Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial 3B.

In this randomized-controlled trial, 34.000 registered non-attendees in the regions Noord-Holland/ Flevoland/ Utrecht and Gelderland will be enrolled for self-sampling.

Previous PROHTECT trials have shown that offering a user-friendly self-sampling method for collecting (cervico-) vaginal 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 CIN2+/CIN3+ lesions were found.

In this PROHTECT-3B trial, we extend the evaluation of offering in two study arms either a lavage self-sampling device or a brush self-sampling device to non-attendees.

For this purpose, 34,000 non-responders from the year 2008 are enrolled for self-sampling. Follow-up of hrHPV-positive self-sampling responders will be performed with cytology via a physician-taken smear.



We aim to reveal:

1. The participation rate of hrHPV positive women in the both study arms;

2. User comfort of both self-sample devices;

3. The number of CIN 2+ and CIN 3+ lesions in both study arms;

4. hrHPV prevalence in both study arms;

5. Compliance in follow-up after a positive hrHPV result.

In the PROHTECT-3B trial, we offer hrHPV testing on self-sampled (cervico-)vaginal specimens obtained by either a lavage device or a brush device. The respons rate of the two devices will be compared. Also, the user comfort and sensitivity and specificity for high grade CIN and cervical cancer (CIN2+/CIN3+) of two devices will be compared.

The hypothesis is that the respons rate of the brush device is at least as good as the respons of the lavage device.

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This randomized-controlled trial is coordinated by the Radboud University Medical Centre (RUMC) and performed in collaboration with VUmc, the screening organizations Mid-West and East and RIVM. In the regions Noord-Holland/ Flevoland/ Utrecht and Gelderland, non-attendees of the regular screening programme will be invited to participate to self-sampling. Based on earlier trials, we expect about 27 percent of these women will respond by sending a self sampled specimen for hrHPV testing, of whom 8-10 percent will be hrHPV positive (Gök, 2010). Randomization of the participants is performed to determine whether the respons rate of the brush self-sampling device is at least as good as the respons rate of the lavage self-sampling device. Follow-up of the HPV positive cases will be performed with cytology via a physician-taken smear.