Comparing different ways to take self-samples for HPV testing for cervical screening

• Register: ISRCTN
• Last refreshed on: 7 September 2021
• Main ID: ISRCTN68980717
• Date of registration: 22/04/2016
• Prospective Registration: Yes
• Primary sponsor: Bart’s Health NHS Trust
• Public title: Comparing different ways to take self-samples for HPV testing for cervical screening
• Scientific title: A randomised-assignment comparison study of the performance of self-collected vaginal samples for Human Papillomavirus (HPV) testing when transported under wet or dry conditions, using different collecting devices
• Date of first enrolment: 22/04/2016
• Target sample size: 600
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN68980717
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Screening, Imaging (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Louise Cadman

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women attending for colposcopic examination at the Royal London Hospital colposcopy clinic
2. Referred as a consequence of abnormal screening cytology and/or positive HPV result
3. Who have a cervix
4. Who give written informed consent
5. Aged 18 years and above

Exclusion criteria:
1. Pregnancy
2. History of excisional or ablative treatment for CIN within the last three years


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Specialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease:
Cancer
Human papilloma virus (HPV)

Intervention(s)

Current interventions as of 08/09/2017:
Before their colposcopy examination women, who have signed a consent form to take part, will firstly be asked to provide a sample of urine using a Colli-Pee collection kit. They will then be asked to take two self-samples, either:

1. Swabs (like cotton buds) - one taken with a Dacron swab and placed into a liquid specimen transport medium and one with a dry flocked swab and transported as a dry sample. The order in which samples are taken is randomised to avoid bias.
or
2. Qvintip and HerSwab self-test kits. This involves women taking a sample with a HerSwab collection device and a sample taken with a Qvintip device. Once again sample order will be randomised. 300 women will be put into each group and given an illustrated instruction sheet. They will also be asked to fill in a short questionnaire about how easy or difficult they found taking each sample. Any smear and biopsy results from the colposcopy, and over the following 9 months or so, will be collected from hospital records. Self-samples will be taken to the Centre for Cancer Prevention. HPV results will be not given to the woman or her doctor as we do not know how reliable they are for clinical care.
They may continue to take the cervico-vaginal samples even if they cannot provide a urine sample.

There is no active follow-up of participants. Passive follow-up of the collection of histology and cytology results will take place. Taking part in the study will not affect routine colposcopy care.

Previous interventions:
Before their colposcopy examination women, who have signed a consent form to take part, will be asked to take two

Primary Outcome(s)

1. The total amount of nucleic acid in the samples (including RNA)
2. Quantification of amplifiable human genomic DNA
3. Estimation of the viral load of HPV16 in the samples
4. Validated HPV platforms which will give quantifiable measures of HPV with some degree of typing

Secondary Outcome(s)

Histological and cytological outcomes and total scores allocated by women to each test on the acceptability questionnaire

Secondary ID(s)

20833

Source(s) of Monetary Support

Cancer Research UK

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 01/12/2027