MC, Kelen GD, Levine DM. A clinical trial to improve 
high blood pressure care in young urban black men: recruitment, follow-up, and outcomes. Am J 
Hypertens 1999;12:548-54. 
137. Parsell G, Gibbs T, Bligh J. Three visual techniques to enhance interprofessional learning. 
Postgrad Med J 1998;74:387-90. 
138. Parsell G, Spalding R, Bligh J. Shared goals, shared learning: evaluation of a 
multiprofessional course for undergraduate students. Med Educ 1998;32:304-11. 
139. Stuttaford M, Bryanston C, Hundt GL, Connor M, Thorogood M, Tollman S. Use of applied 
theatre in health research dissemination and data validation: a pilot study from South Africa. 
Health (London, England : 1997) 2006;10:31-45. 
140. Dodd R, Munck L. Dying for change: poor people’s experience of health and ill-health: 
World Health Organization and World Bank; 2002. 
141. Hsieh H-F, Shannon SE. Three Approaches to Qualitative Content Analysis. Qualitative 
Health Research 2005;15:1277-88. 
142. Vaismoradi M, Jones J, Turunen H, Snelgrove S. Theme development in qualitative content 
analysis and thematic analysis. Journal of Nursing Education and Practice 2016;6:100-10. 
143. Rusk A, Goodman C, Naanyu V, Koech B, Obala A, O'Meara WP. Expanding Access to 
Malaria Diagnosis through Retail Shops in Western Kenya: What Do Shop Workers Think? 
Malaria research and treatment 2013;2013:398143. 
144. Douglas A, Rotich J, Kiptoo P, et al. Development and Validation of a Behavioral 
Assessment for Optimizing Linkage to Hypertension Care in Kenya: The LARK Study. American 
Public Health Association Annual Meeting. Chicago, USA. 2014. 
145. Kim J, Ferrari G, Abramsky T, et al. Assessing the incremental effects of combining 
economic and health interventions: the IMAGE study in South Africa. Bulletin of the World 
Health Organization 2009;87:824-32. 

PT4A Protocol 1.4 23rd November, 2022 
Page 36 of 86 
146.Chen EK, Reid MC, Parker SJ, Pillemer K. Tailoring evidence-based interventions for new 
populations: a method for program adaptation through community engagement. Evaluation & 
the health professions 2013;36:73-92. 
147. Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implementation Science 2017;12:108. 
148. Funnell MM. Peer-based behavioural strategies to improve chronic disease self-
management and clinical outcomes: evidence, logistics, evaluation considerations and needs 
for future research. Family Practice 2010;27:i17-22. 
149. Ogedegbe G, Chaplin W, Schoenthaler A, et al. A practice-based trial of motivational 
interviewing and adherence in hypertensive African Americans. Am J Hypertens 2008;21:1137-
43. 
150. Sanders D, Haines A. Implementation research is needed to achieve international health 
goals. PLoS Med 2006;3:e186. 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 37 of 86 
APPENDIX A.
PT4A AIM 2 STUDY PROTOCOL 
 
Project Title: Human Centered Implementation Research for refining and adapting the Peers and 
Technology for Adherence, Access, Accountability and Analytics (PT4A) Strategy.
Abstract: Medication adherence is a much needed avenue of recourse in order to reduce cardio-
vascular disease (CVD) and death resulting from complications of high BP1-4. To address these 
hurdles, we hypothesize that the PT4A strategy, which has a component of peer delivery of med-
ication and Health Information Technology, can be an effective implementation strategy to posi-
tively influence several micro- and macro-level factors leading to improved adherence to hyper-
tension medications. In this study we will use the human centered design (HCD) approach to 
refine this proposed strategy. HCD is increasingly applied to implementation research, and it has 
successfully been used in previous studies7-8. This process starts with the people you are design-
ing for and ends with new solutions that are tailor-made to suit their needs. It builds upon partici-
patory action research, and our protocol includes: patients who are hypertensive, clinical teams 
providing care to the patients, and community members, who will provide insights on HTN man-
agement in a community setting. Initial stages usually revolve around immersion, observing, and 
contextual framing in which innovators immerse themselves with the problem and community.  
Subsequent stages may then focus on community brainstorming, modeling and prototyping, and 
implementation in community spaces.9 The PT4A Strategy will undergo the following human-cen-
tered design processes: the Inspiration phase, Ideation phase, and Implementation phase. An 
HCD team consisting of individuals representing stakeholder groups: research team, clinicians, 
pharmacists, peers, patients with hypertension, informatics staff, and other providers involved in 
hypertension care will go through a participatory and iterative process to help in refining this im-
plementation strategy. 
In the Inspiration phase we will learn directly from the people we are designing for. In this case 
using qualitative research methods as described in Aim 1, we will conduct a thorough baseline 
contextual assessment of barriers and facilitators for implementing PT4A, and will gain a deeper 
understanding of the patients, community, and healthcare workers needs and opportunities for 
solutions. The interview questions employed participatory techniques that elicited emotional ele-
ments and promoted group interactions. 10-12. The information that will form the guiding themes 
that will inform the PT4A strategy refinement include: (a) perception of adherence to hypertension 
medication, (b) perception of HIT, (c) perceptions regarding the role of social support, (d) percep-
tion of peer delivery, and (e) factors that may impact the success of the PT4A strategy. 
We will explore insights into tangible ideas, divergence and convergence coming closer to the 
solution that can work best. It is the expectation that team members can have varying ideas 
when giving solutions but through the process we are able to get a solution that can work and is 
acceptable with many. 
In the Ideation phase we will make sense of the information learned, identify opportunities for 
design, and prototype possible solutions. During this phase we will look at the actionable items 
around the core structure of using a peer to deliver medication and the use of the mobile device 
as a health information support tool. 
In the Implementation phase we will bring the solution to life, and eventually, to implementation 
in the real world. Once the refined PT4A strategy model is developed, we will conduct o assess 
acceptability and appropriateness. Participants will be recruited through convenience sampling 
and will provide written informed consent. The initial prototype diagrams will convey key 

PT4A Protocol 1.4 23rd November, 2022 
Page 38 of 86 
features of the strategy to the participants and depicted use from the patient, clinician, and peer 
delivery agent perspectives.  
PARTICIPANTS 
A team consisting of individuals representing stakeholder groups (in total number 20): research 
team, clinicians, pharmacists, peers, patients with hypertension, informatics staff, and other pro-
viders involved in hypertension care will make up the design team. They will be recruited from 
across the three counties participating in the study. Participants will be reimbursed for their time, 
transportation and will be served a snack during design team meetings. 
METHODOLOGY:
The design team (DT) will meet for a total of 6 meetings over the course of the process, in order 
to develop and iteratively adapt the integrated door to door peer delivery of medication and Health 
Information Technology (HIT) intervention. 
Preliminary Activities: Baseline information will directly inform our design process. Data col-
lected using qualitative methods that consist of key informant interviews and focus group discus-
sions on the Micro and Macro level contextual factors (individual, family, clinician, health system) 
that might influence the implementation of the PT4A strategy will be presented before commenc-
ing our HCD design process; information on this process can be found in the parent study proto-
col.  
Baseline Technology: All of the HIT components will build upon, and be aligned with, the AM-
PATH Informatics infrastructure that has been established.  
Our PT4A intervention will augment AMRS to support peer-based intervention in four ways:  
1) Decision support and tailored adherence counseling: provide a patient-level and historical ad-
herence summary that includes pill count, self-report, and clinical data synced with AMRS to gen-
erate tailored adherence counseling;  
2) Teleconsultation: facilitate teleconsultation via text or phone call between the patients and cli-
nicians, by the help of the peer. 
3) Tracking and accountability: provide timely prompts to peers when refills are near due, and 
capture participant signature to confirm receipt of medications to improve accountability.  
4) Analytics: patient-level medication use analytics to predict future stock requirements for phar-
macy supply chain. The specific design and implementation of the above will be iteratively im-
proved via the participatory design process. 
Design Process Goals: The Design Team will be asked to identify and prototype potential solu-
tions to issues raised in the baseline needs and contextual assessment, in addition to the following 
4 core elements of the integrated HIT, the door-to-door medication delivery, and peer support 
intervention: 
Design Team Meeting #1: Inspiration 
Session A: 
 
DT members will introduce themselves and review expectations for the design process, 
including the scope of work for the design team and the expected process to be followed 
during the design team, including the role of the research team in co-design and approval 
of the final intervention. 
 
PT4A research team members will introduce human-centered design methods through a 
presentation 

PT4A Protocol 1.4 23rd November, 2022 
Page 39 of 86 
 
DT members will share their personal experiences with patient medication adherence 
challenges and support. 
 
Session B: 
 
PT4A research team will introduce findings from Aim 1 activities; the design team will 
compile salient and interesting insights from the following findings: (a) perception of ad-
herence to hypertension medication; (b) perception of HIT; (c) perceptions regarding the 
role of social support; (d) perception of peer delivery; and (e) factors that may impact the 
success of the PT4A strategy and create post-it notes  
 
Notes will be posted on the walls and arranged into clusters based on topics and patterns, 
forming central themes 
 
 
Expected outcomes: 
 
 Introduction and group logistics 
 Understanding of the HCD process and definition of roles 
 Creation of themes that we lead to development of insight statements. 
 Start the synthesis process of ideation 
 
Design Team Meeting #2: Brainstorming 
Session A: 
 
DT members will engage in icebreaker activities & review previous meeting discussions. 
 
PT4A STUDY research team will identify themes based on summary statements from DT 
Meeting #1 
 
DT will break into small groups and create “How might we…” questions to address sum-
mary statements (i.e. “How might peers best deliver the medication?”) 
 
DT will select up to 5 HMW (How Might We) questions and post them on the wall 
 
Session B: 
 
DT will break into small groups and brainstorm solutions to each problem in 15-minute 
rotations (i.e. “the peers delivering medication and offering psychosocial support”) 
 
 
PT4A team will introduce baseline core functions for the peers as follows and address 
HWM around the following issues to be addressed.  
1) Drug delivery: peers will deliver medication refills to the patient at a convenient location 
and time.  
2) Confirmation of the medicine delivery with the patient delivery details (which drugs, 
quantity, location, date, and time for delivery).  
3) Psychosocial support and adherence counseling: leveraging the peer-patient relation-
ship and using the HIT-generated adherence data, the peer will provide adherence 
counseling and psychosocial support to patients at the time of medication delivery to 

PT4A Protocol 1.4 23rd November, 2022 
Page 40 of 86 
address individual-level adherence barriers and any new issues that may have been 
discovered during Aim 1 activities.  
Beyond the above, the DT may deliberate on additional functions for the peers, or introduce sub-
functions within the above
Expected outcomes: 
 Creation of insight statements that will lead to how might we questions  
 
 
 
Design Team Meeting #3: Conceptualization 
Session A: 
 
DT members will engage in icebreaker activities & review previous meeting discussions. 
 
DT will discuss how might we question and propose each solution, evaluate ad-
vantages/disadvantages, and group similar ideas together 
 
DT will discuss the positive and negative effects of the proposed solutions. 
 
DT will vote to select up to 3 solution ideas for each HMW (How Might We) question 
 
DT will break into small groups and storyboard stakeholders’ experience with this inter-
vention using wall notes 
 
Session B: 
 
DT will discuss each storyboard as a large group and select 1-2 solutions for each HMW 
question that will be prototyped during acceptability testing. If not already discussed, DT 
will address background logistics that underlie this integrated peer support intervention, 
including: 
o The peer role 
 
How peers are recruited (Age, Gender, Education level) 
 
Peer-patient relationship (Interpersonal skills) 
 
The frequency of contact between the peer and the patients 
 
The mechanism of contact with patients (SMS, phone, etc.) 
 
The process of delivery of medication refills to the patient at a convenient 
location and time. 
 
Confirmation of the medication delivery 
Expected outcomes: 
 
 Discuss the strongest solutions proposed 
 
Design Team Meeting #4: Creation 
 
Session A: 
 
DT members will engage in icebreaker activities & review previous meeting discussions 
 
DT members will discuss the solutions in detail and come up with models as to where we 
will refine the proposed intervention 
 
The research team will integrate selected solutions into a first-draft intervention model  

PT4A Protocol 1.4 23rd November, 2022 
Page 41 of 86 
Session B: 
 
The draft interventional model will be presented and members will be asked to provide for 
any additional input they may have. 
 
DT will present intervention model to the study investigators, AMPATH Informatics team, 
and other key stakeholders 
 
Investigators will be invited to provide input and discuss intervention features with the DT 
 
Expected outcomes: 
 
 Present final intervention model 
 
 Finish creation of training materials 
 
 
 
Throughout the process, the research team will develop training materials for providers and peers, 
data collection and encounter forms, and the questionnaires to be used during acceptability test-
ing, PT4A research team members will maintain frequent and ongoing communication with the 
DT throughout the process. The PT4A research team and Informatics team will be responsible 
for ensuring that the DT proposes solutions that are compatible with existing technologic capabil-
ities and feasible within the health system. 
 
Outcomes and Analysis 
Throughout the DT meetings, a designated scribe will take detailed notes, photographs, and audio 
records to capture the design process and how each idea was developed. This data will be used 
as descriptive indicators of our design process and group participation. The DT will submit a first-
draft model of the intervention to the investigators, the research team, and AMPATH Informatics 
team. This model will include the basic features of the intervention, detailed descriptions of the 
different roles involved, and a description of the patient, peer delivery agent and provider experi-
ence in a variety of scenarios. The research team and Informatics team will be responsible for 
creating the prototype of this model for acceptability testing. 
Subaim 2.1: Evaluate the intervention for acceptability and appropriateness 
After the PT4A model prototype is created we will evaluate how applicable and workable the core 
components of PT4A will be more so in terms of cost, complexity, usability, and value. 
Participants (targeted number of 39 in total will be enrolled), this will include representatives of 
the end users of our product, which includes: hypertension patients (5 per site), clinicians (5 per 
site), pharmacy (1 per site) and peers (6 in total). Participants will be recruited through conven-
ience sampling within the 3 counties where we will conduct the study. Participants will be reim-
bursed for time and travel through PT4A funds during those sessions. 
Methods: 
Participants will be recruited through convenience sampling and will provide written informed con-
sent. We will conduct surveys in three counties with a similar distribution of participants to gauge 

PT4A Protocol 1.4 23rd November, 2022 
Page 42 of 86 
perspectives from various stakeholders in the model; this will include patients, peers, and clinical 
staff. Initial prototype diagrams will be shared with the group and presented from the perspective 
of each type of stakeholder to fully inform them of their role within the model. A structured ques-
tionnaire will be used to elicit constructive feedback from the group.  
 
Outcomes and Analysis: 
Statistical Analysis will include descriptive statistics of outcomes of interest including:  
1) Satisfaction with the proposed intervention design, 2) perceived appropriateness, 3) fit within 
existing community and clinical infrastructures, 4) perceived positive or negative effects, 5) ex-
pressed interest or intention to participate, 6) perceived relevance to address adherence to 
medication, 7) barriers to implementation within existing community and clinical infrastructure, 8) 
ease of implementing this intervention. At the conclusion of this analysis, the design team will 
meet to review these outcomes and refine the intervention model as necessary to enhance ac-
ceptability.   
Design Team Meeting #5: Iteration 1 
Session A: 
 
DT members will engage in icebreaker activities and review the last meeting discussions 
 
The PT4A research team will present and discuss findings from acceptability and appro-
priateness testing 
 
DT will group issues raised from the interview surveys into themes and propose inter-
vention updates 
 
Session B: 
 
DT will create an updated intervention model and submit this to the study investigators, 
research team, and Informatics team 
 
DT will be divided into two groups and participate in FGDs to evaluate their experience 
during the HCD process  
 
Subaim 2.2: Conduct a pilot of the intervention and evaluate feasibility 
 
Participants: 
Three health facilities will participate in the pilot (one from each county involved in the study). One 
peer delivery agent will be hired per facility and will be in close contact with clinicians, pharmacy 
staff, and patients at each health facility. The study will include all who are involved in the care for 
these patients and we target to enroll a total of up to 100 patients in this phase. Ten patients per 
facility.  
Inclusion criteria 
 
Greater than 18 years of age. 
 
Currently enrolled in an AMPATH CDM Program 
Exclusion criteria 
 
Acute illness requiring immediate medical attention 
 
Terminal illness 
 
Inability to provide informed consent 
 
 
Methods: 

PT4A Protocol 1.4 23rd November, 2022 
Page 43 of 86 
The pilot study will be conducted over a 3-month period. Peers will be paid through the PT4A 
funds. After recruitment and hiring, they will be on-boarded through a week-long training that will 
cover: i) basic training on hypertension care, ii) use of the PT4A HIT tool to ensure proper docu-
mentation of medication pick-up, medication delivery, and peer-patient encounter documentation; 
iii) providing psychosocial support for hypertensive patients aimed at supporting medication ad-
herence and promoting patient activation. Peers will use the AMRS system (peers will have ac-
cess to a tablet with access to the HIT/AMRS system, and technological support will be provided 
by research and the Ampath informatics team) to request a prescription for a patient in the pro-
vider catchment. The AMRS system will send the prescription from the healthcare provider to the 
pharmacy that covers that network. The pharmacy will prepare individually sealed blister bags in 
individual single seal bags to lower pilferage. Once packaging is complete, the AMRS system will 
send a message to the peer with the name, date/time of delivery, location, type of drug, and 
quantity to ensure the right medication is picked up at the right time. The peer will pick up the 
prescription and then deliver the medication to the patient, confirming receipt by getting a signa-
ture from the patient on the HIT tool. The peer will then request the next installment of medications 
through the AMRS system, taking into account any pills not consumed (remaining in the blister 
pack). This cycle will repeat until the patient has to see the clinician again, where the clinician will 
provide a new prescription. During these deliveries, peers will leverage adherence data to support 
patients and address any barriers to medication adherence. The overall goal of this psychosocial 
support will be increasing patient activation.  
 
