Human Papillomavirus VaccinationPAPRICANCT03592225
Can an Educational Intervention Targeting General Practitioners Increase HPV Vaccination Coverage in AuRA_Lyon (France)
A study testing Educational workshop in people with Human Papillomavirus Vaccination, run by International Agency for Research on Cancer at 1 site in France.
Trial summary
The PAPRICA implementation trial aims to test the efficacy of an educational intervention about HPV vaccination and targeting general practitioners in Lyon Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Papillomavirus Vaccination
- What is being tested?
- Educational workshop
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- general practitioners (GP) from Lyon (69001-69009) from private practice
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Human Papillomavirus Vaccination
- Being tested
- Educational workshop
- Keywords
- General Practitioners, France, RCT, HPV vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational workshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Mar 2016
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of General practitioners are randomized to be allocated either in the intervention group or the control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PATRICIA VILLAIN, PhD, Principal investigator, IARC, WHO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592225
- Sponsor's protocol ID
- PP201704-07
- Acronym
- PAPRICA
- Status last verified
- May 2022
- First submitted
- 19 Apr 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication will be shared after anonymization performed by the PI
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention At PRImary CAre Level - Increasing HPV Vaccination in Lyon.
- ClinicalTrials.gov ID
- NCT03592225
- Acronym / sponsor ID
- PAPRICA / PP201704-07
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- General Practitioners, France, RCT, HPV vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PAPRICA implementation trial aims to test the efficacy of an educational intervention about HPV vaccination and targeting general practitioners in Lyon
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 groups of General practitioners are randomized to be allocated either in the intervention group or the control group
| Arm | Type | Receives |
|---|---|---|
| Educational workshop intervention arm | Other | Behavioral: Educational workshopThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- general practitioners (GP) from Lyon (69001-69009) from private practice
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational workshopthe 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. | Behavioural | Educational workshop intervention arm |
Primary outcome
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.
1 secondary outcome
Assessing change from baseline in GP's attitude and knowledge towards HPV vaccination 1 month after receiving the intervention
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication will be shared after anonymization performed by the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PATRICIA VILLAIN, PhD principal investigator
IARC, WHO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational workshop in people with Human Papillomavirus Vaccination, run by International Agency for Research on Cancer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.