Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cardiovascular Disease Multimorbidity
Sponsor: NYU Langone Health
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 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.
Official title: Addressing Cardiovascular Disease Multimorbidity in Patients Living With HIV in Nigeria
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1050
Start Date
2027-09
Completion Date
2030-08
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
HEARTS
HEARTS 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.
PF
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.
Locations (2)
NYU Langone Health
New York, New York, United States
University of Abuja
Abuja, Federal Capital Territory, Nigeria