 
Outcomes and Analysis: 
We will collect data on implementation such as completeness of the peer delivery, satisfaction of 
the patients, patient activation, and fidelity of delivery strategy. Patient satisfaction will be meas-
ured through a survey adapted from the AIDS Clinical Research Trials Group tool used exten-
sively throughout Kenya and in the Harambee study13. Patient activation will be measured through 
the Patient Activation Measure assessment developed by Insignia Health. Fidelity will be meas-
ured as quantity and quality of intervention delivery as intended, comprised of three components: 
confirmed medication delivery documented by patient e-signature, peer completion of the HIT 
form, and quality of data entry into the HIT form, which will be assessed by checking for com-
pleteness, accuracy and coherent filling of the responses. Completeness of delivery will include 
these metrics of fidelity in addition to other quality assurance measures centering on medication 
packaging as well which will be done by the research assistant as the study goes on. We will also 
conduct surveys with patients, clinicians, and peer delivery agents, focusing on contextual issues 
impacting implementation, suggestions for modifications, and concepts of feasibility, that is, if the 
process of delivery and counseling has been successful or not successful in all the settings and 
the perceived ease of implementing the intervention. We will also evaluate the impact of the pilot 
on absolute mean change in SBP and medication adherence. The primary adherence outcome 
is the pill count adherence ratio, which is the proportion of prescribed doses taken over a 1-month 
time period, assessed at the end of the pilot.  
 
Design Team Meeting #6: Iteration II 
Session A: 
 
DT members will engage in icebreaker activities and review previous discussions  
 
PT4A research team will present and discuss findings from pilot study 
 
DT will group issues raised in FGDs and from study investigators into themes and pro-
pose intervention updates 

PT4A Protocol 1.4 23rd November, 2022 
Page 44 of 86 
Session B: 
 
DT will create a final intervention model and submit this to the study investigators, re-
search team, and Informatics team 
 
The research team will conduct individual surveys with DT members to evaluate their ex-
perience during the HCD process  
 
The research team and Informatics team will be responsible for creating the final intervention 
model that will be used for more widespread implementation. 
 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 45 of 86 
References
1. Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control 
of hypertension in rural and urban communities in high-, middle-, and low-income 
countries. JAMA 2013;310:959-68. 
2. Irazola VE, Gutierrez L, Bloomfield G, et al. Hypertension Prevalence, Awareness, 
Treatment, and Control in Selected LMIC Communities: Results From the NHLBI/UHG 
Network of Centers of Excellence for Chronic Diseases. Global Heart 2016;11:47-59. 
3. Mills KT, Bundy JD, Kelly TN, et al. Global Disparities of Hypertension Prevalence and 
Control: A Systematic Analysis of Population-Based Studies From 90 Countries. 
Circulation 2016;134:441-50. 
4. Whelton PK. The elusiveness of population-wide high blood pressure control. Annual 
review of public health 2015;36:109-30. 
5. Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA. Medication adherence 
leads to lower health care use and costs despite increased drug spending. Health Affairs 
(Project Hope) 2011;30:91-9. 
6. Vedanthan R, Kamano JH, Lee H, Andama B, Bloomfield GS, DeLong AK, Edelman D, 
Finkelstein EA, Hogan JW, Horowitz CR, Manyara S, Menya D, Naanyu V, Pastakia SD, 
Valente TW, Wanyonyi CC, Fuster V. Bridging Income Generation with Group Integrated 
Care for cardiovascular risk reduction: Rationale and design of the BIGPIC study. Am 
Heart J. 2017 Jun;188:175-185. doi: 10.1016/j.ahj.2017.03.012. Epub 2017 Mar 23. 
PMID: 28577673; PMCID: PMC5491075. 
7. Aifah A, Okeke NL, Rentrope CR, Schexnayder J, Bloomfield GS, Bosworth H, et al. Use 
of a human-centered design approach to adapt a nurse-led cardiovascular disease pre-
vention intervention in HIV clinics. Prog Cardiovasc Dis. 2020;63(2):92–100. 18.  
8. Leung CL, Naert M, Andama B, Dong R, Edelman D, Horowitz C, et al. Human-centered 
design as a guide to intervention planning for noncommunicable diseases: the BIGPIC 
study from Western Kenya. BMC Health Serv Res. 2020;20(1):415 
9. Pittsburgh, PA: Iinnovating for people: Handbook of human-centered design methods. 
(2012). LUMA Institute, LLC. 
10. Parsell G, Gibbs T, Bligh J. Three visual techniques to enhance interprofessional 
learning. Postgrad Med J 1998;74:387-90. 
11. Parsell G, Spalding R, Bligh J. Shared goals, shared learning: evaluation of a 
multiprofessional course for undergraduate students. Med Educ 1998;32:304-11. 
12. Stuttaford M, Bryanston C, Hundt GL, Connor M, Thorogood M, Tollman S. Use of 
applied theatre in health research dissemination and data validation: a pilot study from 
South Africa. Health (London, England : 1997) 2006;10:31-45. 
13. Odeny TA, et al. Integration of HIV Care with Primary Health Care Services: Effect on 
Patient Satisfaction and Stigma in Rural Kenya. AIDS Research and Treatment. 
2013;2013:1-10. doi:10.1155/2013/485715 
 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 46 of 86 

PT4A Protocol 1.4 23rd November, 2022 
Page 47 of 86 
APPENDIX B. STUDY INTERVIEW QUESTIONNAIRES
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) Study 
 
Study Instrument: Acceptability of Intervention Measure (AIM) for Patients Living with 
Hypertension  
 
Study ID:
Date:
Age: 
Gender:
1. Education/ Elimu                                                  No formal education/ Hakuna elimu rasmi 
Primary/ Shule ya Msingi                                      Secondary/ Shule ya Upili  
 
Beyond secondary/ Zaidi ya Shule ya Upili              Special training e.g Trade. Insert Mafunzo 
maalum          
                                                                                        kwa mfano biashara 
2. What is your main source of income?/ Chanzo chako kikuu cha mapato ni nini?
Farming/ Ukulima                                    Business/Trade/Biashara                       Teacher/ 
Uwaalimu 
 
Health worker/ Mfanyakazi wa afya  
Other/s (Insert): Ingine
3. What is your estimated monthly income in KES?/ Je! Mapato yako ya kila mwezi 
yanakadiriwa ngapi KES? <1,000            1,000-2,999            3,000-4,999          5,000-
9,999               >10,000 
4. How long have you been living with hypertension/pressure in months? Umeishi kwa 
muda gani na shinikizo la damu / shinikizo (kwa miezi)  
<6 months/ Miezi sita Between 6 months – 1year/ Kati ya miezi sita na mwaka  
 
Between 1-2 years/ Kati ya mwaka mmoja na mbili? >2 years/ Zaidi ya miaka mbili?
5. Where do you mainly seek treatment for hypertension/pressure?/ Unapata wapi mati-
babu ya shinikizo la damu   
Health facility/ Kituo cha afya                         Pharmacy (over the counter medication) Duka la 
dawa                          
Herbalist / Mtaalam wa mimea                                                    (juu ya dawa ya kaunta) 
Not yet sought care/ Bado sijatafuta huduma
Other specify/ Nyingine taja 
6. About how long would it take to get from your home to the nearest chemist/pharmacy if 
you walked to them? Je! Itachukua muda gani kutoka nyumbani kwako kwenda kwa duka 
la dawa lilokaribu ukitembea?  
Less than 15 minutes/ Chini ya dakika 15                       16-30 minutes/ Dakika 16-30  
 
31 minutes to an hour/ dakika 31 hadi saa moja          More than one hour/ Zaidi ya saa moja
7. About how long would it take to get from your home to the nearest healthcare facility if 
you walked to them?/ Je! Itachukua muda gani kutoka nyumbani kwako kwenda kituo cha 
huduma ya afya kilicho karibu ikiwa utatembea kuelekea huko?   
Less than 15 minutes/ Chini ya dakika 15
16-30 minutes/ Dakika 16-30  

PT4A Protocol 1.4 23rd November, 2022 
Page 48 of 86 
31 minutes to an hour/ dakika 31 hadi saa moja          More than one hour/ Zaidi ya saa moja
Instructions to Study Personnel: Read all questions aloud to the patient and record answers on 
questionnaire form.  
 
You were selected to take part in this survey because we value the knowledge you have on our 
topic of discussion. I kindly request for your honest opinions and ideas. There is no wrong or right 
response. You should feel free to say whatever you think and feel.   
There is a plan to start a project that will support people living with hypertension/pressure at the 
community level. The purpose of the project is to assist these individuals take hypertension/pres-
sure medication their as required through a peer-led project. A peer will be someone who is living 
with hypertension/pressure in the community and has been successful in managing their hyper-
tension. The peer will be responsible for a number of things: 
 
Deliver hypertension medication to people living with hypertension/pressure at their most 
convenient location (door-to-door medication delivery).   
 
Provide psychological support to people living with hypertension/pressure during medica-
tion delivery and whenever needed. 
 
Record the health progress of people living with hypertension/pressure in a mobile device 
whenever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician where the individuals living with hy-
pertension receive care to discuss their health progress.  
 
Whenever necessary enable a conversation (either audio or video) between the clinician 
and the patient using the mobile device at the patient’s convenient location. 
 
Insert the revised prototype 
With this revisions to our PT4A strategy, will this prototype do the following for you.  
 
 
 
 
 
 
Completely 
disagree 
Disa-
gree 
Neither 
agree nor 
disagree
Agree 
Complete
agree
1. The HIT-Peer Delivery system 
meets my needs
2. The HIT-Peer Delivery system is 
appealing to me.
3. I like the HIT-Peer Delivery system. 
 
