Randomized Participation Trials: Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sciensano
- Enrollment
- 1,200
- Locations
- 6
- Primary Endpoint
- Difference in response between intervention and control arm (per protocol (PP) and intention to treat analyses [ITT]).
Study Overview
Brief Summary
Small scale data indicate that cervical cancer screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since >3 years randomized to direct reception of a SS kit yielded a response of 78% vs 51% in the control arm.
BELGSSAR will also investigate whether GP's have the information on the most important risk factors for cervical cancer available in their patient files.
Detailed Description
Screening with clinically validated high-risk (hr) HPV tests is more effective in reducing cervical cancer incidence than cytology. Another advantage of hrHPV testing is that it can be performed on self-samples whereas cytology on self-samples shows poor clinical accuracy. hrHPV DNA testing on vaginal self-samples is as accurate on self- as on clinician-taken samples under the condition to use clinically validated PCR-based assays that target DNA sequences of the viral genome.
Offering kits for vaginal self-sampling is more effective than conventional invitations / reminders sent to under-screened women to have a cervical specimen taken by a clinician. Small scale data indicate that screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since >3 years randomized to direct reception of SS kit yielded a response of 78% vs 51% in the control arm.
Risk based cervical cancer screening takes risk factors into account to differentiate screening policies. GPs have knowledge of these risk factors. Demonstration of the knowledge of these risk factors from GP's patient files will be demonstrated through the BELGSSAR trials.
Two self-sampling methods will be used in BELGSSAR:
- vaginal self-sampling using the Evalyn® Brush (Roovers, Oss, NL) and
- first-void urine collection with the Colli-PeeTM (Novosanis, Wijnegem, BE). Depending on the GP practice, collection will take place at home or at the GP office (predefined by the respective GP). The inclusion of urine collection is motivated by the possible lower threshold for women who dislike genital examinations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women who have not been screened for cervical cancer since the last three years
- •visiting their GP for whatever reason
Exclusion Criteria
- •pregnant women,
- •women under active follow-up because of previous cervical abnormality,
- •women who had a total hysterectomy,
- •women who had a history of cervical cancer or a treatment for cervical precancer less than three years ago,
- •non-consenting women,
- •women who are not able to understand and sign the informed consent
Outcomes
Primary Outcomes
Difference in response between intervention and control arm (per protocol (PP) and intention to treat analyses [ITT]).
Time Frame: 2 years and 4 months
Difference in response in women included in the self-sampling arms vs the control arm (per protocol (PP) and intention to treat analyses \[ITT\]). The absolute difference in response rate = proportion with screening test in experimental arm - proportion with screening test in control arm, within 6 months after enrolment. In the PP analysis only women with a screening test on the self-sample according to the specific experimental intervention will be taken into account, whereas in the ITT analysis all screening tests performed within 6 months after enrolment will be considered (also those performed on samples taken by a clinician).
Secondary Outcomes
- Screen test positivity rate (by arm [PP and ITT], GP intervention)(2 years and 7 months)
- Attitude/preferences of women towards self-sampling (assessed through a questionnaire)(2 years and 7 months)
- Presence of information on risk factors(2 years and 7 months)
- net difference in response rate between practices offering vaginal self-sampling devices vs offering urine collection devices • Difference in response between practices offering self-sampling collection at the GP's office vs at home.(2 years and 7 months)
- Absolute response rates in each arm and each GP practice(2 years and 7 months)
- Heterogeneity in response rate differences, over the eight GP practices (assessed by the Cochran Q test for heterogeneity)(2 years and 7 months)
- net difference in response rate between practices offering self-sampling collection at the GP's office vs at home.(2 years and 7 months)