NCT03873376

Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,669 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: Female
• Age: 35 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.

Detailed description

A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Opt-in; Receive offer to order self-sampling kit	Women in the opt-in arm receive an offer to order a HPV self-sampling kit, in addition to information about the study. Women who order, receive a kit that includes a self-sampling brush (Evalyn, Rovers Medical Devices), with instructions for use and a pre-paid envelope for returning the brush for HPV testing. The women are also informed that they can attend ordinary screening, i.e. performed by a physician. Women who choose self-sampling and test positive for high-risk HPV will be 1:1 allocated to follow-up by their general practitioner or a gynecologist. Women who test negative for high-risk HPV return to the ordinary screening program
BEHAVIORAL	Opt-out; Receive self-sampling kit unsolicited	Women in the opt-out arm receive the self-sampling kit directly, without having ordered it themselves. The kit has the same contents, and the follow-up is the same, as that described for the opt-in arm.
BEHAVIORAL	Control; Receive open reminder to be screened by physician	Similar to the procedure of the national screening program, women in the control arm receive a reminder to be screened by their general practitioner, and continues in the ordinary screening program

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-02-28
• Completion: 2020-12-30
• First posted: 2019-03-13
• Last updated: 2022-04-21

Locations

1 site across 1 country: Norway