Actively Recruiting

Phase Not Applicable
Age: 33Years - 75Years
FEMALE
ID04061967

Study of SMS and Electronic Letter Reminders with HPV Self-Sampling to Increase Cervical Cancer Screening Participation

Led by Karolinska Institutet · Updated on 2025-01-14

20000

Participants Needed

6

Research Sites

562 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Skane

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating ways to increase participation in cervical cancer screening among women at higher risk due to irregular attendance or lack of follow-up after abnormal results. Cervical cancer screening in Sweden has successfully reduced cancer cases since the 1960s, but about 38% of women diagnosed with cervical cancer had not participated regularly in screening. This study focuses on improving attendance through different types of reminders and offers of self-sampling kits for HPV testing, aiming to detect treatable precursors of cervical cancer earlier. The study compares sending reminders by SMS, electronic letters, and traditional physical letters to encourage women to participate in screening. Women identified annually through registry data as having increased risk will receive these reminders and may be offered self-sampling kits either directly or by request via the internet. Self-sampling kits include instructions and prepaid envelopes, and submitted samples are analyzed for high-risk HPV types using approved molecular tests. The study includes specific follow-up procedures for women testing positive, involving direct referrals or consultations via SMS and follow-up sampling by trained midwives. Participants will be monitored for their response to summons over a 12-month period. Researchers will assess participation rates and the detection of precancerous conditions. The study uses registry linkages, SMS communication, laboratory testing, and follow-up referrals to track outcomes. The trial started nationally in 2020 after a pilot phase and continues with annual identification of at-risk women, aiming to increase screening attendance and improve early detection of cervical cancer precursors.

CONDITIONS

Official Title

Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

Who Can Participate

Age: 33Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women resident in Region Skane who have had glandular cell changes not followed up
  • Women older than 65 years with cell changes not followed up or no screening participation in the last 10 years
  • Women who have not had a cervical screening test for more than 15 years
Not Eligible

You will not qualify if you...

  • Women who do not consent to participate

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Trial Site Locations

Total: 6 locations

1

Northern Region

Luleå, Norrbotten County, Sweden, 901 87

Actively Recruiting

2

Southern Region

Lund, Skåne County, Sweden, 221 00

Actively Recruiting

3

Western Region

Gothenburg, Västra Götaland County, Sweden, 413 45

Actively Recruiting

4

Southeast Region

Jönköping, Sweden, 581 85

Actively Recruiting

5

Region of Stockholm-Gotland

Stockholm, Sweden, 112 18

Actively Recruiting

6

Region of Middle Sweden

Uppsala, Sweden, 751 85

Actively Recruiting

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Research Team

M

Miriam Elfström, PhD

H

Helena Andersson, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Published Research Related To This Trial

Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study.

Klara Miriam Elfström, Karin Sundström, Sonia Andersson...

https://pubmed.ncbi.nlm.nih.gov/31032904