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Hypertension (HTN)HTN 2NCT07351162

Hypertension Treatment in Nigeria 2.0

A study testing Implementation of a modified WHO HEARTS Hypertension Treatment Bundle in people with Hypertension (HTN), run by Washington University School of Medicine at 49 sites in Nigeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension (HTN)
What is being tested?
Implementation of a modified WHO HEARTS Hypertension Treatment Bundle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
49 sitesNigeria
Study dates
2 Feb 2026to 31 Jan 2030
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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..

Who cannot join

  • 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.

Trial locations and contacts

49 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dike Ojji, MD contact

+234-806-009-4456

dike.ojji@uniabuja.edu.ng

Mark Huffman, MD contact

m.huffman@wustl.edu

49 sites in 1 country

Nigeria49 sites, 49 recruiting

  • Ojoo PHC

    Akinyele, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Bamaina PHC

    Birnin Kudu, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Magajin Gari PHC

    Birnin Kudu, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Sudumina PHC

    Birnin Kudu, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Kachi PHC

    Dutse, Jigawa State

    Dike Ojji, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Kudai PHC

    Dutse, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Sakwaya PHC

    Dutse, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Alakia Model PHC

    Egbeda, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Igun PHC

    Eku, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Okpara Waterside PHC

    Eku, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Orhondo-Eku PHC

    Eku, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Abuja PHC

    Gadam, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Gadam PHC

    Gadam, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Kumbiya Kumbiya PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Madaki PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Nassarawo PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Pantami PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Town PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Tudun Wada PHC

    Gombe, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Alegongo PHC

    Ibadan, Oyo State

    Dike Ojji, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Apete PHC

    Ibadan, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Idi Ogungun PHC

    Ibadan, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Iwo Road PHC

    Ibadan, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Odo-Ona Elewe PHC

    Ibadan, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Oke Bola PHC

    Ibadan, Oyo State

    Dike Ojji, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Oniyanrin PHC

    Ibadan, Oyo State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Oranyan PHC

    Ibadan, Oyo State

    Dike Ojji, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Andaza PHC

    Kiyawa, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Katanga PHC

    Kiyawa, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Kiyawa PHC

    Kiyawa, Jigawa State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Bogo PHC

    Kumo, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Kumo PHC

    Kumo, Gombe State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Amiyi Uhu PHC

    Mbalano, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Mbagwu PHC

    Mbalano, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Nunya Health Centre

    Mbalano, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Nvurunvu PHC

    Mbalano, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Onuaku PHC

    Mbalano, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Edjemuyavwe PHC

    Oghara, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Jesse PHC

    Oghara, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Oghareki PHC

    Oghara, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Ogharefe PHC

    Oghara, Ogharefe

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Amukpe PHC

    Sapele, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Gana PHC

    Sapele, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Urban PHC

    Sapele, Delta

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Amaeke PHC

    Umuahia, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Isiama Afara PHC

    Umuahia, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Oriendu PHC

    Umuahia, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Umuda Isingwu PHC

    Umuahia, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

  • Umukabia PHC

    Umuahia, Abia State

    Dike Ojji, +234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Recruiting

Other trials in Nigeria

About this study

Official title: 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.

Being tested
Implementation of a modified WHO HEARTS Hypertension Treatment Bundle
Keywords
Hypertension, Nigeria, Primary Health Center, HEARTS technical package
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of a modified WHO HEARTS Hypertension Treatment BundleOther

    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.

Study groups in NCT07351162
Study groupRoleWhat they receive
Primary Health Care CentersExperimental50 primary healthcare centers across five Nigerian states will be selected to implement a hypertension treatment program based on the WHO HEARTS hypertension technical package.
Receives: Other: Implementation of a modified WHO HEARTS Hypertension Treatment Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 36 months

  2. Primary Implementation Outcome

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

    Measured: 36 months

Secondary outcomes (13)

  1. Secondary Effectiveness outcome (hypertension treatment)

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

    Measured: 36 months

  2. 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

    Measured: 36 months

  3. 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

    Measured: 36 months

  4. 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

    Measured: 36 months

  5. 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

    Measured: 36 months

  6. 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

    Measured: 36 months

  7. 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

    Measured: 36 months

  8. 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

    Measured: 36 months

  9. 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

    Measured: 36 months

  10. 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

    Measured: 36 months

  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

    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

    Measured: 36 months

  12. 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

    Measured: 36 months

  13. 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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start2 Feb 2026
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This study applies an interrupted time series design
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07351162
Sponsor's protocol ID
UATH/HREC/PR/557/A2
Other IDs
R01HL144708
Acronym
HTN 2
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual patient data will be shared through NHLBI BioData Catalyst

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