Actively Recruiting

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

Research Project on Reminders and Self-Sampling to Increase Participation in Gynecological Cell Sampling for Prevention of Cervical Cancer

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

20000

Participants Needed

6

Research Sites

N/A

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 new ways to increase participation in cervical cancer screening among women at higher risk due to missed follow-ups or irregular attendance. This study focuses on women identified through registry data who may benefit from reminders sent via SMS, electronic letters, or physical letters. Cervical cancer screening has been highly successful in Sweden, preventing many cases, but non-participation remains a significant risk factor for developing the disease. The study sends invitations and reminders using different methods and offers self-sampling kits for HPV testing either by direct mailing or through an online ordering system. The sampling kits include instructions and a prepaid envelope for returning samples. The collected samples are analyzed for HPV types associated with cervical cancer using approved molecular tests, with the testing platform updated in 2022. Follow-up procedures vary based on risk, including direct referrals for women with positive HPV results and reassuring messages for those testing negative. Participants are monitored for their response to invitations over a 12-month period. Researchers measure participation rates, the number of positive HPV screens, and rates of precursors and cases of cervical cancer. The study is conducted nationally with annual identification of women at elevated risk, and follow-up is coordinated through regional contacts. The study began in 2019 and aims to assess whether modern communication methods can improve screening attendance and early detection.

CONDITIONS

Brief 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 transformation not followed-up
  • Women older than 65 years with cell transformation not followed-up or no screening in the last 10 years
  • Women who have not been screened for more than 15 years
Not Eligible

You will not qualify if you...

  • Women who do not consent to participate

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (remote communication via SMS or electronic letter)

Surveillance

Duration - Up to 12 months after the invitation

Participants receive invitations to order an HPV self-sampling test through SMS or electronic letters, and samples are submitted for HPV testing as part of cervical cancer prevention.

No in-person visits; participation involves submitting self-sampling kits by mail

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