Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05950919

Effects of Evidence-based Interventions Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia: A Hybrid Effectiveness-Implementation Stepped Wedge Trial

Led by University of North Carolina, Chapel Hill · Updated on 2025-08-24

5620

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a multi-level intervention called TASKPEN, adapted from the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN), on clinical and implementation outcomes in people living with HIV (PLHIV) who also have cardio-metabolic conditions in Lusaka, Zambia. This hybrid effectiveness-implementation stepped wedge trial aims to assess control of both HIV and cardio-metabolic diseases, intervention reach, and quality of life improvements among the participants. The TASKPEN intervention includes five evidence-based components: integrated HIV and non-communicable disease care in a single service point, adapted WHO PEN protocols and training materials, access to cardio-metabolic screening and laboratory monitoring, an electronic medical record module focused on non-communicable diseases, and a strengthened supply chain for related medications. The trial involves 12 health facilities transitioning sequentially from standard care to the TASKPEN intervention in randomized clusters over several months. Participants will complete bio-behavioral surveys at baseline and at multiple follow-up points, totaling about 5,100 participants across all sites. A nested cohort of approximately 320 participants with cardio-metabolic conditions will be followed longitudinally for detailed clinical outcomes. Researchers will monitor HIV viral suppression, blood pressure, glucose levels, cardiovascular risk scores, medication adherence, and quality of life over up to 24 months, alongside implementation outcomes and factors influencing the intervention's success.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • HIV-infected individuals seeking HIV services at study sites
  • Participants must provide written informed consent
  • For nested cohort: presence of one or more cardio-metabolic conditions or risk factors such as tobacco use, hypertension, diabetes, prediabetes, or dyslipidemia
  • In-depth interview participants must be HIV-positive adults aged 18 or older who have received HIV and/or NCD services at TASKPEN sites
  • Focus group participants must be 18 or older and healthcare workers involved with TASKPEN or HIV/NCD services
  • Key informant interview participants must be 18 or older facility or policy leaders familiar with HIV/NCD issues
  • Implementation questionnaire participants must be HIV-positive adults exposed to TASKPEN or healthcare providers/managers familiar with TASKPEN
  • Costing study participants must be HIV-positive adults who received services at TASKPEN sites or healthcare providers/managers familiar with HIV/NCD issues
Not Eligible

You will not qualify if you...

  • Previous participation in a study survey
  • Individuals seeking one-time services or planning to transfer HIV care to another site
  • Unwilling or unable to provide written informed consent
  • Adults without documented HIV infection or without cardio-metabolic conditions or risk factors
  • In-depth interview participants without evidence of HIV/NCD services received during the study period
  • Implementation questionnaire participants not exposed or familiar with TASKPEN
  • Potential IDI, FGD, or KII participants unwilling or unable to provide written informed consent
  • People planning to transfer HIV care to another site

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Survey

Duration - Short period before intervention introduction

Participants complete a baseline bio-behavioral survey to collect initial health data before introduction of the TASKPEN intervention.

1 visit (in-person)

Intervention Implementation

Duration - Varies by site; at least 6 months after crossover

Participants receive the TASKPEN package, an integrated HIV and cardio-metabolic non-communicable disease care approach adapted for Zambia.

Visits depend on routine care schedules and intervention delivery

Sequential Cross-over Surveys

Duration - Repeated every 6 months up to 24 months

Participants complete follow-up surveys at 6-month intervals to assess health outcomes and intervention effects. Different clusters cross over to the intervention sequentially after each survey.

1 survey visit every 6 months, total up to 5 surveys

Nested Cohort Longitudinal Follow-up

Duration - Up to 24 months

A subgroup of participants with cardio-metabolic conditions are followed longitudinally to monitor detailed clinical outcomes over time.

Regular follow-up visits according to cohort protocol

Trial Site Locations

Total: 12 locations

1

Bauleni Health Center

Lusaka, Zambia

Actively Recruiting

2

Chawama 1st Level Hospital

Lusaka, Zambia

Actively Recruiting

3

Chelstone Urban Health Center

Lusaka, Zambia

Actively Recruiting

4

Chipata 1st Level Hospital

Lusaka, Zambia

Actively Recruiting

5

Kabwata Urban Health Center

Lusaka, Zambia

Actively Recruiting

6

Kalingalinga Urban Health Center

Lusaka, Zambia

Actively Recruiting

7

Kamwala Urban Health Center

Lusaka, Zambia

Actively Recruiting

8

Kanyama 1st Level Hospital

Lusaka, Zambia

Actively Recruiting

9

Makeni Urban Health Center

Lusaka, Zambia

Actively Recruiting

10

Mtendere Health Center

Lusaka, Zambia

Actively Recruiting

11

Ng'ombe Urban Health Center

Lusaka, Zambia

Actively Recruiting

12

Railway Urban Health Center

Lusaka, Zambia

Actively Recruiting

Loading map...

Research Team

C

Chilambwe Mwila, MSc

C

Christy Frimpong, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

#AWARE.HIV Europe: Supporting Healthcare Professionals to Fi...

HIV Infection

Actively Recruiting

28 locations

1MoreStep: Pilot Trial of an Intervention to Increase HIV Ca...

Violence, Domestic

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial.

Michael E Herce, Samuel Bosomprah, Felix Masiye...

https://pubmed.ncbi.nlm.nih.gov/38844992