Cardiovascular DiseasesNCT07909395
Cardiovascular Disease Multimorbidity
A study testing HEARTS and PF in people with Cardiovascular Diseases, run by NYU Langone Health at 2 sites in 2 countries.
Trial summary
This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation [PF] + Healthy Lifestyle Counselling, Evidence-Based… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- HEARTS and PF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2027to Aug 2030
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are registered to receive care at the eligible and enrolled PHC
- Aged 30 years and older
- Have BP 140-179/90-100 mm Hg
- Have type II diabetes mellitus, defined as either: (a) a new diagnosis based on HbA1c >6.5% measured at screening; or (b) a prior clinical diagnosis of type II DM documented in the medical record, currently not on antidiabetic treatment. Patients currently receiving antidiabetic medications are excluded.
- Can provide informed consent
Who cannot join
- BP >180/110 mm Hg
- History of chronic kidney disease (eGFR <35 ml/min)
- History of heart disease
- History of stroke
- Pregnant at time of screening
- Have leg ulcers and/or infection
Show all 13Show fewer
- Have impaired vision
- Have pins and needles sensation
- Have numbness in hands and feet
- Have proteinuria of 2++
- Acutely ill with high blood sugar (random blood sugar ≥15 mmol/l)[EM4.1]
- Unable to provide informed consent
- History of transient ischemic attack (TIA)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gbenga Ogedegbe, MD, MPH contact
2 sites in 2 countries
About this study
Official title: Addressing Cardiovascular Disease Multimorbidity in Patients Living With HIV in Nigeria
This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation [PF] + Healthy Lifestyle Counselling, Evidence-Based Protocols, Access to Essential Medicines and Technology, Risk-Based Management, Team-Based Care, and Systems for Monitoring [HEARTS] package) or the standard care group (HEARTS only)
The study comprises two phases: an R61 Initiation Phase (Years 1-2) involving adaptation of the HEARTS package guided by the chronic care model, stakeholder engagement, infrastructure development, and pilot testing in 2 PHCs; and an R33 Implementation Phase (Years 3-5) involving the cluster RCT. Once randomized, PHCs will participate in a 12-month intervention period followed by a 6-month post-implementation period.
- Conditions
- Cardiovascular Diseases
- Being tested
- HEARTS, PF
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARTSBehavioural
HEARTS is a technical package intended to:
- Identify patients with uncontrolled DM and HTN via medical history, HbA1c assessment, and lipid profile using point-of-care testing;
- Measure patients' weight, height, waist circumference and BP with a valid automated device following standard procedures, and assess patients' CV risk with the World Health Organization (WHO) risk chart; (3) Initiate lifestyle counseling and treatment with antihypertensive and anti-diabetic medications every 1-3 months using Federal Ministry of Health simplified protocols; and (4) Refer patients to physicians.
PFBehavioural
PF involves provision of external expertise on practice redesign and a tailored approach to implementing systems-level changes to improve patient outcomes. PF includes both a role (practice facilitator) and a process for supporting PHCs to build motivation and capacity. Six practice facilitators (each responsible for 5 PHCs) will coordinate meetings with PHC nurses, assist in setting performance goals, and strategize on HEARTS implementation through onsite visits and monthly peer-to-peer telephone calls.
| Study group | Role | What they receive |
|---|---|---|
| R61 - Pilot PHCs | Experimental | The HEARTS package will be pilot tested in 2 PHCs. Receives: Behavioral: HEARTS |
| R33 - HEARTS Only | Active comparator | PHCs assigned to the standard care group, HEARTS only. Receives: Behavioral: HEARTS |
| R33 - PF + HEARTS Package | Experimental | PHCs assigned to the PF + HEARTS implementation group. Receives: Behavioral: HEARTS; Behavioral: PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Fidelity of HEARTS at 12 Months
Fidelity is defined as the utilization of all components of the HEARTS program: identifying PLWH with uncontrolled hypertension (HTN) and diabetes mellitus (DM); measuring patient anthropometrics and BP; initiating lifestyle counseling and medication treatment every 1-3 months; and referring PLWH with complicated HTN and DM to physicians for further care.
Measured: Month 12
Change in Systolic Blood Pressure (SBP) from Baseline to 12 Months
Measured: Baseline, Month 12
Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months
Measured: Baseline, Month 12
Secondary outcomes (8)
Sustainability of HEARTS at 18 Months
Continued utilization of HEARTS components 6 months after completion of the intervention period.
Measured: Month 18
Blood Pressure Control at 12 Months
Proportion of study participants with blood pressure (BP) <140/90 mm Hg at 12 months.
Measured: Month 12
Blood Glucose Control at 12 Months
Proportion of study participants with HbA1c <7% at 12 months.
Measured: Month 12
Number of Sessions with Nurses
Measured: Up to Month 12
Duration of Sessions with Nurses
Measured: Up to Month 12
Number of Anthropometric Measurements
Total number of measurements obtained.
