Community Vital Signs (CVS): An Integrated Community-Based Approach to Identify Undiagnosed Hypertension in Nigeria
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CORE Plus (+), CORE.
- Кому может быть актуально
- Состояния в реестре: Hypertension. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Nigeria
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
If detected early, hypertension (HTN) is treatable; yet, HTN screening rates are low and inequitable in Sub-Saharan Africa (SSA) leaving many people with undiagnosed HTN, especially in urban areas. Thus, it is a high priority to determine the acceptability, effectiveness, and sustainability of strategies to increase rates of BP screening and connections to care in SSA. The overarching goals of this project are to: 1. Adapt evidence-based implementation strategies - called community vital signs (CVS) strategies - to support BP screening and connections to care; 2. Implement the CVS strategies and assess acceptability, test their effectiveness in improving rates of BP screening and connections to care, and understand facilitators and barriers to their sustainability.
Подробное описание
Hypertension (HTN) is a leading modifiable risk factor for global cardiovascular disease and stroke morbidity and mortality. Nigeria, Africa's most populous country, has a high HTN burden. Evidence-based interventions (EBIs) for detection and initiation of treatment for HTN are not widely implemented in Nigeria. These EBIs include widely available BP screening (reaching all adults \>18 years of age) to identify HTN early and connections to ongoing primary care for HTN management. In partnership with community and clinical stakeholders, we are currently adapting community-based strategies shown to be effective in increasing HIV screening and connections to care. The proposed adapted strategies - called community vital signs (CVS) strategies - will utilize community-based screenings, digital technologies, and supportive approaches to connect people to healthcare facilities, leveraging our practice-based research network of community clinics within the Model Innovation Research Centers created by the Nigeria Implementation Science Alliance. The study team will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and EPIS (Exploratory, Preparation, Implementation, Sustainment) implementation science frameworks to guide the project.
Aim 1 / R61 Phase (Year 1): Engage stakeholders to refine and finalize the co-creation of CVS strategies aiming to increase rates of BP screening and connections to care in Nigeria. By the end of the R61 Phase, the study team will have final CVS strategies and will recruit, train, and conduct implementation readiness assessments at 12 community-based sites connected with 12 healthcare facilities in 12 Nigerian cities (2 in each of Nigeria's 6 regions).
R33 Phase (Years 2-5) Aim 2: Implement and assess CVS strategies aiming to increase rates of BP screening at all 12 study sites (n=24,000 participants). The study team will initiate quarterly, community-based BP screenings and evaluate using RE-AIM.
Aim 3: Implement and compare 2 different CVS strategies to make connections to primary care for those found to have high BP readings that meet HTN criteria at all study sites. The study team will conduct a nested, hybrid implementation-effectiveness type III trial using a parallel 2-arm cluster randomized design. Arm A (6 sites, n\~3,000 participants): support connection to primary care by utilizing mHealth digital technologies with bidirectional sharing of BP data between community screening site and primary care clinic, coupled with a voucher for a medication starter kit (core strategies); Arm B (6 sites, n\~3,000 participants): Core strategies plus community health navigators making handoffs to clinic and sending text messages (core+ strategies). This project promotes equitable access to HTN diagnosis and connections to care, especially in cities where HTN prevalence is highest.
It has the potential to significantly increase rates of early HTN detection and prevent the morbidity and mortality associated with the downstream effect of undiagnosed and uncontrolled HTN. It will provide evidence for scale-up of interventions to support self-management of non-communicable chronic diseases in Nigeria and other low- and middle-income countries.
Вмешательства
- Другое CORE Plus (+)
CORE PLUS intervention will use mHealth technologies to create data linkages with primary care facilities/providers, educational materials, a voucher for a medication starter kit PLUS support from a Community Health Advisor who will serve as a connector to primary care for HTN management and send reminder text messages. - Другое CORE
CORE intervention will use mHealth technologies to create data linkages with primary care facilities/providers, educational materials and a voucher for a medication starter kit
Первичные конечные точки
- Reach of intervention [Срок оценки: Any point during the 24 month intervention period]
- Effectiveness of Intervention [Срок оценки: Any point during the 24 month intervention period]
- Adoption of intervention by intervention sites [Срок оценки: Any point during the 24 month intervention period]
- Fidelity to the Implementation of the Intervention [Срок оценки: Years 2-4]
- Maintenance of Intervention [Срок оценки: Years 2-5]
Вторичные конечные точки (3)
- Impact of intervention on diagnoses of HTN [Срок оценки: Years 2-5]
- Cost Effectiveness [Срок оценки: Years 1-5]
- Impact of intervention on BP [Срок оценки: 12 and 24 months after enrollment]
Критерии участия
Критерии включения
- Adult patients (>= 18 years of age)
Критерии исключения
- Children (< 18 years of age)
- prisoners
- neonates
- adults lacking capacity
- taking antihypertensive medications
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
Nigeria · 1 центр
- University of Nigeria, Nsukka — Enugu
Публикации
- Olawepo JO, Ezeanolue EE, Cohen DJ, Ejim EC, Green B, Huguet N, Holderness H, Idemili-Aronu N, Lindner S, Marino M, Odili AN, Onwuekwe I, Orafa ST, DeVoe JE. Testing community-based strategies to increase hypertension screening in Nigeria: a protocol for an effectiveness-implementation hybrid type III cluster-randomized trial. Contemp Clin Trials. 2026 Jun 5;167:108367. doi: 10.1016/j.cct.2026.108 PMID 42250852
Идентификаторы
NCT: NCT06659900 · IRB00027169