PROM SSCOL – Impact of a Papillomavirus Vaccination Promotion Program in Middle School: A Study Protocol for a Randomized Controlled Trial

Abstract Background: In Reunion Island, incidence and mortality for uterine cervical cancer is high, yet coverage rate for HPV vaccination is low. The main objective of the study is to evaluate, the impact of a health promotion program, promoting HPV vaccination, on the proportion of middle school girls who complete the full HPV vaccination schedule (2 or 3 doses) by the end of school year.Methods: This study is a cluster controlled intervention study using a superiority design. A combined health promotion program will be offered, containing: information to students and parents, training of general practitioners and free school-based vaccination (in a "health bus"). Children who will benefit from this program will constitute the intervention group, and will be compared to children from another middle school who will not benefit from any program, constituting the control group.Discussion: Our hypotheses were as follow : Clear and appropriate information for the target population as well as for their parents, will improve their knowledge about HPV vaccination, and thus increase their adherence to this vaccination ; combining information with vaccination in the school setting will reduce any material obstacles that may prevent the vaccination process; raising awareness among general practitioners will enable them to better understand the benefits and risks of HPV vaccination, and thus encourage families, who naturally trust them, to adhere to the program. Final implication would be an extension of this program in all middle schools of the Island and thus increase HPV vaccination coverage.Trial registration: ClinicalTrials.gov ID: NCT04459221