Hypertension Treatment in Nigeria Program 2.0
Phase: NA
Conditions: Hypertension (HTN)
Sponsor: Washington University School of Medicine

 
 
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Page 1 of 34 
PROTOCOL TITLE: Transforming Hypertension Treatment in Nigeria using a Type II Hybrid, 
Interrupted Time Series Design - Aims 2 & 3 
 
NATIONAL CLINICAL TRIAL (NCT) IDENTIFIER: Pending 
 
GRANT NUMBER: R01HL144708 
 
PRINCIPAL INVESTIGATORS: 
Dike Ojji, MBBS, PhD (Contact PI) 
Professor of Medicine and Preventive Cardiology 
College of Health Sciences, University of Abuja  
& Honorary Consultant Physician/Cardiologist 
University of Abuja Teaching Hospital 
Gwagwalada, Abuja, Nigeria 
Tel: +234-806-009-4456 
Email: dike.ojji@uniabuja.edu.ng 
 
Mark D. Huffman, MD, MPH  
William Bowen Professor of Medicine 
Professor of Public Health 
Co-Director, Global Health Center 
Co-Director, Global Health Futures Innovation Research Network 
Washington University School of Medicine 
Saint Louis, MO 63108 
Tel: +1-314-747-9487 
Email: m.huffman@wustl.edu 
 
VERSION NUMBER: 1 
 
VERSION DATE: 15 January 2026 
 
STATEMENT OF COMPLIANCE: 
This trial will be conducted in compliance with this protocol, International Council on 
Harmonization Good Clinical Practice (ICH GCP) and applicable local and federal regulatory 
requirements. The protocol and any other participant-facing materials will be submitted for 
review and approval by Institutional Review Boards (IRBs) and/or Ethics Committees (ECs) as 
well as relevant local institutional ethics committees. 
 
The protocol, recruitment materials, and all participant materials will be submitted to the IRB for 
review and approval. Approval of the protocol must be obtained before any participant is recruited. 
Any amendment to the protocol will require review and approval by the IRB before the changes 
are implemented to the study.  
 
 
INVESTIGATOR’S SIGNATURE: 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines, as described in the 
Statement of Compliance above. 
 

 
 
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Principal Investigators: 
 
Name 
Affiliation 
Telephone 
Email 
Signature 
Mark 
Huffman 
Washington 
University in 
St. Louis 
314-747-9487 
m.huffman@wustl.edu 
 
Dike Ojji 
University of 
Abuja 
+234-806-009-
4456 
dike.ojji@uniabuja.edu.ng  
 
 
 
PROGRAM SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
None 
IND / IDE / HDE #  NA 
Indicate 
Special Population(s) 
 Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size Aim 2: 10,000 participants 
Aim 3: 2,800 participants 
Funding Source National Heart, Lung, and Blood Institute 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site (For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
1. OBJECTIVES 
 
The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program 
is to build upon the success of the first phase of the HTN Program (2020-2023), which 
implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the 
Federal Capital Territory (FCT). This program demonstrated significant improvements in 
hypertension treatment and control. HTN 2.0 will evaluate sustainment of hypertension control 
in the Federal Capital Territory and will expand implementation of the HEARTS bundle to 5 new 
states in 5 geopolitical zones in Nigeria (Abia, Delta, Gombe, Jigawa, and Oyo). Additionally, 
diabetes management will be included through the implementation of the HEARTS-D bundle in 
10 PHCs across the FCT that previously participated in the initial HTN Program. Overall, the 

 
 
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objective of this study is to evaluate the effectiveness of program implementation on 
hypertension and diabetes management in Nigeria. 
 
This protocol represents the activities that will be carried out to implement and evaluate 
effectiveness and implementation outcomes of a system-level hypertension and diabetes control 
program among patients with hypertension and diabetes through an interrupted time series 
design to improve hypertension and diabetes treatment and control at system and patient levels. 
This system-level hypertension control program is modeled after Kaiser Permanente’s Northern 
California (KPNC) Hypertension Program and the World Health Organization (WHO) HEARTS 
package as exemplars for large-scale hypertension control.13 This package was implemented as 
part of the first phase of the Hypertension Treatment in Nigeria Program in the Federal Capital 
Territory. 
 
2. BACKGROUND 
 
Elevated blood pressure and glucose are two leading modifiable risk factors for global 
cardiovascular disease (CVD) morbidity and mortality, including in Nigeria, the most populous 
country in sub-Saharan Africa.7,18,25 In Nigeria, the age-adjusted adult prevalence of 
hypertension and diabetes mellitus is estimated to be 36% and 3.6%, respectively.11,32 Despite 
the large and growing burden of these two conditions, awareness, treatment, and control rates 
for both remain very low.11,18 During the initial funding period of this award, our team 
contextualized, implemented, and evaluated implementation and effectiveness of a multilevel 
bundle of strategies to integrate hypertension services in 60 public, primary healthcare centers 
(PHCs) in the FCT of Nigeria using a type II hybrid, interrupted time series design.2,22 The 
bundle, adapted from the WHO HEARTS technical package, included: 1) a hypertension patient 
registry with empanelment, 2) a simplified, national treatment protocol emphasizing upfront 
fixed-dose combination therapy, 3) team-based care led by community health extension workers 
(CHEWs), 4) quarterly site supervision with monthly performance and quality reporting, and 5) 
reliable access to quality essential medicines and technology supported by a drug revolving 
fund to lower out-of-pocket costs. From January 2020 to December 2023, we recruited 
21,897 adults (142,249 visits) with hypertension from 60 sites and demonstrated a 
remarkable improvement in 6-month rolling average of hypertension control (i.e., blood 
pressure <140/<90 mmHg) from 22% to 56%. The program showed a sustained 
hypertension control rate >50% for nearly 2 years, through the end of follow-up. Our 
detailed implementation assessment, including how HEARTS was normalized into routine care, 
provides a roadmap for scale-up. 
 
We have organized an exceptional group of national, state, and local partners in Nigeria, 
including government health agencies and policymakers, healthcare providers, professional 
bodies, and an advisory board who now co-own this work for this second phase of the program. 
Our collaborators have called on us to develop an updated protocol that includes scale-up of 
hypertension services aligned with national priorities, specifically related to Nigeria’s emerging 
community insurance, basic healthcare provision funds, and health management information 
systems1, as well as integration of diabetes services in public primary care based on the HTN 
Program. We have conducted relevant preliminary work, including mixed methods assessments 
of our previous trial and preliminary readiness assessments for horizontal scale-up4 for 
hypertension and diabetes. 
 
In this protocol, we will use the Implementation Research Logic Model28 to contextualize 
HEARTS and the diabetes module of HEARTS (HEARTS-D). We will also use WHO ExpandNet 
framework31 and RE-AIM framework 8,29 embedded within the Implementation Research Logic 
Model to guide and evaluate implementation and effectiveness of horizontal scale-up of the 
HEARTS bundle in 5 new states in 5 geopolitical zones in Nigeria. We will evaluate 

 
 
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effectiveness and the process implementation of the HEARTS-D bundle implementation on 
diabetes screening, diagnosis, treatment, and control in 10 PHCs in the FCT where we have 
previously integrated hypertensive services during the first phase of this program. We will also 
explore sustainment of hypertension control in these 10 centers, as well as the other previously-
enrolled centers using DHIS-2, the government’s preferred health management information 
system. 
 
Formative Aim 1: Using the Implementation Research Logic Model, conduct mixed 
methods formative research to refine implementation pathways of the HEARTS and 
HEARTS-D bundles in Nigeria. 
 
The research activities for Formative Aim 1 are outlined in a separate protocol. 
 
Aim 2: Evaluate effectiveness (2a) and implementation (2b) of scale-up of the HEARTS 
bundle on hypertension control (<140/<90 mmHg) in 50 primary healthcare centers in 5 
states in Nigeria using a type II hybrid, single arm interrupted time series design.  
 
H2a: We hypothesize that HEARTS implementation will increase hypertension control more in 
the implementation period than the pre-implementation period (1o effectiveness outcome). 
Hypertension treatment, mean systolic and diastolic blood pressure will be 2o effectiveness 
outcomes. Safety outcomes include rates of serious adverse events, adverse events of special 
interest, and laboratory abnormalities. 
 
H2b: We hypothesize that the HEARTS bundle will reach the target population and will be 
adopted, implemented, acceptable, affordable, and maintained as intended. The primary 
implementation outcome will be the dose of quarterly supportive supervision visits measured by 
the proportion of observed/expected visits measured in the implementation period. 
 
