Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05681169 |
| Other study ID # |
Schoolbased HPV-vaccination |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
December 2022 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is designed as a non-randomized implementation study consisting of a user-centered
school-based HPV-counselling and HPV-vaccination (HPVV) program. The aim is to improve HPVV
coverage among children with ethnic minority background with minimum 10%-point in the
intervention group.
Description:
Background:
Human Papillomavirus (HPV)-related cancers are considered the most preventive cancer form due
to vaccination. HPVV in Denmark is a part of a national children vaccination programme.
Despite free access to vaccination, children and adolescents with ethnic minority background
attend substantially less to the vaccination programme than native Danes (79 vs 93%). Among
some ethnic minority groups, the HPVV coverage is as low as 65%. Barriers among ethnic
minorities towards vaccination for HPV are complex, thus insufficient understanding of HPV,
emotional barriers to sexuality and cultural taboos are of significance. Schoolbased
vaccination can improve HPVV uptake, and counselling supporting vaccination could be
significant when targeting ethnic minority families.
Aim:
To test schoolbased HPV-counselling of parents and pupils together with schoolbased HPVV, in
schools with more than 25% ethnic minority pupils, to improve HPVV coverage among children
with ethnic minority background.
Hypotheses and aims:
Hypothesis 1: It is possible to improve participation in HPVV in Denmark when combining
HPV-counselling with school-based vaccination compared to general practitioner-based
vaccination.
- Aim 1: To improve HPVV coverage among pupils attending schools with high concentration of
non-native pupils. The investigators anticipate improving HPVV among ethnic minority pupils
with at least 10%-point, and among native Danish pupils with at least 5%-point.
Hypothesis 2: It is possible to improve participation in HPVV among siblings to enrolled
pupils, solely by improving HPV knowledge and awareness among their parents.
- Aim 2: To improve HPVV coverage among siblings to enrolled pupils.
Hypothesis 3: A close cooperation with user-representatives will improve feasibility and
implementation.
- Aim 3: To develop and evaluate targeted counselling material concerning HPV and HPVV for
parents and children with various ethnical backgrounds, eligible for national implementation.
Materials and methods:
Theoretical framework; The intervention is developed according to Complex Interventions
Framework.Complex interventions contain several interacting components, and the guideline
deals with development, assessment of feasibility, implementation, and evaluation. To
operationalize the elements of the intervention, the investigators have applied a Logic
Model, a graphic tool that illustrates the relationship between activities and intended
outcome. By this, the investigators have combined theoretical knowledge and components of the
intervention to accommodate to possible challenges in implementation.
Research design, study and control population; The intervention is conducted as a
non-randomized implementation study. The intervention will be implemented schoolyear 2022/23.
The intervention group consist of 640 children (11-13 years old) at 5 schools with > 25%
ethnic minority pupils, located in Aarhus, Denmark. The control population will be
approximately 2560 children comparable in age and regions with similar high concentration of
ethnic minority populations.
Developed intervention;
The intervention consists of following core elements:
1. Scholl-based parental HPV-counselling
2. Scholl-based pupil HPV-counselling
3. Scholl-based HPVV
Counselling-material have been developed according to existing knowledge of communication to
ethnic minority parents regarding health issues. The investigators have developed mainly
video and animation, which also helps to ensure methodological rigor. All developed material
has been validated and adapted in cooperation with users-representatives. To support
implementation, the counselling process is designed to demand only few school-professional
resources.
Parental counselling; A. Oral presentation (10 min) explaining HPV and HPVV. It will be given
by a health professional (Medical doctor, Phd-student) at first school-parent meeting, with
ethnic minority ambassadors present.
B. A simple printed presentation will be available in text and pictures (in Arabic, Turkish,
Somali, English and Danish).
C. The oral presentation will be available as a video texted in Arabic, Turkish, Somali,
English and Danish. It will be accessible in a Facebook-group, solely for parents included in
the intervention.
To all parents not attending the school-parent meeting, the investigators will send all
written material and opportunity to submit for participation to both an online personal
mailbox and by letter with a stamped return-envelope.
Pupil counselling; A. In a school-nurse setting, it will consist of an animation (3 min),
which illustrates facts about HPV and vaccination. The storytelling is a conversation between
two kids, diverse in gender and ethnicity and contains subjects as nervousness.
