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

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR792
• Date of registration: 11/10/2006
• Primary sponsor: VU University Medical Center, Department of Pathology
• Public title: Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial.
• Scientific title: Offering hrHPV testing on self-sampled cervicovaginal specimens to women who are non-responder in the conventional cervical screening program. - PROHTECT
• Date of first enrolment: 1/10/2006
• Target sample size: 45000
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=792
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: C.J.L.M. Meijer

• Name: D.A.M. Heideman

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women invited for the cervical cancer screening program (ages 30-60 years), but who are not responding to their invitation as well as their recall (3 months after);
2. Residing in the region covered by district health authorities of North Holland and Flevoland (in the Netherlands).

Exclusion criteria: 1. Not called for screening, i.e., ages under 30 years, or over 60 years;
2. Actively responded to the invitation or first recall of the cervical screening program by undergoing a cervical smear at the general practitioner;
3. Living outside the region covered by district health authorities of North Holland and Flevoland;
4. Under follow-up by gynaecologist for previous non-normal cytology, i.e., abnormal cytology and/or CIN3 lesion or worse less than 2 years before inclusion;
5. Current pregnancy;
6. Status after extirpation of the uterus or amputation of the portio.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Cervical intraepithelial neoplasia (CIN), Cervix cancer

Intervention(s)

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).

Primary Outcome(s)

The primary outcome measure is the change in compliance rate, i.e., the increase in attendance rate of the cervical screening program after a second recall by using self-sampling material for hrHPV testing, compared to a control group that will receive a second recall for cytological testing (similar to the conventional first recall).

Secondary Outcome(s)

The secondary outcome measures include:
1. the women characteristics, i.e., the prevalence of HPV and the number of detected high-grade CIN lesions for compliance of referral and treatment among non-responder women compared to women participating in the conventional screening program.
2. evaluation of the cost-effectiveness of self-sampling when offered in the nation-wide screening program, i.e., counter valuation of the effects on costs versus improved detection rate of premalignant lesions.

Secondary ID(s)

2006/01WBO

ISRCTN45527158

Source(s) of Monetary Support

Comprehensive Cancer Centre (Integraal Kankercentrum), VU University Medical Center, Department of Pathology, National Institute of Public Health and Environmental Protection (RIVM)

Secondary Sponsor(s)

Comprehensive Cancer Center (IKA) Amsterdam

National Institute for Public Health and the Environment (RIVM)