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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Washington University School of Medicine • ClinicalTrials.gov ID: NCT07589387

Registry updated: 2026-10-16
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Description

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.

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.
  • 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.
  • 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.
  • 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.
  • 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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * \- 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.

Conditions

Diabete Mellitus

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record