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NCT Number: NCT07589387

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

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.

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Capillary blood glucose meter, finger-stick glucose meter

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.

Other names: Provider training, Supportive supervision

Primary outcomes

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

    Time frame: 36 months

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

  2. 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

    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.

Secondary outcomes

  1. 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

    Secondary Effectiveness Outcome (diabetes treatment): 6-month rolling average of diabetes treatment levels in the pre-implementation and implementation periods.

  2. 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

    Secondary Effectiveness Outcome (blood sugar control): 6-month rolling average of blood sugar control in the pre-implementation and implementation periods. Control will be defined according to the WHO HEARTS-D module2, specifically: fasting glucose <126 mg/dl, postprandial glucose <160 mg/dl, or HbA1c <7%.

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

    Time frame: 36 months

    Secondary Effectiveness Outcomes (mean fasting glucose levels): 6-month rolling average of mean fasting glucose levels in the pre-implementation and implementation periods.

  4. 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

    Secondary Implementation Outcome:

    A = Number of PHCs who participated in baseline diabetes training B = Total number of selected PHCs

    Calculation: A ÷ B

  5. 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

    Secondary Implementation Outcome:

    A = Number of PHCs who received at least one supportive supervision visit in the past 12 months B = Total number of selected PHCs

    Calculation: A ÷ B

  6. Proportion of eligible PHCs that received at least one audit-and-feedback report within the past 3 months (A ÷ B)

    Time frame: 36 months

    Secondary Implementation Outcome:

    A = Number of PHCs who received at least an audit and feedback report within the past 3-months B = Total number of selected PHCs

    Calculation: A ÷ B

  7. 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

    Secondary Implementation Outcome:

    A = Number of PHCs with a working blood glucose monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs

    Calculation: A ÷ B

  8. Percentage of PHCs with diabetes medicines available on-site on the day of assessment (last supervision visit) (A ÷ B)

    Time frame: 36 months

    Secondary Implementation Outcome:

    A = Number of PHCs with diabetes medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs

    Calculation: A ÷ B

  9. 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

    Secondary Implementation Outcome:

    A = Number of patients who need step up treatment and received it

    B = Total number of patients who are registered per month

    Calculation: A ÷ B, 6-monthly rolling average rate

  10. 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

    Secondary Implementation Outcome:

    A = Number of patients who need step up treatment and received it

    B = Total number of patients who are registered per month

    Calculation: A ÷ B, 6-monthly rolling average rate

Other outcomes

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

    Time frame: 36 months

    Safety Outcome: between-period (pre-implementation versus implementation) differences in proportions of serious adverse events

  2. 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

    Time frame: 36 months

    Safety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.

Study contacts

Contact information is provided by the study sponsor or research team.

Dike Ojji, MD

CONTACT

[email protected]

+234-806-009-4456

Mark Huffman, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Abuja Teaching Hospital

Registry information

Official study title

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

Acronym: HTN2

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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