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

NCT06361628 | Not Yet Recruiting

• 1 other identifier: RIVER-EU WP4
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 4

Brief Summary

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?

Conditions

Vaccination; Health Systems; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

• Intention to vaccinate MMR and/or HPV by questionnaire

  Intention for vaccination against MMR and/or HPV among the underserved communities

  Pre and immediately following the intervention and 6 month post intervention

Secondary Outcomes (4)

• Uptake of MMR and/or HPV vaccinations by questionnaire

  Pre and 6 month post intervention evaluation is necessary

• Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire

  Pre and immediately following the intervention and 6 month post intervention evaluation

• Communication skills of health care professionals using a questionnaire

  Pre intervention and directly post intervention

• Satisfaction of the stakeholders as measured by a questionnaire

  Directly post intervention

Other Outcomes (1)

• Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed

  Through study completion, an average of 1 year

Study Arms (4)

Educational sessions delivered by health promotors in Greece

EXPERIMENTAL

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.

Behavioral: multicomponent intervention on vaccination awareness

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

EXPERIMENTAL

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.

Behavioral: multicomponent intervention on vaccination awareness

Educational sessions delivered by health promotors in Poland

EXPERIMENTAL

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.

Behavioral: multicomponent intervention on vaccination awareness

Educational sessions delivered by health promotors in Slovakia

EXPERIMENTAL

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.

Behavioral: multicomponent intervention on vaccination awareness

Interventions

multicomponent intervention on vaccination awareness 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; Educational sessions delivered by health promotors in Greece; Educational sessions delivered by health promotors in Poland; Educational sessions delivered by health promotors in Slovakia

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• respondents not willing or able to fill out questionnaires

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Prolepsis Institute for Preventive, Environmental and Occupational Medicine: collaborator
• University in Zielona Góra: collaborator
• Pavol Jozef Safarik University: collaborator

Study Sites (4)

Prolepsis

Athens, Athene, 151 25, Greece

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

University of Zielona Gora

Zielona Góra, Lubusz Voivodeship, 65 417, Poland

Location

PJ Šafárik University

Košice, Košice Region, 04180, Slovakia

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Nikole Papaevgeniou, PhD

  Prolepsis Institute for Preventive, Environmental and Occupational Medicine

  PRINCIPAL INVESTIGATOR

• Daniela Fiľakovská, PhD

  UPJS

  PRINCIPAL INVESTIGATOR

• Maria Ganczak, MD PhD

  University Zielona Gora

  PRINCIPAL INVESTIGATOR

• Michael Edelstein, MD PhD

  Bar Ilan University

  PRINCIPAL INVESTIGATOR

• Cornelis Boersma, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janine De Zeeuw, PhD

CONTACT

+31 645552994; j.de.zeeuw@umcg.nl

Pania Karnaki

CONTACT

+30 210 6255700; p.karnaki@prolepsis.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: As per open research protocol - on request to principal investigator University Medical Center Groningen

Locations

SL (1); NL (1); GR (1); PL (1)