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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

21,922

participants targeted

Target at P75+ for not_applicable hypertension

Timeline

Completed

Started Feb 2020

Longer than P75 for not_applicable hypertension

Geographic Reach

1 country

60 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

First Submitted

Initial submission to the registry

November 5, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed

3 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed

Last Updated

May 20, 2025

Status Verified

December 1, 2024

Enrollment Period

3.9 years

First QC Date

November 5, 2019

Last Update Submit

May 19, 2025

Conditions

Hypertension

Keywords

HypertensionNigeriaPrimary Health Center

Outcome Measures

Primary Outcomes (2)

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

Study Arms (1)

Primary Health Care Centers

EXPERIMENTAL

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

Interventions

Evidence-based fixed-dose combination protocol based treatmentOTHER

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).

Primary Health Care Centers

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

Individuals who are not yet adults (minors)
Prisoners or other detained individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Washington University School of Medicinelead
National Heart, Lung, and Blood Institute (NHLBI)collaborator
University of Abuja Teaching Hospitalcollaborator
Resolve to Save Livescollaborator

Study Sites (60)

Agyana PHC

Abaji, Abaji, Nigeria

Location

Central PHC

Abaji, Abaji, Nigeria

Location

Gawu PHC

Abaji, Abaji, Nigeria

Location

Low Cost PHC

Abaji, Abaji, Nigeria

Location

Naharati PHC

Abaji, Abaji, Nigeria

Location

New Township Clinic

Abaji, Abaji, Nigeria

Location

Rimba PHC

Abaji, Abaji, Nigeria

Location

Yaba PHC

Abaji, Abaji, Nigeria

Location

Dakwa PHC