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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL144708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Abuja Teaching Hospital | OTHER |
| University of Abuja | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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, Nigeria. This program demonstrated significant improvements in hypertension treatment and control. HTN 2.0 will expand implementation of the HEARTS bundle to 5 new states in 5 geopolitical zones in Nigeria (Abia, Delta, Gombe, Jigawa, and Oyo) while also evaluating sustainment of hypertension control in the Federal Capital Territory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Health Care Centers | Experimental | 50 primary healthcare centers across five Nigerian states will be selected to implement a hypertension treatment program based on the WHO HEARTS hypertension technical package. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of a modified WHO HEARTS Hypertension Treatment Bundle | Other | The intervention seeks to the scale-up of the World Health Organization HEARTS package in 50 primary healthcare centers across five Nigerian states using a type II hybrid effectiveness implementation design. Following a 12-month pre-implementation period, centers will transition into a 24-month implementation period that includes state-level training of health workers, non-physician hypertension screening, diagnosis, and treatment, simplified hypertension treatment guidelines, monthly audit and feedback, supply chain strengthening, and a drug revolving fund to improve blood pressure lowering medication accessibility. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Outcome | Difference in the 6-month rolling average of hypertension control between the pre-implementation and implementation periods (defined as <140/<90 mm Hg) | 36 months |
| Primary Implementation Outcome | Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness outcome (hypertension treatment) | Difference in hypertension treatment in the 6-month rolling average between the pre-implementation and implementation periods | 36 months |
| Secondary Effectiveness Outcomes (mean systolic blood presure) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events | Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events | 36 months |
| Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of adverse events of special interest |
Inclusion Criteria:
Exclusion Criteria:
This program will not include any of the following special populations:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dike Ojji, MD | Contact | +234-806-009-4456 | dike.ojji@uniabuja.edu.ng | |
| Mark Huffman, MD | Contact | m.huffman@wustl.edu |
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Individual patient data will be shared through NHLBI BioData Catalyst
Data will be available within 1 year of study conclusion
Access to study data will be managed through NHLBI BioData Catalyst.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2026 | Jan 15, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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This study applies an interrupted time series design
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|
Difference in mean systolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods |
| 36 months |
| Secondary Effectiveness Outcome (mean diastolic blood pressure) | Difference in mean diastolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods | 36 months |
| Secondary Implementation Outcomes: Proportion of selected PHCs who participated in baseline hypertension training | A = Number of PHCs who participated in baseline hypertension training B = Total number of selected PHCs Calculation: A ÷ B | 36 months |
| Secondary Implementation Outcome: Proportion of selected PHCs who participated in site initiation training | A = Number of PHCs who participated in site initiation training B = Total number of selected PHCs Calculation: A ÷ B | 36 months |
| Secondary Implementation Outcome: Proportion of selected PHCs who received at least one supportive supervision visit in the past 12 months | 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 | 36 months |
| Secondary Implementation Outcome: Proportion of selected PHCs who received an audit and feedback report within the past 3-months | 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 | 36 months |
| Secondary Implementation Outcome: Percentage of PHCs with a working blood pressure monitor at the site on the day of assessment | A = Number of PHCs with a working blood pressure monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B | 36 months |
| Secondary Implementation Outcome: Percentage of PHCs with blood pressure medicines available on the day of assessment | A = Number of PHCs with blood pressure medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B | 36 months |
| Secondary Implementation Outcome: Percentage of patients with step up indicated who received step up treatment in the last 6-months | 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 | 36 months |
| Secondary Implementation Outcome: Number and proportion of adult patients with hypertension who are registered/total number of adult patients with elevated blood pressure within participating PHCs within the past 3 working days | A = Total number of adult patients who had high BP visits to the health facility within the given dates B = Total number of patients visits to the health facility within the given dates Calculation: A ÷ B | 36 months |
| Secondary implementation Outcome: Monthly proportion of registered patients with appropriate stepped care/total number of registered patients | 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 | 36 months |
| Secondary Implementation Outcome: Monthly proportion of registered patients treated with fixed dose combination therapy/total number of patients on treatment | A = Number of patients who are treated with fixed dose combination therapy B = Total number of patients who are treated per month Calculation: A ÷ B, 6-month rolling average rate | 36 months |
i.e., clinically ascertained angioedema, syncope, lightheadedness/dizziness, edema, inappropriate medication prescription [e.g., ACE or ARB among patients who are pregnant] |
| 36 months |
| Safety Outcome: Between-period (pre-implementation versus implementation) differences in the proportion of hyperkalemia, hypokalemia, and acute kidney injury | Hyperkalemia, hypokalemia, and acute kidney injury measured in a subset of 5 sites and 250 patients (n=500 total) in both pre-implementation and implementation periods. | 36 months |