TASKPEN: Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
Study Details
Study Description
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".
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TASKPEN a package of integrated HIV/NCD services |
Other: TASKPEN
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
|
Outcome Measures
Primary Outcome Measures
- Change in percent of participants with dual HIV and NCD disease control [Baseline to 6 months]
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
- ASCVD risk score [Baseline to 6 months]
Measured by % of participants who experienced improvement in ASCVD risk score between baseline and follow up (e.g. from intermediate to borderline risk category)
Secondary Outcome Measures
- Changes in HIV disease control, as measured by the % of patients with HIV RNA suppression (defined as <1,000 copies/mL) [Baseline to 6 months]
measured by the % of patients with HIV RNA suppression (defined as <1,000 copies/mL)
- Changes in quality of life, as measured by the standardized World Health Organization HIV Quality of Life questionnaire (brief version) [Baseline to 6 months]
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.
- Change in Intervention Reach [Baseline to 6 months]
Proportion of the health care providers accepting to implement the TASKPEN intervention at pilot health facilities
- Change in Intervention appropriateness [Baseline to 6 months]
The "Intervention appropriateness measure (IAM)" among health care 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 appropriateness.
- Change in Intervention Feasibility [Baseline to 6 months]
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.
- Intervention Cost [6 months]
measured by cost per patient treated with the TASKPEN intervention
Eligibility Criteria
Criteria
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;
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hypertension as defined by WHO PEN (i.e., systolic blood pressure (SBP) = 140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg);
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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);
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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:
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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:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chawama 1st Level hospital | Lusaka | Zambia | ||
| 2 | Chilenje 1st level hospital | Lusaka | Zambia | ||
| 3 | George urban health center | Lusaka | Zambia | ||
| 4 | Mtendere health center | Lusaka | Zambia |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- National Heart, Lung, and Blood Institute (NHLBI)
- Centre for Infectious Disease Research in Zambia
- University of Zambia
- Ministry of Health, Zambia
- University of Alabama at Birmingham
- Fogarty International Center of the National Institute of Health
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-3606
- UG3HL156389