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HIVTASKPEN UH3NCT05950919

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 study testing TASKPEN in people with HIV and Non Communicable Diseases, run by University of North Carolina, Chapel Hill at 12 sites in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Non Communicable Diseases
What is being tested?
TASKPEN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,747 participants
Where
12 sitesZambia
Study dates
30 May 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Zambia12 sites

  • Bauleni Health Center

    Lusaka, Zambia

  • Chawama 1st Level Hospital

    Lusaka

  • Chelstone Urban Health Center

    Lusaka

  • Chipata 1st Level Hospital

    Lusaka

  • Kabwata Urban Health Center

    Lusaka

  • Kalingalinga Urban Health Center

    Lusaka

  • Kamwala Urban Health Center

    Lusaka

  • Kanyama 1st Level Hospital

    Lusaka

  • Makeni Urban Health Center

    Lusaka

  • Mtendere Health Center

    Lusaka

  • Ng'ombe Urban Health Center

    Lusaka

  • Railway Urban Health Center

    Lusaka

Other trials in Zambia

About this study

Official title: 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

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.

Read the detailed description

This hybrid effectiveness-implementation stepped wedge trial will be used to evaluate the clinical effectiveness and implementation outcomes and strategies. Investigators will evaluate the effects of TASKPEN on the primary clinical effectiveness outcome of dual HIV/ cardio-metabolic non-communicable diseases (NCD) control at 12 months, and the secondary implementation outcome of intervention reach in the clinic population. Other secondary outcomes will include longitudinal changes in the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator, changes in quality of life per the WHOQOL-HIV-Bref, modification of grade III hypertension, and HIV viral suppression at different accepted thresholds (i.e., <1,000 c/mL, <200 c/ml, <50 c/ml). A cluster will be defined as one health facility and their associated catchment area population (i.e., together a study site). Sequential crossover of sites will take place, from control to intervention, until all 12 clusters (i.e., all 12 sites) are exposed to the intervention before the end of the study. Trained and experienced study staff will conduct a bio-behavioral survey at baseline with approximately 1,020 participants across all study sites before introduction of the TASKPEN intervention. After this baseline survey is completed, four randomly selected clusters (i.e., 4 facilities) will be switched to the TASKPEN intervention (the first orange shaded step in Figure 3) over a ~4-week introduction/ "wash out" period, and then continue with TASKPEN implementation until the end of the trial. Six months later, another survey with 1,020 participants who have not participated previously will be done across all 12 sites at time T1 right before a second block of two clusters (i.e., clusters 5 and 6) are switched to the TASKPEN intervention. After another 6 months, the survey will be repeated, this time as a midline survey, and another two clusters (i.e., clusters 7 and 8) will be switched to the TASKPEN intervention after survey completion. Six months later, at time T3, another survey will be completed with 1,020 participants who have not volunteered previously right before the final four randomly selected clusters (i.e., clusters 9 through 12) switch to the TASKPEN intervention. After all facilities/ sites have received the intervention for at least 6 months, a final "end-line survey" will be administered at time T4. Once the end-line survey is completed, a total of approximately 5,100 participants will have completed a survey.

To overcome the limitations inherent to cross-sectional assessments of patient outcomes, and to facilitate collection of more detailed longitudinal data, a "nested cohort," will be embedded in the larger trial reflecting a representative sample of approximately 320 survey participants with co-morbid cardio-metabolic NCDs identified through study surveys to carefully follow longitudinal clinical outcomes in PLHIV with these conditions.

Embedded in the trial will be concurrent mixed methods data collection to assess implementation outcomes and to understand the mechanisms by which the evidence-based intervention package and associated implementation strategies did, or did not, achieve their intended effects or acted through the conceptual model of change.

Being tested
TASKPEN
Keywords
HIV, cardio-metabolic conditions, TASKPEN, Non Communicable Diseases
Medical subject headings
Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TASKPENOther

    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
Study groups in NCT05950919
Study groupRoleWhat they receive
TASKPENExperimentalThe TASKPEN intervention is a package of five evidence-based intervention (EBI) components that enhances WHO's Package of Essential Noncommunicable Disease Intervention for Primary Care (WHO-PEN) and includes a multi-faceted implementation strategy centred on service integration within routine HIV care settings. The EBI components and multi-faceted strategy have been adapted to the Zambian setting during recently completed formative work."
Receives: Other: TASKPEN
Standard of CareNo interventionScreening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services. When these services are available, they tend to be siloed and offered only for hypertension in general outpatient medical settings that provide urgent care-like services. Healthcare workers do not have protocolized algorithms for NCD management in HIV service delivery settings. NCD equipment is often unavailable in ART and differentiated service delivery (DSD) clinics; most health facilities do not offer haemoglobin A1c or lipid panel testing; and fragmented NCD supply chain management systems mean that essential medications for the management of hypertension, diabetes, and dyslipidemia are often unavailable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use

    Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA <1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.

    Measured: Month 12

  2. Number of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use

    Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA <1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.

    Measured: Month 12

Secondary outcomes (15)

  1. Percent of Participants with Improvement in 10-year ASCVD Risk Score

    Participants who experience numerical improvement in 10-year ASCVD risk score and experience improvement in risk category (for example, change from high risk to intermediate risk, high to borderline risk, borderline to low risk, etc.). Assessed at 12 and 24 months.

    Measured: up to 24 months

  2. Change in Blood Pressure Control from Baseline to Month 12

    Average numerical change in systolic and diastolic blood pressure.

