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Hypertension (HTN)HOPENCT07681726

Project HOPE (Hypertension Outreach Through Partnership and Engagement)

An observational study of Hypertension (HTN), run by Johns Hopkins University at 1 site in Liberia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this study is to learn if a nurse-led, task-shifting, community-based program can help lower blood pressure in adults aged 25 and older with uncontrolled high blood pressure (hypertension) in Monrovia, Liberia. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Hypertension (HTN)
What is being tested?
Project HOPE Intervention
How many people
150 participants
Where
1 siteLiberia
Study dates
1 Feb 2027to 30 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adults aged 25 years and older with Stage 2 hypertension residing in five high-thoroughfare, underserved communities in Monrovia, Liberia (Zubah Town, King Gray, Barchue, Kpelle Town, and Congo Town Back Road), identified and enrolled through community-based mobile clinics (CBMCs) staffed by community health nurses (CHNs) delivering WHO-aligned hypertension treatment within the Ministry of Health's Community Health hypertension management protocols. Target enrollment is 150 patient participants. CHNs directly involved in intervention delivery are also included for pre/post-training surveys and semi-structured interviews.

Patient Participant Inclusion Criteria:

  • Adults aged ≥25 years
  • Stage 2 hypertension defined as either:
  • Systolic Blood Pressure (SBP) ≥160 mmHg at screening (Group A); OR
  • SBP 140-159 mmHg at screening with either documented elevation on more than one visit or a known history of hypertension (e.g., prior clinician diagnosis or current use of antihypertensive medication) (Group B)

Patient Participant Exclusion Criteria:

  • <25 years of age
  • Hypertensive emergency with SBP ≥180 mmHg at screening (these patients will be referred to the nearest health center per local protocol; they may be re-screened for eligibility at a subsequent visit if SBP meets the inclusion criteria above)
  • Diagnosis of end-stage renal disease (ESRD)
  • Condition which interferes with outcome measurement (e.g., dialysis)
  • Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
  • Cognitive impairment or other condition preventing participation in the intervention
  • Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥30 days), screened using the NIAAA Single Alcohol Screening Question
  • Pregnant or planning pregnancy in the next 24 months
  • Currently nursing a child
  • Current participation in another research study focused on reducing blood pressure
  • Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
  • Planning to move out of the geographic area within 7 months
  • Unwillingness to provide informed consent

Community Health Nurse (CHN) Participant Inclusion Criteria:

  • CHNs who were directly involved in delivering the nurse-led community-based hypertension intervention
  • Willing to provide oral informed consent for participation in pre/post-training surveys and semi-structured interviews

Community Health Nurse (CHN) Participant Exclusion Criteria:

  • CHNs who were not directly involved in the delivery of the intervention

Trial locations and contacts

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

Lisa A Cooper, MD, MPH contact

410-955-3008

lisa.cooper@jhmi.edu

Liberia1 site
  • Wellness Partners Clinic

    Monrovia, Montserrado County

    Nicole Cooper, MD, MPH, +231-555-395-650, medicaldirector@wellnesspartnershealth.org

    Cooper

Other trials in Liberia

About this study

The goal of this study is to learn if a nurse-led, task-shifting, community-based program can help lower blood pressure in adults aged 25 and older with uncontrolled high blood pressure (hypertension) in Monrovia, Liberia. The program is delivered through community-based mobile clinics by community health nurses (CHNs) trained in WHO-aligned hypertension care within the Ministry of Health's (MOH) Community Health hypertension management protocols.

Participants will:

Read more
  • Receive blood pressure treatment from trained community health nurses (CHNs) at community-based mobile clinics in their communities, including medication and lifestyle counseling.
  • Complete surveys at their first visit, at 4 to 6 weeks, and at 3 months about their experience, satisfaction, and medication use.
  • Attend follow-up visits at the mobile clinic based on their blood pressure levels.

Community health nurses delivering the program will complete structured training and be invited to complete surveys before and after training, and to take part in interviews about their experience at the end of the study.

The study will take place over 7 months in five high-thoroughfare communities in Monrovia, Liberia, and aims to enroll 150 participants.

