Non Communicable DiseasesTASKPENNCT05005130
Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
A study testing TASKPEN in people with Non Communicable Diseases and HIV, run by University of North Carolina, Chapel Hill at 4 sites in Zambia.
Trial summary
This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Communicable Diseases, HIV
- What is being tested?
- TASKPEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,129 participants
- Where
- 4 sitesZambia
- Study dates
- 20 Sep 2021to 23 Dec 2022
- Phase
- Interventional
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
Who may be able to join
- 18 years of age or older
- non-physician professional or lay/peer health care worker (HCW) involved with HIV and/or NCD service delivery.
- Key Informant Interview (KII) participants:
- 18 years of age or older
- a senior Ministry of Health (MOH) policy maker or health official working at national level in Zambia involved in managing, coordinating, and/or overseeing health services for non-communicable diseases in Zambia.
- In-depth interview participants:
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- emancipated HIV-infected adults 18 years of age or older have a documented cardio-metabolic condition
- HIV-infected
- aged 18 years and older
- seeking care at either of the two ACHIEVE-supported pilot sites who are screened for and/or found to have evidence of one or more of the cardio-metabolic conditions or risk factors.
- Nested cohort participants:
- documented HIV infection
- aged 18 years or older
- have one or more cardio-metabolic conditions or risk factors:
- obesity (defined as BMI > 30 kg/m^2);
- any current tobacco smoking;
- hypertension as defined by WHO PEN (i.e., systolic blood pressure (SBP) = 140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg);
- diabetes mellitus as defined by WHO PEN (i.e. random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or haemoglobin A1c = 48 mmol/mol);
- prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L, impaired glucose tolerance with a two-hour, post-oral glucose tolerance test glucose =7.8 mmol/L but <11.1 mmol/L and a fasting plasma glucose <7.0 mmol/L, and/or haemoglobin A1c 42 to 48 mmol/mol); 6) dyslipidaemia (defined as total cholesterol >4 mmol/L or low density lipoprotein =6 mmol/L); and/or 7) personal history or medication use for heart disease, heart failure, stroke, or other cardio-metabolic complication (including but not limited to coronary artery disease, cerebrovascular disease, myocardial infarction, stroke, or peripheral vascular disease).
- IDI participants:
- HIV-infected
- 18 years of age who were enrolled in the nested cohort and had documented exposure to the TASKPEN intervention at a pilot site.
- FGD participants:
- 18 years of age or older
- a non physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery generally familiar with HIV and/or NCD service delivery at their facility.
- KII participants:
- 18 years of age or older
- a facility-level antiretroviral therapy (ART) or out-patient department (OPD) clinic 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.
Who cannot join
- any potential IDI, FGD, or KII participant if they are unwilling or unable to provide informed consent.
- Objective 2:
- Cross-sectional assessments:
- For the nested cohort component, investigators will exclude:
- adults who have no documented evidence of having established HIV care at the sites.
- people unlikely to remain at the site to the completion of the study follow-up.
- any potential IDI, FGD, or KII participant if they are unwilling or unable to provide written informed consent.
Trial locations and contacts
4 sites in 1 country.
Zambia4 sites
Chawama 1st Level hospital
Lusaka
Chilenje 1st level hospital
Lusaka
George urban health center
Lusaka
Mtendere health center
Lusaka
About this study
Official title: Mixed Methods Formative Research and Pilot Testing of a Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".
Read the detailed description
Using local data and implementation science theories WHO-PEN will be adapted for Zambia, and TASKPEN developed to focus on addressing challenges faced by persons living with HIV (PLHIV) who have cardio-metabolic complications related to HIV or its treatment (e.g. hypertension, diabetes, dyslipidaemia). TASKPEN aims to improve detection and management of these complications.
Formative research activities for objective 1 include focus group discussions (FGDs), surveys and interviews with key stakeholders, which will include in-depth interviews (IDIs) with patients.
