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HypertensionHTNNCT04158154

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

A study testing Evidence-based fixed-dose combination protocol based treatment in people with Hypertension, run by Washington University School of Medicine at 60 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Evidence-based fixed-dose combination protocol based treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21,922 participants
Where
60 sitesNigeria
Study dates
1 Feb 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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).
  • Elevated blood pressure (Systolic Blood Pressure ≥ 130 mmHg or Diastolic Blood Pressure ≥ 80 mmHg) documented or measured by a health care professional (e.g., physician, Community Health Extension Worker, or Community Health Officer).

Who cannot join

  • Individuals who are not yet adults (minors)
  • Prisoners or other detained individuals.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

Nigeria60 sites

  • Agyana PHC

    Abaji, Abaji

  • Central PHC

    Abaji, Abaji

  • Gawu PHC

    Abaji, Abaji

  • Low Cost PHC

    Abaji, Abaji

  • Naharati PHC

    Abaji, Abaji

  • New Township Clinic

    Abaji, Abaji

  • Rimba PHC

    Abaji, Abaji

  • Yaba PHC

    Abaji, Abaji

  • Dakwa PHC

    Abuja, Abuja Municipal Area Council

  • Gbagarape PHC

    Abuja, Abuja Municipal Area Council

  • Gidan Mangoro PHC

    Abuja, Abuja Municipal Area Council

  • Gosa PHC

    Abuja, Abuja Municipal Area Council

  • Gwagwa PHC

    Abuja, Abuja Municipal Area Council

  • Jikwoyi PHC

    Abuja, Abuja Municipal Area Council

  • Kagini PHC

    Abuja, Abuja Municipal Area Council

  • Karon Majigi PHC

    Abuja, Abuja Municipal Area Council

  • Karshi PHC

    Abuja, Abuja Municipal Area Council

  • Karu PHC

    Abuja, Abuja Municipal Area Council

  • Kuchingoro PHC

    Abuja, Abuja Municipal Area Council

  • Lugbe PHC

    Abuja, Abuja Municipal Area Council

  • New Garki Apo PHC

    Abuja, Abuja Municipal Area Council

  • Orozo PHC

    Abuja, Abuja Municipal Area Council

  • Pykassa PHC

    Abuja, Abuja Municipal Area Council

  • Byazhin PHC

    Bwari, Bwari

  • Dei-Dei PHC

    Bwari, Bwari

  • Kawu PHC

    Bwari, Bwari

  • Kogo PHC

    Bwari, Bwari

  • Mpape PHC

    Bwari, Bwari

  • Sabon Gari PHC

    Bwari, Bwari

  • Shere PHC

    Bwari, Bwari

  • Ushafa PHC

    Bwari, Bwari

  • Anagada PHC

    Gwagwalada, Gwagwalada

  • Dagiri CPHC

    Gwagwalada, Gwagwalada

  • Dobi PHC

    Gwagwalada, Gwagwalada

  • Dukpa PHC

    Gwagwalada, Gwagwalada

  • Gwagwalada Township Clinic

    Gwagwalada, Gwagwalada

  • Gwako PHC

    Gwagwalada, Gwagwalada

  • Old-Kutunku PHC

    Gwagwalada, Gwagwalada

  • Paikon PHC

    Gwagwalada, Gwagwalada

  • Rafin Zurfi PHC

    Gwagwalada, Gwagwalada

  • Yimi PHC

    Gwagwalada, Gwagwalada

  • Zuba PHC

    Gwagwalada, Gwagwalada

  • Chukuku PHC

    Kuje, Kuje

  • Gaube CPHC

    Kuje, Kuje

  • Gudunkarya PHC

    Kuje, Kuje

  • Gwargada PHC

    Kuje, Kuje

  • Kiyi PHC

    Kuje, Kuje

  • Kuje PHC

    Kuje, Kuje

  • Kujekwa PHC

    Kuje, Kuje

  • Pegi PHC

    Kuje, Kuje

  • Ashara PHC

    Kwali, Kwali

  • Dabi Bako CPHC

    Kwali, Kwali

  • Dafa PHC

    Kwali, Kwali

  • Gomani PHC

    Kwali, Kwali

  • Kwaita Hausa PHC

    Kwali, Kwali

  • Kwaita Model PHC

    Kwali, Kwali

  • Kwali PHC

    Kwali, Kwali

  • Petti PHC

    Kwali, Kwali

  • Wako PHC

    Kwali, Kwali

  • Yangoji PHC

    Kwali, Kwali

Other trials in Nigeria

About this study

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

Read the detailed description

