Community Vital Signs (CVS): An Integrated Community-Based Approach to Identify Undiagnosed Hypertension in Nigeria

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension
• Intervention / Treatment: Other: CORE; Other: CORE Plus (+)

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.

• Study Type: Interventional
• Enrollment (Estimated): 24000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Enugu, Nigeria
    • University of Nigeria, Nsukka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients (>= 18 years of age)

Exclusion Criteria:

• Children (< 18 years of age)
• prisoners
• neonates
• adults lacking capacity
• taking antihypertensive medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CORE (Arm A); CORE arm will use mHealth technologies to create data linkages with primary care facilities/providers, educational materials and a voucher for a medication starter kit	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
Experimental: CORE PLUS (Arm B); CORE PLUS arm 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of intervention	the rate of participants who were offered BP screening by those who received BP screening	Any point during the 24 month intervention period
Effectiveness of Intervention	Proportion of patients who were screened for HTN and met HTN threshold who were connected to care. This will be a site-level analysis using GEE models.	Any point during the 24 month intervention period
Adoption of intervention by intervention sites	Adoption will be measured using community-observations and period reflections from the site research coordinators who conduct the intervention. The investigators will assess how well-informed community members feel about the purpose of BP screenings, the need to connect to care for ongoing HTN management, the use of tools provided by the team, and if they deviated from the study protocol to achieve the goals of the intervention.	Any point during the 24 month intervention period
Fidelity to the Implementation of the Intervention	Longitudinal data from the Implementation Climate Measure, a survey used to assess implementation readiness, will be summarized within an across intervention sites and GEE models will be used to evaluate changes across time.	Years 2-4
Maintenance of Intervention	Proportion of patients who were screened at baseline who return for a repeat screening. This will be assessed within and across all study sites.	Years 2-5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of intervention on diagnoses of HTN	Percent of people referred for care who get diagnosed with HTN and begin treatment on appropriate medications	Years 2-5
Cost Effectiveness	Mean total annual costs for years 1-5, including intervention preparation and implementation by site and overall.	Years 1-5
Impact of intervention on BP	Percent of people referred for care who have improved BP over time, measured at quarterly screening	12 and 24 months after enrollment

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Nigeria Nsukka

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Screening; Implementation Science; Nigeria; Low-Middle Income
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00027169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No