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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial

Conditions
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Cervix Diseases

Intervention / Treatment
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* Procedure: Self-collecting a vaginal sample with a swab for HPV testing
* Procedure: Collection of cervical sample for routine cervical screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All cervical screening programme defaulters living in Coventry Exclusion Criteria: Pregnancy Total hysterectomy (abdominal/laparoscopic/vaginal) Never been sexually active/ intimate Women who cannot give valid, informed, written consent HPV self-sample returned without a signed consent form Women who request the research team to be excluded from the trial Women who have written to the Screening Services to record their refusal to take part in the NHSCSP 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-sampling<br>(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. | Procedure: Self-collecting a vaginal sample with a swab for HPV testing<br>* The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.<br>* Other names: Copan Floq is used for self-sampling;Procedure: Collection of cervical sample for routine cervical screening<br>* This is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse)<br>* Other names: Routine cervical smear test;|
| Active Comparator: Routine smear<br>(Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter. | Procedure: Collection of cervical sample for routine cervical screening<br>* This is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse)<br>* Other names: Routine cervical smear test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total screening uptake rate in each arm | In the experimental arm, the numerator will be the total number of smear tests + HPV self-tests. In the active control arm, it will be total number of smear tests. | 2 months since the recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HPV positive women who have subsequently had a smear test |  | 2 months since the HPV test result | 
| Proportion of smear positive women referred to colposcopy |  | 1 month since the smear result | 
| Proportion of women referred to colposcopy had attended colposcopy |  | 3 months since the smear result | 
| Proportion of women attended colposcopy had a CIN2+ |  | 4 months since the smear result | 
| Assess the women's attitude towards self-sampling and its feasibility | Analysing data of user questionnaires | 2 months since the recruitment | 
| Assess the women's attitude towards the feasibility of self-sampling | Analysing data of user questionnaires | 2 months since the recruitment |