Non-participation in the cervical screening program and sub-optimal follow-up after
abnormalities or infection with a highly oncogenic HPV type detected in screening are the
main risk factors for cervical cancer. Given this, It is important to reduce barriers to
screening and facilitate participation in the screening program of cervical cancer.
Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in
several research studies as a way to reach women who have not responded to screening
invitations. Women who have been lost to follow-up can also be reached with
self-sampling.
The purpose of this study is to investigate whether SMS reminders and electronic letters
for screening attendance will increase participation compared to the current method where
reminders are sent out with physical letters. In this study, women a with high risk of
developing cervical cancer, due to not fully participating in screening or being followed
up optimally, will be invited. Women are identified through registry linkages annually
that examine screening history and status using a risk algorithm. Women receive an SMS or
an electronic letter with an offer to request a self-sampling kit via the internet. Women
with a higher risk for cervical cancer can be offered a self-sampling kit sent directly
to their home address. The self-sampling kit comes with an instruction on how to take the
sample and a postage-free answer envelope.
Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche)
that analyzes for HPV 16, HPV18 and other oncogenic HPV types. As the screening program
changed the accredited HPV test in 2022 (to BD Onclarity), that test will be used from
the timepoint of the change and onwards.
In the pilot of the study, follow-up is defined as follows:
For those women who are at the highest risk (previous glandular cell changes without
follow-up), all HPV-positive women are referred via SMS directly to a women's clinic
for investigation. HPV-negative women in this group have no increased risk and
receive a text message with a calming message.
Women of an age above the screening program but who have either had a cell change
that is not followed up or who have not participated at all in the last 10 years are
treated in the same way as in paragraph 1.
Finally, the women of screening age who have not taken a cell sample for more than
15 years are identified. This group receive an SMS and HPV-positive women are
referred, via SMS, for renewed sampling by a specially trained so-called dysplasia
midwife. The sample is now being analyzed for both cytology and HPV. If the woman is
HPV positive in both tests and in the case of deviating cytology, the woman is
referred to a women's clinic. In other cases a text message with a reassuring
message is sent.
The study has the usual level of confidence (p <0.05 two-sided) and statistical power
(80%) the ability to demonstrate an increase of participation by 3 times or more.
The protocol was piloted in the Region of Skåne in 2019 and then rolled out nationally in
2020.
The study is rolled out nationally with annual linkages to identify women with an excess
risk for cervical cancer and an adaptive approach to reaching women with SMS, electronic
letters, and physically letters with direct delivery of HPV self-sampling kits or an
option to order a self-sampling kid (depending on risk). The study is coordinated
centrally and each region has a contact person to whom women who need follow-up are
referred.