Aim 3: Evaluate effectiveness and implementation process of the HEARTS-D bundle on 
diabetes screening in 10 primary healthcare centers in Federal Capital Territory that have 
already implemented HEARTS.  
 
H3: We hypothesize that the HEARTS-D implementation will increase diabetes screening more 
in the implementation period than the pre-implementation period (1o outcome). Diabetes 
treatment and control and mean fasting glucose will be 2o effectiveness outcomes. Safety 
outcomes include rates of serious adverse events, adverse events of special interest, and 
hypoglycemia. We will also explore sustainment of hypertension control not only in these 10 
sites but also in the other 50 sites in the Federal Capital Territory that implemented HEARTS 
during the first phase of the program using the District Health Information System -2 (DHIS-2). 
 
This protocol includes implementation and evaluation of a culturally- and contextually adapted 
implementation bundle based on the KPNC and WHO HEARTS programs for hypertension 
diagnosis, treatment, and control at public, primary health centers previously used in the 
Federal Capital Territory and now to be implemented in five expansion states (i.e., Abia, Delta, 
Gombe, Jigawa, Oyo). Implementation pathways have been developed with particular attention 
to overcoming modifiable system- and patient-level barriers to hypertension treatment and 
control across capability, intentional, and system domains using the updated Consolidated 
Framework for Implementation Research (CFIR 2.0, cfirguide.org). Readiness and capacity 
have been assessed at primary health centers (e.g. available staff; information systems; use of 
clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) 
instrument during the formative work for this Program.  
 
1. PROGRAM ENDPOINTS 

 
 
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Primary Effectiveness Outcome (Aim 2) 
• 
Difference in the 6-month rolling average of hypertension control between the pre-
implementation and implementation periods (defined as <140/<90 mm Hg) 
 
Primary Implementation Outcome (Aim 2) 
• 
Dose of quarterly supportive supervision visits measured by the proportion of 
observed/expected visits during the implementation period.  
 
*Refer to the Research Plan for a detailed account of secondary and exploratory implementation 
outcomes. 
 
Secondary Effectiveness Outcomes (Aim 2) 
• 
Difference in the 6-month rolling average between the pre-implementation and 
implementation periods and will include: 
o Hypertension treatment  
o Mean systolic blood pressure 
o Mean diastolic blood pressure 
o Hypertension control (more stringent target), defined by blood pressure <130/80 
mm Hg 
 
Safety Outcomes 
Safety outcomes will include between-period (pre-implementation versus implementation) 
differences in the proportion of:  
• 
Serious adverse events 
• 
Adverse events of special interest (i.e., clinically ascertained angioedema, syncope, 
lightheadedness/dizziness, edema, inappropriate medication prescription [e.g., ACE or 
ARB among patients who are pregnant]) 
• 
Hyperkalemia, hypokalemia, and acute kidney injury measured in a subset of 5 sites and 
250 patients (n=500 total) in both pre-implementation and implementation periods.  
 
*We will also assess for unanticipated problems to adhere to US federal regulations. 
 
Definitions of Treatment and Control 
Adults with hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg measured on two separate 
occasions or taking blood pressure lowering drugs) or adults with controlled (SBP <140 mmHg 
and DBP <90 mmHg) hypertension among those who are treated with blood pressure lowering 
drugs, will be continuously registered at participating primary healthcare centers. Once an 
individual is registered, they will be considered empaneled and will be asked to return regularly 
(e.g., monthly, quarterly) for follow-up monitoring and treatment at the primary healthcare center 
to achieve sustained hypertension control.  
 
These analyses will assume the following for hypertension treatment (T) and control (C) at each 
month i (i=1…36) across all participating sites: 
 
𝑁! = 𝑁𝑢𝑚𝑏𝑒𝑟 𝑁𝑒𝑤𝑙𝑦 𝑅𝑒𝑔𝑖𝑠𝑡𝑒𝑟𝑒𝑑! + 𝑁𝑢𝑚𝑏𝑒𝑟 𝑃𝑟𝑒𝑣𝑖𝑜𝑢𝑠𝑙𝑦 𝑅𝑒𝑔𝑖𝑠𝑡𝑒𝑟𝑒𝑑 𝑅𝑒𝑡𝑢𝑟𝑛𝑒𝑑! 
 
The number of hypertensive registrants is defined as the number of patients with hypertension 
who are newly registered during any calendar month plus the total number of previously 
registered individuals who returned to primary health centers in that month for ongoing care. 

 
 
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Registrants who return for follow up care more than one time in a calendar month will be 
counted once for this analysis. 
 
𝑇! = 𝑁𝑢𝑚𝑏𝑒𝑟 𝑁𝑒𝑤𝑙𝑦 𝑃𝑟𝑒𝑠𝑐𝑟𝑖𝑏𝑒𝑑! + 𝑁𝑢𝑚𝑏𝑒𝑟 𝐶𝑜𝑛𝑡𝑖𝑛𝑢𝑖𝑛𝑔 𝐵𝑃 𝐿𝑜𝑤𝑒𝑟𝑖𝑛𝑔 𝑀𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛!
𝑁!
 
 
Treatment will be calculated each month across all participating sites. Treatment is defined at a 
patient level as an ongoing or new prescription of any BP-lowering medication during the 
calendar month.  
 
𝐶! = 𝑁𝑢𝑚𝑏𝑒𝑟 𝑤𝑖𝑡ℎ 𝑆𝐵𝑃 < 140 𝑚𝑚𝐻𝑔 𝑎𝑛𝑑 𝐷𝐵𝑃 < 90 𝑚𝑚𝐻𝑔!
𝑁!
 
 
Control will be calculated each month across all participating sites. Control is defined at a 
patient level as measured SBP <140 mm Hg and DBP <90 mm Hg during the calendar month. 
We will also evaluate a more stringent target (<130/<80 mm Hg) as a secondary outcome. 
 
Refer to the Statistical Analysis Plan for further details on planned sensitivity and subgroup 
analysis. 
 
Primary Effectiveness Outcome (Aim 3 ) 
• 
The primary outcome will be the difference in the 6-month rolling average of the 
diabetes screening among eligible patients, screening defined as a random plasma 
glucose screening among adults with symptoms of hyperglycemia or a fasting plasma 
glucose among adults > 18 years old and body mass index > 25 kg/m2 in accordance 
with HEARTS-D, between the pre-implementation and implementation periods. 
Hemoglobin A1c may also be used if available. 
 
*Symptoms of hyperglycemia include but are not limited to thirst, frequent urination, blurring of 
vision, fatigue, unintentional weight loss. 
 
Primary Implementation Outcomes (Aim 3) 
• 
Dose of quarterly supportive supervision visits measured by the proportion of 
observed/expected visits during the implementation period.  
 
Secondary Effectiveness Outcomes (Aim 3) 
• 
Secondary outcomes will compare the 6-month rolling average of diabetes treatment, 
blood sugar control, and mean fasting glucose levels in the pre-implementation and 
implementation periods. 
 
Safety Outcomes (Aim 3) 
Safety outcomes will include between-period (pre-implementation versus implementation) 
differences in proportions of:  
• 
Serious adverse events 
• 
Adverse events of special interest (e.g., hypoglycemia, hyperglycemia, medication 
allergies, common medication side effects) in pre-implementation and implementation 
periods.  
 
*We will assess for unanticipated problems to adhere to US federal regulations. 
 
Definitions of Treatment and Control: 

 
 
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• 
Treatment will be defined by the prescription of any glucose lowering drug. Control will 
be defined according to the WHO HEARTS-D module2, specifically: fasting glucose <126 
mg/dl, postprandial glucose <160 mg/dl, or HbA1c <7%.  
 
*Refer to research plan for additional details 
 
2. PROGRAM INTERVENTION(S) / INVESTIGATIONAL AGENT(S) 
The intervention is based on a culturally- and contextually adapted implementation bundle 
based on the KPNC, WHO HEARTS programs for hypertension diagnosis, treatment, and 
control, and WHO HEARTS-D programs for diabetes diagnosis, treatment, and control. The 
KPNC model, also based on the Hypertension Detection and Follow-up Study, includes 5 
components.10,13 The WHO HEARTS and WHO HEARTS-D package is based on 5 domains for 
hypertension and diabetes programming respectively.  
 
