Hypertension Treatment in Nigeria 2.0

NCT07351162 | Not Yet Recruiting DMC

• 2 other identifiers: UATH/HREC/PR/557/A2R01HL144708
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension (HTN)

Keywords

Hypertension; Nigeria; Primary Health Center; HEARTS technical package

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Secondary Effectiveness outcome (hypertension treatment)

  36 months

• Secondary Effectiveness Outcomes (mean systolic blood presure)

  36 months

• Secondary Effectiveness Outcome (mean diastolic blood pressure)

  36 months

• Secondary Implementation Outcomes: Proportion of selected PHCs who participated in baseline hypertension training

  36 months

• Secondary Implementation Outcome: Proportion of selected PHCs who participated in site initiation training

  36 months

Other Outcomes (3)

• 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

  36 months

• Safety Outcome: Between-period (pre-implementation versus implementation) differences in the proportion of hyperkalemia, hypokalemia, and acute kidney injury

  36 months

Study Arms (1)

Primary Health Care Centers

EXPERIMENTAL

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

Interventions

Implementation of a modified WHO HEARTS Hypertension Treatment Bundle OTHER

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.

Primary Health Care Centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Dike Ojji, MD

CONTACT

+234-806-009-4456; dike.ojji@uniabuja.edu.ng

Mark Huffman, MD

CONTACT

m.huffman@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William Bowen Professor of Medicine, Professor of Public Health, Co-Director Global Health Center and Global Health Futures

Model Details: This study applies an interrupted time series design

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 1 year of study conclusion
• Access Criteria: Access to study data will be managed through NHLBI BioData Catalyst.