Effects of a Package of Evidence-based Interventions and Implementation Strategies Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia

NCT05950919 | Recruiting DMC

• 2 other identifiers: 22-22524UH3HL156389-03
• Study Type: interventional
• Target: 5,620
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to evaluate the effects of a multi-level intervention known as "TASKPEN," adapted from the World Health Organization (WHO) Package of Essential Noncommunicable Disease Interventions (WHO-PEN) for the Zambian public health system, on clinical and implementation outcomes for persons living with HIV (PLHIV) with co-morbid cardio-metabolic conditions in Lusaka, Zambia.

Conditions

HIV; Non Communicable Diseases

Keywords

HIV; cardio-metabolic conditions; TASKPEN; Non Communicable Diseases

Outcome Measures

Primary Outcomes (2)

• Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use

  Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA \<1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.

  Month 12

• Number of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use

  Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA \<1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.

  Month 12

Secondary Outcomes (15)

• Percent of Participants with Improvement in 10-year ASCVD Risk Score

  up to 24 months

• Change in Blood Pressure Control from Baseline to Month 12

  Baseline, Month 12

• Change in Blood Pressure Control from Baseline to Month 24

  Baseline, Month 24

• Number of Participants with Severe Hypertension

  up to 24 months

• Percent of Participants with Severe Hypertension

  1, 12 and 24 months

Other Outcomes (9)

• Number of Participants Reached

  0, 12, and 24 months

• Percent of Participants Reached

  0, 12, and 24 months

• Number of Facilities Adopting TASKPEN

  0, 12, and 24 months

Study Arms (2)

TASKPEN

EXPERIMENTAL

The TASKPEN intervention is a package of five evidence-based intervention (EBI) components that enhances WHO's Package of Essential Noncommunicable Disease Intervention for Primary Care (WHO-PEN) and includes a multi-faceted implementation strategy centred on service integration within routine HIV care settings. The EBI components and multi-faceted strategy have been adapted to the Zambian setting during recently completed formative work."

Other: TASKPEN

Standard of Care

NO INTERVENTION

Screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services. When these services are available, they tend to be siloed and offered only for hypertension in general outpatient medical settings that provide urgent care-like services. Healthcare workers do not have protocolized algorithms for NCD management in HIV service delivery settings. NCD equipment is often unavailable in ART and differentiated service delivery (DSD) clinics; most health facilities do not offer haemoglobin A1c or lipid panel testing; and fragmented NCD supply chain management systems mean that essential medications for the management of hypertension, diabetes, and dyslipidemia are often unavailable

Interventions

TASKPEN OTHER

The package of integrated HIV/NCD services: 1. Integrated non-communicable/HIV care ("one stop shop" for services) 2. WHO PEN protocols, algorithm, \& training materials adapted for Zambia 3. Access to cardio-metabolic condition screening \& laboratory monitoring 4. Non-communicable disease-focused electronic medical record module 5. Strengthened NCD medication supply chain

TASKPEN

Eligibility Criteria

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

You may qualify if:

• In-depth interview (IDI) participants must be
• HIV-positive adults
• =18 years of age
• survey and/or cohort participants and
• had received HIV and/or NCD services at a TASKPEN study site.
• Focus group discussion (FGD) participants must be:
• =18 years of age;
• a non-physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery; and
• generally familiar with HIV and/or NCD service delivery at their facility.
• Key informant interview (KII) participants must be:
• =18 years of age;
• a facility-level ART, DSD, out-patient department (OPD), or relevant clinic leader/ 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.
• Implementation questionnaire participants must be:
• HIV-positive adults

You may not qualify if:

• Investigators will exclude adult IDI participants who have no evidence of having received HIV and/or NCD services at the sites during the study period, adult implementation questionnaire
• participants who were not exposed/ familiar with the TASKPEN intervention, as well as - people unwilling or unable to provide written informed consent.
• Investigators will exclude any potential IDI, FGD, or KII study participant if they are unwilling or unable to provide written informed consent.

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
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (12)

Bauleni Health Center

Lusaka, Zambia

RECRUITING

Chawama 1st Level Hospital

Lusaka, Zambia

RECRUITING

Chelstone Urban Health Center

Lusaka, Zambia

RECRUITING

Chipata 1st Level Hospital

Lusaka, Zambia

RECRUITING

Kabwata Urban Health Center

Lusaka, Zambia

RECRUITING

Kalingalinga Urban Health Center

Lusaka, Zambia

RECRUITING

Kamwala Urban Health Center

Lusaka, Zambia

RECRUITING

Kanyama 1st Level Hospital

Lusaka, Zambia

RECRUITING

Makeni Urban Health Center

Lusaka, Zambia

RECRUITING

Mtendere Health Center

Lusaka, Zambia

RECRUITING

Ng'ombe Urban Health Center

Lusaka, Zambia

RECRUITING

Railway Urban Health Center

Lusaka, Zambia

RECRUITING

Related Publications (1)

• Herce ME, Bosomprah S, Masiye F, Mweemba O, Edwards JK, Mandyata C, Siame M, Mwila C, Matenga T, Frimpong C, Mugala A, Mbewe P, Shankalala P, Sichone P, Kasenge B, Chunga L, Adams R, Banda B, Mwamba D, Nachalwe N, Agarwal M, Williams MJ, Tonwe V, Pry JM, Musheke M, Vinikoor M, Mutale W. Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial. Implement Sci Commun. 2024 Jun 6;5(1):61. doi: 10.1186/s43058-024-00601-z.

  PMID: 38844992 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Herce, MD, MPH

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Wilbroad Mutale, MBChB, MPhil, PhD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chilambwe Mwila, MSc

CONTACT

260 966 608354; Chilambwe.Mwila@cidrz.org

Christy Frimpong, MPH

CONTACT

christiana.frimpong@cidrz.org

Study Design

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

Model Details: hybrid effectiveness-implementation stepped wedge trial

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: May 30, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 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 (12)