Effect of Fee on Attendance in Cervical Cancer Screening

Not Applicable

Completed

• Conditions: Cervical Dysplasia
• Interventions: Other: Screening without fee

• Registration Number: NCT02378324
• Lead Sponsor: Göteborg University

Brief Summary

Several reasons can explain non-attendance in cervical cancer screening. In low resource settings the attendance is even lower. The effect of fee as contributing reason of non attendance has not been studied before why the investigators decided to study this in a low resource setting as a randomised trial.

Detailed Description

Non-attendance in the cervical cancer screening programme is the most important factors why Swedish women contract the disease. Low attendance rate is observed in districts with low socioeconomic resources. Several reasons can explain this, including the existence of a fee. A low attendance rate in low resource districts is also noticed in Gothenburg, Sweden. After multiple interventions the coverage has slightly increased. None of the interventions included the aspect of the fee. The investigators decided to study the effect of fee abolishment in a randomized control trial emanating from the regular cervical cancer-screening program. Method: Randomized Control Trial (RCT). Women in low resource areas of Gothenburg, due for screening, January-July 2013, were randomised to receive an offer of a free test or receiving the regular invitation stating the regular fee of 100 Swedish kronor (SEK) (≈11 €). Power calculation has shown 80 % power to detect an increase in participation of 20% at 1972 participants.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2015-01-05
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-04
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3124

Inclusion Criteria

• All women in the designated geographical area, consecutively enrolled in planned screening according to standard routine. I.e women are invited if they are between 23 and 60 years of age and don't have a pap smear registered the last three or five years according to age.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention and control	Screening without fee	Intervention arm: screening without fee.

Primary Outcome Measures

Name	Time	Method
Difference in attendance	6 months	Information from the database regarding study arm was linked, via citizen unique personal number, to the National Cervical Screening Quality Register. From this database aggregated information of attendance was extracted. The effect of the intervention on attendance was calculated as relative risks.

Secondary Outcome Measures

Name	Time	Method
Differences in attendance stratified for age groups, home districts and previous pap smear history.	6 months	Before analysing the results of which kind of invitation the woman got, age group, previous pap smear history and district, all personal information was anonymized.