HypertensionNCT06659900
Community Vital Signs (CVS): An Integrated Community-Based Approach to Identify Undiagnosed Hypertension in Nigeria
A study testing CORE Plus (+) and CORE in people with Hypertension, run by Oregon Health and Science University at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CORE Plus (+) and CORE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24,000 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>= 18 years of age)
Who cannot join
- Children (< 18 years of age)
- prisoners
- neonates
- adults lacking capacity
- taking antihypertensive medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CORE Plus (+), CORE
- Keywords
- Screening, Hypertension, Low-Middle Income, Nigeria, Implementation Science
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
COREOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: CORE Plus (+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of intervention
the rate of participants who were offered BP screening by those who received BP screening
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Years 2-5
Secondary outcomes (3)
Impact of intervention on diagnoses of HTN
Percent of people referred for care who get diagnosed with HTN and begin treatment on appropriate medications
Measured: Years 2-5
Cost Effectiveness
Mean total annual costs for years 1-5, including intervention preparation and implementation by site and overall.
Measured: Years 1-5
Impact of intervention on BP
Percent of people referred for care who have improved BP over time, measured at quarterly screening
Measured: 12 and 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nigeria Nsukka
- Responsible party
- Principal investigator, Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659900
- Sponsor's protocol ID
- IRB00027169
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Aug;167:108367. doi: 10.1016/j.cct.2026.108367. Epub 2026 Jun 5.
PubMed 42250852
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Vital Signs (CVS): An Integrated Community-Based Approach to Identify Undiagnosed Hypertension in Nigeria
- ClinicalTrials.gov ID
- NCT06659900
- Acronym / sponsor ID
- IRB00027169
- Conditions
- Hypertension
- Keywords
- Screening, Hypertension, Low-Middle Income, Nigeria, Implementation Science
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Nigeria Nsukka
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORE (Arm A) | Experimental | Other: CORECORE arm will use mHealth technologies to create data linkages with primary care facilities/providers, educational materials and a voucher for a medication starter kit |
| CORE PLUS (Arm B) | Experimental | Other: CORE Plus (+)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>= 18 years of age)
Key exclusion criteria (5 listed)
- Children (< 18 years of age)
- prisoners
- neonates
- adults lacking capacity
- taking antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 PLUS (Arm B) |
| CORECORE intervention 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 (Arm A) |
Primary outcome
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
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.
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.
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 42250852Olawepo 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 Aug;167:108367. doi: 10.1016/j.cct.2026.108367. Epub 2026 Jun 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORE Plus (+) and CORE in people with Hypertension, run by Oregon Health and Science University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of intervention (time frame: Any point during the 24 month intervention period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06659900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.