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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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HIV, Non Communicable Diseases

Intervention / Treatment
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* Other: TASKPEN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASKPEN<br>a package of integrated HIV/NCD services | Other: TASKPEN<br>* The package of integrated HIV/NCD services: 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) Trained non-physician providers able to provide integrated care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent of participants with dual HIV and NCD disease control | measured by an HIV RNA level of <200 copies per milliliter on the most recent measure and systolic blood pressure <140 mmHg on most recent measure, hemoglobin A1c <7.0% on most recent measure, and/or total cholesterol <5.2 mmol/L | Baseline to 6 months | 
| ASCVD risk score | Measured by % of participants who experienced improvement in ASCVD risk score between baseline and follow up (e.g. from intermediate to borderline risk category) | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HIV disease control, as measured by the % of patients with HIV RNA suppression (defined as <1,000 copies/mL) | measured by the % of patients with HIV RNA suppression (defined as <1,000 copies/mL) | Baseline to 6 months | 
| Changes in quality of life, as measured by the standardized World Health Organization HIV Quality of Life questionnaire (brief version) | User and provider feedback. The WHOQOL-BREF measures quality of life across 4 domains (Physical Health, Psychological, Social Relationships, and Environment). The minimum score is 0 and maximum is 100. Higher scores correspond to greater perceived quality of life. | Baseline to 6 months | 
| Change in Intervention Reach | Proportion of the health care providers accepting to implement the TASKPEN intervention at pilot health facilities | Baseline to 6 months | 
| Change in Intervention appropriateness | The Intervention appropriateness measure (IAM) among health care 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 appropriateness. | Baseline to 6 months | 
| Change in Intervention Feasibility | measured by the Feasibility of Intervention Measure (FIM) among health care providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater feasibility. | Baseline to 6 months | 
| Intervention Cost | measured by cost per patient treated with the TASKPEN intervention | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Non Communicable Diseases, WHO-PEN