B. The children will get a tote bag with a postcard, supporting the facts given in the
animation and with an opportunity to submission by parents.
C. The school-nurse will facilitate a conversation about vaccination and nervousness, using 5
question-cards.
School-based HPVV; First vaccination (HPVV1) will be offered after element 1-2 have been
completed; the second (HPVV2) will be offered minimum five months later. Both will be given
at pre-defined dates during school hours by qualified doctors and nurses. Dates will be
visible on posters at school and reminder will be send to parents via school communication
platform and text messages if this is selected by parents when submitting their child for
vaccination.
Evaluation plan:
Quantitative and qualitative outcome, see outcome section.
Power calculation; The investigators have enrolled 5 schools, corresponding to approximately
640 children. 2560 children will be allocated to the control group (1:4 ratio). In both
groups, roughly half of these children will be native Danes and the other half will be ethnic
minorities. Estimating that minority pupils have a HPVV coverage of 65%, the study will be
able to detect a difference of approximately 10 percent points in vaccination coverage
between intervention and control group in the stratified analyses with a risk of type 1 error
of 5% and type 2 error of 10% (power 90%).
Data sources and statistical analysis; The intervention group has been identified by The
Municipality of Aarhus and the control group will be identified in the Danish Civil
Registration System, as will parents and siblings to both intervention and control groups.
Information on children's' ethnicity, and demographic and socioeconomic status on parents
will be obtained from Statistics Denmark. Data on HPVV 1 and 2 will be collected from The
Danish National Health Service Register through the Danish Health Data Authority.
Demographic and socioeconomic characteristics will be presented as numbers and proportions
and differences between intervention and control groups tested using Pearson's chi-squared
test. Regression analyses will be used to estimate the relative risk of not being vaccinated
between intervention and control group. If differences between intervention and control group
are identified, both crude and adjusted estimates will be presented with 95% confidence
intervals. All analyses will be performed using STATA V.17.
Ethical Considerations; The project will be conducted in accordance with the Good Clinical
Practice Guidelines, and is reported to the Data Protection Agency in Central Denmark Region
(ref.nr. 761330, 1-16-02-494-21) and Central Denmark Region's Committees on Biomedical
Research (1-10-72-274-21). Parents must submit their child for vaccination via written
informed consent. HPVV will be offered at pre-defined dates during school hours and provided
by qualified medical professionals according to existing guidelines. Each HPVV will be
registered in The National Danish Childhood Vaccination Register. All data will be handled
according to the EU's General Data Protection Regulation and all sensitive information will
be handled safely by using REDcap. The municipality of Aarhus will provide personal data on
intervention group in order to perform the invention and data processing agreement about
disclosure has been concluded. Interviews will be executed in accordance with the Helsinki
Declaration's rules on voluntariness and anonymity.
Collaborators and user-representatives:
From the Municipality of Aarhus, Department of Children and Youth, we have a consultant
dedicated to the project. The project has been approved by political and administrative
leaders, and these are close collaborators. Two school-nurses are user-representatives.
"Neighbourhood mothers" is a national volunteer organization of minority women trained in
health, family and the Danish society. They constitute a large group of user-representatives.
10 mothers and children with various ethnic and social background are user-representatives,
as well as 2 health professionals with cultural insight. The non-governmental organization
"Sex og Samfund" [sex and society] has contributed with consultation regarding counselling
material.
Perspectives:
The perspectives of initiating school-based HPVV, is to create equal opportunities for
participation in primary prevention from HPV-related cancer for all children living in
Denmark. Results from this study may be used in future preventive interventions, and material
can be used in future school-based vaccination programs.
The investigators expect that the intervention will contribute to minimize misinformation and
taboos related to HPVV among ethnic minority families, causing the intervention to indirectly
benefit the HPVV attendance of the family's other children, and contribute to reduce
inequality in Danish health care.
This project is the first step in a larger project with an overall aim to improve HPV-related
cervical cancer prevention among minority groups in Denmark, which takes place in a cross
regional collaboration between Aarhus University Hospital, Odense University Hospital and
Randers Regional Hospital.
