Can an Educational Intervention Targeting General Practitioners Increase HPV Vaccination Coverage in AuRA_Lyon (France)

Human Papillomavirus Vaccination Clinical Trial

— PAPRICA  

Official title:

Prevention At PRImary CAre Level - Increasing HPV Vaccination in Lyon.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03592225
• Other study ID #: PP201704-07
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2022
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The PAPRICA implementation trial aims to test the efficacy of an educational intervention about HPV vaccination and targeting general practitioners in Lyon

Description:

The PAPRICA study aims to test if an intervention directed to General Practitioners (GP) to train them in methods for recommending HPV vaccine with greater confidence and efficiency is effective to increase HPV vaccination coverage in France. As each health professional is associated in France to a specific reference number i.e. "RPPS number", RPPS numbers for all General Practitioners (GP) from the city of Lyon will be randomly allocated either to the intervention arm or to the control arm to ensure that each arm contains 50% of the total number of GPs. After allocation, GPs in the allocation arm will be identified and invited to attend the intervention i.e. a 3-hour workshop at IARC in the presence of HPV vaccination specialists. The effect of the intervention on the HPV vaccination coverage in Lyon will be measured through HPV vaccines reimbursement data extracted from the Inter-Scheme National Information System within the National Health Insurance System (SNIIR-AM : Système National d'Information Inter-Régimes de l'Assurance Maladie ). Linkable data between girls and General Practitioners (GP) via RPPS numbers will allow us to allocate girls either in the intervention or the control arm. Vaccination coverage will be estimated within each of these cohorts.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• general practitioners (GP) from Lyon (69001-69009) from private practice

Exclusion Criteria:

Related Conditions & MeSH terms

• Human Papillomavirus Vaccination

Intervention

Behavioral:
• Educational workshop
the intervention is a 3 hours educational workshop designed to address all the potential questions that the general practitioners (GP) and their patients might have regarding HPV vaccination.

Locations

Country	Name	City	State
France	International Agency for Research on Cancer (IARC)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
International Agency for Research on Cancer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3. Assessing change from control group in mothers and girls' attitude and knowledge towards HPV vaccination 18 months after the intervention	Parents and girls whose GP are in the intervention arm will be interviewed 18 months after the intervention to assess whether or not their attitude towards HPV vaccination has changed. Parents and girls whose GP are in the control arm will be used as control.	18 months
Primary	Assessing change from baseline HPV vaccination coverage of Lyon's girls aged 11-14 obtained by the GP from the intervention arm at 18 months after the intervention (increase in number of vaccinated girls as assessed by questionnaire in the study cohort)	The French SNIIRAM (Système national d'information inter-régimes de l'assurance maladie) database will be used to calculate a proxy of HPV vaccination coverage. SNIIRAM contains anonymous and individualized data for all health expenditure claims in France. Data related to HPV and DTP (Diphtheria,Tetanus, Pertussis) vaccines prescribed by GP from Lyon will be extracted from SNIIRAM for girls aged 10-14. These data will be assigned either to the intervention or control arm by linkage with GP's ID DTP booster coverage, which is stable overtime and very high in France (92%), will be used as a control.	18 months
Secondary	Assessing change from baseline in GP's attitude and knowledge towards HPV vaccination 1 month after receiving the intervention	GP's attitude and knowledge towards HPV vaccination will be assessed before and 1 month after the intervention through a specific questionnaire designed to measure GP's knowledge and beliefs upon HPV vaccination.	1 month