NCT05005130: TASKPEN

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

Completed NA Results posted Last updated 30 January 2024

What this trial tests

NA trial testing TASKPEN in Non Communicable Diseases in 1,129 participants. Completed in 23 December 2022.

Timeline

20 September 2021

Primary endpoint
23 December 2022

23 December 2022

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	1,129
Start date	20 September 2021
Primary completion	23 December 2022
Estimated completion	23 December 2022
Sites	4 locations across Zambia

Drugs / interventions tested

• TASKPEN

Conditions studied

• Non Communicable Diseases — all drugs for Non Communicable Diseases →
• HIV — all drugs for HIV →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Non Communicable Diseases or HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Percent of Participants With Dual HIV and Blood Pressure Control Primary · Baseline to 6 months

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)

Group	Value	95% CI
Standard of Care	52
TASKPEN	60

Number of Clinics That Adopted the Intervention (Intervention Adoption) Secondary · 6 months

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.

Group	Value	95% CI
Standard of Care	1
TASKPEN	1

Number of Trained Healthcare Providers (Intervention Reach) Secondary · During 2 weeks prior to initiation of TASKPEN

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.

Group	Value	95% CI
Cluster 1 Healthcare Providers (George)	29
Cluster 2 Healthcare Providers (Chilenje)	60

Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL) Secondary · Baseline to 6 months

Measured by the percent of patient participants with HIV RNA suppression (defined as \<1,000 copies/mL)

Group	Value	95% CI
Standard of Care	85
TASKPEN	89

Change in Intervention Appropriateness Secondary · Baseline to 6 months

The "Intervention appropriateness measure (IAM)" among healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater appropriateness.

Group	Value	95% CI
Healthcare Providers During Standard of Care	4.69	± 0.44
Healthcare Providers During TASKPEN	4.18	± 0.39

Change in Intervention Acceptability Secondary · Baseline to 6 months

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.

Group	Value	95% CI
Healthcare Providers During Standard of Care	4.7	± 0.44
Healthcare Providers During TASKPEN	4.34	± 0.33

Change in Intervention Feasibility Secondary · Baseline to 6 months

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.

Group	Value	95% CI
Healthcare Providers During Standard of Care	4.66	± 0.56
Healthcare Providers During TASKPEN	4.16	± 0.44

Intervention Cost Per Patient Secondary · 6 months

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).

Group	Value	95% CI
Standard of Care	352.53	± 23.81
TASKPEN	287.5	± 101.02

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of signing informed consent through completion of each survey period, a combined total of 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care

Serious: 0/636 (0%)

Deaths: 4/636

TASKPEN

Serious: 0/465 (0%)

Deaths: 1/465

Other adverse events (2 terms — click to expand)

Reaction	System	Standard of Care	TASKPEN
Hypertension	Cardiac disorders	—	—
Out of Range Glucose	Endocrine disorders	—	—

Data from ClinicalTrials.gov NCT05005130 adverse events section.

Sponsor's own description

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".

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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 randomize
   Herce ME, Bosomprah S, Masiye F, Mweemba O, et al · · 2024 · cited 6× · PMID 38844992 · DOI 10.1186/s43058-024-00601-z
2. Dissemination and implementation research coordination and training to improve cardiovascular health in people living with HIV in sub-Saharan Africa: the research coordinating center of the HLB-SIMPLe Alliance.
   Tetteh EK, Effah W, de las Fuentes L, Steger-May K, et al · · 2024 · cited 4× · PMID 38845055 · DOI 10.1186/s43058-024-00599-4