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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2023

Detailed Description

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.

Interventions

  • Other: Evidence-based hypertension treatment
    • The World Health Organization HEARTS package includes healthy lifestyle counseling, evidence-based treatment protocols, access to essential medicines and technology, team-based care, and systems for monitoring. 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.

Arms, Groups and Cohorts

  • Experimental: Primary Health Care Centers
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline Slope of Treatment Rate
    • Time Frame: Through study completion, 45 months
    • Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention.
  • Change from Baseline Slope of Control Rate
    • Time Frame: Through study completion, 45 months
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark Huffman, Director, Institute for Global Health – Center for Global Cardiovascular Health; Quentin D. Young Professor of Health Policy; Associate Professor of Preventive Medicine (Epidemiology) and Medicine (Cardiology) – Northwestern University
  • Overall Official(s)
    • Mark D Huffman, MD, MPH, Principal Investigator, Northwestern University Feinberg School of Medicine
    • Dike B Ojji, MD, PhD, Principal Investigator, University of Abuja Teaching Hospital
  • Overall Contact(s)
    • Abigail S Baldridge, MS, 3125033911, abigail.baldridge@northwestern.edu

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