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

NCT05005130 | Completed Results

• 2 other identifiers: 20-3606UG3HL156389
• Study Type: interventional
• Target: 1,129
• Locations: 1 country
• Sites: 4

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".

Conditions

Non Communicable Diseases; HIV

Keywords

HIV; Non Communicable Diseases; WHO-PEN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Clinics That Adopted the Intervention (Intervention Adoption)

  6 months

• Number of Trained Healthcare Providers (Intervention Reach)

  During 2 weeks prior to initiation of TASKPEN

• Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)

  Baseline to 6 months

• Change in Intervention Appropriateness

  Baseline to 6 months

• Change in Intervention Acceptability

  Baseline to 6 months

Study Arms (2)

Cluster 1 (George)

EXPERIMENTAL

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

Other: TASKPEN

Cluster 2 (Chilengi)

EXPERIMENTAL

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

Other: TASKPEN

Interventions

TASKPEN 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 1 (George); Cluster 2 (Chilengi)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• any potential IDI, FGD, or KII participant if they are unwilling or unable to provide informed consent.
• Objective 2:
• Cross-sectional assessments:
• 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:
• 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).

Sponsors & Collaborators

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

Study Sites (4)

Chawama 1st Level hospital

Lusaka, Zambia

Location

Chilenje 1st level hospital

Lusaka, Zambia

Location

George urban health center

Lusaka, Zambia

Location

Mtendere health center

Lusaka, Zambia

Location

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Herce, MD, MPH, MSc
• Organization: University of North Carolina at Chapel Hill

michael_herce@med.unc.edu

919-966-2537

Study Officials

• Michael Herce, MD, MPH, MSc

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Wilbroad Mutale, MBChB, MPhil, MPhil, PhD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 13, 2021
• Study Start: September 20, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: from 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

ZA (4)