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

May 19, 2025 updated by: Mark Huffman, Washington University School of Medicine
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21922

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Abaji, Nigeria
        • Agyana PHC
      • Abaji, Nigeria
        • Central PHC
      • Abaji, Nigeria
        • Gawu PHC
      • Abaji, Nigeria
        • Low Cost PHC
      • Abaji, Nigeria
        • Naharati PHC
      • Abaji, Nigeria
        • New Township Clinic
      • Abaji, Nigeria
        • Rimba PHC
      • Abaji, Nigeria
        • Yaba PHC
      • Bwari, Nigeria
        • Byazhin PHC
      • Bwari, Nigeria
        • Dei-Dei PHC
      • Bwari, Nigeria
        • Kawu PHC
      • Bwari, Nigeria
        • Kogo PHC
      • Bwari, Nigeria
        • Mpape PHC
      • Bwari, Nigeria
        • Sabon Gari PHC
      • Bwari, Nigeria
        • Shere PHC
      • Bwari, Nigeria
        • Ushafa PHC
      • Gwagwalada, Nigeria
        • Anagada PHC
      • Gwagwalada, Nigeria
        • Dagiri CPHC
      • Gwagwalada, Nigeria
        • Dobi PHC
      • Gwagwalada, Nigeria
        • Dukpa PHC
      • Gwagwalada, Nigeria
        • Gwagwalada Township Clinic
      • Gwagwalada, Nigeria
        • Gwako PHC
      • Gwagwalada, Nigeria
        • Old-Kutunku PHC
      • Gwagwalada, Nigeria
        • Paikon PHC
      • Gwagwalada, Nigeria
        • Rafin Zurfi PHC
      • Gwagwalada, Nigeria
        • Yimi PHC
      • Gwagwalada, Nigeria
        • Zuba PHC
      • Kuje, Nigeria
        • Chukuku PHC
      • Kuje, Nigeria
        • Gaube CPHC
      • Kuje, Nigeria
        • Gudunkarya PHC
      • Kuje, Nigeria
        • Gwargada PHC
      • Kuje, Nigeria
        • Kiyi PHC
      • Kuje, Nigeria
        • Kuje PHC
      • Kuje, Nigeria
        • Kujekwa PHC
      • Kuje, Nigeria
        • Pegi PHC
      • Kwali, Nigeria
        • Ashara PHC
      • Kwali, Nigeria
        • Dabi Bako CPHC
      • Kwali, Nigeria
        • Dafa PHC
      • Kwali, Nigeria
        • Gomani PHC
      • Kwali, Nigeria
        • Kwaita Hausa PHC
      • Kwali, Nigeria
        • Kwaita Model PHC
      • Kwali, Nigeria
        • Kwali PHC
      • Kwali, Nigeria
        • Petti PHC
      • Kwali, Nigeria
        • Wako PHC
      • Kwali, Nigeria
        • Yangoji PHC
    • Abuja Municipal Area Council
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Dakwa PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Gbagarape PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Gidan Mangoro PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Gosa PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Gwagwa PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Jikwoyi PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Kagini PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Karon Majigi PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Karshi PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Karu PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Kuchingoro PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Lugbe PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • New Garki Apo PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Orozo PHC
      • Abuja, Abuja Municipal Area Council, Nigeria
        • Pykassa PHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, 45 months
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.
Through study completion, 45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Resolve to Save Lives
University of Abuja Teaching Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark D Huffman, MD, MPH, Northwestern University Feinberg School of Medicine
  • Principal Investigator: Dike B Ojji, MD, PhD, University of Abuja Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UATH/HREC/PR/2019/002
  • 1R01HL144708-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data will be shared through NHLBI BioLINCC.

IPD Sharing Time Frame

Data will be available within 1 year of study conclusion.

IPD Sharing Access Criteria

Access to study data will be managed through NHLBI BioLINCC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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