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

Study Overview
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Brief Summary
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The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

Detailed Description
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This study includes the implementation and evaluation of a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment at primary health centers in Abuja, Nigeria. The intervention has been adapted based on a local needs' assessment including evidence synthesis and specific exploration of health care workers' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment, including fixed-dose combination and patient self-management, and patients' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable system- and patient-level barriers to hypertension treatment and control across capability, intentional, and system domains using the Consolidated Framework for Implementation Research. Preparedness and capacity have been assessed at primary health centers (e.g. available staff; information systems; use of clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) instrument during the formative work for this study. The multi-level implementation package includes: 1) patient registration and empanelment (health system level), 2) standard treatment protocol (national policy level), 3) encouragement of fixed-dose combination therapy (health system level), 4) team-based care (health worker level), and 5) home blood pressure monitoring and health coaching (patient-level).

Official Title
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Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

Conditions
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Hypertension

Intervention / Treatment
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* Other: Evidence-based fixed-dose combination protocol based treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years). Elevated blood pressure (Systolic Blood Pressure ≥ 130 mmHg or Diastolic Blood Pressure ≥ 80 mmHg) documented or measured by a health care professional (e.g., physician, Community Health Extension Worker, or Community Health Officer). Exclusion Criteria: Individuals who are not yet adults (minors) Prisoners or other detained individuals.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: This study applies an interrupted time series design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Health Care Centers<br>Selected primary health care centers in Abuja will implement a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment. | Other: Evidence-based fixed-dose combination protocol based treatment<br>* The intervention has been adapted based on a local needs' assessment including exploration of health care workers and patient's knowledge, attitudes, and behaviors related to HTN, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable barriers to HTN treatment and control across capability, intentional, and system domains using CFIR. Sites will randomly be assigned to receive either: Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 2 separate pills); Step 3 amlodipine 10 mg + losartan 100 mg (as 4 separate pills); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo) or Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 1 single pill combo); Step 3 amlodipine 10 mg + losartan 100 mg (as 2 single pill combo); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Slope of Treatment Rate | Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention. | Through study completion, 45 months | 
| Change from Baseline Slope of Control Rate | Hypertension control is defined as a Systolic Blood Pressure <140 mmHg and Diastolic Blood Pressure <90 mmHg. Control rates are calculated monthly, over 9 months of baseline and 39 months of intervention. | Through study completion, 45 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Nigeria, Primary Health Center