This study includes the implementation and evaluation of a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment at primary health centers in Abuja, Nigeria. The intervention has been adapted based on a local needs' assessment including evidence synthesis and specific exploration of health care workers' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment, including fixed-dose combination and patient self-management, and patients' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable system- and patient-level barriers to hypertension treatment and control across capability, intentional, and system domains using the Consolidated Framework for Implementation Research. Preparedness and capacity have been assessed at primary health centers (e.g. available staff; information systems; use of clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) instrument during the formative work for this study. The multi-level implementation package includes: 1) patient registration and empanelment (health system level), 2) standard treatment protocol (national policy level), 3) encouragement of fixed-dose combination therapy (health system level), 4) team-based care (health worker level), and 5) home blood pressure monitoring and health coaching (patient-level).

Conditions
Hypertension
Being tested
Evidence-based fixed-dose combination protocol based treatment
Keywords
Hypertension, Nigeria, Primary Health Center
Medical subject headings
Hypertension

What participants receive

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

  • Evidence-based fixed-dose combination protocol based treatmentOther

    The intervention has been adapted based on a local needs' assessment including exploration of health care workers and patient's knowledge, attitudes, and behaviors related to HTN, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable barriers to HTN treatment and control across capability, intentional, and system domains using CFIR. Sites will randomly be assigned to receive either: Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 2 separate pills); Step 3 amlodipine 10 mg + losartan 100 mg (as 4 separate pills); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo) or Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 1 single pill combo); Step 3 amlodipine 10 mg + losartan 100 mg (as 2 single pill combo); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo).

Study groups in NCT04158154
Study groupRoleWhat they receive
Primary Health Care CentersExperimentalSelected primary health care centers in Abuja will implement a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment.
Receives: Other: Evidence-based fixed-dose combination protocol based treatment

What is being measured

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

  1. Change from Baseline Slope of Treatment Rate

    Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention.

    Measured: Through study completion, 45 months

  2. Change from Baseline Slope of Control Rate

    Hypertension control is defined as a Systolic Blood Pressure <140 mmHg and Diastolic Blood Pressure <90 mmHg. Control rates are calculated monthly, over 9 months of baseline and 39 months of intervention.

    Measured: Through study completion, 45 months

Timeline

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

  1. First posted8 Nov 2019
  2. Study start1 Feb 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

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
21,922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158154
Sponsor's protocol ID
UATH/HREC/PR/2019/002
Other IDs
1R01HL144708-01
Acronym
HTN
Status last verified
Dec 2024
First submitted
5 Nov 2019
Last updated
20 May 2025
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 BioLINCC.

Publications

  • Iyer G, Ripiye N, Orji IA, Shedul GL, Shedul GJ, Ugwuneji EN, Ojo TM, Okpetu E, Osagie S, Kandula N, Toma MM, Oshundele BR, Eze SV, Jamro EL, Obiezu-Umeh C, Baldridge AS, Hirschhorn LR, Ojji DB, Huffman MD. Impact evaluation of the Hypertension Treatment in Nigeria program using the Translational Science Benefits Model. J Clin Transl Sci. 2026 Jul 13;10(1):e130. doi: 10.1017/cts.2026.10790. eCollection 2026.

    PubMed 42534330

  • Ye J, Hirschhorn LR, Baldridge AS, Jamro EL, Orji IA, Shedul GL, Ripiye NR, Ojo TM, Eze H, Shedul GJ, Ugwuneji EN, Okoli RCB, Ale BM, Osagie S, Sanuade OA, Iyer G, Kandula NR, Ojji DB, Huffman MD. Implementation outcomes from the Hypertension Treatment in Nigeria program: results from a type 2 hybrid interrupted time series trial. Implement Sci. 2025 Nov 26;21(1):1. doi: 10.1186/s13012-025-01472-1.

