A randomized clinical trial to test the effectiveness of a multifaceted intervention to increase HPV vaccination rates

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Study physicians will be randomized into two groups (control and intervention). A statistician not involved in the study performs the randomization. They will use stratified randomization. 1. GPs who are not already a member of the cantonal vaccination programs are randomized after stratification 2. GP practice level. If more than one GP from the same practice participates in the study, the researchers will allocate them to the same group 3. Number of performed HPVv during the baseline period Both groups receive a general study instruction, which consists of basic information about the order of the study, study conduct and reporting. Both groups will receive a basic educational session about vaccination. Control group: All GPs in the control group will receive a basic educational session about vaccination and the current national vaccination recommendations. The session will include all basic information about HPV and HPV vaccination to ensure that all GPs know how to provide vaccinations according to the current recommendations. Intervention group: In addition to the basic educational session about vaccinations, GPs in the intervention group will receive an intervention consisting of three parts: 1. Detailed information about HPV and HPVv 2. Information about the announcement communication method in delivering vaccinations 3. Information about logistics and administrative issues regarding the HPVv Duration of the intervention: about 3‐4 hours of training. Follow‐up. There is no specific follow up of patients in this study CONDITION: Human papillomavirus ; Infections and Infestations PRIMARY OUTCOME: Overall number of HPVv given in the first 6 months, reported in a specific case report form (CRF) at month 6 SECONDARY OUTCOME: ; 1. HPVv uptake (1st dose [with exception of baseline period and month 6] and overall vaccination doses) in the intervention group and control group, reported in a specific case report form (CRF) during the baseline period and at 2, 4, 6, and 12 months; 2. The change in HPVv uptake (overall vaccination doses) reported in a specific case report form (CRF) from baseline to defined timepoints (2, 4, 6 and 12 months) between the intervention group and control group; 3. The change in HPV and HPVv knowledge and attitudes (at GP level) measured using a questionnaire at baseline and month 6; 4. Basic demographic data of HPV vaccinated patients (gender and age), provided by GPs in the CRF after 6 and 12 months; 5. HPVv first vaccination or booster vaccination, request of patient or recommendation by GP (or both), and HPVv given alone or in combination with other vaccines, provided by GPs in the CRF after 6 and 12 months; INCLUSION CRITERIA: The study patient population is equal to the target population of the vaccines of interest. GPs will provide vaccinations according to the current Swiss vaccination recommendations publicized by the Swiss Ministry of Health (Swiss vaccination schedule 2020)
Epistemonikos ID: 94a8f074f13d381b507ebdccacd474a50807d90a
First added on: Oct 16, 2021