Clinical trial NCT05005130: Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Communicable Diseases
HIV
Keywords: HIV
Non Communicable Diseases
WHO-PEN
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Centre for Infectious Disease Research in Zambia
name: University of Zambia
name: Ministry of Health, Zambia
name: University of Alabama at Birmingham
name: Fogarty International Center of the National Institute of Health
First posted: 2021-08-13
Enrollment: 1129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility 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;
  * 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.

Primary outcomes:
measure: Change in Percent of Participants With Dual HIV and Blood Pressure Control
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Number of Clinics That Adopted the Intervention (Intervention Adoption)
timeFrame: 6 months
measure: Number of Trained Healthcare Providers (Intervention Reach)
timeFrame: During 2 weeks prior to initiation of TASKPEN
measure: Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)
timeFrame: Baseline to 6 months
measure: Change in Intervention Appropriateness
timeFrame: Baseline to 6 months
measure: Change in Intervention Acceptability
timeFrame: Baseline to 6 months
measure: Change in Intervention Feasibility
timeFrame: Baseline to 6 months
measure: Intervention Cost Per Patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chawama 1st Level hospital
city: Lusaka
country: Zambia
facility: Chilenje 1st level hospital
city: Lusaka
country: Zambia
facility: George urban health center
city: Lusaka
country: Zambia
facility: Mtendere health center
Study officials:
affiliation: University of North Carolina
name: Michael Herce, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Wilbroad Mutale, MBChB, MPhil, MPhil, PhD
role: PRINCIPAL_INVESTIGATOR
References: