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Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3
Sponsor: Washington University School of Medicine
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.
Official title: Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design - Aim 3
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2800
Start Date
2026-02-14
Completion Date
2030-01-31
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Implementation of program based on WHO HEARTS-D guidelines
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.
Metformin
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.
Glimepiride
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.
Point-of-care blood glucose monitor (glucometer) and compatible test strips
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.
HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)
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.
Locations (10)
New Township Abaji
Abaji, Nigeria
Gbagarape PHC
Abuja, Nigeria
Gidan Mangoro
Abuja, Nigeria
Pyakasa PHC
Abuja, Nigeria
Byazhin
Bwari, Nigeria
Gtc Gwagwalada
Gwagwalada, Nigeria
Old Kutunku
Gwagwalada, Nigeria
Kuje PHC
Kuje, Nigeria
Dabi Bako
Kwali, Nigeria
KAWLI
Kwali, Nigeria