Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine

NCT ID: NCT06361628

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-06-01

Brief Summary

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The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated.

The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia?

Detailed Description

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The general objective of the study is to improve access to vaccination by addressing relevant system level barriers to increase HPV and MMR (where applicable) vaccine intention and uptake among the target groups. The investigators expect that the intervention will address health system barriers to improve increase in access to information on vaccination and vaccination services.

A prospective multicomponent intervention study will be performed between 1st of April 2024 and 31st of July 2025 that will be evaluated using a pre and post design as well as a participatory approach during the implementation. As part of the multicomponent intervention a preparatory phase is taken place before this period of time. The multicomponent intervention consists of training of health promotors and healthcare professionals, and of educational sessions to community members and navigation. The educational sessions will be offered at suitable and accessible locations for the target population.

The five communities targeted in are the following:

1. The migrant community in Greece (HPV and MMR)
2. Turkish and Moroccan women in the Netherlands (HPV)
3. The Ukrainian community in Poland (HPV and MMR)
4. The Roma community in Slovakia (HPV)

Conditions

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Vaccination Health Systems Knowledge, Attitudes, Practice

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Educational sessions delivered by health promotors in Greece

In this approach, medical professionals and health promoters-trusted members of the community-will educate refugee and migrant parents. The focus is on enhancing awareness of HPV/MMR and fostering a greater willingness to vaccinate their children/adolescents. Multicultural schools and migrant associations are the locations where the educational sessions will be provided.

Group Type EXPERIMENTAL

multicomponent intervention on vaccination awareness

Intervention Type BEHAVIORAL

Educational sessions to create awareness on HPV and MMR (were addressed) vaccination that is culturally sensitive health information and provided in an easily understandable manner by trained health promoters (and healthcare professionals) to underserved communities. Support for navigation and access to vaccines.

Educational sessions delivered by health promotors and healthcare professionals in the Netherlands

Trusted community health members will be trained and will act as health promotors in the intervention. Together with health care professionals they will offer educational sessions on HPV vaccination at locations close to where people live (in the neighborhoods) and locations communities are familiar with, such as community centers, schools, health centers, religious places or offices of foundations/non-governmental organizations. Together with local stakeholders it will be verified that locations are also acceptable for the target communities. A navigation component is also included and participants will be contacted 1 week and 3 months after the educational sessions and reminded to get vaccinated and will be asked if they still have questions or need help to find their way to get vaccinated.

Group Type EXPERIMENTAL

multicomponent intervention on vaccination awareness

Intervention Type BEHAVIORAL

Educational sessions to create awareness on HPV and MMR (were addressed) vaccination that is culturally sensitive health information and provided in an easily understandable manner by trained health promoters (and healthcare professionals) to underserved communities. Support for navigation and access to vaccines.

Educational sessions delivered by health promotors in Poland

This intervention is based on the principle of face-to-face and online health education, where Ukrainian parents are educated by general practitioners to raise HPV/MMR awareness and increase willingness to child/adolescent vaccination.

Group Type EXPERIMENTAL

multicomponent intervention on vaccination awareness

Intervention Type BEHAVIORAL

Educational sessions to create awareness on HPV and MMR (were addressed) vaccination that is culturally sensitive health information and provided in an easily understandable manner by trained health promoters (and healthcare professionals) to underserved communities. Support for navigation and access to vaccines.

Educational sessions delivered by health promotors in Slovakia

Roma health mediators will be trained on HPV vaccination and thereafter will offer educational sessions to the underserved communities. Educational sessions take place at either municipalities, schools, community centers, local health care providers and public health authorities.

Group Type EXPERIMENTAL

multicomponent intervention on vaccination awareness

Intervention Type BEHAVIORAL

Educational sessions to create awareness on HPV and MMR (were addressed) vaccination that is culturally sensitive health information and provided in an easily understandable manner by trained health promoters (and healthcare professionals) to underserved communities. Support for navigation and access to vaccines.

Interventions

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multicomponent intervention on vaccination awareness

Educational sessions to create awareness on HPV and MMR (were addressed) vaccination that is culturally sensitive health information and provided in an easily understandable manner by trained health promoters (and healthcare professionals) to underserved communities. Support for navigation and access to vaccines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* parents of children eligible for MMR and/or HPV vaccination according to country guidelines on those specific vaccines

Exclusion Criteria

* respondents not willing or able to fill out questionnaires
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prolepsis Institute for Preventive, Environmental and Occupational Medicine

OTHER

Sponsor Role collaborator

University in Zielona Góra

OTHER

Sponsor Role collaborator

Pavol Jozef Safarik University

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikole Papaevgeniou, PhD

Role: PRINCIPAL_INVESTIGATOR

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Daniela Fiľakovská, PhD

Role: PRINCIPAL_INVESTIGATOR

UPJS

Maria Ganczak, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Zielona Gora

Michael Edelstein, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Bar Ilan University

Cornelis Boersma, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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Prolepsis

Athens, Athene, Greece

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

University of Zielona Gora

Zielona Góra, Lubusz Voivodeship, Poland

Site Status

PJ Šafárik University

Košice, Košice Region, Slovakia

Site Status

Countries

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Greece Netherlands Poland Slovakia

Central Contacts

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Janine De Zeeuw, PhD

Role: CONTACT

+31 645552994

Pania Karnaki

Role: CONTACT

+30 210 6255700

Facility Contacts

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Pania Karnaki

Role: primary

+30 210 6255700

Nikole Papaevgeniou, PhD

Role: backup

Janine de Zeeuw, PhD

Role: primary

+31 6 45552994

Maria Ganczak, MD PhD

Role: primary

Daniela Fiľakovská, PhD

Role: primary

+421 55 234 3390

Other Identifiers

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RIVER-EU WP4

Identifier Type: -

Identifier Source: org_study_id

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