Utilizing Nurses to Staff an Ebola Vaccine Clinical Trial in Sierra Leone during the Ebola Outbreak

Autor: Wendi McDonald, Susan T. Goldstein, Rosalind J Carter, Patricia M Abu, Ayesha Koker, Joseph Edem-Hotah, Elizabeth T. Luman
Rok vydání: 2018
Předmět:
Zdroj: The Journal of infectious diseases. 217(suppl_1)
ISSN: 1537-6613
Popis: The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was the first investigational vaccine trial conducted in Sierra Leone. STRIVE enrolled and vaccinated about 8000 healthcare and frontline workers and followed them for 6 months post-vaccination. Few in-country healthcare workers had previous experience with clinical trials. Retired nurses, veteran nurses, and recently graduated nurses were hired to fill critical study roles including study site management, screening participants for enrollment, vaccine administration, post-vaccination follow-up, and providing clinical nursing care and advice. In addition to role-specific training, nurses received general training on the study protocol and implementation, Good Clinical Practices, and documentation for clinical trials. Training in documentation and supervision was especially challenging; ongoing refresher training should be built into standard operating procedures for future similar clinical studies. Using local nurses to conduct study activities had both short- and long-term positive impacts for the study, the nurses themselves, the community, and the country’s health system. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].
Databáze: OpenAIRE