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

ISRCTN ISRCTN45527158
DOI https://doi.org/10.1186/ISRCTN45527158
Secondary identifying numbers 2006/01WBO
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

Study website

Contact information

Dr D A M Heideman
Scientific

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

dam.heideman@vumc.nl

Study information

Study designRandomised controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeScreening
Scientific titlePRotection by Offering Human papillomavirus Testing on sElf-sampled Cervicovaginal specimens Trial
Study acronymPROHTECT
Study objectivesThe 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) studiedCervical Intraepithelial Neoplasia (CIN), cervix cancer, uterus
InterventionIn 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 typeOther
Primary outcome measureThe 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 measuresThe 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.
Overall study start date01/10/2006
Completion date01/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants45000
Total final enrolment28073
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2006
Date of final enrolment01/03/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center
Hospital/treatment centre

Department of Pathology
PO Box 7057
Amsterdam
1007 MB
Netherlands

cjlm.meijer@vumc.nl
http://www.vumc.nl/
ROR logo https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

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

BMC - Part of Springer Nature Springer Nature