Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentre for Infectious Disease Research in Zambia

About this trial

Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential Non-communicable Diseases (PEN) Plus intervention using the Interactive Systems Framework (ISF) and then implement and monitor the impact. The ISF framework proposes and organizes several implementation strategies to achieve Evidence Based Implementation (EBI) adaptation. We will apply these strategies at 2 first level hospitals (Peri-Urban and Rural) to ensure local adaptation and work towards scaling up of the WHO-PEN Plus in the rest of Zambia. This process will be inclusive, involving a Stakeholder Consultation Group that shall include the Zambian Non-Communicable diseases and injuries (NCDI) Poverty Commission and shall report bi-annually to a Project Advisory Board (PAB) chaired by the Permanent Secretary of the Ministry of Health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presenting with chronic NCDs

Disqualifiers

Refusing to be followed up prospectively for routine visits

Trial population

All individuals in Zambian community that live around the Intervention facilities and present with NCDs or are known NCD patients.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Supportive treatment

    Combination product

    Buffering of drugs and or equipment to the MOH to ensure that HCWs are able to manage the patients that attend the NCD clinics set up within the first level hospitals.

Treatment groups

2,084 Participants
are divided into 5 treatment groups
Group A: Lusaka - Matero FLH1 intervention
Group B: Central - Mwachisompola FLH1 intervention
Group C: Central - Kapiri Mposhi DH1 intervention
Group D: Chifubu first level hospital0 interventions
Group E: Chipata district hospital0 interventions

Trial outcomes

Primary outcomes

1

Percentage increase in patients with severe and complex NCDs diagnosed and managed at first-level hospitals according to WHO PEN-Plus guidelines.

Increased access to quality NCD services at primary care level.

Time frame
6 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centre for Infectious Disease Research in Zambia

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator