A randomised trial of human papillomavirus (HPV) testing in primary cervical screening

ISRCTN	ISRCTN25417821
DOI	https://doi.org/10.1186/ISRCTN25417821
Secondary identifying numbers	HTA 98/04/99; HTA 98/04/64

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 29/10/2021

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

http://cancerhelp.cancerresearchuk.org/trials/does-an-hpv-test-as-well-as-a-cervical-smear-test-improve-screening-for-cervical-cancer

Contact information

Prof Henry C Kitchener
Scientific

Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom

Phone	+44 (0)161 276 6646
Email	henry.c.kitchener@manchester.ac.uk

Study information

Study design	Pragmatic randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Scientific title	A randomised trial of human papillomavirus (HPV) testing in primary cervical screening
Study acronym	ARTISTIC
Study hypothesis	1. To study a randomised population of women undergoing cytological screening in whom an HPV test result is revealed with a smaller cohort in whom the result is concealed. 2. To study the psychological and psychosexual differences between corresponding cytological groups in the two study arms. 3. To study the economic benefits or otherwise of HPV testing. 4. To study the predictive ability of HPV testing positive or negative in the presence of normal cytology in terms of future risk, and screening intervals. 5. To see if HPV testing achieves a more efficient protocol following "inadequate" smears and low grade smears. 6. To evaluate the relevance of viral persistence and load in predicting risk. 7. To evaluate sensitivity, specificity and negative predictive value of HPV testing. 8. To compare the results of different HPV testing methods in terms of objective 7 and also to examine interlaboratory variation. More details can be found at: http://www.hta.ac.uk/1162 Protocol can be found at: http://www.ncchta.org/protocols/199800040064.pdf Updated 14/01/2008: the anticipated start and end dates of this trial were updated from 01/04/2000 and 31/03/2006 to 01/06/2001 and 30/11/2009, respectively. Updated 30/09/2013: the NIHR has awarded funding to extend the follow-up of this trial until 2015. This will be done by linkage with national screening and cancer registration records without recontacting patients.
Ethics approval(s)	North West Multi-centre Research Ethics Committee, approved on 18/08/2000 (ref: MREC 00/8/30)
Condition	Cervical cancer
Intervention	Women who are attending for cervical screening, all of whom will have a smear and an HPV test, will be individually randomised in a ratio of 3:1 to a study arm (HPV test revealed) and a control arm (HPV test concealed). The control arm will be managed by routine clinical practice as per national guidelines with a rescreen and HPV test at 3 years. 1. High grade smears (HPV +ve or -ve) - routine management (colposcopy) 2. Low grade smears (HPV +ve) - routine management (colposcopy) 3. Low grade smears (HPV -ve) - repeat smear at 6/12. If abnormal, colposcopy 4. Normal smears (HPV +ve) - repeat HPV test at 12/12. If persistent HPV +ve, patient choice between colposcopy and surveillance 5. Normal smears (HPV -ve) - rescreen at 36/12. Colposcope 500 volunteers to address true sensitivity.
Intervention type	Other
Primary outcome measure	1. Reduction of high and low grade smears in the HPV revealed arm, at the next screening round 2. The difference in psychological and psychosexual outcomes in the HPV revealed arm as a consequence of knowledge of the HPV test result 3. Cost: the number of women experiencing the cost generating events (cytology, HPV test, colposcopy, biopsy and treatment and ad hoc primary care consultations) will be identified and the associated unit costs will be estimated and attached to these events to determine total costs in each arm. Cost effectiveness will be presented as an incremental cost per additional high grade smear detected, and as an incremental cost per life year gained and per quality adjusted life year gained (estimated by extrapolating from the trial endpoint using modelling techniques).
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2001
Overall study end date	01/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	28,000 women
Total final enrolment	24510
Participant inclusion criteria	Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/06/2001
Recruitment end date	01/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare

Manchester
M13 0JH
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	main results	01/07/2009		Yes	No
Results article	results on cost effectiveness and psychosocial effects	01/11/2009		Yes	No
Protocol article	protocol	01/02/2010		Yes	No
Results article	extended follow-up results	01/04/2011		Yes	No
Results article	extended follow-up results	01/04/2014		Yes	No
Plain English results		08/09/2009	29/10/2021	No	Yes

Editorial Notes

29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.