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A randomised trial of human papillomavirus (HPV) testing in primary cervical screening
DOI 10.1186/ISRCTN25417821
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised trial of human papillomavirus (HPV) testing in primary cervical screening
Scientific title
Serial number at source HTA 98/04/99; HTA 98/04/64
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.
Lay summary http://cancerhelp.cancerresearchuk.org/trials/does-an-hpv-test-as-well-as-a-cervical-smear-test-improve-screening-for-cervical-cancer
Ethics approval North West Multi-centre Research Ethics Committee, approved on 18/08/2000 (ref: MREC 00/8/30)
Study design Pragmatic randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cervical cancer
Participants - inclusion criteria Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/06/2001
Anticipated end date 01/01/2015
Status of trial Ongoing
Patient information material
Target number of participants 28,000 women
Interventions 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.
Primary outcome measure(s) 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 measure(s) Not provided at time of registration
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2009 main results in http://www.ncbi.nlm.nih.gov/pubmed/19540162
2009 results on cost effectiveness and psychosocial effects in http://www.ncbi.nlm.nih.gov/pubmed/19891902
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20007387
2011 extended follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/21334200
2014 extended follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/24762804
Contact name Prof  Henry C  Kitchener
  Address Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
  City/town Manchester
  Zip/Postcode M13 0JH
  Country United Kingdom
  Tel +44 (0)161 276 6646
  Fax +44 (0)161 276 6134
  Email henry.c.kitchener@manchester.ac.uk
Sponsor University of Manchester (UK)
  Address Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Sponsor website: http://www.manchester.ac.uk/
Date applied 25/04/2003
Last edited 07/05/2014
Date ISRCTN assigned 25/04/2003
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