Read the detailed description

This pilot uses a quasi-experimental, hybrid type 1 effectiveness-implementation design to assess both the clinical effectiveness and implementation outcomes of a nurse-led, community-based hypertension intervention in an urban Liberian setting. The intervention is embedded within the Ministry of Health's (MOH) National Community Health Strategy 2023-2032 and operationalizes the MOH's new Community Health hypertension management protocols, which adapt WHO pharmacologic and non-pharmacologic guidelines to the local context.

Care is delivered by community health nurses (CHNs) operating out of community-based mobile clinics (CBMCs) sited in five contiguous, high-thoroughfare communities (Zubah Town, King Gray, Barchue, Kpelle Town, and Congo Town Back Rd). The communities are within 15-20 minutes of each other to support shared logistics and continuity of care across mobile clinic visits. Recruitment occurs over the first 3 months of the 7-month pilot period; each enrolled participant is then followed for 3 months.

CHNs complete a multi-day, competency-based training program led by the Johns Hopkins Center for Health Equity (JHCHE) in partnership with the Liberian implementation team. Training covers standardized BP measurement using a "screen and confirm" protocol (including a 5-minute pre-measurement rest and automated triplicate readings), WHO-aligned pharmacologic step-up algorithm adapted to local formulary and context, and structured non-pharmacologic counseling using a patient-facing Options Tool adapted from the RICH LIFE trial (covering diet, physical activity, smoking cessation, adherence support, danger-sign recognition, and social drivers of hypertension). Motivational interviewing techniques and simplified treatment protocols under physician oversight follow the Addressing Hypertension Care in Africa (ADHINCRA) model. Ongoing technical assistance and remote protocol-fidelity monitoring are provided by the JHCHE team.

The study is being conducted under a dual-Institutional Review Board (IRB) structure: the Liberian team holds local IRB approval for the patient-care component, while Johns Hopkins Medicine (JHM) IRB approval covers all CHN-facing research activities and a secondary evaluation of patient outcomes using the limited data set. The work is intended to generate real-world evidence to inform scale-up of equitable, nurse-led chronic disease care across urban and peri-urban communities in Liberia and comparable health systems.

Being tested
Project HOPE Intervention
Keywords
Hypertension, Blood Pressure, Nurse-Led Intervention, Task Shifting, Community Health Nurses, Liberia, Mobile Clinic, Low-Resource Settings
Medical subject headings
Hypertension

What participants receive

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

  • Project HOPE InterventionBehavioural

    Patients will receive nurse-led treatment for uncontrolled hypertension that includes:

    1. Pharmacological treatment in line with the MOH's non-communicable disease protocols and World Health Organization (WHO) Guidelines for the pharmacological treatment of hypertension in adults 1. Medications include calcium channel blockers, thiazide diuretics, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs).
    2. Non-pharmacological treatment including education and counseling on lifestyle interventions (healthy diet, exercise, active non-sedentary lifestyle +/- smoking cessation as needed), medication adherence, danger signs and social factors contributing to hypertension.

    The mobile clinics will be in the same community at a specific day of the week, each week, enabling patients to come back for a follow-up on the same day during a future week (either next week or after 4-6 weeks, based on blood pressure readings)

Study groups in NCT07681726
Study groupRoleWhat they receive
Nurse-Led Community-Based Hypertension Care CohortThe source population will be community residents living in high thoroughfare areas within five communities (Zubah Town, King Gray, Barchue, Kpelle Town and Congo Town Back Rd) in Monrovia, Liberia. The designated communities are within 15-20 minutes of each other. Patients can receive care at a neighboring site if they miss the day of the week when the clinic is set up in their neighborhood. Patients and community health promoters will have a schedule for all five days that the mobile clinic will move through these communities.
Receives: Behavioral: Project HOPE Intervention

What is being measured

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

  1. Change in Systolic Blood Pressure

    Within subject change from baseline in systolic blood pressure at the last measurement will be calculated. We will report the mean (95% confidence interval (CI)) in the change. A reduction in systolic blood pressure of ≥ 5 mmHg will be considered clinically significant.

    A ≥5 mmHg reduction would be considered clinically meaningful/significant but this will not stop medication titration. Patients showing improvement but still uncontrolled will continue escalation per protocol.

    Measured: Baseline to 6 months

Secondary outcomes (6)
  1. Participants with Controlled Blood Pressure

    The percent and exact binomial 95% CI of participants with controlled blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) at their last visit will be calculated.

