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

Official title

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

Overview

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

• Other 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
• Drug 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.
• Drug 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.
• Device 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.
• Behavioral 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.

Primary outcome measures

• Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period. [Time frame: 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 [Time frame: 36 months]

Secondary outcome measures (10)

• Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods [Time frame: 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 [Time frame: 36 months]
• Difference in 6-month rolling average mean fasting plasma glucose (mg/dL) between pre-implementation and implementation periods [Time frame: 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) [Time frame: 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) [Time frame: 36 months]
• Proportion of eligible PHCs that received at least one audit-and-feedback report within the past 3 months (A ÷ B) [Time frame: 36 months]
• Percentage of PHCs with a working blood glucose monitor on-site on the day of assessment (last supervision visit) (A ÷ B) [Time frame: 36 months]
• Percentage of PHCs with diabetes medicines available on-site on the day of assessment (last supervision visit) (A ÷ B) [Time frame: 36 months]
• 6-monthly rolling average percentage of registered diabetes patients with clinically indicated step-up who received step-up treatment within 6 months (A = patients needing and receiving step-up; B = patients registered per month) [Time frame: 36 months]
• 6-monthly rolling average monthly proportion of registered diabetes patients receiving appropriate stepped care, out of total registered patients (A ÷ B) [Time frame: 36 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07589387 · UATH/HREC/PR/557/A3 · R01HL144708

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