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

Knowledge, Attitudes, Practice Clinical Trial

— RIVER-EU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361628
• Other study ID #: RIVER-EU WP4
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: Janine De Zeeuw, PhD
• Phone: +31 645552994
• Email: j.de.zeeuw[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice
• Vaccination

Intervention

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.

Locations

Country	Name	City	State
Greece	Prolepsis	Athens	Athene
Netherlands	University Medical Center Groningen	Groningen
Poland	University of Zielona Gora	Zielona Góra	Lubusz
Slovakia	PJ Šafárik University	Košice	Košice Region

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Center Groningen	Pavol Jozef Safarik University, Prolepsis Institute for Preventive, Environmental and Occupational Medicine, University in Zielona Góra

Countries where clinical trial is conducted

Greece,  Netherlands,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Communication skills of health care professionals using a questionnaire	Communication skills of healthcare professionals to deliver appropriate information	Pre intervention and directly post intervention
Secondary	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