Component 
KPNC Model 
WHO HEARTS Model 
WHO HEARTS-D 
HTN 2.0 Program 
Registry 
HTN patient registration 
using baseline data 
collected in the 
formative period 
HTN patient registration 
Patient registry and 
empanelment 
HTN and diabetes 
patient registration 
and longitudinal 
empanelment 
Performance 
Reports 
Monthly quality and 
performance reports, 
including treatment and 
control rates to sites  
Information systems 
that allow for 
continuous, real-time 
program improvement 
Information systems 
to support quality 
reporting and 
improvement. 
Monthly automated 
quality and 
performance 
feedback reports. 
Real-time registry 
dashboard for patient 
follow-up 
Simplified 
Treatment 
Guidelines & 
Patient Care 
Simplified treatment 
guidelines 
 
Use of fixed-dose 
combinations, such as 
lisinopril-HCTZ as first 
line treatment 
Protocols that include 
specific medications, 
doses, and steps to 
streamline care and 
improve adherence and 
control 
 
Use of fixed dose 
combinations 
 
Patient-centered care 
with simpler medication 
regimens, no or 
reduced-cost 
medications and follow-
up visits 
Simplified treatment 
guidelines (see 
research plan) 
 
Use of fixed-dose 
combinations, such 
as glibenclamide and 
metformin as first line 
treatment. 
Simplified treatment 
guideline and 
national HTN 
consensus protocol 
 
Federal Ministry of 
Health Diabetes 
Treatment Protocol 
for the Nigeria-
Package of Essential 
Non-communicable 
Diseases (Nigeria-
PEN) at the Primary 
Healthcare 
Supply 
Chain 
Streamlined medication 
options 
Ensuring a reliable, 
uninterrupted supply of 
quality blood pressure 
lowering medicines 
Access to functioning 
glucometers, test 
strips, and essential 
medicines supported 
by a drug revolving 
fund.  
Supply chain 
strengthening 
through a drug 
revolving fund for 
blood pressure 
lowering drug 
availability and 
affordability 
Non-
Physician 
Care 
Non-physician follow-up 
2-4 weeks after 
medication changes 
Use of non-physician 
health workers to 
prescribe, adjust, and 
intensify medication 
Team based care 
and non-physician 
follow up.  
Empowerment and 
enablement of 
CHEWs as first line 
for diagnosis, 

 
 
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All drug classes are listed on the 2023 Nigerian Essential Medicines List and are recommended 
by the 2023 Nigerian standardized treatment guidelines for hypertension, including fixed-dose 
combination therapy (health.gov.ng). Nigeria has created a standard treatment guideline for 
hypertension, which will be the basis of the treatment protocol for the HTN Program. Nigeria 
also has a preliminary diabetes mellitus protocol: Diabetes Treatment Protocol for the Nigeria-
Package of Essential Non-communicable Diseases (Nigeria-PEN) at the Primary Healthcare. 
Medication supply chain optimization will be supported by implementation of a drug revolving 
fund based on the study team’s previous work. 
 
3. PROCEDURES INVOLVED 
Aim 2: Evaluate effectiveness (2a) and implementation (2b) of horizontal scale-up of the 
HEARTS bundle on hypertension control (<140/<90 mmHg) in 50 primary healthcare 
centers in 5 states in Nigeria using a type II hybrid, single arm interrupted time series 
design.  
 
Pre-implementation period. At the start of the 12-month pre-implementation period, we will 
conduct one-day in-person training at the state level to implement a hypertension registry that 
captures relevant pre-implementation data. We will ensure that sites have functioning blood 
pressure monitors but will not include training related to hypertension diagnosis, treatment, and 
control to minimize the risk of contamination. We will not provide supportive supervision, nor will 
we implement a drug revolving fund during this period for similar reasons.  
 
Implementation period. The 24-month implementation period will start when we conduct two-day 
in person training at the state-level based on the US Centers for Disease Control and 
Prevention Hypertension Management Training curriculum.5 We used this program for the 
Hypertension Academy (n=575 participants) during the initial funding period. This program 
includes didactic, group-based, and hands-on education and training to promote knowledge and 
skill transfer, which will be measured during pre- and post-training assessments based on levels 
1 (reaction), 2 (learning), and 3 (behavior) of the Kirkpatrick framework.15 Implementation 
training will also be conducted with pharmacists to promote appropriate dispensation of 
medications and drug revolving fund implementation. During the implementation period, sites 
will receive quarterly in-person site supervision visits by trained members of the study team to 
provide ongoing training and support. In limited instances where there are security concerns at 
PHCs, remote or centralized training will be used, as we have previously done. Health workers 
who are not directly involved with the study will have the opportunity to participate in additional 
virtual training through mDoc, and in-person training through the Hypertension Academy led by 
Dr. Ojji, which will be available during Years 4-5. Co-I Baldridge will contribute to training 
assessments and analyses based on her previous experience.3 
 
Primary healthcare centers will transition from the pre-implementation to implementation period 
by receiving monthly automated quality and performance feedback reports, real-time 
regimens based on 
physician orders and 
protocols 
treatment and 
management of 
patients with HTN 
and diabetes 
Supportive 
Supervision 
 
 
Implementation 
strategy to provide 
guidance, 
mentorship, and 
resource allocation to 
healthcare workers to 
improve performance  
Implementation 
strategy to provide 
guidance, 
mentorship, and 
resource allocation to 
healthcare workers to 
improve performance  

 
 
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dashboarding, simplified treatment guidelines, hypertension protocols, non-physician follow up 
after medication changes, supportive supervision, and implementation of a drug revolving fund. 
Transition from baseline to implementation period may be asynchronous within and between 
primary healthcare centers. The components of the baseline and intervention periods are 
considered standard of care.   
  
Patients will be registered in a longitudinal hypertension registry regardless of study phase. 
Upon the first diagnosis of hypertension, or visit to the PHC during the registration period, 
participant data will be captured in the participant treatment card by a healthcare worker at the 
PHC. The participant will be administered a hypertension treatment card including vitals and a 
unique program identifier. The participant will be instructed to bring this card with them to 
subsequent visits for purposes of tracking their blood pressure over time. A participant treatment 
card will also be retained by the PHC to capture baseline and longitudinal participant information 
including demographics, contact information, medical history, blood pressures, laboratory 
measures, hypertension medications and adverse events. The data comprise information that 
would typically be found within a medical record. Patient treatment cards will be updated at each 
subsequent visit with blood pressures, changes in medication, new laboratory values, and 
adverse event information.  
  
Registry data will be abstracted to REDCap either by a primary healthcare worker (e.g. record 
officer) at the PHC or by a member of the research team. The PHC may choose to transition to 
electronic data collection during the program after consultation with the research team.   
  
Primary healthcare centers will transition from the pre-implementation to the implementation 
period between 9-15 months of baseline data collection. Transition to the implementation period 
will be considered initiated upon completion of hypertension training including review and 
provision of simplified treatment guidelines and hypertension protocols. After training 
completion, the primary healthcare center will begin receiving monthly automated quality and 
performance feedback reports, supportive supervision, and a drug revolving fund. Sites may 
also implement a real-time registry dashboard using REDCap. The dates of initiation of each 
bundle component at each primary healthcare center will be captured.   
  
Participant data will be continuously monitored by both the primary healthcare center and the 
research team using centralized data monitoring. Participant data will be reviewed at minimum 
monthly by the research team, including review of all adverse events. The components of the 
pre-implementation period are considered standard of care.    
 