 
4. I would like to be enrolled in  the 
HIT-Peer Delivery system. 
 
 
 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 49 of 86 
 
Intervention Appropriateness Measure (IAM) 
 
Completely 
disagree 
Disa-
gree 
Neither 
agree 
nor dis-
agree
Agree 
Complet
agree
The HIT-Peer Delivery system seems fitting.
 
 
 
 
 
The HIT-Peer Delivery system seems suita-
.
 
 
 
 
 
The HIT-Peer Delivery system seems appli-
ble. 
 
 
 
 
 
The HIT-Peer Delivery system seems like a 
od match.
 
 
 
 
 
Total Score:  

PT4A Protocol 1.4 23rd November, 2022 
Page 50 of 86 
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) 
Study 
 
Study Instrument: Acceptability of Intervention Measure (AIM) for Health Care Team  
 
Study ID: 
Date:
Age: 
Gender:
1. What is your primary role at the facility?
MO CO 
Nurse  Other staff (specify) 
2. How long have you served as a health provider for Hypertensive patients? 
3. What is your interaction with patients living with Hypertension? 
Instructions to Study Personnel: Read all questions aloud to the healthcare provider and record 
answers on questionnaire form.  
 
You were selected to take part in this survey because we value the knowledge you have on our 
topic of discussion. I kindly request for your honest opinions and ideas. There is no wrong or right 
response. You should feel free to say whatever you think and feel.   
There is a plan to start a project that will support people living with hypertension/pressure at the 
community level. The purpose of the project is to assist these individuals take hypertension/pres-
sure medication their as required through a peer-led project. A peer will be someone who is living 
with hypertension/pressure in the community and has been successful in managing their hyper-
tension. The peer will be responsible for a number of things: 
 
Deliver hypertension medication to people living with hypertension/pressure at their most 
convenient location (door-to-door medication delivery).   
 
Provide psychological support to people living with hypertension/pressure during medica-
tion delivery and whenever needed. 
 
Record the health progress of people living with hypertension/pressure in a mobile device 
whenever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician where the individuals living with hy-
pertension receive care to discuss their health progress.  
 
Whenever necessary enable a conversation (either audio or video) between the clinician 
and the patient using the mobile device at the patient’s convenient location. 
 
Insert the revised prototype 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
C

PT4A Protocol 1.4 23rd November, 2022 
Page 51 of 86 
With this revisions to our PT4A strategy, will this prototype do the following for you.  
 
Intervention Appropriateness Measure (IAM) 
 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree
Completely 
agree 
1. The HIT-Peer Delivery system 
seems fitting.
 
 
 
 
 
2. The HIT-Peer Delivery system 
seems suitable. 
 
 
 
 
 
3. The HIT-Peer Delivery system 
seems applicable. 
 
 
 
 
 
4. The HIT-Peer Delivery system 
seems like a good match. 
 
 
 
 
 
Weiner, B.J., Lewis, C.C., Stanick, C. et al. Psychometric assessment of three newly devel-
oped implementation outcome measures. Implementation Sci 12, 108 (2017). 
https://doi.org/10.1186/s13012-017-0635-3 
1. The HIT-Peer Delivery system meets the 
patients needs 
2. The HIT-Peer Delivery system is appeal-
ing to both the patient and I healthcare pro-
vider
3. I like the HIT-Peer Delivery system. 
 
4. I would like my patients enrolled in the 
HIT-Peer Delivery system. 
 
 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 52 of 86 
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) 
Study 
 
Study Instrument: Acceptability of Intervention Measure (AIM) for PEERS  
Study ID: 
Date:
Age: 
Gender:
1. Education/ Elimu                                                  No formal education/ Hakuna elimu rasmi 
Primary/ Shule ya Msingi                                      Secondary/ Shule ya Upili  
 
Beyond secondary/ Zaidi ya Shule ya Upili              Special training e.g Trade. Insert Mafunzo 
maalum          
                                                                                        kwa mfano biashara 
2. What is your main source of income?/ Chanzo chako kikuu cha mapato ni nini?
Farming/ Ukulima                                    Business/Trade/Biashara                       Teacher/ Uwaalimu 
 
Health worker/ Mfanyakazi wa afya  
Other/s (Insert): Ingine
3. How long have you worked as a peer?
4. What is your estimated monthly income in KES?/ Je! Mapato yako ya kila mwezi yanakadiriwa 
ngapi  
KES?<1,000            1,000-2,999            3,000-4,999          5,000-9,999              >10,000 
5. How long have you been living with hypertension/pressure in months? Umeishi kwa muda 
gani na shinikizo la damu / shinikizo (kwa miezi) 
<6 months/ Miezi sita Between 6 months – 1year/ Kati ya miezi sita na mwaka  
 
Between 1-2 years/ Kati ya mwaka mmoja na mbili? >2 years/ Zaidi ya miaka mbili?
6. Where do you mainly seek treatment for hypertension/pressure?/ Unapata wapi matibabu ya 
shinikizo la damu
Health facility/ Kituo cha afya
Pharmacy (over the counter medication) Duka la dawa      
Herbalist / Mtaalam wa mimea                                                    (juu ya dawa ya kaunta) 
Not yet sought care/ Bado sijatafuta huduma
Other specify/ Nyingine taja 
7. About how long would it take to get from your home to the nearest chemist/pharmacy if you 
walked to them? Je! Itachukua muda gani kutoka nyumbani kwako kwenda kwa duka la dawa li-
lokaribu ukitembea?  
Less than 15 minutes/ Chini ya dakika 15                       16-30 minutes/ Dakika 16-30  
 
31 minutes to an hour/ dakika 31 hadi saa moja          More than one hour/ Zaidi ya saa moja
8. About how long would it take to get from your home to the nearest healthcare facility if you 
walked to them?/ Je! Itachukua muda gani kutoka nyumbani kwako kwenda kituo cha huduma ya afya 
kilicho karibu ikiwa utatembea kuelekea huko?   
Less than 15 minutes/ Chini ya dakika 15                      16-30 minutes/ Dakika 16-30  
 
31 minutes to an hour/ dakika 31 hadi saa moja          More than one hour/ Zaidi ya saa moja

PT4A Protocol 1.4 23rd November, 2022 
Page 53 of 86 
Instructions to Study Personnel: Read all questions aloud to the patient and record answers on ques-
tionnaire form.  
 
You were selected to take part in this survey because we value the knowledge you have on our topic of 
discussion. I kindly request for your honest opinions and ideas. There is no wrong or right response. 
You should feel free to say whatever you think and feel.   
There is a plan to start a project that will support people living with hypertension/pressure at the commu-
nity level. The purpose of the project is to assist these individuals take hypertension/pressure medica-
tion their as required through a peer-led project. A peer will be someone who is living with hyperten-
sion/pressure in the community and has been successful in managing their hypertension. The peer will 
be responsible for a number of things: 
 
Deliver hypertension medication to people living with hypertension/pressure at their most con-
venient location (door-to-door medication delivery).  
 
Provide psychological support to people living with hypertension/pressure during medication de-
livery and whenever needed. 
 
Record the health progress of people living with hypertension/pressure in a mobile device when-
ever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician where the individuals living with hyperten-
sion receive care to discuss their health progress.  
 
Whenever necessary enable a conversation (either audio or video) between the clinician and the 
patient using the mobile device at the patient’s convenient location. 
 
Insert the revised prototype 

PT4A Protocol 1.4 23rd November, 2022 
Page 54 of 86 
With this revisions to our PT4A strategy, will this prototype do the following for you?  
Intervention Appropriateness Measure (IAM) 
 
Completely 
disagree 
Disagree 
Neither 
agree 
nor dis-
agree 
Agree
Complete
agree 
. The HIT-Peer Delivery system seems fitting.
 
 
 
 
 
. The HIT-Peer Delivery system seems suitable.
 
 
 
. The HIT-Peer Delivery system seems applica-
le. 
 
 
 
 
 
. The HIT-Peer Delivery system seems like a 
ood match.
 
 
 
 
 
Completely disa-
gree 
Disagree 
Neither 
agree nor 
disagree
Agree 
Comple
agree
1. The HIT-Peer Delivery system 
meets my needs
 
 
 
 
2. The HIT-Peer Delivery system is ap-
pealing to me. 
 
 
 
 
3. I like the HIT-Peer Delivery system.
 
 
4. I would like to be enrolled in  the 
HIT-Peer Delivery system. 
 
 
 
 
Total Score: 

PT4A Protocol 1.4 23rd November, 2022 
Page 55 of 86 
Subaim 2.2: Conduct a pilot of the intervention and evaluate feasibility
AIM 2.2 Study Instrument: EVALUATION OF FEASIBILITY QUESTIONNAIRE FOR PA-
TIENTS 
Hello, my name is _______. I am a research assistant for the PT4A study. I am approaching you as 
you have participated as a patient in the PT4A program and as such our feedback would be helpful for 
the program. I would like to ask you some questions to learn about your experiences with the PT4A 
program. I will ask you questions about your physical health, your mental health, and how you feel 
when you interact with a peer from the PT4A program. Your answers will help me understand what 
types of services people who are living with high blood pressure need to stay healthy.  
. 
 
Do you have any questions? 
 
Ok, let’s begin 
 
 
Now I would like to hear about your experience with the PT4A peer delivery program. Please answer 
honestly and to the best of your knowledge. All responses are confidential.  
1. When you receive medication and counseling from a peer, how often do the peers treat you with 
courtesy and respect? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
2. When you receive medication and counseling from a peer, how often do the peers listen carefully to 
you? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
3. When you receive medication and counseling from a peer, how often do the peers ask for your opin-
ion regarding your healthcare? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
4.When you receive medication and counseling from a peer, how often are you satisfied with the 
amount of time your peer spends with you? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 

PT4A Protocol 1.4 23rd November, 2022 
Page 56 of 86 
Please tell me how much you agree or disagree with the following statements
5.The peers in the PT4A delivery program can be trusted to keep my medical information private and 
confidential.
Strongly agree
 Agree 
 Disagree 
 Strongly Disagree 
6.Whenever you had questions about your medications or health which you brought up to the peer, 
how often were you satisfied about the answers you received from the peer? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
7. When you receive medication and counseling from a peer, how often did you get clear instructions 
on how to use/take the medication? 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
8. Did you feel the peer having the Mobile Device helped with record keeping for the next clinical en-
counter you had with your doctor? 
 Strongly agree 
 Agree 
 Disagree 
 Strongly Disagree 
9. Did the Mobile Device help you have a consultation with a healthcare provider for any emerging 
medical issue? Yes                              No 
Do you feel that the use of the mobile device helped you to manage the arising medical issue that 
came up?  
 Strongly agree 
 Agree 
 Disagree 
 Strongly Disagree 
10. Did the use of a peer to deliver medication has improve your health? 
 Strongly agree 
 Agree 
 Disagree 
 Strongly Disagree 
11. Did the use of a peer to offer psychosocial support help you improve your quality of life? 
 Strongly agree 
 Agree 
 Disagree 

PT4A Protocol 1.4 23rd November, 2022 
Page 57 of 86 
Strongly Disagree 
11. Has the use of a peer to deliver medication helped you to adhere to medication and you have expe-
rienced few if no symptoms associated with Hypertension  
 Strongly agree 
 Agree 
 Disagree 
Strongly Disagree
AIM 2.2 Study Instrument: EVALUATION OF DELIVERY PROCESS AND COMPLETENESS 
QUESTIONNAIRE FOR PATIENTS 
Now I would like to hear about your feedback on the  PT4A medication delivery process. 
Please answer honestly and to the best of your knowledge. All responses are confidential. 
Successful/proper deliveries 
The peers delivered the right medication as requested 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
The medication was delivered on the date expected
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
The medication was delivered at the time expected
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
Medication packaging
The medication was properly sealed during the delivery 
All the time
 A lot of the time 
 Some of the time 
 None of the time 
The medication was properly labeled and the dosage indicated 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
The medication was properly labeled and the dosage indicated 
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
The peer was able to give you instructions for medication use 
 All the time

PT4A Protocol 1.4 23rd November, 2022 
Page 58 of 86 
A lot of the time
Some of the time
None of the time
The medication brand changes were clearly communicated
 All the time 
 A lot of the time 
 Some of the time 
 None of the time 
The medication payments reflected the amount of medication received
All the time
 A lot of the time 
 Some of the time 
None of the time
Total Scores

PT4A Protocol 1.4 23rd November, 2022 
Page 59 of 86 
APPENDIX C. INTERVIEW GUIDES FOR FEASIBILITY EVALUATION 
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) 
Study 
 
Study Instrument: Focus Group Discussion (FGD) Guide for Clinical Team 
FGD moderator: ____________________________________________ 
FGD note taker: ______________________________________________ 
Date: ____/____/2022
County: ___________________________________
Start Time: _____________________________________________ 
End Time: _____________________________________________ 
FGD: 
 
Inform the participants about the study guided by the study information sheet.  
 
Provide participants with an opportunity to ask questions. 
 
Obtain written consent from each participant privately. (2 copies per participants) 
 
Provide each participant with a copy of their signed informed consent form. 
 
Complete the demographic survey for each participant privately. 

PT4A Protocol 1.4 23rd November, 2022 
Page 60 of 86 
Demographic Survey
Indicate or insert your responses as necessary 
1. Study ID: 
2. State your age (Years)
3. Sex 
Male 
Female
4. What is your primary 
role at the facility?
MO 
CO
Nurse
Other staff (specify) 
5. How long have you 
served as a health pro-
vider?
6. Have you interacted 
with patients living with 
Hypertension? 
Yes 
No 
NB: To be completed for each participant  

PT4A Protocol 1.4 23rd November, 2022 
Page 61 of 86 
Summary of observations during FGD
Moderator and note taker: In the space below, please provide a summary of the FGD ses-
sion you just had including both verbal and nob-verbal cues. 
 
 

PT4A Protocol 1.4 23rd November, 2022 
Page 62 of 86 
Focus Group Discussion Guide
Clinical Team 
 
   
******************************************************** 
Opening Remarks 
Hello.   My name is ______XXX_________ and I will help guide our discussion today. Thank you 
for welcoming us to your community.   ___XXX___________ is also present today to help take 
notes during our discussions. We will also be recording this session using a tape recorder (show 
the participants the tape recorder). This will help us capture what you say without missing out on 
anything. Your opinions and experiences are very important to us since it will help us understand 
how to develop health program to assist individuals living with hypertension in your community.  
 
You were selected to take part in this discussion because we value your feedback regarding your 
experience in PT4A program I kindly request for your honest opinions and ideas. There is no 
wrong or right response. You should feel free to say whatever you think and feel.  You are wel-
come to say as much or as little as you want.  I am eager to hear what you have to say. Do you 
have any questions about what I have said so far?   
  
 
FGD rules 
Before we start, I would like as to you mention some of the rules that will guide our discussion  
 
1. There are no right or wrong answers. We expect that you will have differing points of view. 
Please feel free to share your point of view even if it differs from what others have said. 
 
2. We are recording this session as we discussed, because we do not want to miss any of 
your comments. No names will be included in any reports. Your comments are confiden-
tial. Please speak loudly for I want to be accurate in capturing what you say. 
 
3. Don’t feel like you have to respond all the time. But if you want to follow up on something 
that someone has said, you want to agree, or disagree, or give an example, feel free to 
do that.  
 
4. I am here to ask questions, listen, and make sure everyone has a chance to share. We’re 
interested in hearing from each of you. So if you are talking a lot, I may ask you to give 
others a chance. We just want to make sure all of you have a chance to share your ideas. 
 
5. If you have a cell phone, please put it on quiet mode.  
 

PT4A Study Guides 
Page 63 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
Now let us start discussions about your perceptions about the PT4A Intervention. 
A. PT4A intervention:
PT4A project was started to support people living with hypertension/pressure at the community 
level. The purpose of the project was to assist these individuals take hypertension/pressure med-
ication as required through a peer-led project. This peer led project used a mobile device similar 
to regular mobile phone, a smart phone, or a tablet. The mobile device enabled us to deliver 
hypertension health services to the patients in a safe, confidential, and timely manner. The device, 
supported patients in treatment counseling; delivering medications to the patients; accounting for 
the types of medications delivered, quantity, and amount of fees the patients pays at the time of 
delivery (like an Mpesa transaction); and also connecting the patients with their doctor whenever 
they needed.. In doing so, a peer collected health information from the patients on a regular basis 
on this mobile device. 
 A peer was someone living with hypertension/pressure in the community who had been suc-
cessful in managing their hypertension. The peer was responsible for a number of things: 
 
Delivering hypertension medication to people living with hypertension/pressure at their 
most convenient location (door-to-door medication delivery).  
 
Confirming payment of medication (Mpesa transaction) by people living with hyperten-
sion/pressure before issuing the medication. 
 
Providing psychological support to people living with hypertension/pressure during medi-
cation delivery and whenever needed. 
 
Recording the health progress of people living with hypertension/pressure in a mobile 
device whenever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician, to discuss the progress of an in-
dividual living with hypertension. 
 
Whenever it was necessary, they enabled a conversation (intervention: either audio or 
video) between the clinician and the patient using the mobile device at the patient’s con-
venient location. 
  
1. What did you think about this peer-led project in supporting individuals living with hyperten-
sion in the community? 
Probe: 
 
What parts of the project did you like? Why? 
 
What part of the project didn’t you like? Why? 
 
Parts of the project that were easily carried out? Why? 
 
Parts of the project that were difficult to carry out? Why? 
 
 
2. What were the advantages of this kind of peer-led program? 
Probe: 
 
Advantages of peers leading the delivery of health services 
 
Advantages of door to door drug delivery  
 
Advantages of peers providing psychological support to individuals living with hyper-
tension at the community level 
 
Advantages of peers recording health information of the individuals receiving hyper-
tension medication at the community on the mobile device (Probe: quality of care, 
provider-patient communication, privacy and confidentiality) 

PT4A Study Guides 
Page 64 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
 
Advantages of doctor and the patient having a clinical meeting using a mobile device 
at the community level (Probe: quality of care, provider-patient communication, pri-
vacy and confidentiality) 
 
3. What were the disadvantages of this kind of peer-led program? 
Probe:  
 
Disadvantages of peers leading the delivery of health services 
 
Disadvantages of door to door drug delivery  
 
Disadvantages of peers providing psychological support to individuals living with hy-
pertension at the community level 
 
Disadvantages of peers recording health information of the individuals receiving hy-
pertension medication at the community on the mobile device (Probe: quality of care, 
provider-patient communication, privacy and confidentiality) 
 
Disadvantages of doctor and the patient having a clinical meeting using a mobile de-
vice at the community level (Probe: quality of care, provider-patient communication, 
privacy and confidentiality) 
 
4. In what ways did this peer-led program affect the management of hypertension at the com-
munity level? 
Probe:  
 
How did it affect medication adherence for individuals living with hypertension? 
 
How did it affect follow-up of individuals living with hypertension? 
 
How did it effect on how hypertension is perceived in the community?  
 
5. In what ways did this peer-led program affect the management of hypertension at the facility 
level? 
Probe:  
 
Positive effects (How did this program complement the efforts in clinic?) 
 
Negative effects (How did this make it challenging to manage hypertension at the 
clinic level 
 
6. In what ways did this peer-led affect the way care for hypertension/pressure is offered dur-
ing the current COVID pandemic? 
 
B. Peers  
Now let us talk more specifically about the peers who delivered these health services to individ-
uals living with hypertension at the community.  
7. What are your perception about the peers that were used to implement the PT4A  interven-
tion 
Probe: 
 
characteristics of the peer 
 
Qualifications/skill 
 
Training  
 
Integrity 
 
C. Mobile device 

PT4A Study Guides 
Page 65 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
Now let us talk more about the mobile device used to deliver these health services to individuals 
living with hypertension at the community.  
 
8. What is your perception of mobile device used by the peers to deliver the PT4A interven-
tion?  
9. What are the mobile device features that were most useful in implementing the PT4A inter-
vention? 
Probe: 
 
Type of device 
 
Size of device 
 
Connectivity 
 
Content 
 
Data flow 
 
Care facilitation features 
 
10. What were the mobile device features that were not useful in implementing the PT4A inter-
vention? 
Probe: 
 
Type of device 
 
Size of device 
 
Connectivity 
 
Content 
 
Data flow 
 
Care facilitation features 
 
11. What was your perception about the mobile payment mode used to pay for the Hypertension 
medications in the PT4A intervention? 
12. How did the use of a mobile device impact the delivery of hypertension services at the com-
munity? 
 
 
D. Recommendation for improving the PT4A project  
 
We are about to end our discussion today. But before we end, we would like to hear about some 
of your recommendations for improving the proposed peer-led project to support individuals liv-
ing with hypertension.  
 
13. What is your perception about the uptake of this peer led project in your facility? 
14. Would you recommend this peer-led project to other individuals living with HTN? Why 
15. What would be your recommendation for improving this peer-led project? Probe: 
 
Parts of the project that could be improved. How? 
16. What would make this peer led project acceptable as part of standard care? 
17. What would make this peer-led project sustainable? 
 
 
 
E. Closing 

PT4A Study Guides 
Page 66 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
We have now come to the end of our discussions today. Thank you for your time and participa-
tion. We very much appreciate your comments, discussion, and input. We plan to take into ac-
count everything that was said today as we continue to improve the services we offer to your 
community. 
 
Do you have any questions related to our discussion today? 
 
NB: Before ending 
 
Remind participants about the confidentiality of the interview.  
 
Ask if there is anything that wasn’t raised that should have been that is important 
to know in understanding their perception about the peer-led intervention.  
 
Offer lunch stipend and provide contact information for any future questions they 
may have.  
 
Thank participants once again for their time.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PT4A Study Guides 
Page 67 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) 
Study/  
Study Instrument: Focus Group Discussion (FGD) Guide for Individuals living with Hy-
pertension  
 
FGD moderator/ Msimamizi: ____________________________________________ 
FGD note taker/ Mchukua noti: ______________________________________________
Date/ Tarehe: ____/____/2022
County/ Kaunti: ___________________________________
Category of FGD (tick)/ Aina ya Majadiliano ya Kikundi 
[ ] Men living with hypertension / Wanaume wanoishi na Shinikizo la damu/ Pressure 
[ ] Women living with hypertension/ Wanawake Wanaoishi na Shinikizo la damu/ Pres-
sure 
[ ] Community members/ Wanachama wa Jamii 
Start Time/ Saa ya Kuanza: _____________________________________________ 
End Time/ Saa ya Kumaliza: _____________________________________________ 
FGD: 
 
Inform the participants about the study guided by the study information sheet.  
 
Provide participants with an opportunity to ask questions. 
 
Obtain written consent from each participant privately. (2 copies per participants) 
 
Provide each participant with a copy of their signed informed consent form. 
 
Complete the demographic survey for each participant privately. 

PT4A Study Guides 
Page 68 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
Demographic Survey for Individuals Living with Hypertension
Indicate or insert your responses as necessary 
1.
Study ID:/ Nambari ya Utafiti:
 
2. State your age (Year 
of Birth)/ Taja umri wako 
(Mwaka wa kuzaliwa)
3. Sex/ Jinsia
Male 
Kiume)
Female (Kike) 
4. Education/ Elimu 
No formal 
education/ 
Hakuna 
elimu rasmi 
Primary/ 
Shule ya 
Msingi 
Second-
ary/ Shule 
ya Upili 
Beyond 
second-
ary/ 
Zaidi ya 
Shule ya 
Upili
Special training e.g 
Trade. Insert 
Mafunzo maalum  
kwa mfano biashara 
5. What is your main 
source of income?/ 
Chanzo chako kikuu 
cha mapato ni nini? 
Farming/ 
Ukulima 
Busi-
ness/ 
Trade/Bi-
ashara 
Teacher/ 
Uwaalimu 
Health 
worker/ 
Mfanyak
azi wa 
afya  
Other/s (Insert): In-
gine 
6. What is your estimated 
monthly income in KES?/ 
Je! Mapato yako ya kila 
mwezi yanakadiriwa 
pesa ngapi (Kes? 
<1,000
1,000-
2,999 
3,000-
4,999 
5,000-
9,999 
 >10,000 
8. How long have you 
been living with hyperten-
sion/pressure in months?
Umeishi na shinikizo la 
damu / pressure  (kwa 
miezi ngapi 
<6 months/ 
Miezi sita 
Between 6 months – 
1year/ Kati ya miezi 
sita na mwaka? 
Be-
tween 1-
2 years 
Kati ya 
mwaka 
mmoja 
na 
mbili?
>2 years/ Zaidi ya 
miaka mbili? 
9. Where do you mainly 
seek treatment for hyper-
tension/pressure? / 
Unapata wapi matibabu 
ya shinikizo la damu/ 
pressure 
Health fa-
cility/ Kituo 
cha afya/ 
name the 
health 
facility 
 
 
 
 
 
Phar-
macy 
(over the 
counter 
medica-
tion) Duka 
la dawa / 
dawa ya 
kaunta) 
 
Herbalist 
/ Mtaalam 
wa dawa 
za 
Kienyeji 
Not yet 
sought 
care/ 
Bado 
sijatafut
a 
huduma 
Other specify/ 
Nyingine taja 

PT4A Study Guides 
Page 69 of 86 
PT4A_post intervention Interview Guides FGDs, Individuals living with HTN  
10. About how long 
would it take to get from 
your home to the nearest 
chemist/pharmacy if you 
walked to them? Je! 
Itachukua muda gani 
kutoka nyumbani 
kwako kwenda kwa 
duka la dawa lilokaribu 
ukitembea? 
Less than 
15 minutes/
Chini ya 
dakika 15  
16-30 
minutes/ 
Dakika 
16-30 
31 
minutes to 
an hour/ 
dakika 31 
hadi saa 
moja 
More than one hour/ Zaidi ya 
saa moja 
11. About how long 
would it take to get from 
your home to the nearest 
healthcare facility if you 
walked to them?/Je! 
Itachukua muda gani 
kutoka nyumbani 
kwako kwenda kituo 
cha huduma ya afya 
kilicho karibu ikiwa 
utatembea kuelekea 
huko?  
Less than 
15 minutes/ 
Chini ya 
dakika 15 
16-30 
minutes/ 
Dakika 
16-30 
31 
minutes to 
an hour/ 
dakika 31 
hadi saa 
moja 
More than one hour/ Zaidi ya 
saa moja 
NB: To be completed for each participant  

PT4A_Peer team Interview Guide Post-Intervention. 
Page 70 of 86
Summary of observations during FGD
Moderator and note taker: In the space below, please provide a summary of the FGD ses-
sion you just had including both verbal and nob-verbal cues.  
 
 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 71 of 86
Focus Group Discussion Guide
Individuals living with Hypertension  
 
   
******************************************************** 
Opening Remarks 
Hello.   My name is ______XXX_________ and I will help guide our discussion today..   
___XXX___________ is also present today to help take notes during our discussions. We will 
also be recording this session using a tape recorder (show the participants the tape recorder). 
This will help us capture what you say without missing out on anything. Your opinions and expe-
riences are very important to us since it will help us understand how to develop health program 
to assist more people living with hypertension in your community.  
 
You were selected to take part in this discussion because you participated in this study and we 
value your experiences and knowledge on our topic of discussion. I kindly request for your honest 
opinions and ideas. There is no wrong or right response. You should feel free to say whatever 
you think and feel.  You are welcome to say as much or as little as you want.  I am eager to hear 
what you have to say. Do you have any questions about what I have said so far?   
  
 
FGD rules 
Before we start, I would like as to you mention some of the rules that will guide our discussion  
 
6. There are no right or wrong answers. We expect that you will have differing points of view. 
Please feel free to share your point of view even if it differs from what others have said. 
 
