One-Stop health check: can integrated care tame HIV and heart disease together?
NCT ID NCT05950919
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This trial tests a package of services called TASKPEN, which combines HIV care with screening and treatment for high blood pressure, diabetes, and tobacco use. It involves over 5,700 adults living with HIV in Lusaka, Zambia. The goal is to see if this integrated approach helps more people control both their HIV and their heart or metabolic conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TASKPEN (integrated HIV and non-communicable disease care package)
- What this could lead to
- If successful, this could show that combining HIV and chronic disease care in one visit improves health for people with both conditions, especially in low-resource settings.
- What could go wrong
- This is a large implementation study, not a drug trial, so results may depend heavily on local health system factors and may not apply elsewhere. Success is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5,747 people
The number who actually took part.
- Started
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May 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bauleni Health Center
Lusaka, Zambia, Zambia
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Chawama 1st Level Hospital
Lusaka, Zambia
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Chelstone Urban Health Center
Lusaka, Zambia
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Chipata 1st Level Hospital
Lusaka, Zambia
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Kabwata Urban Health Center
Lusaka, Zambia
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Kalingalinga Urban Health Center
Lusaka, Zambia
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Kamwala Urban Health Center
Lusaka, Zambia
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Kanyama 1st Level Hospital
Lusaka, Zambia
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Makeni Urban Health Center
Lusaka, Zambia
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Mtendere Health Center
Lusaka, Zambia
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Ng'ombe Urban Health Center
Lusaka, Zambia
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Railway Urban Health Center
Lusaka, Zambia
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Other studies related to the condition(s) this trial covers.
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