Schoolbased HPV-counselling and -Vaccination, a User-centred Intervention Targeting Children and Parents With Ethnic Minority Background
Phase: NA
Conditions: HPV, Complex Intervention
Sponsor: University of Aarhus

 
 
 
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Project title: School-based HPV-counselling and -vaccination. A user-centred intervention targeting 
children and parents with ethnic minority background.  
 
NCT number: Not yet assigned 
 
 
Date of the document: last reviewed 2nd of January 2023. 
 
 
 
 
 
 
 
 
Academic title and name: Medical Doctor, PhD-student Mrs. Anne Katrine Leonhard. 
 
Project group: 
 
Sara Badre-Esfahani: MD, PhD. Department of Gynaecology and Obstetrics in Horsens Regional Hospital. 
 
Lone Kjeld Petersen: MD consultant, Professor and head of OPEN at the University of Southern Denmark and 
Odense University Hospital. 
 
Mette Bach Larsen: MScPH, PhD, senior researcher at Randers Regional Hospital. 
 
Lene Seibæk: RN, PhD, associate professor at University of Aarhus, professor at University of Greenland, and 
senior researcher at the Department of Gynaecology and Obstetrics plus Research Centre for Patient 
Involvement at Aarhus University Hospital. 
 
 
 
 
 
 

 
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Project description  
 
Background 
Every year, almost 900 are diagnosed with HPV-related cancer in Denmark (DK) (1). This even though 
HPV-related cancers are considered the most preventive cancer forms due to effective vaccination. 
HPV-vaccination (HPVV) (Gardasil 9®) is estimated to protect against 90% of all cervical cancers 
(2,3) and protects against all other HPV-related cancer forms as well (4). In DK a gender-neutral 
HPVV program was implemented as part of the children vaccination-program in 2019. 
 
Although overall HPVV coverage is generally high in DK (80%), it is lower among ethnic minorities 
(5). Thus, immigrants have an overall lower HPVV coverage than native Danes (79% vs. 93%), with 
country specific variation as low as 65% (5). Adding to this, some ethnic minority women, have a high 
level of combined non-attendance in HPVV and screening at 30% compared to 10% for native Danes 
(6). Furthermore 25% of all boys in DK does not get HPVV regardless of their ethnic background (7). 
The reasons for non-attending HPVV are complex and covers insufficient awareness, cultural taboos 
related to the genital area and sexuality, emotional barriers such as fear that vaccination could lead to 
promiscuity, and finally a general mistrust in general practitioners (GPs) (8,9) 
 
School-based HPVV can improve participation (10) and coverage among children of all ethnicities 
(11). Studies have shown positive attitudes towards counselling supporting school-based vaccination 
(12), but to increase the attendance of ethnic minority children, communication needs to follow 
examined guidelines regarding communicating with ethnic minority citizens concerning health issues 
(13, 14). Communication needs to be uniform, simple, and in ethnic minority languages. The 
environment must be trustworthy and reliable, and the information is best adopted if visual, with an 
opportunity for repetition (15). 
 
Hypotheses and aims 
Hypothesis 1: It is possible to improve participation in HPVV in DK when combining HPV-
counselling with school-based vaccination compared to GP-based vaccination.  
- 
Aim 1: To improve HPVV coverage among pupils attending schools with high concentration of 
non-native pupils. We 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 

 
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The intervention is developed according to Complex Interventions Framework (16, 17). Complex 
interventions contain several interacting components, and the guideline deals with development, 
assessment of feasibility, implementation, and evaluation (Figure 1). To operationalize the elements of 
the intervention, we have applied a Logic Model, a graphic tool that illustrates the relationship between 
activities and intended outcome (18, 19). By this, we have combined theoretical knowledge and 
components of the intervention to accommodate to possible challenges in implementation (Table 1). 
 
Research design, study and control population 
The intervention is conducted as a non-randomized implementation study (Figure 2). 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 (Table 2). 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. For timeline, see Table 3. 
 
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 (15, 20). We have developed mainly video and 
animation, which also help 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 (21). 
 
Parental counselling 
A. Oral presentation (10 min) explaining HPV and HPVV. It will be given by the 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 we will send all written material and opportunity 
to submit for participation to both 'e-boks' 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. This as a contact from child to parent, a known pathway for 
information in especially families with ethnic minority background. 

