NCT05005130

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,129 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 called "TASKPEN".

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

Interventions

Type	Name	Description
OTHER	TASKPEN	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: 1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia 2. Access to cardio-metabolic condition screening \& laboratory monitoring 3. Non communicable disease-focused electronic medical record module 4. Integrated non-communicable/HIV care ("one stop shop" for services) 5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2021-08-13
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

4 sites across 1 country: Zambia