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

NCT04158154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21922

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Evidence-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 & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Abuja Teaching Hospital

    collaborator OTHER

  • Resolve to Save Lives

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark D Huffman, MD, MPH · Northwestern University Feinberg School of Medicine

  • Dike B Ojji, MD, PhD · University of Abuja Teaching Hospital

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158154 on ClinicalTrials.gov