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Evaluating a health intervention for people living with HIV and cardio-metabolic conditions in Zambia

Z 32201 - 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: A Type II Hybrid Effectiveness-implementation Stepped Wedge Trial

Not applicable Interventional University of North Carolina, Chapel Hill · NCT05950919

This study is testing a new health program to see if it helps people living with HIV and heart or diabetes issues in Zambia feel better over a year.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment5620 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of North Carolina, Chapel Hill Academic / other
Locations12 sites (Lusaka and 11 other locations)
Trial IDNCT05950919 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of a multi-level intervention called TASKPEN, which is based on the World Health Organization's Package of Essential Noncommunicable Disease Interventions. The trial will involve a hybrid effectiveness-implementation design, where clinical outcomes related to HIV and cardio-metabolic diseases will be evaluated over 12 months. Participants will include HIV-infected adults seeking services at various health facilities in Lusaka, Zambia, with a focus on those also experiencing cardio-metabolic conditions. The study will utilize a stepped wedge approach, transitioning health facilities from a control phase to the intervention phase sequentially.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-infected adults aged 18 and older who are seeking HIV services and have co-morbid cardio-metabolic conditions.

Not a fit: Patients who are not currently seeking HIV services or those who plan to transfer their care elsewhere may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the management of HIV and related cardio-metabolic conditions, enhancing patient health outcomes.

How similar studies have performed: Other studies have shown promise with similar multi-level interventions for managing co-morbid conditions in HIV patients, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Objective 1:

Cross-sectional patient surveys (n=5100): all HIV-infected adults aged 18 years and older who seek HIV services at the study sites.

Following the baseline survey, investigators will exclude anyone who previously participated in a study survey. Investigators will also exclude people who present for one time services or who plan to transfer their HIV care to another site. Finally, people unwilling or unable to provide written informed consent will be excluded.

For the nested cohort, inclusion (n=320) participants will need to have been enrolled in a study survey and have evidence of one or more of the following cardio-metabolic conditions or risk factors at the time of the survey:

* Any current tobacco use (any tobacco use within 30 days of the survey, whether daily or non-daily use);
* Hypertension as defined by WHO PEN/ HEARTS (i.e., systolic blood pressure (SBP) =140 mmHg and/or diastolic blood pressure (DBP) =90 mmHg);
* Diabetes mellitus as defined by WHO PEN/ HEARTS (i.e., random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or hemoglobin A1c = 48 mmol/mol or =6.5%; and/or compatible clinical diagnosis);
* Prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L and/or haemoglobin A1c 42 to 48 mmol/mol or between 6.0-6.4%); and/or
* Dyslipidaemia (defined as total cholesterol =5.2 mmol/L or low-density lipoprotein =3.4 mmol/L).
* Investigators will exclude adults who have no documented evidence of HIV infection, or who do not have a cardio-metabolic NCD or risk factor of interest. Investigators will also exclude people who did not participate in a patient survey, plan to transfer their HIV care to another site, or are unwilling/ unable to provide written informed consent.

Objective 2 Participant inclusion criteria

In-depth interview (IDI) participants must be

* HIV-positive adults
* =18 years of age
* survey and/or cohort participants and
* had received HIV and/or NCD services at a TASKPEN study site.

Focus group discussion (FGD) participants must be:

* =18 years of age;
* a non-physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery; and
* generally familiar with HIV and/or NCD service delivery at their facility.

Key informant interview (KII) participants must be:

* =18 years of age;
* a facility-level ART, DSD, out-patient department (OPD), or relevant clinic leader/ manager/ in-charge, or policy maker at district, provincial, or national level in Zambia; and
* generally familiar with HIV and/or NCD-related issues in their community.

Implementation questionnaire participants must be:

* HIV-positive adults
* =18 years of age
* who had exposure to the TASKPEN intervention at a study site OR
* =18 years of age,
* a facility-level healthcare provider or manager at district, provincial, or national level in Zambia, and
* familiar with the TASKPEN intervention.

Costing study participants must be:

* HIV-positive adults
* =18 years of age
* who had received HIV and/or NCD services at a TASKPEN study site OR
* =18 years of age and
* a facility-level healthcare provider or manager at facility, district, provincial, or national level in Zambia, and generally familiar with HIV and/or NCD-related issues.

Participant exclusion criteria

* Investigators will exclude adult IDI participants who have no evidence of having received HIV and/or NCD services at the sites during the study period, adult implementation questionnaire
* participants who were not exposed/ familiar with the TASKPEN intervention, as well as - people unwilling or unable to provide written informed consent.
* Investigators will exclude any potential IDI, FGD, or KII study participant if they are unwilling or unable to provide written informed consent.

Where this trial is running

Lusaka and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIVNon Communicable Diseasescardio-metabolic conditionsTASKPEN
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.