VaccinationRIVER-EUNCT06361628
Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine
A study testing multicomponent intervention on vaccination awareness in people with Vaccination and Health Systems, run by University Medical Center Groningen at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Health Systems, Knowledge, Attitudes, Practice
- What is being tested?
- multicomponent intervention on vaccination awareness
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 May 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- parents of children eligible for MMR and/or HPV vaccination according to country guidelines on those specific vaccines
Who cannot join
- respondents not willing or able to fill out questionnaires
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Greece1 site
Prolepsis
Athens, Athene, 151 25
Pania Karnaki, +30 210 6255700, p.karnaki@prolepsis.gr
Nikole Papaevgeniou, PhD, n.papaevgeniou@prolepsis.gr
Netherlands1 site
University Medical Center Groningen
Groningen, 9713 GZ
Janine de Zeeuw, PhD, +31 6 45552994, j.de.zeeuw@umcg.nl
Poland1 site
University of Zielona Gora
Zielona Góra, Lubusz Voivodeship, 65 417
Maria Ganczak, MD PhD, m.ganczak@inm.uz.zgora.pl
Slovakia1 site
PJ Šafárik University
Košice, Košice Region, 04180
Daniela Fiľakovská, PhD, +421 55 234 3390, daniela.filakovska@upjs.sk
About this study
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
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?
Read the 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:
- The migrant community in Greece (HPV and MMR)
- Turkish and Moroccan women in the Netherlands (HPV)
- The Ukrainian community in Poland (HPV and MMR)
- The Roma community in Slovakia (HPV)
- Conditions
- Vaccination, Health Systems, Knowledge, Attitudes, Practice
- Being tested
- multicomponent intervention on vaccination awareness
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent intervention on vaccination awarenessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: multicomponent intervention on vaccination awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to vaccinate MMR and/or HPV by questionnaire
Intention for vaccination against MMR and/or HPV among the underserved communities
Measured: Pre and immediately following the intervention and 6 month post intervention
Secondary outcomes (4)
Uptake of MMR and/or HPV vaccinations by questionnaire
MMR and/or HPV vaccination uptake among the underserved communities
Measured: 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
Measured: 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
Measured: 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
Measured: Directly post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Prolepsis Institute for Preventive, Environmental and Occupational Medicine, University in Zielona Góra, Pavol Jozef Safarik University
- Responsible party
- Sponsor
- Investigators
- Nikole Papaevgeniou, PhD, Principal investigator, Prolepsis Institute for Preventive, Environmental and Occupational MedicineDaniela Fiľakovská, PhD, Principal investigator, UPJSMaria Ganczak, MD PhD, Principal investigator, University Zielona GoraMichael Edelstein, MD PhD, Principal investigator, Bar Ilan UniversityCornelis Boersma, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361628
- Sponsor's protocol ID
- RIVER-EU WP4
- Acronym
- RIVER-EU
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing according to the European Union open research guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06361628
- Acronym / sponsor ID
- RIVER-EU / RIVER-EU WP4
- Conditions
- Vaccination, Health Systems, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Prolepsis Institute for Preventive, Environmental and Occupational Medicine, University in Zielona Góra, Pavol Jozef Safarik University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- The migrant community in Greece (HPV and MMR)
- Turkish and Moroccan women in the Netherlands (HPV)
- The Ukrainian community in Poland (HPV and MMR)
- The Roma community in Slovakia (HPV)
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Educational sessions delivered by health promotors in Greece | Experimental | Behavioral: multicomponent intervention on vaccination awarenessIn 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. |
| Educational sessions delivered by health promotors and healthcare professionals in the Netherlands | Experimental | Behavioral: multicomponent intervention on vaccination awarenessTrusted 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. |
| Educational sessions delivered by health promotors in Poland | Experimental | Behavioral: multicomponent intervention on vaccination awarenessThis 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. |
| Educational sessions delivered by health promotors in Slovakia | Experimental | Behavioral: multicomponent intervention on vaccination awarenessRoma 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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- parents of children eligible for MMR and/or HPV vaccination according to country guidelines on those specific vaccines
Key exclusion criteria (1 listed)
- respondents not willing or able to fill out questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multicomponent intervention on vaccination awarenessEducational 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. | Behavioural | 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 |
Primary outcome
Intention to vaccinate MMR and/or HPV by questionnaire
Time frame: Pre and immediately following the intervention and 6 month post intervention
Intention for vaccination against MMR and/or HPV among the underserved communities
4 secondary outcomes
Uptake of MMR and/or HPV vaccinations by questionnaire
Time frame: Pre and 6 month post intervention evaluation is necessary
Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire
Time frame: Pre and immediately following the intervention and 6 month post intervention evaluation
Communication skills of health care professionals using a questionnaire
Time frame: Pre intervention and directly post intervention
Satisfaction of the stakeholders as measured by a questionnaire
Time frame: Directly post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. Sharing according to the European Union open research guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikole Papaevgeniou, PhD principal investigator
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
Daniela Fiľakovská, PhD principal investigator
UPJS
Maria Ganczak, MD PhD principal investigator
University Zielona Gora
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multicomponent intervention on vaccination awareness in people with Vaccination and Health Systems, run by University Medical Center Groningen at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Netherlands, Poland, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janine De Zeeuw, PhD (+31 645552994, j.de.zeeuw@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to vaccinate MMR and/or HPV by questionnaire (time frame: Pre and immediately following the intervention and 6 month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.