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

Conditions

Cervical cancer Cancer Malignant neoplasm of cervix uteri

Henry C Kitchener, Karen Canfell, Clare Gilham, Alexandra Sargent, Chris Roberts et al. (7 authors)

Health Technology Assessment2014-04-01147 citations

10.3310/hta18230

Epigenetic variability in cells of normal cytology is associated with the risk of future morphological transformation.

Teschendorff AE, Jones A, Fiegl H, Sargent A, Zhuang JJ, Kitchener HC, Widschwendter M.

2012-03-27144 citations

10.1186/gm323

HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial.

Kitchener HC, Almonte M, Thomson C, Wheeler P, Sargent A, Stoykova B, Gilham C, Baysson H, Roberts C, Dowie R, Desai M, Mather J, Bailey A, Turner A, Moss S, Peto J.

2009-06-17258 citations

10.1016/s1470-2045(09)70156-1

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 (H

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration	—

Countries

England, United Kingdom

Outcome results

None listed