7. We are recording this session as we discussed, because we do not want to miss any of 
your comments. No names will be included in any reports. Your comments are confiden-
tial. Please speak loudly for I want to be accurate in capturing what you say. 
 
8. Don’t feel like you have to respond all the time. But if you want to follow up on something 
that someone has said, you want to agree, or disagree, or give an example, feel free to 
do that.  
 
9. I am here to ask questions, listen, and make sure everyone has a chance to share. We’re 
interested in hearing from each of you. So if you are talking a lot, I may ask you to give 
others a chance. We just want to make sure all of you have a chance to share your ideas. 
 
10. If you have a cell phone, please put it on quiet mode.  
 
 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 72 of 86
A. PT4A intervention: 
PT4A project was started to support people living with hypertension/pressure at the community 
level. The purpose of the project was to assist these individuals take hypertension/pressure med-
ication as required through a peer-led project. This peer led project used a mobile device similar 
to regular mobile phone, a smart phone, or a tablet. The mobile device enabled us to deliver 
hypertension health services to the patients in a safe, confidential, and timely manner. The device, 
supported patients in treatment counseling; delivering medications to the patients; accounting for 
the types of medications delivered, quantity, and amount of fees the patients pays at the time of 
delivery (like an Mpesa transaction); and also connecting the patients with their doctor whenever 
they needed.. In doing so, a peer collected health information from the patients on a regular basis 
on this mobile device. 
 A peer was someone living with hypertension/pressure in the community who had been suc-
cessful in managing their hypertension. The peer was responsible for a number of things: 
 
Delivering hypertension medication to people living with hypertension/pressure at their 
most convenient location (door-to-door medication delivery).  
 
Confirming payment of medication (Mpesa transaction) by people living with hyperten-
sion/pressure before issuing the medication. 
 
Providing psychological support to people living with hypertension/pressure during medi-
cation delivery and whenever needed. 
 
Recording the health progress of people living with hypertension/pressure in a mobile 
device whenever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician, to discuss the progress of an in-
dividual living with hypertension. 
 
Whenever it was necessary, they enabled a conversation (intervention: either audio or 
video) between the clinician and the patient using the mobile device at the patient’s con-
venient location. 
I would first like to ask you questions regarding your perception and experience with the PT4A 
project 
  
18. What did you think about this peer-led project in supporting you as an individual living with 
hypertension in the community? 
Probe: 
 
What parts of the project did you like? Why? 
 
What part of the project didn’t you like? Why? 
 
19. What were your experiences with peers leading the delivery of hypertension services in the 
community? 
Probe: 
 
What did you like? Why? 
 
What didn’t you like? Why? 
 
20. What were your experiences with peers delivering medication at your convenient location in 
the community? 
Probe: 
 
What did you like? Why? 
 
What didn’t you like? Why? 
 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 73 of 86
21. What were your experiences with peers providing psychological support to you in the com-
munity? 
Probe: 
 
What did you like? Why? 
 
What didn’t you like? Why? 
 
22. What is your perception of peers recording your health information on a mobile device?  
Probe: 
 
Privacy and confidentiality. 
 
23. What is your perception of you and the doctor having a clinical meeting using a mobile de-
vice at the community? 
Probe:  
 
Quality of care 
 
Provider-patient communication 
 
Privacy and confidentiality 
 
24. What is your perception about the mobile payment mode used to pay for the Hypertension 
medications in the PT4A intervention? 
 
25. What are your perceptions about the characteristics of the peers who delivered the hyper-
tension services to your at the community? 
Probe: 
 
Age 
 
Gender 
 
Personality 
 
Academic qualification 
 
Skill/Training 
 
26. In what ways did this peer-led program affect your hypertension care? 
Probe:  
 
 
How did it affect your medication adherence? 
 
How did it affect your clinic adherence?  
 
How did it affect the quality of care you received? 
 
B. Recommendation for improving the PT4A project  
We are about to end our discussion today. But before we end, we would like to hear about some 
of your recommendations for improving this peer-led project to support individuals living with hy-
pertension/pressure 
 
27. Would you recommend this peer-led project to other individuals living with HTN? Why 
 
28. What would be your recommendation for improving this peer-led project? Probe: 
 
Parts of the project that could be improved. How? 
 
C. Closing 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 74 of 86
We have now come to the end of our discussions today. Thank you for your time and participa-
tion. We very much appreciate your comments, discussion, and input. We plan to take into ac-
count everything that was said today.  
Do you have any questions related to our discussion today? 
NB: Before ending
 
Remind participants about the confidentiality of the interview.  
 
Ask if there is anything that wasn’t raised that should have been that is important 
to know in understanding their perception about the peer-led intervention.  
 
Offer lunch stipend and provide contact information for any future questions they 
may have.  
 
Thank participants once again for their time.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 75 of 86
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) 
Study 
 
Study Instrument: Key Informant Interview Guide for Peers Team. 
FGD moderator: ____________________________________________
FGD note taker: ______________________________________________ 
Date:  ____/____/2022 
County: ___________________________________ 
Start Time: _____________________________________________ 
End Time: _____________________________________________ 
FGD: 
 
Inform the participants about the study guided by the study information sheet.  
 
Provide participants with an opportunity to ask questions. 
 
Obtain written consent from each participant privately. (2 copies per participants) 
 
Provide each participant with a copy of their signed informed consent form. 
 
Complete the demographic survey for each participant privately. 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 76 of 86
Demographic Survey
Indicate or insert your responses as necessary 
1. Study ID: 
2. State your age (Years)
3. Sex 
Male 
Female
5. How long have you 
served as a peer?
6. How long have you in-
teracted with patients liv-
ing with Hypertension? 
NB: To be completed for each participant  
 
 
 
 
 
 
 
 
 
 

PT4A_Peer team Interview Guide Post-Intervention. 
Page 77 of 86
Key Informant Interview Guide
Peers Team 
 
   
******************************************************** 
Opening Remarks 
Hello.   My name is ______XXX_________ and I will help guide our discussion today. Thank you 
for welcoming us to your community.   ___XXX___________ is also present today to help take 
notes during our discussions. We will also be recording this session using a tape recorder (show 
the participants the tape recorder). This will help us capture what you say without missing out on 
anything. Your opinions and experiences are very important to us since it will help us understand 
how helpful the intervention was for patients with hypertension. 
 
You were selected to take part in this discussion because we value your feedback regarding your 
experience in PT4A program. I kindly request for your honest opinions and ideas. There is no 
wrong or right response. You should feel free to say whatever you think and feel.  You are wel-
come to say as much or as little as you want.  I am eager to hear what you have to say. Do you 
have any questions about what I have said so far?   
  
 
FGD rules 
Before we start, I would like as to you mention some of the rules that will guide our discussion  
 
1. There are no right or wrong answers. We expect that you will have differing points of view. 
Please feel free to share your point of view  
 
2. We are recording this session as we discussed, because we do not want to miss any of 
your comments. No names will be included in any reports. Your comments are confiden-
tial. Please speak loudly for I want to be accurate in capturing what you say. 
 
 
3. I am here to ask questions, listen, and make sure everyone has a chance to share. We’re 
interested in hearing from each of you. So if you are talking a lot, I may ask you to give 
others a chance. We just want to make sure all of you have a chance to share your ideas. 
 
4. If you have a cell phone, please put it on quiet mode.  
 

PT4A Protocol 1.4 7th November, 2022
Page 78 of 86 
Now let us start our discussion with talking about how the project was perceived and the impact 
it had on individuals living with hypertension. 
 
D. PT4A intervention: 
There is a plan to start a project that will support people living with hypertension/pressure at the 
community level. The purpose of the project is to assist these individuals take hypertension/pres-
sure medication as required through a peer-led project. This peer led project will use a mobile 
device similar to regular mobile phone, a smart phone, or a tablet. The mobile device will enable 
us to deliver hypertension health services to the patients in a safe, confidential, and timely man-
ner. With the device, we will support the patients in treatment counseling; delivering medications 
to the patients; accounting for the types of medications delivered, quantity, and amount of fees 
the patients pays at the time of delivery (like an Mpesa transaction); and also connecting the 
patients with their doctor whenever they need.. To do so, a peer will need to collect health infor-
mation from the patients on a regular basis on this mobile device. 
 A peer will be someone who is living with hypertension/pressure in the community and has 
been successful in managing their hypertension. The peer will be responsible for a number of 
things: 
 
Deliver hypertension medication to people living with hypertension/pressure at their most 
convenient location (door-to-door medication delivery).  
 
Confirm payment of medication (Mpesa transaction) by people living with hyperten-
sion/pressure before issuing the medication. 
 
Provide psychological support to people living with hypertension/pressure during medi-
cation delivery and whenever needed. 
 
Record the health progress of people living with hypertension/pressure in a mobile de-
vice whenever they are in contact with a person living with hypertension/pressure. 
 
Using the mobile device, communicate with a clinician, to discuss the progress of an in-
dividual living with hypertension. 
 
Whenever necessary enable a conversation (intervention: either audio or video) between 
the clinician and the patient using the mobile device at the patient’s convenient location. 
I would first like to ask you questions regarding your perception and experience with the PT4A 
project  
 
1. Could you kindly describe your role in the PT4A intervention? 
 
2. What was your general perception of the PT4A intervention project? 
Probe: 
 
What parts of the project did you like? Why? 
 