Objective 2 launches the TASKPEN pilot and fully task-shifts the TASKPEN package to non-physician healthcare workers (NPHWs) and integrates it within the President's Emergency Plan for AIDS Relief (PEPFAR) -supported HIV service delivery platform. A mix of IDIs, FGDs, key informant interviews, and patient and implementation surveys with implementation actors to evaluate feasibility, acceptability, and other implementation outcomes
- Conditions
- Non Communicable Diseases, HIV
- Being tested
- TASKPEN
- Keywords
- HIV, Non Communicable Diseases, WHO-PEN
- 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
TASKPEN is the name of the package of implementation strategies proposed by the investigators that are intended to deliver the WHO PEN intervention in routine HIV clinical practice settings in Zambia. TASKPEN has five components which will be the subject of stakeholder consultation and adaptation in this formative research protocol. The package of integrated HIV/NCD services includes:
- WHO PEN protocols, algorithm, \& training materials adapted for Zambia
- Access to cardio-metabolic condition screening \& laboratory monitoring
- Non communicable disease-focused electronic medical record module
- Integrated non-communicable/HIV care ("one stop shop" for services)
- Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 (George) | Experimental | 3 months without TASKPEN (Standard of Care) and 6 months with TASKPEN. Receives: Other: TASKPEN |
| Cluster 2 (Chilengi) | Experimental | 6 months without TASKPEN (Standard of Care) and 3 months with TASKPEN Receives: Other: TASKPEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Participants With Dual HIV and Blood Pressure Control
Measured by an HIV RNA level of <1000 copies per mL on the most recent measure and systolic blood pressure <140 mmHg and/or diasystolic blood pressure <90 mmHg. Dual control defined as HIV control (i.e., viral load <1,000 c/mL for those with a documented viral load + evidence of 6MMD for those with missing viral load) + Hypertension control (SBP<140 mmHg AND DBP<90 mmHg)
Measured: Baseline to 6 months
Secondary outcomes (7)
Number of Clinics That Adopted the Intervention (Intervention Adoption)
Adoption measured based on Reach Evaluation Adoption Implementation and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) which are implementation-oriented and empirically supported frameworks for adapting, introducing, and evaluating evidence-based interventions in routine practice settings. The number of facilities initiating TASKPEN intervention integrated care at approximately 6 months after TASKPEN introduction.
Measured: 6 months
Number of Trained Healthcare Providers (Intervention Reach)
Number of healthcare providers working at the pilot clinic antiretroviral therapy (ART), differentiated service delivery (DSD), and outpatient departments who were trained in the implementation of the TASKPEN intervention package.
Measured: During 2 weeks prior to initiation of TASKPEN
Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)
Measured by the percent of patient participants with HIV RNA suppression (defined as <1,000 copies/mL)
Measured: Baseline to 6 months
Change in Intervention Appropriateness
The "Intervention appropriateness measure (IAM)" among healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater appropriateness.
Measured: Baseline to 6 months
Change in Intervention Acceptability
Measured by the "Acceptability of Intervention measure (AIM)" among health care providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater acceptability.
Measured: Baseline to 6 months
Change in Intervention Feasibility
Measured by the "Feasibility of Intervention Measure (FIM)" among Healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater feasibility.
Measured: Baseline to 6 months
Intervention Cost Per Patient
Measured by cost per patient and reported in Zambian Kwacha. The analysis focused on the expenditures paid out of pocket for HIV and hypertension care. These data were collected from one site only (Chilenje).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Sep 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Communicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Centre for Infectious Disease Research in Zambia, University of Zambia, Ministry of Health, Zambia, University of Alabama at Birmingham, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Michael Herce, MD, MPH, MSc, Principal investigator, University of North CarolinaWilbroad Mutale, MBChB, MPhil, MPhil, PhD, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005130
- Sponsor's protocol ID
- 20-3606
- Other IDs
- UG3HL156389
- Acronym
- TASKPEN
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2021
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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