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

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.

NCT Number	NCT07753681
Lead Sponsor	Centre for Infectious Disease Research in Zambia Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Conditions	Cardiac Diseases, Sickle Cell Disease, Hypertension, Diabetes Mellitus, Heart Failure, Congenital Heart Disease, Rheumatic Heart Disease, Epilepsy +3 more
Enrollment	2,084 participants
Start Date	2022-08-08
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-07