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Hypertension Treatment in Nigeria 2.0

Hypertension Treatment in Nigeria Program 2.0

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07351162
Acronym
HTN 2
Enrollment
10000
Registered
2026-01-20
Start date
2026-02-01
Completion date
2030-01-31
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension (HTN)

Keywords

Hypertension, Nigeria, Primary Health Center, HEARTS technical package

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.

Interventions

OTHERImplementation 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
University of Abuja Teaching Hospital
CollaboratorOTHER
University of Abuja
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study applies an interrupted time series design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Effectiveness Outcome36 monthsDifference in the 6-month rolling average of hypertension control between the pre-implementation and implementation periods (defined as \<140/\<90 mm Hg)
Primary Implementation Outcome36 monthsDose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.

Secondary

MeasureTime frameDescription
Secondary Effectiveness outcome (hypertension treatment)36 monthsDifference in hypertension treatment in the 6-month rolling average between the pre-implementation and implementation periods
Secondary Effectiveness Outcomes (mean systolic blood presure)36 monthsDifference in mean systolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods
Secondary Effectiveness Outcome (mean diastolic blood pressure)36 monthsDifference in mean diastolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods
Secondary Implementation Outcomes: Proportion of selected PHCs who participated in baseline hypertension training36 monthsA = Number of PHCs who participated in baseline hypertension training B = Total number of selected PHCs Calculation: A ÷ B
Secondary Implementation Outcome: Proportion of selected PHCs who participated in site initiation training36 monthsA = Number of PHCs who participated in site initiation training B = Total number of selected PHCs Calculation: A ÷ B
Secondary Implementation Outcome: Proportion of selected PHCs who received at least one supportive supervision visit in the past 12 months36 monthsA = 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
Secondary Implementation Outcome: Proportion of selected PHCs who received an audit and feedback report within the past 3-months36 monthsA = 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
Secondary Implementation Outcome: Percentage of PHCs with a working blood pressure monitor at the site on the day of assessment36 monthsA = 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
Secondary Implementation Outcome: Percentage of PHCs with blood pressure medicines available on the day of assessment36 monthsA = 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
Secondary Implementation Outcome: Percentage of patients with step up indicated who received step up treatment in the last 6-months36 monthsA = 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
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 days36 monthsA = 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
Secondary implementation Outcome: Monthly proportion of registered patients with appropriate stepped care/total number of registered patients36 monthsA = 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
Secondary Implementation Outcome: Monthly proportion of registered patients treated with fixed dose combination therapy/total number of patients on treatment36 monthsA = 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

Contacts

CONTACTDike Ojji, MD
dike.ojji@uniabuja.edu.ng+234-806-009-4456
CONTACTMark Huffman, MD
m.huffman@wustl.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026