Project HOPE (Hypertension Outreach Through Partnership and Engagement)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •<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
研究组 & 干预措施
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.
干预措施: Project HOPE Intervention (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: Baseline to 6 months
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.
次要结局
- 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 Completion(Baseline to 6 months)