The Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER)

University Hospitals Coventry and Warwickshire NHS Trust

Status: Withdrawn

Conditions: Cervix Diseases

Treatments: Procedure: Collection of cervical sample for routine cervical screening; Procedure: Self-collecting a vaginal sample with a swab for HPV testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02779621

203560

Details and patient eligibility

About

To explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. Women in the control group will only receive the routine screening invitation letter. The total screening uptake rate, 2 months since the recruitment in each group will be compared.

Full description

The aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the NHS to prevent cervical cancer. We plan to identify all defaulters living in Coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. They will be randomized 1:1 to intervention and control arms. Women in the control arm will be sent a routine screening letter reminding them to have a smear test. Women in the intervention arm will be given the option of self-sampling for HPV testing, if they do not wish to have a smear test. They could order a self-HPV test by returning a slip in the pre-paid envelope. We then send the woman a vaginal self-collection kit. Self-collected sample will be returned to the laboratory for HPV testing. Whilst HPV positives (10-15%) will be advised to have a smear test, HPV negatives will be advised to accept their next smear test invitation.

Sex: Female

Ages: 30 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All cervical screening programme defaulters living in Coventry

Exclusion criteria

1. Pregnancy
2. Total hysterectomy (abdominal/laparoscopic/vaginal)
3. Never been sexually active/ intimate
4. Women who cannot give valid, informed, written consent
5. HPV self-sample returned without a signed consent form
6. Women who request the research team to be excluded from the trial
7. Women who have written to the Screening Services to record their refusal to take part in the NHSCSP
8. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Self-sampling

Experimental group

Description:

(Self-collecting a vaginal sample with a swab for HPV testing) Women in the experimental arm will have the option of vaginal self-sampling for HPV testing, in addition to the routine screening test. They can choose one of them.

Treatment:

Procedure: Self-collecting a vaginal sample with a swab for HPV testing

Procedure: Collection of cervical sample for routine cervical screening

Routine smear

Active Comparator group

Description:

(Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter.

Treatment:

Procedure: Collection of cervical sample for routine cervical screening