Z 32201 - 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: A Type II Hybrid Effectiveness-implementation Stepped Wedge Trial

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

• =18 years of age

• who had exposure to the TASKPEN intervention at a study site OR

• =18 years of age,

• a facility-level healthcare provider or manager at district, provincial, or national level in Zambia, and

• familiar with the TASKPEN intervention.

⁃ Costing study participants must be:

• HIV-positive adults

• =18 years of age

• who had received HIV and/or NCD services at a TASKPEN study site OR

• =18 years of age and

• a facility-level healthcare provider or manager at facility, district, provincial, or national level in Zambia, and generally familiar with HIV and/or NCD-related issues.

Locations
Other Locations
Zambia
Bauleni Health Center
RECRUITING
Lusaka
Chawama 1st Level Hospital
RECRUITING
Lusaka
Chelstone Urban Health Center
RECRUITING
Lusaka
Chipata 1st Level Hospital
RECRUITING
Lusaka
Kabwata Urban Health Center
RECRUITING
Lusaka
Kalingalinga Urban Health Center
RECRUITING
Lusaka
Kamwala Urban Health Center
RECRUITING
Lusaka
Kanyama 1st Level Hospital
RECRUITING
Lusaka
Makeni Urban Health Center
RECRUITING
Lusaka
Mtendere Health Center
RECRUITING
Lusaka
Ng'ombe Urban Health Center
RECRUITING
Lusaka
Railway Urban Health Center
RECRUITING
Lusaka
Contact Information
Primary
Chilambwe Mwila, MSc
Chilambwe.Mwila@cidrz.org
260 966 608354
Backup
Christy Frimpong, MPH
christiana.frimpong@cidrz.org
Time Frame
Start Date: 2023-05-30
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 5620
Treatments
Experimental: TASKPEN
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.
No_intervention: Standard of Care
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
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, Zambia, Fogarty International Center of the National Institute of Health, Centre for Infectious Disease Research in Zambia, National Heart, Lung, and Blood Institute (NHLBI), University of Zambia
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov