Project HOPE (Hypertension Outreach Through Partnership and Engagement)

NCT07681726 | Not Yet Recruiting

• 1 other identifier: IRB00520896
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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:

• 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.

Conditions

Hypertension (HTN)

Keywords

Hypertension; Blood Pressure; Nurse-Led Intervention; Task Shifting; Community Health Nurses; Liberia; Mobile Clinic; Low-Resource Settings

Outcome Measures

Primary Outcomes (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.

  Baseline to 6 months

Secondary Outcomes (6)

• Participants with Controlled Blood Pressure

  Baseline to 6 months

• Adherence (Percentage of Participants)

  Baseline to 6 months

• Adherence (Proportion of medication days missed)

  Baseline to 6 months

• Acceptability as assessed by the Theoretical Framework of Acceptability

  Baseline to 6 months

• Satisfaction and Trust

  Baseline to 6 months

Study Arms (1)

Nurse-Led Community-Based Hypertension Care Cohort

The 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.

Behavioral: Project HOPE Intervention

Interventions

Project HOPE Intervention BEHAVIORAL

Patients will receive nurse-led treatment for uncontrolled hypertension that includes: A. 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). B. 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)

Nurse-Led Community-Based Hypertension Care Cohort

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• \<25 years of age
• 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
• 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
• CHNs who were not directly involved in the delivery of the intervention

Sponsors & Collaborators

• Johns Hopkins University: lead
• Center for Advancing Health Systems Innovations (CAdHSI): collaborator
• Wellness Partners Foundation: collaborator

Study Sites (1)

Wellness Partners Clinic

Monrovia, Montserrado County, Liberia

Location

Related Publications (5)

• 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.

  PMID: 36592818 BACKGROUND

• 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.

  PMID: 35232455 BACKGROUND

• 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.

  PMID: 22922431 BACKGROUND

• 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.

  PMID: 29715303 BACKGROUND

• 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.

  PMID: 32526534 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lisa A Cooper, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Nicole Cooper, MD, MPH

  Wellness Partners Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Cooper, MD, MPH

CONTACT

410-955-3008; lisa.cooper@jhmi.edu

Nicole Cooper, MD, MPH

CONTACT

+231-555-395-650; medicaldirector@wellnesspartnershealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

LI (1)