    Measured: Baseline to 6 months

  2. Adherence (Percentage of Participants)

    Medication adherence will be measured at the last visit using a self-report measure of the extent of medical nonadherence by Voils which included three questions:

    1. I took all doses of my blood pressure medication. B. I missed or skipped at least one dose of my blood pressure medication. C. I was not able to take all of my blood pressure medication. If the participant reports being non-adherent on any of the three adherence yes/no questions, the participant will be coded as non-adherent. If they report being adherent on all three questions they will be coded as adherent. The percent and exact binomial 95% CI for adherent will be reported.

    Measured: Baseline to 6 months

  3. Adherence (Proportion of medication days missed)

    Thee proportion of days (out of 7) that the participant missed taking medications using a single-item self-report medication adherence question and report the mean proportion and 95% CI will be reported.

    Measured: Baseline to 6 months

  4. Acceptability as assessed by the Theoretical Framework of Acceptability

    The investigators will measure four constructs: (a) affective attitude, (b) burden, (c) perceived effectiveness, and (d) opportunity costs, and the (e) overall acceptability rating from the theoretical framework of acceptability (TFA). Items (a) and (b) will be scored such that a score of 1 represents the least desirable response and a score of 5 represents the most desirable response. Items (c), (d) and (e) will have yes/no responses. A composite/summary measure will be created by dichotomizing the 5-point items (Yes = 4 and 5 vs No =1, 2, and 3). Then, a sum of the number of positive responses on the 5 items will be created. A score of 4 on this composite/summary measure (score range: 0-5, higher score better) would be considered ≥ 80% acceptability and would be considered a success at the last visit.

    Measured: Baseline to 6 months

  5. Satisfaction and Trust

    The investigators will measure participant satisfaction and trust using the single item questions. The mean and 95% CI of the responses will be reported. A score of ≥ 4.0 will indicate satisfaction or trust, respectively. These questions are scored using a Likert's scale (score range: 1-5, higher score better) with the following options and scores: Strongly Disagree (1), Disagree (2), Neither Agree nor Disagree (3), Agree (4) Strongly Agree (5)

    Measured: Baseline to 6 months

  6. Study Completion

    The proportion and 95% CI of the participants who did not complete the study will be reported. If available, reasons for withdrawal will also be reported.

    Measured: Baseline to 6 months

Timeline

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

  1. First posted2 Jul 2026
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681726
Sponsor's protocol ID
IRB00520896
Acronym
HOPE
Status last verified
Sep 2026
First submitted
26 Jun 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Commodore-Mensah Y, Sarfo FS, Turkson-Ocran RA, Foti K, Mobula LM, Himmelfarb CD, Carson KA, Appiah LT, Degani M, Lang'at C, Nyamekye G, Molello NE, Ahima R, Cooper LA. Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial. Contemp Clin Trials. 2023 Feb;125:107077. doi: 10.1016/j.cct.2022.107077. Epub 2022 Dec 30.

    PubMed 36592818
  • Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.

    PubMed 35232455
  • Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.

    PubMed 22922431
  • Ogedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, Iwelunmor J, Awudzi KY, Quakyi KN, Mogaverro J, Khurshid K, Tayo B, Cooper R. Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana. PLoS Med. 2018 May 1;15(5):e1002561. doi: 10.1371/journal.pmed.1002561. eCollection 2018 May.

    PubMed 29715303
  • Cooper LA, Marsteller JA, Carson KA, Dietz KB, Boonyasai RT, Alvarez C, Ibe CA, Crews DC, Yeh HC, Miller ER 3rd, Dennison-Himmelfarb CR, Lubomski LH, Purnell TS, Hill-Briggs F, Wang NY; RICH LIFE Project Investigators. The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities. Am Heart J. 2020 Aug;226:94-113. doi: 10.1016/j.ahj.2020.05.001. Epub 2020 May 8.

    PubMed 32526534

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension (HTN), run by Johns Hopkins University at 1 site in Liberia.

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

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Liberia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lisa A Cooper, MD, MPH (410-955-3008, lisa.cooper@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure (time frame: Baseline to 6 months). 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 NCT07681726, which also lists 5 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 8 Sep 2026.

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