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

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".

Study Overview

• Status: Completed
• Conditions: HIV; Non Communicable Diseases
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 1129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Chawama 1st Level hospital
  • Lusaka, Zambia
    • Chilenje 1st level hospital
  • Lusaka, Zambia
    • George urban health center
  • Lusaka, Zambia
    • Mtendere health center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Objective 1

Focus group discussion participants/implementation survey participants:

Inclusion:

• 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:

• emancipated HIV-infected adults 18 years of age or older have a documented cardio-metabolic condition

Exclusion:

• any potential IDI, FGD, or KII participant if they are unwilling or unable to provide informed consent.

Objective 2:

Cross-sectional assessments:

Inclusion:

• 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:

Inclusion:

• 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.

Exclusion criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cluster 1 (George); 3 months without TASKPEN (Standard of Care) and 6 months with TASKPEN.	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: 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)
Experimental: Cluster 2 (Chilengi); 6 months without TASKPEN (Standard of Care) and 3 months with TASKPEN	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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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.	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.	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.	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).	6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Alabama at Birmingham; Fogarty International Center of the National Institute of Health; Centre for Infectious Disease Research in Zambia; Ministry of Health, Zambia; University of Zambia
• Investigators: Principal Investigator: Michael Herce, MD, MPH, MSc, University of North Carolina; Principal Investigator: Wilbroad Mutale, MBChB, MPhil, MPhil, PhD, Centre for Infectious Disease Research in Zambia

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HIV; WHO-PEN; Non Communicable Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 20-3606; UG3HL156389 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: from 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No