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SNCTP000004461 | ISRCTN55473884 | BASEC2020-02341

Die Wirkung einer vielschichtigen Intervention für Ärzte und Ärztinnen auf die Impfrate gegen HPV in der Schweizer Grundversorgung: Eine cluster-randomisierte klinische Studie.

Data source: BASEC (Imported from 23.02.2024), WHO (Imported from 15.02.2024)
Changed: Jan 13, 2024, 1:00 AM
Disease category: Other Cancer, Infections and Infestations

Brief description of trial (Data source: BASEC)

Eine Infektion mit HPV kann zur Entstehung von Krebs führen. In der Schweiz empfiehlt das BAG daher eine Impfung gegen HPV, welche bisher vor allem von Kinderärzten*innen und Frauenärzten*innen durchgeführt wird. Die Impfquote in der Schweiz ist jedoch unter der vom BAG empfohlenen Marke von 80%. Bisherige Studien haben gezeigt, dass besonders in der Hausarztmedizin grosses Potential besteht zu einer Verbesserung der nationalen Impfquote beizutragen. Ziel dieser Studie ist es daher zu prüfen, ob eine gezielte, vielschichtige Fortbildung für Hausärzte*innen zu einer Erhöhung der Impfquote führt.

Health conditions investigated(Data source: BASEC)

Primärprävention einer Infektion mit humanen Papillomaviren (HPV).

Health conditions (Data source: WHO)

Human papillomavirus
Infections and Infestations

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

In dieser Studie wird geprüft, ob eine gezielte, vielschichtige Fortbildung für Hausärzte*innen zu einer Erhöhung der Impfquote führt. Diese Fortbildung enthält detaillierte Informationen über 1) HPV und HPV Impfungen, 2) Informationen wie Impfungen am besten mit Patienten*innen kommuniziert werden können, 3) allgemeine Informationen zu administrativen und logistischen Punkten im Kontext der HPV Impfung.

Ärzte*innen in der Kontrollgruppe bekommen eine Fortbildung über Impfungen im Allgemeinen. Da diese Fortbildung das Impfverhalten der Ärzte*innen in der Kontrollgruppe auch beeinflussen kann, erhalten auch die Ärzte*innen in der Interventionsgruppe diese Fortbildung. Ärzte*innen in der Kontrollgruppe kennen den wahren Zweck der Studie nicht.

Interventions (Data source: WHO)

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

Criteria for participation in trial (Data source: BASEC)

Ebene Arzt:
- Arzt/Ärztin arbeitet in der Grundversorgung und bietet die folgenden Impfungen gemäss dem Schweizer Impfplan an: Mumps/Masern/Röteln, Meningokokken, Pneumokokken, HPV, FSME, Varizellen, Herpes Zoster und Hepatitis A/B.

Ebene Patient:
- Es können alle Patienten*innen eingeschlossen werden, welche sich gemäss dem Schweizer Impfplan für eine der genannten Impfungen qualifizieren.

Exclusion criteria (Data source: BASEC)

Ebene Arzt:
- Arzt/Ärztin arbeitet mehrheitlich (>50%) pädiatrisch.
- Arzt/Ärztin arbeitet mehrheitlich (>50%) gynäkologisch.
- Arzt/Ärztin ist Schularzt oder führt Impfungen an Schulen durch.

Ebene Patient:
- Für Patienten*innen gelten die Ausschlusskriterien für die genannten Impfungen gemäss dem aktuellen Schweizer Impfplan.

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: Both
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)
Exclusion criteria: Does not meet inclusion criteria

Further information on the trial in WHO primary registry

https://www.isrctn.com/ISRCTN55473884

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN55473884
Further information on trial

Date trial registered

Jun 4, 2021

Incorporation of the first participant

Sep 1, 2021

Recruitment status

Completed

Academic title (Data source: WHO)

Impact of a multifaceted, targeted intervention on the human papillomavirus vaccination rate in Swiss Primary Care: a cluster randomized controlled trial

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Prospective cluster randomized controlled trial (Prevention)

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

Overall number of HPVv given in the first 6 months, reported in a specific case report form (CRF) at month 6

Secundary end point (Data source: WHO)

Current secondary outcome measures as of 13/02/2023:

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 3, 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 time points (3, 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

_____

Previous secondary outcome measures:

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

Contact information (Data source: WHO)

Merck Sharp and Dohme, Universit?tsspital Z?rich, Universit?t Z?rich

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

Data sharing statement to be made available at a later date
All results will be published in an international peer-reviewed journal. Currently no further documents are available.

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. med. Andreas Plate
+41 44 255 7503
Andreas.Plate@usz.ch

Contact for scientific information (Data source: WHO)

Andreas
Plate
Pestalozzistrasse 24
+41 (0)442557503
andreas.plate@usz.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

08.12.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-02341

Secondary ID (Data source: WHO)

Nil known
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