Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07351162

Hypertension Treatment in Nigeria 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hypertension (HTN) Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 outcomes

  1. Primary Effectiveness Outcome

    Time frame: 36 months

    Difference in the 6-month rolling average of hypertension control between the pre-implementation and implementation periods (defined as <140/<90 mm Hg)

  2. Primary Implementation Outcome

    Time frame: 36 months

    Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.

Secondary outcomes

  1. Secondary Effectiveness outcome (hypertension treatment)

    Time frame: 36 months

    Difference in hypertension treatment in the 6-month rolling average between the pre-implementation and implementation periods

  2. Secondary Effectiveness Outcomes (mean systolic blood presure)

    Time frame: 36 months

    Difference in mean systolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods

  3. Secondary Effectiveness Outcome (mean diastolic blood pressure)

    Time frame: 36 months

    Difference in mean diastolic blood pressure in the 6-month rolling average between the pre-implementation and implementation periods

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

    Time frame: 36 months

    A = Number of PHCs who participated in baseline hypertension training B = Total number of selected PHCs

    Calculation: A ÷ B

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

    Time frame: 36 months

    A = Number of PHCs who participated in site initiation training B = Total number of selected PHCs

    Calculation: A ÷ B

  6. Secondary Implementation Outcome: Proportion of selected PHCs who received at least one supportive supervision visit in the past 12 months

    Time frame: 36 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

  7. Secondary Implementation Outcome: Proportion of selected PHCs who received an audit and feedback report within the past 3-months

    Time frame: 36 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

  8. Secondary Implementation Outcome: Percentage of PHCs with a working blood pressure monitor at the site on the day of assessment

    Time frame: 36 months

    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

  9. Secondary Implementation Outcome: Percentage of PHCs with blood pressure medicines available on the day of assessment

    Time frame: 36 months

    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

  10. Secondary Implementation Outcome: Percentage of patients with step up indicated who received step up treatment in the last 6-months

    Time frame: 36 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

  11. 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

    Time frame: 36 months

    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

  12. Secondary implementation Outcome: Monthly proportion of registered patients with appropriate stepped care/total number of registered patients

    Time frame: 36 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

  13. Secondary Implementation Outcome: Monthly proportion of registered patients treated with fixed dose combination therapy/total number of patients on treatment

    Time frame: 36 months

    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

Other outcomes

  1. Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events

    Time frame: 36 months

    Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of serious adverse events

  2. Safety Outcome: between-period (pre-implementation versus implementation) differences in the proportion of adverse events of special interest

    Time frame: 36 months

    i.e., clinically ascertained angioedema, syncope, lightheadedness/dizziness, edema, inappropriate medication prescription [e.g., ACE or ARB among patients who are pregnant]

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

    Time frame: 36 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dike Ojji, MD

CONTACT

[email protected]

+234-806-009-4456

Mark Huffman, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Abuja
  • University of Abuja Teaching Hospital

Registry information

Official study title

Hypertension Treatment in Nigeria Program 2.0

Acronym: HTN 2

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.