    Measured: Baseline, Month 12

  3. Change in Blood Pressure Control from Baseline to Month 24

    Average numerical change in systolic and diastolic blood pressure.

    Measured: Baseline, Month 24

  4. Number of Participants with Severe Hypertension

    Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg. Assessed at Baseline, 12 and 24 months.

    Measured: up to 24 months

  5. Percent of Participants with Severe Hypertension

    Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg

    Measured: 1, 12 and 24 months

  6. Average Change in Haemoglobin A1c and Fasting Glucose

    Mean change in HgbA1c and/or fasting blood glucose from baseline at last assessment. Assessed at Baseline, 12 and 24 months.

    Measured: Baseline up to 24 months

  7. Ideal Cardiovascular Health (CVH)

    Average change in Ideal CVH score on a 0-7 point Likert scale The Ideal CVH is based on the following factors: (1) Smoking: never or former smoker; (2) Body mass index<23 kg/m^2; (3) Physical activity: ≥150 min/wk of moderate-intensity physical activity, ≥75 min/wk of vigorous intensity physical activity, or ≥150 min/wk of moderate or vigorous intensity physical activity; (4) Diet: 4 or 5 healthy dietary components as defined below; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL. For diet, the ideal metric is determined based on intake of fruits and vegetables (≥450 g/d), fish (≥198 g/wk), fiber-rich whole grains (≥85 g/d), sodium (<1500 mg/d), sugar-sweetened beverages (≤1 liter/wk).

    To calculate the ideal CVH score, each metric is given 1 point and the number of ideal CVH metrics is added up for each participant. The range of scores is 0 to 7 inclusive with higher scores indicating better cardiovascular health.

    Measured: 1, 12, and 24 months

  8. Number of Participants with HIV-1 Viral Suppression

    To be assessed at empirically supported thresholds of <1,000 c/mL, <200 c/mL, and <50 c/mL.

    Measured: 0, 12, and 24 months

  9. Percent of Participants with HIV-1 Viral Suppression

    To be assessed at empirically supported thresholds of <1,000 c/mL, <200 c/mL, and <50 c/mL.

    Measured: 0, 12, and 24 months

  10. Number of Participants Retained in HIV Care

    Number of participants with evidence of being retained in HIV care within the last ~180 days.

    Measured: 0, 12, and 24 months

  11. Percent of Participants Retained in HIV Care

    Percent of participants with evidence of being retained in HIV care within the last ~180 days.

    Measured: 1, 12, and 24 months

  12. Variation of Medication Possession Ratio (MPR) ART

    Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for antiretroviral therapy (ART).

    Measured: 0, 12 and 24 months

  13. Variation of Medication Possession Ratio (MPR) NCD Medications

    Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for NCD medications.

    Measured: 0, 12 and 24 months

  14. Number of Participants with an Increase in Quality of Life (QOL)

    Number of participants with an increase in quality of life score. Assessed at 12 and 24 months.

    A version of the World Health Organization (WHO)QOL-HIV BREF will be used with 31 questions over 6 domains adapted to the Zambia context. We will present an overall score where a higher score indicate a higher quality of life. Most items are scaled in a positive direction, but some domains (i.e., #1, #2, #3, and #6) are scaled in a negative direction and will be recoded (as 6 minus question score) such that high scores reflect better quality of life. The mean score of items within each domain will be used to calculate a domain score. The means scores will then multiplied by 4 to make domain scores comparable with the overall scores used in the WHOQOL, so that scores range between 4 and 20. An overall average score across all 6 domains will be reported.

    Measured: up to 24 months

  15. Percent of Participants with an Increase in Quality of Life

    Percent of participants with an increase in quality of life score. Assessed at 12 and 24 months.

    A version of the WHOQOL-HIV BREF will be used with 31 questions over 6 domains adapted to the Zambia context. We will present an overall score where a higher score indicate a higher quality of life. Most items are scaled in a positive direction, but some domains (i.e., #1, #2, #3, and #6) are scaled in a negative direction and will be recoded (as 6 minus question score) such that high scores reflect better quality of life. The mean score of items within each domain will be used to calculate a domain score. The means scores will then multiplied by 4 to make domain scores comparable with the overall scores used in the WHOQOL, so that scores range between 4 and 20. An overall average score across all 6 domains will be reported.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start30 May 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
hybrid effectiveness-implementation stepped wedge trial
Masking
None (open label)
Enrolment
5,747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05950919
Sponsor's protocol ID
22-2252
Other IDs
4UH3HL156389-03
Acronym
TASKPEN UH3
Status last verified
Feb 2026
First submitted
10 Jul 2023
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.

    PubMed 42370263

  • Herce ME, Bosomprah S, Masiye F, Mweemba O, Edwards JK, Mandyata C, Siame M, Mwila C, Matenga T, Frimpong C, Mugala A, Mbewe P, Shankalala P, Sichone P, Kasenge B, Chunga L, Adams R, Banda B, Mwamba D, Nachalwe N, Agarwal M, Williams MJ, Tonwe V, Pry JM, Musheke M, Vinikoor M, Mutale W. 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. Implement Sci Commun. 2024 Jun 6;5(1):61. doi: 10.1186/s43058-024-00601-z.

    PubMed 38844992

Questions about this trial

What is this clinical trial studying?

A study testing TASKPEN in people with HIV and Non Communicable Diseases, run by University of North Carolina, Chapel Hill at 12 sites in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950919, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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