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

June 6, 2025 updated by: Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reach of intervention
Time Frame: Any point during the 24 month intervention period
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
Time Frame: Any point during the 24 month intervention period
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
Time Frame: Any point during the 24 month intervention period
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
Time Frame: Years 2-4
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
Time Frame: Years 2-5
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of intervention on diagnoses of HTN
Time Frame: Years 2-5
Percent of people referred for care who get diagnosed with HTN and begin treatment on appropriate medications
Years 2-5
Cost Effectiveness
Time Frame: Years 1-5
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
Time Frame: 12 and 24 months after enrollment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nigeria Nsukka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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