PRotection by Offering Human papillomavirus Testing on sElf-sampled Cervicovaginal specimens Trial

ISRCTN	ISRCTN45527158
DOI	https://doi.org/10.1186/ISRCTN45527158
Protocol serial number	2006/01WBO
Sponsor	VU University Medical Center
Funder	Comprehensive Cancer Centre (Integraal Kankercentrum) (The Netherlands) 2. VU University Medical Center (The Netherlands) 3. National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D A M Heideman
Scientific

VU University Medical Center
Department of Pathology
PO Box 7057
Amsterdam
1007 MB
Netherlands

Email	dam.heideman@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title	PRotection by Offering Human papillomavirus Testing on sElf-sampled Cervicovaginal specimens Trial
Study acronym	PROHTECT
Study objectives	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 Human PapillomaVirus (HPV) testing, and consequently the (cost)-effectiveness of screening will be enhanced due to increased detection of high grade Cervical Intraepithelial Neoplasia (CIN) lesions or worse (more than or equal to CIN grade two to three)?
Ethics approval(s)	The PROHTECT trial has been approved by the Dutch Ministry of Health, Welfare and Sports (reference number: 2006/01WBO), date of approval: 11/05/2006. In addition, the Ethics Board of the VU University Medical Center has approved the study.
Health condition(s) or problem(s) studied	Cervical Intraepithelial Neoplasia (CIN), cervix cancer, uterus
Intervention	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 randomised 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 high-risk Human PapillomaVirus (hrHPV) in the self-taken specimen (intervention group, hrHPV test results disclosed).
Intervention type	Other
Primary outcome measure(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).
Key secondary outcome measure(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.
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	45000
Total final enrolment	28073
Key inclusion criteria	1. Women invited for the cervical cancer screening program (ages 30 to 60 years), but who are not responding to their invitation as well as their recall (three months after) 2. Residing in the region covered by district health authorities of North Holland and Flevoland (in the Netherlands)
Key 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 CIN three lesion or worse less than two years before inclusion 5. Current pregnancy 6. Status after extirpation of the uterus or amputation of the portio
Date of first enrolment	01/10/2006
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1007 MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/03/2010	06/01/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/01/2021: Publication reference and total final enrolment added.