Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
NCT05005130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1129
Last updated 2024-01-30
Summary
This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".
Conditions
- Non Communicable Diseases
- HIV
Interventions
- OTHER
-
TASKPEN
TASKPEN is the name of the package of implementation strategies proposed by the investigators that are intended to deliver the WHO PEN intervention in routine HIV clinical practice settings in Zambia. TASKPEN has five components which will be the subject of stakeholder consultation and adaptation in this formative research protocol. The package of integrated HIV/NCD services includes: 1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia 2. Access to cardio-metabolic condition screening \& laboratory monitoring 3. Non communicable disease-focused electronic medical record module 4. Integrated non-communicable/HIV care ("one stop shop" for services) 5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
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 -
University of Alabama at Birmingham
collaborator OTHER -
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, MSc · University of North Carolina
-
Wilbroad Mutale, MBChB, MPhil, MPhil, PhD · Centre for Infectious Disease Research in Zambia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-20
- Primary Completion
- 2022-12-23
- Completion
- 2022-12-23
Countries
- Zambia
Study Locations
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