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

May 19, 2022 updated by: International Agency for Research on Cancer

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • International Agency For Research On Cancer (IARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Educational workshop intervention arm
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
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.
NO_INTERVENTION: Control arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 18 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing change from baseline in GP's attitude and knowledge towards HPV vaccination 1 month after receiving the intervention
Time Frame: 1 month
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3. Assessing change from control group in mothers and girls' attitude and knowledge towards HPV vaccination 18 months after the intervention
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Agency for Research on Cancer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: PATRICIA VILLAIN, PhD, IARC, WHO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PP201704-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

from March 2016 to October 2020

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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