Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial 2.
Recruiting
- Conditions
- Cervical intraepithelial neoplasia (CIN), Cervix cancer
- Registration Number
- NL-OMON23580
- Lead Sponsor
- VU University Medical Center, Department of Pathology, Comprehensive Cancer Center (IKA) Amsterdam , National Institute for Public Health and the Environment (RIVM).
- Brief Summary
Bais et al. Int. J. Cancer 2007; 120(7):1505-1510.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30000
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 Noord-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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method The secondary outcome measures include:<br /> <br>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;<br /> <br>2. Evaluation of the cost-effectiveness and feasibility of self-sampling when offered in the nation-wide screening program.