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

No results posted yet for this study

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

More Related Trials

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 NCT05950919 on ClinicalTrials.gov