    PubMed 41299526

  • Baldridge AS, Odukwe A, Dabiri O, Mobisson LN, Munnee MM, Ogboye A, Aryee DNK, Mwale R, Akpakli J, Orji IA, Okoli RCB, Ripiye NR, Ojji DB, Huffman MD, Kandula NR, Hirschhorn LR. Implementation of the Extension for Community Healthcare Outcomes Model for Hypertension Education of Frontline Health Care Workers in the Federal Capital Territory, Nigeria: Explanatory Sequential Mixed Methods Evaluation. J Med Internet Res. 2025 Apr 24;27:e66351. doi: 10.2196/66351.

    PubMed 40273438

  • Shedul GL, Ripiye N, Jamro EL, Orji IA, Shedul GJ, Ugwuneji EN, Okpetu E, Ale BM, Osagie S, Baldridge AS, Kandula NR, Huffman MD, Ojji D, Hirschhorn L. Supportive supervision visits in a large community hypertension programme in Nigeria: implementation methods and outcomes. BMJ Open Qual. 2025 Mar 24;14(1):e003163. doi: 10.1136/bmjoq-2024-003163.

    PubMed 40127954

  • Baldridge AS, Orji IA, Shedul GL, Iyer G, Jamro EL, Ye J, Akor BO, Okpetu E, Osagie S, Odukwe A, Dabiri HO, Mobisson LN, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Enhancing hypertension education of community health extension workers in Nigeria's federal capital territory: the impact of the extension for community healthcare outcomes model on primary care, a quasi-experimental study. BMC Prim Care. 2024 Sep 7;25(1):334. doi: 10.1186/s12875-024-02579-y.

    PubMed 39244554

  • Baldridge AS, Goldstar N, Bellinger GC, DeNoma AT, Orji IA, Shedul GL, Okoli RCB, Ripiye NR, Odukwe A, Dabiri O, Mobisson LN, Ojji DB, Huffman MD, Kandula NR, Hirschhorn LR. Formative Evaluation and Adaptation of a Hypertension Extension for Community Health Outcomes Program for Healthcare Workers within the Federal Capital Territory, Nigeria. Glob Heart. 2023 Nov 27;18(1):64. doi: 10.5334/gh.1277. eCollection 2023.

    PubMed 38045112

  • Ojji DB, Sancilio A, Shedul GL, Orji IA, Chopra A, Abu J, Akor B, Ripiye N, Akinlade F, Okoye D, Okpetu E, Eze H, Odoh E, Baldridge AS, Tripathi P, Abubakar H, Jamda AM, Hirschhorn LR, McDade T, Huffman MD. Nigeria healthcare worker SARS-CoV-2 serology study: Results from a prospective, longitudinal cohort. PLOS Glob Public Health. 2023 Jan 17;3(1):e0000549. doi: 10.1371/journal.pgph.0000549. eCollection 2023.

    PubMed 36962953

  • Sanuade OA, Ale BM, Baldridge AS, Orji IA, Shedul GL, Ojo TM, Shedul G, Ugwuneji EN, Egenti N, Omitiran K, Okoli R, Eze H, Nwankwo A, Hirschhorn LR, Chopra A, Ye J, Tripathi P, Banigbe B, Kandula NR, Huffman MD, Ojji DB; Hypertension Treatment in Nigeria Program Investigators. Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster randomized trial. J Clin Hypertens (Greenwich). 2023 Feb;25(2):127-136. doi: 10.1111/jch.14632. Epub 2023 Jan 20.

    PubMed 36660886

  • Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.

    PubMed 35918703

  • Ojji DB, Baldridge AS, Orji IA, Shedul GL, Ojo TM, Ye J, Chopra A, Ale BM, Shedul G, Ugwuneji EN, Egenti NB, Aluka-Omitiran K, Okoli RCB, Eze H, Nwankwo A, Banigbe B, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD; Hypertension Treatment in Nigeria Program Investigators. Characteristics, treatment, and control of hypertension in public primary healthcare centers in Nigeria: baseline results from the Hypertension Treatment in Nigeria Program. J Hypertens. 2022 May 1;40(5):888-896. doi: 10.1097/HJH.0000000000003089. Epub 2022 Jan 15.

    PubMed 35034080

Questions about this trial

What is this clinical trial studying?

A study testing Evidence-based fixed-dose combination protocol based treatment in people with Hypertension, run by Washington University School of Medicine at 60 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Slope of Treatment Rate (time frame: Through study completion, 45 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04158154, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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