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

Not Applicable

Completed

• Conditions: Cervical cancer; Cancer; Malignant neoplasm of cervix uteri

• Registration Number: ISRCTN25417821
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19540162 main results 2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19891902 results on cost effectiveness and psychosocial effects 2010 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/20007387 protocol 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21334200 extended follow-up results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24762804 extended follow-up results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-25
• Study Completion: 2015-01-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24510

Inclusion Criteria

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Reduction of high and low grade smears in the HPV revealed arm, at the next screening round<br> 2. The difference in psychological and psychosexual outcomes in the HPV revealed arm as a consequence of knowledge of the HPV test result<br> 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).<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration