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

NCT ID: NCT05005130

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-12-23

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

Conditions

Non Communicable Diseases; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cluster 1 (George)

3 months without TASKPEN (Standard of Care) and 6 months with TASKPEN.

Group Type: EXPERIMENTAL

TASKPEN

Intervention Type: OTHER

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)

Cluster 2 (Chilengi)

6 months without TASKPEN (Standard of Care) and 3 months with TASKPEN

Group Type: EXPERIMENTAL

TASKPEN

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

University of Zambia

OTHER

Sponsor Role: collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Herce, MD, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Wilbroad Mutale, MBChB, MPhil, MPhil, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Infectious Disease Research in Zambia

Locations

Chawama 1st Level hospital

Lusaka, , Zambia

Chilenje 1st level hospital

Lusaka, , Zambia

George urban health center

Lusaka, , Zambia

Mtendere health center

Lusaka, , Zambia

Countries

Zambia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UG3HL156389

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-3606

Identifier Type: -

Identifier Source: org_study_id