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

NCT06659900 | Enrolling By Invitation DMC

• 1 other identifier: IRB00027169
• Study Type: interventional
• Target: 24,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Screening; Hypertension; Low-Middle Income; Nigeria; Implementation Science

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Impact of intervention on diagnoses of HTN

  Years 2-5

• Cost Effectiveness

  Years 1-5

• Impact of intervention on BP

  12 and 24 months after enrollment

Study Arms (2)

CORE (Arm A)

EXPERIMENTAL

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 PLUS (Arm B)

EXPERIMENTAL

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 (+)

Interventions

CORE Plus (+) OTHER

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.

CORE PLUS (Arm B)

CORE OTHER

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

CORE (Arm A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>= 18 years of age)

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Nigeria Nsukka: collaborator

Study Sites (1)

University of Nigeria, Nsukka

Enugu, Nigeria

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

NG (1)