Treatment Steps: 
Protocol 1 
1. If BP > 140/90 mmHg: Start amlodipine 5 mg 
2. After 1 month, measure BP, if still high treat with amlodipine 5 mg + losartan 50 mg 
3. After 1 month, measure BP again. If still high treat with amlodipine 10 mg + losartan 100 
mg 
4. After 1 month, measure BP again. If still high treat with amlodipine 10 mg+ losartan 100 
mg + HCTZ 25 mg. 
5. After 1 month, measure BP again. If still high refer to specialist hypertension 
management 
 
*If initial BP > 160/100 mg, but <180/110 mmHg, start at step 2 
*If initial BP > 180/110 mmHg, give step 3 drugs and refer to emergency unit of nearest general 
hospital within 1 hour 

 
 
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Notes: 
• 
Single pill combination of amlodipine plus losartan is preferred to free combination 
• 
HCTZ= Hydrochlorothiazide 
• 
Telmisartan 40 mg and 80 mg if available is preferable to losartan 
• 
May substitute HCTZ 25 mg with amiloride, 2.5 mg/HCTZ 25 mg if HCTZ is 
unavailable 
 
*If medication cost is a factor impacting availability or accessibility of the medications listed in 
protocol 1, protocol 2 may instead be used. 
Protocol 2:  
1. If BP > 140/90 mmHg: Start amlodipine 5 mg 
2. After 1 month, measure BP, if still high treat with amlodipine 5 mg + moduretic ½ tablet 
(amiloride 2.5 mg + HCTZ 25 mg). 
3. After 1 month, measure BP again. If still high treat with amlodipine 10 mg + moduretic ½ 
tablet (amiloride 2.5 mg + HCTZ 25 mg). 
4. After 1 month, measure BP again. If still high refer to specialist hypertension 
management 
 
*If initial BP > 160/100 mg, but <180/110 mmHg, start at step 2 
*If initial BP > 180/110 mmHg, give step 3 drugs and refer to emergency unit of nearest general 
hospital within 1 hour 
 
Notes: 
• 
Single pill combination of amlodipine plus losartan is preferred to free combination 
• 
Telmisartan 40 mg and 80 mg if available is preferable to losartan 
• 
May substitute HCTZ 25 mg with amiloride 2.5mg/HCTZ 25 mg if HCTZ is 
unavailable 
• 
Moduretic ½ tablet (amiloride 2.5mg/HCTZ 25 mg) 
 
 
Aim 3: Evaluate effectiveness and implementation process of HEARTS-D bundle on 
diabetes screening in 10 primary healthcare centers in Federal Capital Territory that have 
already implemented HEARTS. 
  
Summary. This aim uses an interrupted time series design to compare diabetes screening, 
diagnosis, treatment, and control between the pre-implementation (12 months) and 
implementation (24 months) periods in 10 primary healthcare centers in the Federal Capital 
Territory. These sites have already demonstrated the ability to register, empanel, treat, and 
control patients with hypertension during the first phase of the study, which will continue during 
this second phase. These sites will expand their service provision to include the diabetes 
module through HEARTS, also known as HEARTS-D.   
 
Pre-implementation period. At the start of the 12-month pre-implementation period, we will 
conduct one-day in-person training at the state level to implement a diabetes and diabetes 
screening registry that captures relevant pre-implementation data. We will ensure that sites 
have functioning glucometer and test strips but will not include training related to diabetes 
diagnosis, treatment, and control to minimize the risk of contamination. We will not provide 
supportive supervision, nor will we implement a drug revolving fund. 
 

 
 
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Implementation period. The 24-month implementation period will start when we conduct two-day 
in person training based on the HEARTS-D curriculum33 with least 2 health care workers 
(physician, nurse, community health extension worker, pharmacist) and 1 record officer at each 
of the 10 sites. We will assess pre-/post-training test scores to evaluate knowledge transfer. 
Sites will receive an initial stock of supplies aligned with the WHO Package of Essential 
Noncommunicable Disease Interventions for Primary Care (e.g., functioning glucometer, test 
strips, and glucose lowering medications).34 We will also expand the existing drug revolving 
fund41 at these 10 sites, which currently supports accessibility (i.e., availability + affordability) of 
blood pressure lowering drugs, to include metformin and glibenclamide. Similar to our work on 
hypertension, this approach aligns with Nigeria’s national guidelines for drug revolving fund 
operations.19 Sites will also receive quarterly supervision for diabetes and hypertension care, 
similar to how we have conducted this in the first phase of the program. These visits allowed the 
research team to provide quality reports, monitor bundle implementation, evaluate screening 
and diagnosis rates compared with clinic logs, and adapt and problem-solve based on site-
specific challenges. 
 
Screening and Diagnosis  
All adults 18 years of age or older showing signs of hyperglycemia, OR all adults aged 18 years 
of age or older who are overweight (BMI > 25 kg/m2) will be screened for diabetes.  
• 
Normal:  
o 
Fasting blood glucose < 5.6 mmol/L  
o 
Random blood glucose < 7.8 mmol/L  
 
• 
Pre-Diabetes 
o 
Fasting blood glucose >5.6 mmol/L but < 7.0 mmol/L 
o 
Random blood glucose >7.8 mmol/L but < 11.2 mmol/L 
 
• 
Diabetes:  
o 
Fasting blood glucose ≥ 7.0 mmol/L  
o 
Random blood glucose ≥ 11.1 mmol/L  
 
If the participant does not have previously diagnosed diabetes but has a fasting blood glucose 
or random blood glucose reading in the diabetes range, then a follow up fasting blood glucose 
reading will be obtained either the next day (for PHC’s that have daily diabetes testing 
capabilities) or on the second/third day (for PHC’s that do not have daily diabetes testing 
capabilities). Two abnormal blood glucose values will be required for a diabetes diagnosis and 
participation in this study. On the other hand, repeat testing for a diabetes diagnosis is not 
required for patients with unequivocal hyperglycemia defined as patients having a random 
plasma glucose ≥ 11.1 mmol/L and symptoms consistent with hyperglycemia (polyuria, 
polydipsia, etc.). 
  
Treatment Steps  
*Uncontrolled blood glucose is defined as random blood glucose levels exceeding 11.1 mmol/L 
while receiving treatment. 
 
Step 1  
• 
Indication: Random blood glucose at diagnosis is ≥ 11.1 mmol/L but < 11.7 mmol/L  
• 
Treatment: Metformin 500 mg once daily  
• 
Action: Review after 1 month. If uncontrolled  then proceed to Step 2  
 
Step 2  
• 
Indication: Random blood glucose ≥ 11.7 mmol/L  
• 
Treatment: Metformin 1000 mg once daily  
• 
Action: Review after 1 month. If uncontrolled, then proceed to Step 3  

 
 
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Step 3  
• 
Indication: Random blood glucose ≥ 13.3 mmol/L  
• 
Treatment: Metformin 1000 mg twice daily  
• 
Action: Review after 1 month. If uncontrolled, then proceed to Step 4  
 
Step 4  
• 
Indication: Random blood glucose ≥ 16.7 mmol/L  
• 
Treatment: Metformin 1000 mg twice daily + Glibenclamide 5 mg once daily  
(Increase Glibenclamide gradually to max 15 mg daily)  
• 
Action: Review after 1 month. If still uncontrolled, then proceed to Step 5  
 
Step 5 – Referral Criteria  
 
Refer to higher-level care or specialist if any of the following apply:  
• 
Uncontrolled after Step 4 
• 
Pregnancy  
• 
Vision impairment (e.g., cataracts, retinopathy)  
• 
Peripheral neuropathy (numbness, tingling, burning)  
• 
Leg ulcers or infections  
• 
Proteinuria defined as ≥1+ on dipstick on ≥2 occasions, or unexplained haematuria 
• 
Abnormal urea & electrolytes defined as the values outside of normal ranges listed 
below 
• 
Potassium: 3.5-5.2 mmol/l 
• 
Sodium: 135-145 mEq/L 
• 
Creatinine (Adult men: ~0.7–1.3 mg/dL (62–115 µmol/L), Adult women: ~0.6–1.1 
mg/dL (53–97 µmol/L)) 
• 
 
• 
Acute illness with RBS > 15 mmol/L  
• 
Poor control on maximum tolerated oral agents  
• 
Suspected kidney disease (physical symptoms indicative of kidney disease such as 
polyuria, edema) 
 
Note: If kidney disease is present or suspected, then CHEWs will be asked to consult a 
physician before initiating or continuing glibenclamide.  
 
Outcomes  
Primary Effectiveness Outcome (Aim 3 ) 
• 
The primary outcome will be the difference the 6-month rolling average of the diabetes 
screening among eligible patients, defined as a random plasma glucose screening 
among adults with symptoms of hyperglycemia or a fasting plasma glucose among 
adults 18 years of age and body mass index > 25 kg/m2 in accordance with HEARTS-D, 
between the pre-implementation and implementation periods. 
 
Primary Implementation Outcomes (Aim 3) 
• 
Dose of quarterly supportive supervision visits measured by the proportion of 
observed/expected visits during the implementation period.  
 
Secondary Effectiveness Outcomes (Aim 3) 
• 
Secondary outcomes will compare the 6-month rolling average of diabetes treatment 
and control and mean fasting glucose levels in the pre-implementation and 
implementation periods. 

 
 
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Safety Outcomes (Aim 3) 
Safety outcomes will include between-period (pre-implementation versus implementation) 
differences in rates of:  
• 
Serious adverse events 
• 
Adverse events of special interest (e.g., hypoglycemia, hyperglycemia, medication 
allergies, common medication side effects) in pre-implementation and implementation 
periods.  
 
