Effects of a Package of Evidence-based Interventions and Implementation Strategies Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia
NCT05950919 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5620
Last updated 2025-08-24
Summary
The purpose of this study is to evaluate the effects of a multi-level intervention known as "TASKPEN," adapted from the World Health Organization (WHO) Package of Essential Noncommunicable Disease Interventions (WHO-PEN) for the Zambian public health system, on clinical and implementation outcomes for persons living with HIV (PLHIV) with co-morbid cardio-metabolic conditions in Lusaka, Zambia.
Conditions
- HIV
- Non Communicable Diseases
Interventions
- OTHER
-
TASKPEN
The package of integrated HIV/NCD services: 1. Integrated non-communicable/HIV care ("one stop shop" for services) 2. WHO PEN protocols, algorithm, \& training materials adapted for Zambia 3. Access to cardio-metabolic condition screening \& laboratory monitoring 4. Non-communicable disease-focused electronic medical record module 5. Strengthened NCD medication supply chain
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Centre for Infectious Disease Research in Zambia
collaborator OTHER -
University of Zambia
collaborator OTHER -
Ministry of Health, Zambia
collaborator OTHER_GOV -
Fogarty International Center of the National Institute of Health
collaborator NIH -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Michael Herce, MD, MPH · University of North Carolina
-
Wilbroad Mutale, MBChB, MPhil, PhD · Centre for Infectious Disease Research in Zambia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-30
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-01
Countries
- Zambia
Study Locations
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