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

Not Applicable

Completed

• Conditions: HIV; Non Communicable Diseases
• Interventions: Other: TASKPEN

• Registration Number: NCT05005130
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-13
• Study Start: 2021-09-20
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-11
• Results First Submitted: 2023-11-06
• Results First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1129

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cluster 2 (Chilengi)	TASKPEN	6 months without TASKPEN (Standard of Care) and 3 months with TASKPEN
Cluster 1 (George)	TASKPEN	3 months without TASKPEN (Standard of Care) and 6 months with TASKPEN.

Primary Outcome Measures

Name	Time	Method
Change in Percent of Participants With Dual HIV and Blood Pressure Control	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)

Secondary Outcome Measures

Name	Time	Method
Number of Clinics That Adopted the Intervention (Intervention Adoption)	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.
Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)	Baseline to 6 months	Measured by the percent of patient participants with HIV RNA suppression (defined as \<1,000 copies/mL)
Number of Trained Healthcare Providers (Intervention Reach)	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.
Change in Intervention Appropriateness	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.
Change in Intervention Acceptability	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.
Change in Intervention Feasibility	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.
Intervention Cost Per Patient	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).

Trial Locations

Locations (4)

George urban health center; 🇿🇲 Lusaka, Zambia

Mtendere health center; 🇿🇲 Lusaka, Zambia

Chilenje 1st level hospital; 🇿🇲 Lusaka, Zambia

Chawama 1st Level hospital; 🇿🇲 Lusaka, Zambia