Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3

NCT07589387 | Not Yet Recruiting DMC

• 2 other identifiers: UATH/HREC/PR/557/A3R01HL144708
• Study Type: interventional
• Target: 2,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.

Conditions

Diabete Mellitus

Keywords

Nigeria; Primary Health Center; HEARTS-D

Outcome Measures

Primary Outcomes (2)

• Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.

  Primary Implementation Outcome: Description: Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.

  36 months

• Difference in 6-month rolling average diabetes screening in eligible adults (random plasma glucose with hyperglycemia symptoms; fasting plasma glucose if ≥18 y and BMI >25 kg/m²; or HbA1c) per WHO HEARTS-D, pre- vs. implementation

  Primary effectiveness outcome: 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.

  36 months

Secondary Outcomes (10)

• Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods

  36 months

• Difference in 6-month rolling average blood sugar control (per WHO HEARTS-D: fasting plasma glucose <126 mg/dL, postprandial <160 mg/dL, or HbA1c <7%) between pre-implementation and implementation periods

  36 months

• Difference in 6-month rolling average mean fasting plasma glucose (mg/dL) between pre-implementation and implementation periods

  36 months

• Proportion of selected primary health centers (PHCs) that participated in baseline diabetes training (A ÷ B; A = PHCs that participated, B = total selected PHCs)

  36 months

• Proportion of selected PHCs that received at least one supportive supervision visit in the past 12 months (A ÷ B; B = total selected PHCs)

  36 months

Other Outcomes (2)

• Difference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods

  36 months

• Difference in the proportion of patients with adverse events of special interest (hypoglycemia, hyperglycemia, medication allergies, common medication side effects) between pre-implementation and implementation periods

  36 months

Study Arms (1)

Primary Health Care Centers in the Federal Capital Territory

EXPERIMENTAL

10 primary healthcare centers in Nigeria's Federal Capital Territory who previously demonstrated capacity to deliver hypertension care in HTN 1.0.

Other: Implementation of program based on WHO HEARTS-D guidelines; Drug: Metformin; Drug: Glimepiride; Device: Point-of-care blood glucose monitor (glucometer) and compatible test strips; Behavioral: HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)

Interventions

Implementation of program based on WHO HEARTS-D guidelines OTHER

This study uses an interrupted time series design to compare diabetes screening, diagnosis, treatment, and control across a 12-month pre-implementation period and a 24-month implementation period in 10 primary healthcare centers in Nigeria's Federal Capital Territory. Sites previously demonstrated capacity to deliver hypertension care and will continue hypertension services while expanding to diabetes care through the HEARTS diabetes module (HEARTS-D). Pre-implementation includes registry setup and provision of glucometers without diabetes treatment training. Implementation includes HEARTS-D training, supply provision, expansion of the drug revolving fund to diabetes medicines, and quarterly supportive supervision.

Primary Health Care Centers in the Federal Capital Territory

Metformin DRUG

Description: Oral biguanide used as first-line glucose-lowering therapy within the HEARTS-D stepped-care protocol. Dosing per protocol: 500 mg once daily (Step 1), 1000 mg once daily (Step 2), 1000 mg twice daily (Step 3 and Step 4). Supplied through the expanded drug revolving fund during the implementation period.

Primary Health Care Centers in the Federal Capital Territory

Glimepiride DRUG

Oral sulfonylurea used as add-on therapy at Step 4 of the HEARTS-D stepped-care protocol when blood glucose remains uncontrolled on metformin. Starting dose 1 mg once daily, titrated by 1-2 mg to a maximum of 8 mg daily. Supplied through the expanded drug revolving fund during the implementation period.

Primary Health Care Centers in the Federal Capital Territory

Point-of-care blood glucose monitor (glucometer) and compatible test strips DEVICE

Point-of-care capillary blood glucose monitor with compatible single-use test strips and lancets, used at participating primary health centers for diabetes screening, diagnosis, and monitoring per WHO HEARTS-D. Glucometers and test strips are provided to all sites during pre-implementation (registry setup) and replenished during implementation through the supply chain and drug revolving fund.

Also known as: Capillary blood glucose meter, finger-stick glucose meter

Primary Health Care Centers in the Federal Capital Territory

HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs) BEHAVIORAL

Structured training of CHEWs on the HEARTS-D protocol covering diabetes screening, diagnosis, stepped-care treatment, follow-up, and referral, delivered at the start of the implementation period and reinforced by quarterly supportive supervision visits with audit-and-feedback throughout the 24-month implementation period.

Also known as: Provider training, Supportive supervision

Primary Health Care Centers in the Federal Capital Territory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Abuja Teaching Hospital: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Dike Ojji, MD

CONTACT

+234-806-009-4456; dike.ojji@uniabuja.edu.ng

Mark Huffman, MD

CONTACT

m.huffman@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Global Health Center Co-Director

Model Details: This study applies an interrupted time series design

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 1 year of study conclusion
• Access Criteria: Access to study data will be managed through NHLBI BioData Catalyst.