Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine (RIVER-EU)

Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine Uptake in Underserved Communities in Greece, The Netherlands, Poland and Slovakia

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Knowledge, Attitudes, Practice; Vaccination; Health Systems
• Intervention / Treatment: Behavioral: multicomponent intervention on vaccination awareness

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janine De Zeeuw, PhD; Phone Number: +31 645552994; Email: j.de.zeeuw@umcg.nl
• Study Contact Backup: Name: Pania Karnaki; Phone Number: +30 210 6255700; Email: p.karnaki@prolepsis.gr

Study Locations

• Greece
  • Athene
    • Athens, Athene, Greece, 151 25
      • Prolepsis
      • Contact: Pania Karnaki; Phone Number: +30 210 6255700; Email: p.karnaki@prolepsis.gr
      • Contact: Nikole Papaevgeniou, PhD; Email: n.papaevgeniou@prolepsis.gr
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
    • Contact: Janine de Zeeuw, PhD; Phone Number: +31 6 45552994; Email: j.de.zeeuw@umcg.nl
• Poland
  • Lubusz
    • Zielona Góra, Lubusz, Poland, 65 417
      • University of Zielona Gora
      • Contact: Maria Ganczak, MD PhD; Email: m.ganczak@inm.uz.zgora.pl
• Slovakia
  • Košice Region
    • Košice, Košice Region, Slovakia, 04180
      • PJ Šafárik University
      • Contact: Daniela Fiľakovská, PhD; Phone Number: +421 55 234 3390; Email: daniela.filakovska@upjs.sk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of MMR and/or HPV vaccinations by questionnaire	MMR and/or HPV vaccination uptake among the underserved communities	Pre and 6 month post intervention evaluation is necessary
Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire	Knowledge concerning MMR and/or HPV vaccinations among the target group	Pre and immediately following the intervention and 6 month post intervention evaluation
Communication skills of health care professionals using a questionnaire	Communication skills of healthcare professionals to deliver appropriate information	Pre intervention and directly post intervention
Satisfaction of the stakeholders as measured by a questionnaire	Satisfaction of stakeholders (health promotors and health professionals) with the implementation process and the intervention itself	Directly post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed	Addressed health system barriers to improve access to MMR and/or HPV vaccinations among the underserved communities	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Pavol Jozef Safarik University; University in Zielona Góra; Prolepsis Institute for Preventive, Environmental and Occupational Medicine
• Investigators: Principal Investigator: 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, UMCG

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RIVER-EU WP4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing according to the European Union open research guidelines.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: As per open research protocol - on request to principal investigator University Medical Center Groningen
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; 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