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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04158154
Acronym
HTN
Enrollment
21922
Registered
2019-11-08
Start date
2020-02-01
Completion date
2023-12-31
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Nigeria, Primary Health Center

Brief summary

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

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).

Interventions

OTHEREvidence-based fixed-dose combination protocol based treatment

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).

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Abuja Teaching Hospital
CollaboratorOTHER
Resolve to Save Lives
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study applies an interrupted time series design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Slope of Treatment RateThrough study completion, 45 monthsHypertension 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 RateThrough study completion, 45 monthsHypertension 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.

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026