What part of the project didn’t you like? Why? 
 
Parts of the project that were easily carried? What made it easy? 
 
Parts of the project that were difficult to carry out? What made it difficult? 
 
3. Now I would like you to share your experiences of the difference components of the PT4A 
intervention. How was your experience of; 
 
Delivering HTN medication to individuals living with HTN?  

PT4A Protocol 1.4 7th November, 2022
Page 79 of 86 
 
Providing psychological support to individuals living with hypertension at the commu-
nity level 
 
Recording health information of the individuals receiving hypertension medication at 
the community on the mobile device (Probe: quality of care, provider-patient commu-
nication, privacy and confidentiality) 
 
Facilitating the doctor and the patient to have a clinical meeting using a mobile de-
vice at the community level (Probe: quality of care, provider-patient communication, 
privacy and confidentiality) 
 
 
4. In what ways did the PT4A intervention affect the management of hypertension in the com-
munity? 
 
Probe:  
 
 
How did it affect medication adherence for individuals living with hypertension? 
 
How did it affect clinic adherence for individuals living with hypertension?  
 
E. Mobile device. 
 
Now let us talk more about the mobile device you used to deliver these health services to indi-
viduals living with hypertension at the community.  
  
5. What was your perception about the mobile device you used as you delivered the PT4A in-
tervention in the community 
Probe: 
 
What did you like about the mobile device? 
 
What didn’t you like about the mobile device? 
6. What mobile device features were useful in implementing the PT4A intervention? 
Probe: 
 
Content 
 
Data flow 
 
 Connectivity 
7. What mobile device features were not useful in implementing the PT4A intervention? 
Probe: 
 
Content 
 
Data flow 
 
Connectivity 
 
8. What was your perception about the mobile payment mode used to pay for the hypertension 
medications in the PT4A intervention? 
Probe: 
 
What did you like about the mobile payment? 
 
What didn’t you like about the mobile payment? 
 
 
9. How did the use of a mobile device impact the delivery of hypertension services at the com-
munity? 

PT4A Protocol 1.4 7th November, 2022
Page 80 of 86 
F. Peers.
Following your experience as a peer in the PT4A project, I would now like us to talk about the 
qualities of a peer who would lead the delivery of PT4A intervention at the community.  
10. What characteristics would be important for a peer to have if they were to lead the PT4A in-
tervention in the community  
Probe: 
 
Age 
 
Gender 
 
Personality 
 
Academic qualification 
 
Skill 
 
11. What are your perceptions about the training you received from PT4A facilitators? 
Probe: 
 
How relevant was the training in preparing you to conduct your duties as a peer in 
the PT4A intervention? 
 
How adequate was the training in accomplishing your duties as a peer in the PT4A 
intervention? 
 
What additional training aspects should be considered in the future for peers in the 
PT4A intervention? 
 
 
G. Recommendation for improving the PT4A project  
We are about to end our discussion today. But before we end, we would like to hear about some 
of your recommendations for improving the proposed peer-led project to support individuals liv-
ing with hypertension.  
 
12. What is your perception about the uptake of this peer led project in your facility? 
13. Would you recommend this peer-led project to other individuals living with HTN? Why 
14. What would be your recommendation for improving this peer-led project? Probe: 
 
Parts of the project that could be improved. How? 
15. What would make this peer led project acceptable in the community? 
16. What would make this peer-led project sustainable in the community? 
H. Closing 
We have now come to the end of our discussions today. Thank you for your time and participa-
tion. We very much appreciate your comments, discussion, and input. We plan to take into ac-
count everything that was said today as we continue to improve the services we offer to your 
community. 
 
Do you have any questions related to our discussion today? 
 
NB: Before ending 
 
Remind participants about the confidentiality of the interview.  
 
Ask if there is anything that wasn’t raised that should have been that is important 
to know in understanding their perception about the peer-led intervention.  

PT4A Protocol 1.4 7th November, 2022
Page 81 of 86 
 
Offer lunch stipend and provide contact information for any future questions they 
may have.  
 
Thank participants once again for their time.  
 
 
 
Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) Study 
 
Study Instrument: Focus Group Discussion (FGD) Guide for Design Team- Meeting 6. 
 
 
FGD moderator: ____________________________________________
FGD note taker: ______________________________________________
Date:  ____/____/2022 
County: ___________________________________ 
Start Time: _____________________________________________ 
End Time: _____________________________________________ 
FGD: 
 
Inform the participants about the study guided by the study information sheet.  
 
Provide participants with an opportunity to ask questions. 
 
Obtain written consent from each participant privately. (2 copies per participants) 
 
Provide each participant with a copy of their signed informed consent form. 
 
Complete the demographic survey for each participant privately. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic Survey 

PT4A Protocol 1.4 7th November, 2022
Page 82 of 86 
Indicate or insert your responses as necessary
1. Study ID:
2. State your age (Years) 
3. Sex 
Male 
Female 
4. Where are you from? 
Uasin-Gishu 
County 
Trans-Nzoia County
Bungoma County
5. Which group are you 
representing in the design 
team? 
Health care 
Team 
Patients 
Team 
Peers
Team  
Other (specify)
6. How many design team 
meetings did you attend? 
NB: To be completed for each participant  
Focus Group Discussion Guide 
Design Team 
Opening Remarks: Human-centered design is a creative approach to 
problem solving. It emphasizes issues that are important to community 
stakeholders rather than leadership or administrators. This design process 
is focused on understanding the needs of the community, generating 
many ideas from different perspectives, building tangible prototypes, and 
iteratively improving the solution based on stakeholder feedback.

PT4A Protocol 1.4 7th November, 2022
Page 83 of 86 
During our Design Team meetings, we worked through phases of Inspi-
ration, Brainstorming, Conceptualization, Creation, and Iteration. Through 
this process, we have learned much about the human-centered design 
methods and how they may be used to create a combined health infor-
mation technology (HIT) and peer support program for PT4A. We have 
asked you to participate today because you have been a part of the PT4A 
Design Team. The purpose of this discussion is to reflect on your experi-
ence during the design process and provide feedback to the facilitators. 
 
FGD rules
 
Before we start, I would like as to you mention some of the rules that will guide our 
discussion  
 
11. There are no right or wrong answers. We expect that you will have differing points of 
view. Please feel free to share your point of view even if it differs from what others have 
said. 
 
12. We are recording this session as we discussed, because we do not want to miss any of 
your comments. No names will be included in any reports. Your comments are confiden-
tial. Please speak loudly for I want to be accurate in capturing what you say. 
 
13. Don’t feel like you have to respond all the time. But if you want to follow up on something 
that someone has said, you want to agree, or disagree, or give an example, feel free to 
do that.  
 
14. I am here to ask questions, listen, and make sure everyone has a chance to share. We’re 
interested in hearing from each of you. So if you are talking a lot, I may ask you to give 
others a chance. We just want to make sure all of you have a chance to share your ideas. 
 
15. If you have a cell phone, please put it on quiet mode.  
 
 
A.DESIGN TEAM EXPERIENCE 
1. Reflecting back to our first meeting, what is your understanding of human-
centered design? 
o Probe:
 
What were the goals of the design team? 
2. Why did you volunteer to join the Design Team for 
PT4A? 
o Probe: 
 
What were your expectations for 
this design process? 
 
Did this design process meet your 
expectations? Why or why not? 

PT4A Protocol 1.4 7th November, 2022
Page 84 of 86 
3. What have you learned during the human-centered design process?
o
Probe:
What have you learned about yourself?
 
 What have you learned about others in this group? 
 
 What have you learned about your community? 
 
What have you learned about the health system?
4. Do you think that you will use what you have learned during the design 
process in the future? Please explain. 
5. Often in group discussion, some participants may speak up and ex-
press opinions more than others. To what extent did every member 
of the Design Team participate equally in discussion?
o Probe:  
 
How have we succeeded to encourage participa-
tion from everyone in the group? 
 What challenges have we faced in encouraging partici-
pation from everyone in the group?
 
Were the opinions of each participant considered 
equally? Please explain.
6. Often in group discussion, there are times when there is dis-
agreement between participants. How were disagreements 
addressed on the Design Team? 
o Probe:
 
When disagreements occurred, did the De-
sign Team reach a consensus before mov-
ing on? Please explain. 
7. Reflecting on our work so far, to what extent did the Design 
Team incorporate: feedback from the community during the de-
sign process? 
8. Reflecting on our work so far, to what extent did the Design Team
incorporate feedback from the PT4A investigators during the de-
sign process?
9. How do you feel about the current intervention model? 
Probe: 
 
How confident are you that it meets the orig-
inal goals of our design team? 
 
What are your thoughts about how this inter-
vention was received by patients? 
 
What are your thoughts about how this inter-
vention was received by providers and other 
health care workers? 
 

PT4A Protocol 1.4 7th November, 2022
Page 85 of 86 
B.RECOMMENDATION FOR IMPROVING HCD MEETINGS.
10. What would be your recommendation for improving these design team 
meetings? 
 
C. 
CLOSING 
Thank you for your time and participation. We very much appreciate your. Com-
ments, discussion, and input. We plan to consider everything that was said 
today as we continue to improve the services we offer to your community. 
Do you have any questions related to our discussion today?
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PT4A Protocol 1.3 14th July, 2022