Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial

BACKGROUND: On Reunion Island, incidence and mortality for uterine cervical cancer is high, yet coverage rate for human papillomavirus (HPV) vaccination is low. OBJECTIVE: 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 attend this program will constitute the intervention group and will be compared to children from another middle school who will not attend the program constituting the control group. RESULTS: Recruitment began in October 2020. In the intervention school, of 780 students, 245 were randomly selected in the 12 classes. In the control school, 259 students out of 834 were randomly selected. CONCLUSIONS: In this study, we explore the impact of a health promotion program combining information toward students, parents, and general practitioners with free school-based vaccination. We expect a significantly higher HPV vaccination coverage in the intervention school as compared to the control school, whether it be among girls or boys. The final implication would be an extension of this program in all middle schools on the Island and thus an increase in HPV vaccination coverage. TRIAL REGISTRATION: ClinicalTrials.gov NCT04459221; https://clinicaltrials.gov/ct2/show/NCT04459221 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35695