To improve safety monitoring, 5 PHCs with adequate staff and capacity for laboratory testing will 
be selected for routine collection of urine, blood glucose, urea, creatinine, and electrolytes 
for 100 patients (20 patients per PHC) starting or escalating therapy.  
 
*We will assess for unanticipated problems to adhere to US federal regulations. 
 
Definitions of Treatment and Control: 
• 
Treatment will be defined by the prescription of any glucose lowering drug. Control will 
be defined according to the WHO HEARTS-D module33 specifically: fasting glucose 
<126 mg/dl, postprandial glucose <160 mg/dl or HbA1c <7% (when available).  
  
Sustainment of hypertensive services in the Federal Capital Territory. We will evaluate temporal 
trends of hypertension treatment and control during the study period in the 10 participating 
PHCs among patients with and without diabetes using District Health Information System - 2 
(DHIS-2). We will assess for linear trends and will account for clustering among PHCs. We will 
then compare the trends in hypertension control with the other 50 PHCs in the Federal Capital 
Territory that previously implemented HEARTS during the initial funding period. At the 
recommendation of the Federal Ministry of Health, PHCs are now reporting data on vital signs 
and blood pressure lowering medications to DHIS-2 for centralized monitoring of hypertension 
service integration. We have already used an Application Programming Interface (API) from 
REDCap to demonstrate feasibility of de-identified data transfer to facilitate monitoring and 
evaluation. We have also received de-identified data from DHIS-2 through the Nigeria 
Hypertension Control Initiative for comparison with the HTN Program.  
 
4. DATA AND SPECIMEN BANKING 
 
No specimens will be banked as a part of this program. 
 
Data will be collected at public, primary healthcare centers in the form of a hypertension 
treatment card for participants with hypertension and diabetes treatment cards for participants 
with diabetes. Patients will be administered a hypertension/diabetes card for their own use. Data 
from the site hypertension/diabetes treatment cards will be abstracted to REDCap by healthcare 
workers at the primary healthcare center or by the research team. 
 
Data will be collected electronically in a REDCap database housed at University of Abuja. Only 
trained program staff or healthcare workers with University of Abuja approved access privileges 
will have access to the electronic database. We will restrict export rights to the program 
statisticians and database manager only. All exports will be housed in secure Washington 
University Box folder, or University of Abuja folder with restricted access. Washington University 
Box backs up data daily to prevent loss. Refer to the DSMP and DMP for details on data and 
safety monitoring and quality checks.  
 

 
 
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The HTN Program team will retain all program records required by applicable regulatory bodies 
in a secure and safe facility for a minimum period of seven years. Access to program records 
will be limited to program team members, unless through written application to and approval by 
the program Steering Committee. 
 
5. SHARING RESULTS WITH PARTICIPANTS 
 
During the program participants with hypertension will receive a hypertension treatment card 
upon which blood pressure information will be recorded at each visit. Participants with diabetes 
will receive a diabetes treatment card with blood glucose information recorded at each visit.  
 
After completion of the program, to ensure that our results are used by researchers, 
policymakers, and community-based organizations, we will:  
1. Make our research findings available at www.ClinicalTrials.gov (Identifier: pending), as 
required by US law. 
2. Peer review all published products with the research team, study partners, and patient 
advocacy group.  
3. Include local Nigerian investigators and community collaborators as authors.  
4. Follow requirements of the sponsor, the National Heart, Lung, and Blood Institute of the 
NIH, to make all research papers made freely available to the public through PubMed 
Central (https://www.ncbi.nlm.nih.gov/pmc/) at the time of publication with data available 
thereafter in accordance with NHLBI policy through NHLBI BioData Catalyst. 
5. Make the study protocols and instruments available to other researchers through an 
open access journal and the University of Abuja website. Both English and French 
versions will be made available to allow for dissemination to French-speaking African 
countries, especially those in west Africa. 
6. Report the results at conferences that target researchers, community health providers, 
and policymakers.  
7. Hold a writing retreat to produce a Science to Community report that will be in English, 
Hausa, Igbo, and Yoruba. 
8. Write health article and opinion editorials for local Nigerian newspapers.  
9. Present our project to the Patient Advocacy Group for input and help with dissemination.  
10. Make Science to Community report widely available throughout Nigeria.  
11. Work with University of Abuja media department, the International Society of Media in 
Public Health, and Resolve to Save Lives to strategize methods for disseminating 
findings through Nigerian local and national television, radio, newspaper, and online 
outlets. 
12. If the proposed health care and patient-level interventions show effectiveness, then we 
will develop an implementation manual, which can be disseminated throughout Nigeria 
as well as other countries.   
13. The proposed dissemination plan will be evaluated as part of the implementation 
evaluation through completion of the proposed activities, number of individuals and 
organizations that participate in these activities, and resulting spread and scale of the 
system-, health worker-, and patient-level strategies.  
 
6. PROGRAM TIMELINES 
 
Patients will participate in the program from the time they registered until completion of the 
program. Patients will be continuously registered throughout the entire program, over 3 years of 
registration. The primary analysis will be completed within 12 months of program completion. 
Refer to the timeline below for details.  

 
 
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7. INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion and Exclusion Criteria:  
Patients diagnosed with hypertension (SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg measured on 
two separate occasions or treated with a blood pressure lowering drug), according to 2019 
Nigeria Hypertension Guidelines or with controlled (SBP <140 mm Hg and DBP <90 mm Hg) 
hypertension among those who are treated with blood pressure lowering drugs will be 
continuously registered. Patients will be registered upon the first diagnosis of hypertension or 
visit to the primary healthcare center during the registration period.   
 
Aim 2 Inclusion criteria: 
• 
Adults (≥18 years old), 
• 
Elevated blood pressure (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) documented or 
measured by a health care professional (e.g., physician, CHEW, or community health 
officer) on two separate occasions or taking a BP-lowering medication, or a history of 
hypertension. 
• 
Pregnant women are eligible for this program, or 
• 
Cognitively impaired adults are eligible for this program. 
This program will not include any of the following special populations:  

 
 
Version Date: January 15th 2026  
Page 16 of 34 
• 
Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years 
old, or 
• 
Prisoners or other detained individuals.  
 
Aim 3 Inclusion Criteria: 
Patients will be screened for diabetes with symptoms of hyperglycemia or BMI >25 kg/m2 and 
over the age of 18 years old. Upon first or previous diagnosis, diabetes patients will be 
registered.  
 
• 
Adults (≥18 years), 
• 
Patients with previous diabetes diagnosis  
• 
Patients with persistently elevated random glucose >200 mg/dl, fasting glucose >126 
mg/dl, or hemoglobin A1c >6.5% on two or more occasions (when available)  
• 
Patients taking glucose lowering medications 
• 
Pregnant women are eligible for this program, or 
• 
Cognitively impaired adults are eligible for this program. 
This program will not include any of the following special populations:  
• 
Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years 
old, or 
• 
Prisoners or other detained individuals.  
 
8. VULNERABLE POPULATIONS 
 
Pregnant women and cognitively impaired adults are eligible for this program. This program 
included evidence-based treatment and standard of care based on the 2019 Nigeria 
hypertension guidelines. Pregnant women may be registered and treated per the 2019 Nigeria 
hypertension guidelines, which recommends referral for specialist management. Cognitively 
impaired individuals may be registered and treated per current and local hypertension 
guidelines. Pregnant women with diabetes will be included in the registry but will be referred for 
specialist management.  
  
9. PARTICIPANT POPULATION(S) 
 
Aim 2 Participants: 
Location 
Category/Group: 
Target Patient Visits 
Abia 
Adults 
12,600 patient visits 
Delta 
Adults 
12,600 patient visits 
Gombe 
Adults 
12,600 patient visits 
Jigawa 
Adults 
12,600 patient visits 
Oyo 
Adults  
12,600 patient visits 
Total: 
 
63,000 patient visits 
 
Aim 3 Participants: 
Location 
Category/Group: 
Target Patient Visits 
Federal Capital 
Territory (FCT) 
Adults 
18,000 patient visits 

 
 
Version Date: January 15th 2026  
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Total: 
 
18,000 patient visits 
 
10. RECRUITMENT METHODS 
 
A community awareness campaign for hypertension will be conducted in the 5 new states and a 
community awareness campaign for diabetes will be conducted in the Federal Capital Territory. 
Participants will not be recruited but will be continuously registered upon initial diagnosis of 
hypertension or diabetes or first presentation at a participating primary healthcare center with 
pre-existing controlled or uncontrolled hypertension or diabetes. For WHO HEARTS participants 
will be registered at 50 primary healthcare centers across 5 states, for WHO HEARTS-D 
participants will be registered at 10 primary healthcare centers across the Federal Capital 
Territory.  
 
11. COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
 
Participants will not be compensated for participation in this program.  
 
12.  WITHDRAWAL OF PARTICIPANTS 
 
If the treating health worker, study team, or DSMB deems it unsafe for any participant to 
continue any program procedures, then he / she may withdraw the participant. If a participant is 
incarcerated, becomes terminally ill, or experiences any other circumstance that would make 
continued involvement in the program unfeasible or unethical, then the HTN Program team may 
withdraw the participant. In all cases, any data already collected will not be removed from the 
program database and may still be used in analyses unless explicitly requested by the 
participant.  
 
13. RISKS TO PARTICIPANTS 
 
During this program, participants will be prescribed blood pressure and glucose lowering 
medications, it is possible that participants may experience adverse effects from these 
medications. These risks are considered no more than minimal in the course of routine clinical 
care, provided that health workers have sufficient training, supervision, and monitoring.  
 
14. POTENTIAL BENEFITS TO PARTICIPANTS 
 
During this program, participants may be prescribed blood pressure lowering medications, 
which may help control their blood pressure and lower their risk for cardiovascular related 
events during this period. Participants may be prescribed blood glucose lowering medications, 
which may help control their blood glucose levels and lower their risk for adverse health effects 
due to high blood glucose levels during this period.  
 
15. DATA MANAGEMENT AND CONFIDENTIALITY 
 
Data Management 
Electronic data will be stored in the eCRFs maintained using the University of Abuja REDCap 
platform. Thus, only trained study team members with appropriate credentials and passwords 
will have ability to enter and view program data. Export rights will be restricted to the program 
statisticians only, and de-identified data will only be exported when necessary for reporting and 
quality control purposes to a restricted Washington University Box folder or to a restricted 
location at University of Abuja.  

 
 
Version Date: January 15th 2026  
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To ensure data quality, we will build in field validation(s) and branching logic within the forms, 
use a first / second pass data entry workflow, and we will use the field comment logs and data 
resolution workflow module within REDCap. Before obtaining data entry rights in production, 
program team members must complete a training and pilot test entry of hypothetical data. We 
will document these training sessions and successful completion of any program data entry 
practicums. 
 
Further, we will perform centralized monitoring through Data and Status Quality Reports 
(DSQRs) and REDCap reporting features. The DSQRs will use the REDCap application 
programming interface (API) functionality to export the program data and then restructure and 
summarize the data using statistical software, such as R or SAS. The output for these DSQRs 
will be housed on Washington University Box folder or University of Abuja’s secure servers with 
restricted access to program team members only. The reports will be reviewed and discussed 
bi-weekly, on average, but once the systems are in place and code generated, the reports may 
be updated in real-time.  
 
The contents of these reports may continually evolve throughout the course of the program, but 
they will focus on the following essential program data: 
 
• 
Baseline and follow-up information – registration, demographics, clinical history, 
treatment and control, drug classes and number baseline and follow-up SBP, DBP, 
glucose, and hemoglobin A1c,  
• 
Primary and secondary response variables 
• 
SAEs and AEs of special interest 
For the purposes of these reports, we will present data in aggregate form overall and by 
program site. In addition to these general data summarizations, we plan to employ statistical 
methods for monitoring clinical trial data.16The general strategies include: 
 
• 
Exploration of:  
o Descriptive statistic summaries overall and by site for essential program data as 
indicated above. 
o Frequency of outlying values overall and by site. 
o Process measures overall and by site: 
§ 
Outlier and inlier rates 
§ 
Blood pressure measurement digit preference (0, 5, even numbers) 
§ 
Blood glucose digit preference (whole number-mg/dL) 
§ 
Correlation coefficients of key covariates 
§ 
Deviations, SAEs, and AEs of special interest by site 
§ 
Timeliness of data entry  
§ 
Proportion of dropouts / losses to follow-up 
• 
Evaluating important response and safety data univariately and also longitudinal 
trajectories over time (within the same person). 
• 
Multivariate techniques involving principal components (PC1 vs. PC2) and examining 
multivariate outliers. For example, we may examine mean for individual center vs. that of 
all other centers. Plot PCs for p-values for all variables and identify outliers (those 
outside of the central cloud). 
• 
Tests on randomness – Benford’s law on the distribution of digits. 

 
 
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Statistical Design and Sample Size 
The statistical design of the program intervention includes evaluation of effectiveness and 
implementation co-primary outcomes. For effectiveness outcomes, we will use an interrupted 
time series design with analysis plans and power calculations outlined in the Statistical Analysis 
Plan, which use conservative baseline treatment and control estimates, effect sizes, and 
temporal trend rates to minimize the risk of being underpowered to detect a potential difference 
while operating within a feasible project size, timeline, and budget. For implementation 
outcomes, we will use mixed methods analysis using the RE-AIM framework to triangulate both 
routinely collected quantitative data and qualitative data to evaluate the reach, secondary 
effectiveness, adoption, implementation, and maintenance, acceptability, and cost of the 
implementation bundle for Aims 2 and 3. 
 
We will evaluate change in temporal trends for primary and secondary outcomes through 
segmented linear regression, aggregating data across primary health care centers by month 
(centered to time=0 when intervention is implemented). To evaluate the individual effects of 
bundle components and time variance in implementation on our primary outcomes, we will use 
patient-level mixed effects models including random effects to account for clustering at the 
primary healthcare center level. We will perform sensitivity analyses by both excluding and 
restricting repeated measures of the same patients over the program period. 
 
Please refer to the Statistical Analysis Plan for additional details on statistical design and power.  
 
 
16. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS 
 
The DSMP documents the provisions to monitor the data and ensure safety of all program 
participants. Briefly, (1) we have convened an independent DSMB consisting of five members 
with diverse backgrounds and fields of expertise; (2) the DSMB will meet at minimum every 6-12 
months to review safety and essential program data; (3) we will employ centralized statistical 
monitoring approaches as mentioned above and in the SAP to monitor data quality and safety; 
and (4) we plan for targeted on-site monitoring by research staff through supported supervision. 
 
17. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
 
Information regarding patient privacy relevant to data and specimens is described within this 
protocol in section Data and Specimen Banking.  
 
18. COMPENSATION FOR RESEARCH-RELATED INJURY 
 
This program is investigator-initiated. If participants become ill or are injured as a result of this 
program (medications, devices or procedures), then they will be directed to seek medical 
treatment through their doctor or treatment center of choice and to promptly tell the program 
doctor or health worker about any illness or injury. The researchers and clinical staff will not pay 
for medical care required because of a bad outcome resulting from participation in this program.  
 
19. ECONOMIC BURDEN TO PARTICIPANTS 
 
We do not anticipate that patients will experience economic burdens related to participation in 
this program. Evaluation and treatment of hypertension will be performed according to clinical 
practice guidelines. 

 
 
Version Date: January 15th 2026  
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20. CONSENT PROCESS 
 
Participants will not be consented for this system-level intervention based on standard of care. A 
waiver of consent for the HTN Program will be sought from the Federal Capital Territory Health 
Research Ethics Committee and University of Abuja Teaching Hospital Ethics Board, and the 
Washington University in St. Louis Institutional Review Board.  
 
21. NON-ENGLISH-SPEAKING PARTICIPANTS 
 
We anticipate registering Yoruba-, Igbo-, Hausa-, and English-speaking participants in this HTN 
Program. Participant facing materials are designed for comprehension by non-literate and non-
English speaking individuals.  
 
22. WAIVER OR ALTERATION OF CONSENT PROCESS 
 
Participants will not be consented for this system-level intervention that seeks to strengthen the 
current standard of care. A waiver of consent for the HTN Program will be sought from the 
Federal Capital Territory Health Research Ethics Committee, University of Abuja Teaching 
Hospital Ethics Board, and the Washington University in St. Louis Institutional Review Board.  
 
23. PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
 
This program is conducted in Nigeria, where HIPAA does not apply. Information regarding 
patient privacy relevant to data and specimens is described within this protocol in section Data 
and Specimen Banking.  
 
24. QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
 
The University of Abuja is 1 of the 40 Federal Government owned universities in Nigeria. It is in 
the Federal Capital of Nigeria and was established in 1988 as a dual-mode university with the 
mandate to run conventional and distance learning programs. The University of Abuja 
encourages and promotes scholarship and the conduct research in all fields of learning and 
human endeavor which is related to the social, cultural and economic needs of the people of 
Nigeria. The University of Abuja works in collaboration her sister institution, the University of 
Abuja Teaching Hospital for the training of medical students and conduct of medical research. 
The University of Abuja Teaching Hospital campus houses the Cardiovascular Research Unit 
which is involved in conducting and coordinating different types of cardiovascular including 
community-based studies, large observational hospital- based studies which are either cohort or 
longitudinal randomized controlled trials and national and international collaborative research 
work. The University has an Information Communication Technology (ICT) Center that is well 
equipped to provide computing facilities to support teaching, research, consultancy and 
administrative activities for all Units in the University. The center has appropriate modern 
hardware and software as well as highly skilled personnel and has the responsibility of 
developing a robust ICT infrastructure and corresponding services to facilitate the teaching, 
learning, research and administrative functions of the University. Research staff at the 
University of Abuja and University of Abuja Teaching Hospital will oversee all aspects of this 
program.  
 
25. MULTI-SITE RESEARCH 
 

 
 
Version Date: January 15th 2026  
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Drs. Ojji and Huffman will co-lead the overall oversight, management, and coordination of the 
proposed program as the co-principal investigators. Dr. Ojji will oversee personnel and staff 
recruitment and management in Abuja. Chidubem Okoli will serve as the Nigeria project 
manager and will be responsible for day-to-day management of the proposed research activities 
with support from research nurses, Ms. Glory Hansen and Regina Asuku, data quality officer 
Ms. Confidence Alo-Joseph, and data entry staff, Ms. Charity Akor. Dr. Charles Goss will serve 
as lead biostatistician. Drs. Ming Cheng and Mansi Agarwal will serve as a program 
biostatisticians. Dr. Julia López will be responsible for assisting in qualitative data collection and 
analysis with support from Dr. Hirschhorn and oversight by Drs. Huffman and Ojji. Ms. Valerie 
Graham will be the US project manager. 
 
The research team will communicate in weekly operations team meetings and at least quarterly 
with the program sponsor. The REDCap electronic data capture system will serve as a bi-
directional communication platform for our primary healthcare centers. We will also create and 
utilize an email listserv to send out quarterly newsletters of our progress. 
 
All required approvals (initial, continuing review and modifications) will be obtained from the 
Federal Capital Territory Health Research Ethics Committee, University of Abuja Teaching 
Hospital Health Research Ethics Committee, and Washington University IRB. All modifications 
will be communicated to sites, and approved, including approval by the IRB of record, before the 
modification is implemented. All engaged participating sites will safeguard data, including 
secure transmission of data, as required by local information security policies. All local site 
investigators will conduct the program in accordance with applicable federal regulations and 
local laws. All non-compliance with the program protocol or applicable requirements will be 
reported in accordance with local policy. 
 
 
 
 

 
 
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TABLE 1: IMPLEMENTATION OUTCOMES TABLE (Definitions for Implementation Outcomes 
at Program, Center, and Individual Levels) 
 
Level 
Outcome 
Method of 
calculation   
Data 
source 
Timing 
REACH 
Program 
(aim 2) 
Number of 
participating 
PHCs/total 
number of 
PHCs in all 
participating 
states 
A = Number of 
participating PHCs 
B = Total number of 
PHCs in all 
participating states 
Calculation: A ÷ B 
Registry 
data 
Baseline 
Program 
(aim 3) 
Number of 
PHC’s 
participating in 
the FCT/ total 
number of 
PHCs in HTN 
1.0 
A: Number of 
participating PHCs in 
the FCT 
B: Total number of 
PHCs in HTN 1.0 (60) 
Calculation: A ÷ B 
Registry 
data 
Baseline 
Center 
(aim 2) 
Diversity of 
participating 
PHCs and staff 
in terms of size, 
ward, baseline 
staffing levels 
PHCs’ size = Number 
of patients; Number of 
visits  
 
Diversity of PHCs in 
terms of ward = 
Number of PHCs in 
each area council 
 
Diversity of staff = 
Number of staff in 
each area council at 
the baseline 
supervision visit 
Registry 
data, 
supervision 
data 
Baseline 
to study 
end 
 
Center 
(aim 3) 
Diversity of 
participating 
PHCs and staff 
in terms of size, 
ward, baseline 
staffing levels 
PHCs’ size = Number 
of patients; Number of 
visits  
 
Diversity of PHCs in 
terms of ward = 
Number of PHCs in 
each area council 
 
Diversity of staff = 
Number of staff in 
each area council at 
the baseline 
supervision visit 
Registry 
data, 
supervision 
data 
Individual 
(aim 2) 
Number of adult 
patients with 
BPs measured / 
total number of 
Total number of adult 
patient visits to the 
health facility within 
the given dates 
Supervision 
data 

 
 
Version Date: January 15th 2026  
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adult patients 
within 
participating 
PHCs within the 
given dates 
documented at the first 
and last supervision 
visits, N 
 
Of these adult 
patients, how many 
had their BP checked 
during their visit? N 
(%) 
 
Of the patients who 
had their BP checked, 
how many had high 
BP? Median N (%) 
EFFECTIVENESS Program 
(aim 2) 
Hypertension 
control within 
the overall 
system of 
participating 
PHCs between 
the pre-
implementation 
and 
implementation 
periods, defined 
by 6-month 
rolling average 
(defined as 
<140/90 mm 
Hg) 
6-month rolling 
average control rate 
(<140<90) for all 
PHCs 
Registry 
data 
Baseline 
to study 
end 
 
Program 
(aim 2) 
Hypertension 
control within 
the overall 
system of 
participating 
PHCs for the 
implementation 
period, defined 
by 6-month 
rolling average 
(defined as 
<130/80 mm 
Hg) 
6-month rolling 
average hypertension 
control rate (<130/80 
mm Hg) for all PHCs 
Registry 
data 
Program 
(aim 2) 
Mean SBP and 
DBP within the 
overall system 
of participating 
PHCs for the 
implementation 
period, defined 
by 6-month 
6-month rolling 
average SBP for all 
PHCs 
 
6-month rolling 
average DBP for all 
PHCs 
 
Registry 
data 

 
 
Version Date: January 15th 2026  
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rolling average 
and based on 
last visit 
Last visit’s SBP for all 
PHCs 
 
Last visit’s DBP for all 
PHCs 
Center 
(aim 2) 
Control rates 
across 
participating 
PHCs for the 
implementation 
period, defined 
by 6-month 
rolling average 
6-month rolling 
average control rate  
Registry 
data 
Center 
(aim 2) 
Mean SBP and 
DBP across 
participating 
PHCs for the 
implementation 
period, defined 
by 6-month 
rolling average 
and based on 
last visit 
6-month rolling 
average SBP  
 
6-month rolling 
average DBP  
 
Last visit’s SBP  
 
Last visit’s DBP  
Registry 
data 
 
Program 
(aim 3) 
Secondary 
outcomes will 
compare the 6-
month rolling 
average of 
diabetes 
treatment and 
control and 
mean fasting 
glucose levels in 
the pre-
implementation 
and 
implementation 
periods. 
2o 
effectiveness 
outcome 
 
6-month rolling 
average diabates 
treatment and control 
in the implementation 
period compared with 
the pre-
implementation period 
Registry 
data 
Baseline 
to study 
end 
 
Program 
(aim 3) 
The primary 
outcome will be 
the difference in 
the 6-month 
rolling average 
of the diabetes 
screening 
among eligible 
Total number of adult 
patient visits to the 
health facility within 
the given dates 
documented at the first 
and last supervision 
visits, N 
 
Supervision 
data 
Baseline 
to end 

 
 
Version Date: January 15th 2026  
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patients, defined 
as a random 
plasma glucose 
screening 
among adults 
with symptoms 
of 
hyperglycemia 
or a fasting 
plasma glucose 
or hemoglobin 
A1c testing 
(when available) 
among adults > 
18 years old 
and body mass 
index > 25 
kg/m2 in 
accordance with 
HEARTS-D, 
between the 
pre-
implementation 
and 
implementation 
periods. 
1o 
effectiveness 
outcome 
 
Of the eligible adult 
patients (i.e., those 
with symptoms of 
hyperglycemia or 
meeting screening 
criteria), how many 
had their glucose or 
hemoglobin A1c 
checked during their 
visit? N (%) 
 
