NCT03592225

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7.1 years

First QC Date

April 19, 2018

Last Update Submit

May 19, 2022

Conditions

Human Papillomavirus Vaccination

Keywords

General PractitionersFranceRCTHPV vaccination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessing change from baseline in GP's attitude and knowledge towards HPV vaccination 1 month after receiving the intervention

    1 month

Other Outcomes (1)

  • 3. Assessing change from control group in mothers and girls' attitude and knowledge towards HPV vaccination 18 months after the intervention

    18 months

Study Arms (2)

Educational workshop intervention arm

OTHER

The group of general practitioners (GP) from Lyon (France), about 300, that will be invited to attend the 3 hours educational workshop about HPV vaccination. After the workshop, the GPs will return to their normal health care practice.

Behavioral: Educational workshop

Control arm

NO INTERVENTION

The group of general practitioners (GP) from Lyon (France), about 300, that will NOT be invited to attend the 3 hours educational workshop about HPV vaccination. These GPs perform their normal health care practice.

Interventions

Educational workshopBEHAVIORAL

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.

Educational workshop intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Agency for Research on Cancer (IARC)

Lyon, 69008, France

Location

Study Officials

  • PATRICIA VILLAIN, PhD

    IARC, WHO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2 groups of General practitioners are randomized to be allocated either in the intervention group or the control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

July 19, 2018

Study Start

March 1, 2016

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication will be shared after anonymization performed by the PI

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
from March 2016 to October 2020
Access Criteria
(1)Data from RPSS and SNIIRAM databases and data originated from original data analysis: All data will be stored in encrypted and password-locked files at IARC, while transmission of information via electronic means will be performed using encrypted data files. Measures ensuring confidentiality of personel data will be used. (2) Data generated from GPs: Data collected from questionnaires and focus groups will be anonymous, aggregated and no linkage between GP's opinion and attitude about vaccination and identity will be possible. Data will be kept and used according to the Data Protection Act (DPA). The Data Protection Act (DPA) of 1978 (revised in 2004) is the main law protecting data privacy in France. Data from GPs will be stored in encrypted and password-locked files at IARC. Only anonymised data will be transferred to IARC external collaborators.

Locations

FR(1)