Community Vital Signs (CVS): An Integrated Community-Based Approach to Identify Undiagnosed Hypertension in Nigeria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CORE Plus (+), CORE.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other 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
Primary outcome measures
- Reach of intervention [Time frame: Any point during the 24 month intervention period]
- Effectiveness of Intervention [Time frame: Any point during the 24 month intervention period]
- Adoption of intervention by intervention sites [Time frame: Any point during the 24 month intervention period]
- Fidelity to the Implementation of the Intervention [Time frame: Years 2-4]
- Maintenance of Intervention [Time frame: Years 2-5]
Secondary outcome measures (3)
- Impact of intervention on diagnoses of HTN [Time frame: Years 2-5]
- Cost Effectiveness [Time frame: Years 1-5]
- Impact of intervention on BP [Time frame: 12 and 24 months after enrollment]
Eligibility criteria
Inclusion criteria
- Adult patients (>= 18 years of age)
Exclusion criteria
- Children (< 18 years of age)
- prisoners
- neonates
- adults lacking capacity
- taking antihypertensive medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Nigeria · 1 center
- University of Nigeria, Nsukka — Enugu
Publications
- 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
Identifiers
NCT: NCT06659900 · IRB00027169