Of the eligible patients 
who had their glucose 
checked, how many 
had elevated glucose 
(fasting or random) or 
elevated hemoglobin 
A1c? Median N (%) 
ADOPTION 
Program 
(aim 2) 
Percentage of 
patients treated 
with fixed dose 
combination 
therapies in the 
last 6 months 
A = Number of 
patients in HTN 2.0 
Program that were 
treated with fixed dose 
combination therapies 
in the last 6 months. 
B = Total number of 
patients in HTN 2.0 
Program 
 
Calculation: A ÷ B  
Registry 
data 
Baseline 
to study 
end 
 
Program 
(aim 3) 
Percentage of 
patients treated 
with glucose 
lowering drugs 
in the last 3-
months 
A = Number of 
patients in the FCT in 
the HTN 2.0 Program 
aim 3 that were 
treated with glucose 
lowering drugs in the 
last 3 months. 
B = Total number of 
patients in the FCT in 
Registry 
Data 
Baseline 
to study 
end 

 
 
Version Date: January 15th 2026  
Page 26 of 34 
the HTN 2.0 Program 
aim 3 
 
Calculation: A ÷ B  
IMPLEMENTATION Program 
(aim 2) 
Proportion of 
observed site 
supervision 
visits to 
expected visits 
 
1o 
implementation 
outcome 
A = Number of 
supportive supervision 
visits 
B = Expected number 
of quarterly supportive 
supervision visits 
 
Calculation: A ÷ B 
Supervision 
data 
Baseline 
to study 
end 
Program 
(aim 3) 
Proportion of 
observed site 
supervision 
visits to 
expected visits 
 
1o 
implementation 
outcome 
A = Number of 
supportive supervision 
visits 
B = Expected number 
of quarterly supportive 
supervision visits 
 
Calculation: A ÷ B 
Supervision 
data 
Program 
(aim 2) 
Proportion of 
selected PHCs 
who participated 
in baseline 
hypertension 
training 
A = Number of PHCs 
who participated in 
baseline hypertension 
training 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 3) 
Proportion of 
selected PHCs 
who participated 
in baseline 
diabetes training 
A = Number of PHCs 
who participated in 
baseline diabetes 
training 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 2) 
Proportion of 
selected PHCs 
who participated 
in site initiation 
training 
A = Number of PHCs 
who participated in site 
initiation training  
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 

 
 
Version Date: January 15th 2026  
Page 27 of 34 
Program 
(aim 2) 
Proportion of 
selected PHCs 
who received at 
least one 
supportive 
supervision visit 
in the past 12 
months 
A = Number of PHCs 
who received at least 
one supportive 
supervision visit in the 
past 12 months 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 3) 
Proportion of 
selected PHCs 
who received at 
least one 
supportive 
supervision visit 
in the past 12 
months 
A = Number of PHCs 
who received at least 
one supportive 
supervision visit in the 
past 12 months 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B 
Supervision 
data 
Program 
(aim 2) 
Proportion of 
selected PHCs 
who received an 
audit and 
feedback 
report within the 
past 3-months 
A = Number of PHCs 
who received at least 
an audit and feedback 
report within the past 
3-months  
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 3) 
Proportion of 
eligible PHCs 
who received an 
audit and 
feedback 
report within the 
past 3-months 
A = Number of PHCs 
who received at least 
an audit and feedback 
report within the past 
3-months  
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 2) 
Percentage of 
PHCs with a 
working blood 
pressure 
monitor at the 
site on the day 
of assessment 
A = Number of PHCs 
with a working blood 
pressure monitor at 
the site on the day of 
assessment (time 
point: last supervision 
visit) 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 

 
 
Version Date: January 15th 2026  
Page 28 of 34 
Program 
(aim 3) 
Percentage of 
PHCs with a 
working blood 
glucose monitor 
at the site on 
the day of 
assessment 
A = Number of PHCs 
with a working blood 
glucose monitor at the 
site on the day of 
assessment (time 
point: last supervision 
visit) 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 2) 
Percentage of 
PHCs with 
blood pressure 
medicines 
available on the 
day of 
assessment 
A = Number of PHCs 
with blood pressure 
medicines available on 
the day of assessment 
(time point: last 
supervision visit) 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 3) 
Percentage of 
PHCs with 
diabetes 
medicines 
available on the 
day of 
assessment 
A = Number of PHCs 
with diabetes 
medicines available on 
the day of assessment 
(time point: last 
supervision visit) 
B = Total number of 
selected PHCs  
 
Calculation: A ÷ B  
Supervision 
data 
Program 
(aim 2) 
Percentage of 
patients with 
step up 
indicated who 
received step up 
treatment in the 
last 6-months 
A = Number of 
patients who need 
step up treatment and 
received it 
 
B = Total number of 
patients who are 
registered per month 
 
Calculation: A ÷ B, 6-
monthly rolling 
average rate 
Registry 
data 
 
Program 
(aim 3) 
Percentage of 
patients with 
step up 
indicated who 
received step up 
treatment in the 
last 6-months 
A = Number of 
patients who need 
step up treatment and 
received it 
 
Registry 
data 
 

 
 
Version Date: January 15th 2026  
Page 29 of 34 
B = Total number of 
patients who are 
registered per month 
 
Calculation: A ÷ B, 6-
monthly rolling 
average rate 
Center 
(aim 2) 
Number and 
proportion of 
adult patients 
with 
hypertension 
who are 
registered/total 
number of adult 
patients with 
elevated blood 
pressure within 
participating 
PHCs within the 
past 3 working 
days 
A = Total number of 
adult patients who had 
high BP visits to the 
health facility within 
the given dates 
 
B = Total number of 
patients visits to the 
health facility within 
the given dates 
 
Calculation: A ÷ B 
Supervision 
data 
 
Center 
(aim 2) 
Monthly 
proportion of 
registered 
patients with 
appropriate 
stepped 
care/total 
number of 
registered 
patients 
A = Number of 
patients who need 
step up treatment and 
received it 
 
B = Total number of 
patients who are 
registered per month 
 
Calculation: A ÷ B, 6-
monthly rolling 
average rate 
Registry 
data 
Center 
(aim 3) 
Monthly 
proportion of 
registered 
patients with 
appropriate 
stepped 
care/total 
number of 
registered 
patients 
A = Number of 
patients who need 
step up treatment and 
received it 
 
B = Total number of 
patients who are 
registered per month 
 
Calculation: A ÷ B, 6-
monthly rolling 
average rate 
Registry 
data 

 
 
Version Date: January 15th 2026  
Page 30 of 34 
Center 
(aim 2) 
Monthly 
proportion of 
registered 
patients treated 
with fixed dose 
combination 
therapy/total 
number of 
patients on 
treatment 
A = Number of 
patients who are 
treated with fixed dose 
combination therapy 
 
B = Total number of 
patients who are 
treated per month 
 
Calculation: A ÷ B, 6-
month rolling average 
rate 
Registry 
data 
MAINTENANCE 
Program 
(aim 2) 
Proportion of 
participating 
PHCs who 
maintain 
hypertension 
control above 
baseline at 12 
and 24 months 
A = Number of PHCs 
who maintain 
hypertension control 
above baseline rates 
at 12, and 24 months 
after implementation 
B = Total number of 
selected PHCs 
 
Calculation: A+B 
Registry 
data 
Baseline 
to study 
end 
Program 
(aim 2) 
Proportion of 
participating 
PHCs without 
blood pressure 
medication 
stockouts at 
each quarter 
A = Number of PHCs 
without blood pressure 
medication stockouts 
B = Total number of 
selected PHCs 
 
Calculation: A ÷ B = 0  
Supervision 
data 
Program 
(aim 3) 
Proportion of 
participating 
PHC’s without 
glucose 
lowering 
medication 
stockouts at 
each quarter 
A = Number of PHCs 
without glucose 
lowering medication 
stockouts 
B = Total number of 
selected PHCs 
 
Calculation: A ÷ B = 0 
Supervision 
data 
Program 
(aim 3) 
Proportion of 
aim 3 
participating 
PHCs who 
maintain 
glucose control 
above baseline 
at 12 and 24 
months 
A = Number of PHCs 
who maintain glucose 
control above baseline 
at 12, and 24 months 
after implementation 
B = Total number of 
PHCs in aim 3 
 
Calculation: A+B 
Registry 
Data 
 
 
TABLE 2: PROTOCOL AMENDMENT HISTORY 
 

 
 
Version Date: January 15th 2026  
Page 31 of 34 
Version 
Date 
Description of Change 
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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