Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial.

After the introduction of cervical screening programs, cervical cancer incidence decreased impressively. Prevention of uterine cervical cancer is possible due to relatively slowly progressing premalignant lesions, i.e. the mean duration for development of cervical cancer is 13-15 years, that can be detected by cervical cytology or hrHPV-testing, and can be treated effectively. A major problem with current cervical screening programs, however, is that the compliance rate is subject to improvement. Even in well organized invitational programs by the National health authorities, attendance rates reach 63-65% with an additional 7 or 8% of 'passive response' or 'opportunistic screened' women. Almost 25%-30% of the invited women remained unprotected because they do not respond to the general screening invitation (these women are referred to as 'non-responders'). Most importantly, this fraction of unprotected women is responsible for 40-50% of all detected carcinomas.
Our pilot study (Bais et al.) has shown that offering a user-friendly self-sampling method for collecting cell material at home enabled the recruitment of about one-third of these women, who are otherwise unwilling or unable to submit to cytological screening, into the screening program. Consequently, a significant number of premalignant lesions were found. In this PROHTECT trial, we extend the evaluation of offering sampling at home with accompanied high-risk human papillomavirus (hrHPV) testing to the region North Holland and Flevoland in the Netherlands targeting 45.000 non-responders, aiming to reveal:
1)the effect on the attendance rate in the cervical screening program.
2)the non-responder characteristics (i.e., clinical features: percentage of hrHPV positivity and percentage of high grade CIN lesions or worse (>=CIN2-3) found) in comparison to women participating in the conventional screening program.
3)the cost-effectiveness of offering self-sampling in the nation-wide screening program

The main aims of the PROHTECT trial are to find out whether the compliance rate of the cervical screening programme can be improved by offering a self-sampling method for collecting cervicovaginal cell material at home for HPV testing, and consequently the (cost-)effectiveness of screening will be enhanced due to increased detection of high grade CIN lesions or worse (>=CIN2-3) ?

In the PROHTECT trial, the effect of the addition of offering self-sampling at home to women who are not responding to the invitation of the regular cervical screening program as well as a first recall, onto the participation rate is evaluated in a randomized controlled trial design.
During the trial, participants will receive either a second recall for the regular screening (control group), or receive a kit for self-sampling of a cervicovaginal specimen at home and subsequent referral recommendations based on the presence or absence of hrHPV in the self-taken specimen (intervention group, hrHPV test results disclosed).