NCT07909395Not yet recruiting
Cardiovascular Disease Multimorbidity
Addressing Cardiovascular Disease Multimorbidity in Patients Living With HIV in Nigeria
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1050 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 1 Sept 2027
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- NYU Langone Health
- Diseases
- HIV
- NCT number
- NCT07909395
What you commit to
- Study type: Interventional
- Planned participants: 1050
- From 1 Sept 2027 to the primary completion date, 28 Feb 2030
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of heart disease
- History of stroke
- Have leg ulcers and/or infection
- History of transient ischemic attack (TIA)
Lab values
- History of chronic kidney disease (eGFR \<35 ml/min)
- Acutely ill with high blood sugar (random blood sugar ≥15 mmol/l)\[EM4.1\]
Other
- BP \>180/110 mm Hg
- Pregnant at time of screening
- Have impaired vision
- Have pins and needles sensation
- Have numbness in hands and feet
- Have proteinuria of 2++
- Unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Abuja Coordinator of this site? Confirm its status | Abuja | Nigeria | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.