Measured: Up to Month 12
Number of Lifestyle Counseling Sessions
Measured: Up to Month 12
Number of Documented Referrals
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startSep 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gbenga Ogedegbe, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909395
- Sponsor's protocol ID
- 26-00534
- Other IDs
- 1R61HL184905-01
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nafesa.kanneh@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Cardiovascular Disease Multimorbidity in Patients Living With HIV in Nigeria
- ClinicalTrials.gov ID
- NCT07909395
- Acronym / sponsor ID
- 26-00534
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 2 Nov 2026 (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.
This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation [PF] + Healthy Lifestyle Counselling, Evidence-Based Protocols, Access to Essential Medicines and Technology, Risk-Based Management, Team-Based Care, and Systems for Monitoring [HEARTS] package) or the standard care group (HEARTS only)
The study comprises two phases: an R61 Initiation Phase (Years 1-2) involving adaptation of the HEARTS package guided by the chronic care model, stakeholder engagement, infrastructure development, and pilot testing in 2 PHCs; and an R33 Implementation Phase (Years 3-5) involving the cluster RCT. Once randomized, PHCs will participate in a 12-month intervention period followed by a 6-month post-implementation period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R61 - Pilot PHCs | Experimental | Behavioral: HEARTSThe HEARTS package will be pilot tested in 2 PHCs. |
| R33 - HEARTS Only | Active comparator | Behavioral: HEARTSPHCs assigned to the standard care group, HEARTS only. |
| R33 - PF + HEARTS Package | Experimental | Behavioral: HEARTS, Behavioral: PFPHCs assigned to the PF + HEARTS implementation group. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are registered to receive care at the eligible and enrolled PHC
- Aged 30 years and older
- Have BP 140-179/90-100 mm Hg
- Have type II diabetes mellitus, defined as either: (a) a new diagnosis based on HbA1c >6.5% measured at screening; or (b) a prior clinical diagnosis of type II DM documented in the medical record, currently not on antidiabetic treatment. Patients currently receiving antidiabetic medications are excluded.
- Can provide informed consent
Key exclusion criteria (13 listed)
- BP >180/110 mm Hg
- History of chronic kidney disease (eGFR <35 ml/min)
- History of heart disease
- History of stroke
- Pregnant at time of screening
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 |
|---|---|---|
| HEARTSHEARTS is a technical package intended to: 1. Identify patients with uncontrolled DM and HTN via medical history, HbA1c assessment, and lipid profile using point-of-care testing; 2. Measure patients' weight, height, waist circumference and BP with a valid automated device following standard procedures, and assess patients' CV risk with the World Health Organization (WHO) risk chart; (3) Initiate lifestyle counseling and treatment with antihypertensive and anti-diabetic medications every 1-3 months using Federal Ministry of Health simplified protocols; and (4) Refer patients to physicians. | Behavioural | R33 - HEARTS Only, R33 - PF + HEARTS Package, R61 - Pilot PHCs |
| PFPF involves provision of external expertise on practice redesign and a tailored approach to implementing systems-level changes to improve patient outcomes. PF includes both a role (practice facilitator) and a process for supporting PHCs to build motivation and capacity. Six practice facilitators (each responsible for 5 PHCs) will coordinate meetings with PHC nurses, assist in setting performance goals, and strategize on HEARTS implementation through onsite visits and monthly peer-to-peer telephone calls. | Behavioural | R33 - PF + HEARTS Package |
Primary outcome
Implementation Fidelity of HEARTS at 12 Months
Time frame: Month 12
Fidelity is defined as the utilization of all components of the HEARTS program: identifying PLWH with uncontrolled hypertension (HTN) and diabetes mellitus (DM); measuring patient anthropometrics and BP; initiating lifestyle counseling and medication treatment every 1-3 months; and referring PLWH with complicated HTN and DM to physicians for further care.
Change in Systolic Blood Pressure (SBP) from Baseline to 12 Months
Time frame: Baseline, Month 12
Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months
Time frame: Baseline, Month 12
8 secondary outcomes
Sustainability of HEARTS at 18 Months
Time frame: Month 18
Blood Pressure Control at 12 Months
Time frame: Month 12
Blood Glucose Control at 12 Months
Time frame: Month 12
Number of Sessions with Nurses
Time frame: Up to Month 12
Duration of Sessions with Nurses
Time frame: Up to Month 12
Number of Anthropometric Measurements
Time frame: Up to Month 12
Number of Lifestyle Counseling Sessions
Time frame: Up to Month 12
Number of Documented Referrals
Time frame: Up to Month 12
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nafesa.kanneh@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Gbenga Ogedegbe, MD, MPH contact
Gbenga Ogedegbe, MD, MPH principal investigator
NYU Langone Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEARTS and PF in people with Cardiovascular Diseases, run by NYU Langone Health at 2 sites in 2 countries.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Contact Nafesa Kanneh (646-491-1623, Nafesa.kanneh@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Fidelity of HEARTS at 12 Months (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.