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NCT05950919Completed

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

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

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
5747 (actual)
First submitted
10 Jul 2023
Start date
30 May 2023
Primary completion date
31 Dec 2025
Lead sponsor
University of North Carolina, Chapel Hill
Diseases
HIV
NCT number
NCT05950919

What you commit to

  • Study type: Interventional
  • Participants enrolled: 5747
  • From 30 May 2023 to the primary completion date, 31 Dec 2025
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chawama 1st level Hospital
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Kamwala Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Kabwata Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Railway Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Bauleni Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Ng'ombe Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Makeni Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Kanyama 1st Level Hospital
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status
Kalingalinga Urban Health Center
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LusakaZambiaUnknown status
Mtendere Health Center
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LusakaZambiaUnknown status
Chipata 1st Level Hospital
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LusakaZambiaUnknown status
Chelstone Urban Health Center
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.