Improving Heart Disease Care for People Living With HIV in Nigeria
Tests a heart care program in clinics for people living with HIV.
Plain-language title generated from the registry record
Registry title: Cardiovascular Disease Multimorbidity
Key facts
- Where
- Abuja, NigeriaSee the site
Where in Nigeria
- University of AbujaAbuja, NigeriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NYU Langone Health
- Trial code
- NCT07909395
- Record updated
- 2 November 2026
- Original description
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)Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: History of heart disease; History of stroke; Have leg ulcers and/or infection; History of transient ischemic attack (TIA); History of chronic kidney disease (eGFR <35 ml/min); Acutely ill with high blood sugar (random blood sugar ≥15 mmol/l)[EM4.1]; 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.