 
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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 AULA and text messages if this is selected by parents when submitting their 
child for vaccination. 
 
Evaluation plan 
Quantitative outcome 
Primary:  HPVV coverage between intervention and control group as a total and stratified by ethnicity. 
Secondary: HPVV coverage for siblings of included pupils compared to an age- and area matched 
control group.  
 
Qualitative evaluation 
Parents’ and school professionals’ perceptions of the intervention will be qualitatively evaluated by 
focus-group interviews. The participants will be strategically selected among attending and non- 
attending, and represent various schools, cultural and socio-economic conditions. The interviews will 
be framed by a semi-structured interview guide, and data will be analysed and validated consecutively 
with Malterud’s text analytical method (22). 
 
Power calculation 
We 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 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 

 
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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 with ’e-boks’, and 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. 
 
Research plan  
Anne Katrine Leonhard will be daily project manager and overall project leader. The PhD will follow 
the estimated timeline as shown in Figure 3, included already completed preparation scholarship.  
 
Supervisors 
Lene Seibæk will be main supervisor, responsible for the qualitative methods and overall project. Sara 
Badre-Esfahani will contribute as project leader as well as co-supervisor. Lone Kjeld Petersen will be 
responsible clinician and co-supervisor. Mette Bach Larsen will be responsible for the quantitative 
methods and co-supervisor.  
 
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 Alderman Thomas Medom, and May-Britt Kullberg, 
leader of the department, are close collaborator. 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. “Sex og Samfund” has contributed with consultation regarding 
counselling material. 
 
Perspectives 
The perspectives of initiating school-based HPPV, is to create equal opportunities for participation in 
primary prevention from HPV-related cancer for all children living in DK. Results from this study may 
be used in future preventive interventions, and material can be used in future school-based vaccination 
programs. 
 
We 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 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 DK, which takes place in a cross regional collaboration 

 
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between Aarhus University Hospital, Odense University Hospital and Randers Regional Hospital 
(Figure 4).  
 
 

 
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Figures 
 
Figure 1: Key elements in developing and evaluating complex interventions according to the Complex 
Interventions Framework (17). 
  

 
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Figure 2: quasi-experimental design. 
 
 
 
Figure 3: Timeframe, PhD. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Months 
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
Years
1
2
3
Intervention
Schoolbased counselling
School-based HPVV
Implementation analysis
Modelling process and outcomes
Quantitative analysis
m
m
m
Qualitative analysis
Surveillance and monitoring
Communication
Publications
1
2
3
Presentations
Thesis  
Thesis
Phd related
Relevant Phd course attendance
Teaching
Exchange

 
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Figure 4: Overview over patterns of attendance in HPVV and cervical cancer screening among Danish 
and minority women according to age as well as focus and age intervals in three studies. Study 1, 
which is the centre of this application, aims to improve HPVV coverage among minority children in 
Denmark (green box), study 2 aims to improve cervical cancer screening among young minority 
women in Denmark (blue box) and study3 aims to improve cervical cancer screening among older 
minority women in Denmark (orange box). 
 
 
 

 
 
 
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Tables 
 
Table 1: Logic Model of intervention “School-based HPV-counselling and -vaccination” 
 
RESSOURCES 
ACTIVITIES/ 
PRODUCTS 
CLIENTS 
RESULTS 
Short-term 
Intermediate 
Long-term 
Human 
Theory and development of 
intervention  
- Neighbourhood mothers 
- The municipality of Aarhus  
- School nurses 
- Negin Jaafar 
 
Intervention 
- School nurses 
- School teachers 
- Vaccination staff 
- The municipality of Aarhus  
- Neighbourhood mothers 
 
 
  
Parent counselling 
- Oral, 15 min. 
- Movie (oral 
performance) 
 
Pupils education 
- Movie (animation, 
facts) 
- In writing (postcard) 
- Script for school 
nurses 
- Question cards 
 
Additional effort  
- letter with stamped 
envelope 
 
HPV-vaccination, first 
- Poster with short 
information (for parents, 
at school) 
- Script for vaccinators  
- Guideline for 
vaccination 
  
HPV-vaccination, 
second 
- Script for vaccinators 
- Guideline for 
vaccination 
Pupils in 
fourth, fifth 
and sixth 
grade and 
their parents, 
at schools in 
the 
Municipality 
of Aarhus 
with 25% or 
more pupils 
with ethnical 
minority 
background. 
 
