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

HIV Clinical Trial

— TASKPEN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005130
• Other study ID #: 20-3606
• Secondary ID: UG3HL156389
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 called "TASKPEN".

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1129
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Non Communicable Diseases
• Noncommunicable Diseases

Intervention

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)

Locations

Country	Name	City	State
Zambia	Chawama 1st Level hospital	Lusaka
Zambia	Chilenje 1st level hospital	Lusaka
Zambia	George urban health center	Lusaka
Zambia	Mtendere health center	Lusaka

Sponsors (7)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centre for Infectious Disease Research in Zambia, Fogarty International Center of the National Institute of Health, Ministry of Health, Zambia, National Heart, Lung, and Blood Institute (NHLBI), University of Alabama at Birmingham, University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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