Clinical trial NCT06361628: Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination
Health Systems
Knowledge, Attitudes, Practice
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
name: University in Zielona Góra
name: Pavol Jozef Safarik University
First posted: 2024-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

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)

Eligibility criteria: 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

Primary outcomes:
measure: Intention to vaccinate MMR and/or HPV by questionnaire
timeFrame: Pre and immediately following the intervention and 6 month post intervention
Secondary outcomes:
measure: Uptake of MMR and/or HPV vaccinations by questionnaire
timeFrame: Pre and 6 month post intervention evaluation is necessary
measure: Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire
timeFrame: Pre and immediately following the intervention and 6 month post intervention evaluation
measure: Communication skills of health care professionals using a questionnaire
timeFrame: Pre intervention and directly post intervention
measure: Satisfaction of the stakeholders as measured by a questionnaire
timeFrame: Directly post intervention
Other outcomes:
measure: Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed
timeFrame: Through study completion, an average of 1 year
Locations:
city: Athens
country: Greece
facility: Prolepsis
state: Athene
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Zielona Góra
country: Poland
facility: University of Zielona Gora
state: Lubusz
city: Košice
country: Slovakia
facility: PJ Šafárik University
state: Košice Region
Study officials:
affiliation: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
name: Nikole Papaevgeniou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPJS
name: Daniela Fiľakovská, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Zielona Gora
name: Maria Ganczak, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bar Ilan University
name: Michael Edelstein, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCG
name: Cornelis Boersma, PhD
role: PRINCIPAL_INVESTIGATOR
References: