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

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005130 on ClinicalTrials.gov