 
”Attitude” 
 
Parents 
- Change of behavior 
(increased HPV-
vaccinated pupils) 
- Awareness 
- Perception of 
  relevance 
- Knowledge 
- Understanding 
- Motivation for 
screening 
 
Pupils 
- Change of behavior 
(increased HPV-
vaccinated pupils) 
-- Own provision  
- Knowledge 
- Understanding 
- Motivation 
- Positive interaction 
between students 
towards vaccination 
 
”Behavior” 
 
Parents 
- Change of behavior 
 (Women participate in 
screening) 
- Ambassadors and 
advice of HPV-
vaccination in local 
environment 
- Decision about other 
children getting HPV-
vaccinated 
 
Pupils 
- Positive influence of 
related children by 
positive mention of 
HPV-vaccination and 
prevention of disease by 
vaccination 
”Conditions” 
 
Parents  
- Change in environmental 
tradition for HPV-
vaccination 
- Less taboos related HPV 
and HPV-vaccination 
- Reduced fear of sexual 
behavior after HPV-
vaccination due to change of 
focus 
- Change in culture about 
prevention of disease 
- Increased awareness about 
other cancer-preventing 
offers (breast, colon etc.) 
 
Pupils  
- Change in future 
behavior by increased 
attendance to both 
screening and vaccination 
of children in future 
generations. 
- Increased talk and 
awareness about HPV and 
HPV-vaccination. 
 
Society 
- Increased focus and 
interest regarding school-
based vaccination 

 
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Assumptions and contextual factors 
Environment  
- 
Anti-first-mover environment. Need for ambassadors 
locally. 
- 
High trust to volunteers and health professionals (not 
GP’s). 
- 
High trust to school and school-nurses. 
- 
Positive mention by role-models and in media will benefit the 
outcome 
 
Culture 
- 
Storytelling about preventing disease is more effective than 
focus on HPV being a sexual transmitted disease and best 
given before debut of sexual activity. 
- 
Fear of change in sexual behavior after HPV-vaccination. 
- 
Broad presentation of ethnicities and authorities in project 
group and cooperators benefits the outcome of the project. 
- 
Information pathway from child to parent 
 
Intervention – form and materials 
- 
Minimal information about project will benefit the 
outcome → the less information and material, more 
manageable and larger participation to vaccination. 
- 
The more uniform the intervention is, the stronger are our 
scientific methods. 
- 
Nervousness among pupils must be taken into account. 
Minimal nervousness → more gets vaccinated. 
- 
Counselling of both parents and pupils will cause positive 
attitude to vaccination. 
- 
Animation is the best platform for pupils 
- 
Pupils want facts about HPV, cancer and vaccination. 
- 
Pupils will have positive interaction between one another 
regards vaccination and counteract nervousness. 
- 
We will not cluster and provoke anti-vaccination behavior by 
being progressive. 
 
External Factors 
- 
Eventual circumstances due to COVID-19 such as homeschool. 
- 
Negative media attention of HPVV 
- 
Another project in the local community regarding vaccination 
(COVID-19), risk of double-nudging. 
- 
Religious focus on sexual transmitted HPV-infection, and hereby 
increased fear of change in sexual behavior, possibly by senior 
religious figure.  

 
 
 
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Table 2: Schools and classes 
 
No. 
School 
%-minority 
pupils 
Participating classes 
Total pupils 
1 
Ellehøjskolen 
91% 
5th and 6th grade 
64 
2 
Møllevangskolen 
46% 
4th, 5th and 6th grade 
127 
3 
Skjoldhøjskolen 
38% 
4th, 5th and 6th grade 
 
130 
 
4 
Bakkegårdsskolen 
30% 
4th, 5th and 6th grade 
114 
5 
Sabro-Korsvejskolen 
25% 
4th, 5th and 6th grade 
201 
 
TOTAL 
46% (Mean) 
 
636 
 
Table 3: Timeline of intervention 
 
 
 

 
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