Hypertension Treatment in Nigeria 2.0 (HTN 2)

Hypertension Treatment in Nigeria Program 2.0

The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory, Nigeria. This program demonstrated significant improvements in hypertension treatment and control. HTN 2.0 will expand implementation of the HEARTS bundle to 5 new states in 5 geopolitical zones in Nigeria (Abia, Delta, Gombe, Jigawa, and Oyo) while also evaluating sustainment of hypertension control in the Federal Capital Territory.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension (HTN)
• Intervention / Treatment: Other: Implementation of a modified WHO HEARTS Hypertension Treatment Bundle

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dike Ojji, MD; Phone Number: +234-806-009-4456; Email: dike.ojji@uniabuja.edu.ng
• Study Contact Backup: Name: Mark Huffman, MD; Email: m.huffman@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years old),
• Elevated blood pressure (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) documented or measured by a health care professional (e.g., physician, community health extension worker, or community health officer) on two separate occasions or taking a BP-lowering medication, or a history of hypertension.
• Pregnant women are eligible for this program, or
• Cognitively impaired adults are eligible for this program..

Exclusion Criteria:

This program will not include any of the following special populations:

• Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years old, or
• Prisoners or other detained individuals.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Primary Health Care Centers; 50 primary healthcare centers across five Nigerian states will be selected to implement a hypertension treatment program based on the WHO HEARTS hypertension technical package.

Other: Implementation of a modified WHO HEARTS Hypertension Treatment Bundle; The intervention seeks to the scale-up of the World Health Organization HEARTS package in 50 primary healthcare centers across five Nigerian states using a type II hybrid effectiveness implementation design. Following a 12-month pre-implementation period, centers will transition into a 24-month implementation period that includes state-level training of health workers, non-physician hypertension screening, diagnosis, and treatment, simplified hypertension treatment guidelines, monthly audit and feedback, supply chain strengthening, and a drug revolving fund to improve blood pressure lowering medication accessibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Outcome	Difference in the 6-month rolling average of hypertension control between the pre-implementation and implementation periods (defined as <140/<90 mm Hg)	36 months
Primary Implementation Outcome	Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness outcome (hypertension treatment)	Difference in hypertension treatment in the 6-month rolling average between the pre-implementation and implementation periods	36 months
Secondary Effectiveness Outcomes (mean systolic blood presure)	Difference in mean systolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods	36 months
Secondary Effectiveness Outcome (mean diastolic blood pressure)	Difference in mean diastolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods	36 months
Secondary Implementation Outcomes: Proportion of selected PHCs who participated in baseline hypertension training	A = Number of PHCs who participated in baseline hypertension training B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Proportion of selected PHCs who participated in site initiation training	A = Number of PHCs who participated in site initiation training B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Proportion of selected PHCs who received at least one supportive supervision visit in the past 12 months	A = Number of PHCs who received at least one supportive supervision visit in the past 12 months B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Proportion of selected PHCs who received an audit and feedback report within the past 3-months	A = Number of PHCs who received at least an audit and feedback report within the past 3-months B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Percentage of PHCs with a working blood pressure monitor at the site on the day of assessment	A = Number of PHCs with a working blood pressure monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Percentage of PHCs with blood pressure medicines available on the day of assessment	A = Number of PHCs with blood pressure medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B	36 months
Secondary Implementation Outcome: Percentage of patients with step up indicated who received step up treatment in the last 6-months	A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate	36 months
Secondary Implementation Outcome: Number and proportion of adult patients with hypertension who are registered/total number of adult patients with elevated blood pressure within participating PHCs within the past 3 working days	A = Total number of adult patients who had high BP visits to the health facility within the given dates B = Total number of patients visits to the health facility within the given dates Calculation: A ÷ B	36 months
Secondary implementation Outcome: Monthly proportion of registered patients with appropriate stepped care/total number of registered patients	A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate	36 months
Secondary Implementation Outcome: Monthly proportion of registered patients treated with fixed dose combination therapy/total number of patients on treatment	A = Number of patients who are treated with fixed dose combination therapy B = Total number of patients who are treated per month Calculation: A ÷ B, 6-month rolling average rate	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events	Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events	36 months
Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of adverse events of special interest	i.e., clinically ascertained angioedema, syncope, lightheadedness/dizziness, edema, inappropriate medication prescription [e.g., ACE or ARB among patients who are pregnant]	36 months
Safety Outcome: Between-period (pre-implementation versus implementation) differences in the proportion of hyperkalemia, hypokalemia, and acute kidney injury	Hyperkalemia, hypokalemia, and acute kidney injury measured in a subset of 5 sites and 250 patients (n=500 total) in both pre-implementation and implementation periods.	36 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Abuja Teaching Hospital; University of Abuja

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Nigeria; Primary Health Center; HEARTS technical package
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: UATH/HREC/PR/557/A2; R01HL144708 (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 BioData Catalyst
• 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 BioData Catalyst.
• 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