ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000962639

Ethics application status

Approved

Date submitted

1/06/2023

Date registered

5/09/2023

Date last updated

5/09/2023

Date data sharing statement initially provided

5/09/2023

Date results provided

5/09/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Human Papillomavirus (HPV) Technology Validation Study for the the ABBOTT Alinity HPV testing platform comparing the accuracy of HPV testing using a self-collected swab sample, with using a sample taken by a clinician using a liquid-based cytology sample, for adult participants undergoing cervical cancer screening in New Zealand.

Scientific title

Human Papillomavirus (HPV) Technology Validation Study for the ABBOTT Alinity HPV testing platform comparing the accuracy of HPV testing using a self-collected swab sample, with using a sample taken by a clinician using a liquid-based cytology sample, for adult participants undergoing cervical cancer screening in New Zealand.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1293-2923

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cervical cancer screening

Condition category

Condition code

Cancer

Cervical (cervix)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparison of HPV test results between samples taken using a vaginal swab and a clinician-collected liquid-based cytology (LBC) sample. Instructions provided to participants about how to collect a self-sample have been supplied to this study with permission to use, by Professor Marion Saville, Executive Director, Australian Centre for the Prevention of Cervical Cancer. The instructions have already been used in analogous trials in Australia.
A vaginal swab sample will be self-collected by people who are about to have a colposcopy. It is anticipated that the consent process will take 10-15 minutes of in-clinic time as the Participant Information will be sent to potential participants prior to their attendance at the clinic. The time taken to collect the self-sample will be about 1 minute. The sample will be taken while the person is getting changed for their colposcopy. The colposcopist will then take a second clinician-collected LBC sample. The additional time taken to collect the clinician-taken sample will also be about 1 minute, given that the person will already be having a colposcopy independently to the study. Both samples will be tested for high-risk HPV. The samples will be processed using the ABBOTT Alinity HPV testing platform. A copy of the consent form will be sent to the laboratory with the samples and will be securely stored in the laboratory. The consent forms will only be accessible to those directly involved in the study. A specific laboratory request form has been developed for the project so that this is clear when the samples arrive in the laboratory. The clinician-collected samples are part of regular clinical services and the collection and processing of these samples in parallel with the self-collected samples, provide documentation and quality assurance processes for those participating in the study because all cases will be recorded in colposcopy and laboratory databases and will be subject to usual quality considerations in terms of accuracy of patient identification, sample identification and security of reporting results. There will be a trial investigator at each of three colposcopy site providing samples, who will be responsible for ensuring that all staff involved in the study are aware of their roles and responsibilities for conducting the study and there will be a laboratory scientist at the laboratory who will be responsible for ensuring that any staff involved in processing or reporting the trial results, know about the trial and their role in it. Trial data will be collated in the laboratory where processing occurs. There is a specific process to manage any discordant results between the two sample types, in a clinically-safe manner. This has been agreed with the colposcopists participating in the sample collection. The swab-collected HPV test result will be compared with the clinician-collected HPV test result to determine whether the swab-collected samples achieve acceptable levels of sensitivity and specificity in order to validate the use of swab-collected samples for HPV testing. Participants will be provided with a consent form, instructions about how to take a self-sample and the swab to use. Sample collection will occur at three colposcopy clinics in New Zealand, with all samples analysed at the same laboratory where the HPV test technology is being validated for swab collection. The colposcopy staff are already experienced at taking clinician-taken samples at colposcopy. The clinic will be provided with the consent form, a laboratory request form, the SurePath vials needed for the clinician-collected samples and the swabs needed for the swab-collected samples, as well as instructions to give participants about how to take their self-collected swab-sample.
Consent forms will be sent to prospective participants with their colposcopy clinic appointment to give them time to consider participation before they arrive at the colposcopy clinic. There is no other engagement with participants after their colposcopy visit. They will have access to their results and a summary of the trial, should they request these.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

The clincian-collected LBC sample processed for HPV testing is the comparator

Control group

Active

Outcomes

Primary outcome [1]

The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the sensitivity with 95% Wilson score binomial confidence intervals for detecting HPV16. Validation of the self-collection method will be achieved by comparing the sensitivity of detection of HPV16 with the sensitivity of the clinician-collected samples for HPV16.

Timepoint [1]

In the trial, 320 paired samples will be tested, collected at three colposcopy clinics. The trial is estimated to take up to 7 months to collect the samples with a further month for the analysis of results.

Primary outcome [2]

The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the specificity with 95% Wilson score binomial confidence intervals for detecting HPV16. Validation of the self-collection method will be achieved by comparing the specificity of detection of HPV16 with the specificity of the clinician-collected samples for HPV16.

Timepoint [2]