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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design - Aim 3

Conditions

Diabete Mellitus

Being tested

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

Keywords

Nigeria, Primary Health Center, HEARTS-D

Medical subject headings

Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Implementation of program based on WHO HEARTS-D guidelinesOther

  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.

• MetforminDrug

  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.

• GlimepirideDrug

  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 stripsDevice

  Also called Capillary blood glucose meter, finger-stick glucose meter

  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)Behavioural

  Also called Provider training, Supportive supervision

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 36 months

2. Difference in 6-month rolling average of blood glucose control in patients with diabetes (random blood glucose ≤11.1 mmol/L while receiving treatment; or fasting plasma glucose/HbA1c within target, as available) per WHO HEARTS-D, pre- vs. implementation

   Primary effectiveness outcome: The primary outcome will be the difference in the 6-month rolling average of blood glucose control among patients with diabetes, control defined as random blood glucose ≤ 11.1 mmol/L (or fasting plasma glucose/HbA1c within target, as available) while receiving treatment, in accordance with HEARTS-D, between the pre-implementation and implementation periods.

   Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 May 2026
2. Study start14 Feb 2026
3. Primary completion30 Apr 2029 (estimated)
4. Study completion31 Jan 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Diabete MellitusStudies of the same condition, open and under way.
• More trials run by Washington University School of MedicineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.