Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Cervical cancer is a highly preventable disease. To not attend an organized cervical cancer screening program increases the risk for cervical dysplasia and cervical cancer. The aim is to investigate the participation rate in three different intervention groups for non- attendees in the Swedish national program for cervical screening.

Who can participate?
Women who have not participated in the cervical cancer screening programme during the last six years if aged 30-49 and the last eight years if aged 50-64.

What does the study involve?
Women participating in the study are offered different methods for cervical cancer screening; a visit to a midwife for a Pap smear or an HPV self-test.

What are the possible benefits and risks of participating?
If women participate and dysplasia is detected it can be treated before it develops into cervical cancer.
We can not identify any risk of great importance.

Where is the study run from?
Faculty of Medicine and Health Sciences, Linköping University, Sweden.

When is the study starting and how long is it expected to run for?
April 2016 to December 2017.

Who is funding the study?
ALF Grants Region Östergötland, Sweden.

Who is the main contact?
Dr Caroline Lilliecreutz

Trial website

Contact information



Primary contact

Dr Caroline Lilliecreutz


Contact details

Department of Obstetric and Gynaecology
Womens clinic
Plan 14
Universitets sjukhuset Linköping
+46 708731124

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Participation in interventions and recommended follow-up for non-attendees in cervical cancer screening- taking the women's own preferred test method into account - a Swedish randomised controlled trial


Study hypothesis

The participation rate will increase if the non-attendees can choose between different test methods presented by a midwife in a telephone call (an HPV self-test or Pap Smear in the clinic) or if they receive an HPV self-test directly by post for sampling rather than yearly invitations (routine procedure)

Ethics approval

Approved 12/04/2016, Regional Ethical Review Board in Linköping, Sweden (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00;, ref: Dnr 2015/480-31

Study design

Single centre Interventional randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact detalis to request participant information sheet


Cervical cancer and cervix dysplasia


Non-attendees are defined as women who had not participated in the cervical cancer screening programme during the last six years if aged 30 - 49, and the last eight years if aged 50 - 64. This strategy was in accordance with the Swedish age-differentiated screening intervals at that time. The population was defined as non-attendees living in the region of Östergötland, Sweden on March 8th 2016. Data are extracted from the Swedish national cervical cancer screening registry (NKCx) which has almost 100% coverage of invitations. The results of Pap smears and biopsies and variables can be extracted from the unique national social security number for each individual. The results from the HPV self-tests are extracted from a local registry in the clinic. Data concerning follow-up results are obtained until the 31st of December 2017 when the study period will end. The non-attendees’ addresses are obtained from the Swedish Population Register (SPR). The trial was not registered before the enrolment of participants started because it was not recommended by the Ethical board.

The non-attendees are randomly, 1:1:1, assigned to one of three different groups: telephone, HPV self-test, or control with no intervention except for the yearly invitations (routine procedure). The study groups are computer randomised and adjusted for area code and age by a statistician uninvolved in the study. All three groups received the yearly invitations. The first analysed sample, Pap smear or HPV test, in all groups is referred to as the index sample. We will consider that the different interventions had an effect if an HPV self-test is ever returned during the study period or a Pap smear is analysed within six months from the date a study invitation letter is sent. Non-attendees randomised to the telephone group are offered a choice of different sampling options. Invitation letters are posted between April 1st 2016 and 31st May 2017 (telephone) and September 30th 2017 (HPV self-test).

Intervention type



Drug names

Primary outcome measure

Participation rate measured using patient records at six months after invitations were sent

Secondary outcome measures

1. Choice of intervention measured using patient records at the end of the study
2. Cytological diagnoses found in the index Pap smear at the time of analysis

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Non- attendees (defined as women who had not participated in the cervical cancer screening programme during the last six years if aged 30-49 and the last eight years if aged 50-64)

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

All women 30-64 years old that had participated after the last invitation as recommended in the cervical cancer screening program

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Linköping University
Department of Obstetrics and Gynaecology Division of Children's and Women's Health Faculty of Medicine and Health Sciences

Sponsor information


Linköping University Hospital

Sponsor details

Womens clinic plan 14
University Hospital
581 85
+46 70 5086031

Sponsor type

Research organisation



Funder type


Funder name

ALF Grants Region Östergötland

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Publication in scientific paper during 2020. Presentation in congress and for staff.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in (added 05/07/2020)

Publication citations

Additional files

Editorial Notes

05/07/2020: Publication reference added. 23/01/2020: Trial’s existence confirmed by Regional Ethical Review Board in Linköping, Sweden