Cervix DiseasesPROMOTERNCT02779621
The Potential for HPV Self-testing to Promote Participation in Cervical Screening
A study testing Self-collecting a vaginal sample with a swab for HPV testing and Collection of cervical sample for routine cervical screening in people with Cervix Diseases, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Diseases
- What is being tested?
- Self-collecting a vaginal sample with a swab for HPV testing and Collection of cervical sample for routine cervical screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 25 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All cervical screening programme defaulters living in Coventry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of Coventry & Warwickshire
Coventry, Warwickshire, CV2 2DX
About this study
Official title: A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial
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.
Read the detailed 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.
- Conditions
- Cervix Diseases
- Being tested
- Self-collecting a vaginal sample with a swab for HPV testing, Collection of cervical sample for routine cervical screening
- Medical subject headings
- Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-collecting a vaginal sample with a swab for HPV testingProcedure or surgery
Also called Copan Floq is used for self-sampling
The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.
Collection of cervical sample for routine cervical screeningProcedure or surgery
Also called Routine cervical smear test
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)
| Study group | Role | What they receive |
|---|---|---|
| Self-sampling | Experimental | (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. Receives: 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 | (Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter. Receives: Procedure: Collection of cervical sample for routine cervical screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months since the recruitment
Secondary outcomes (6)
Proportion of HPV positive women who have subsequently had a smear test
Measured: 2 months since the HPV test result
Proportion of smear positive women referred to colposcopy
Measured: 1 month since the smear result
Proportion of women referred to colposcopy had attended colposcopy
Measured: 3 months since the smear result
Proportion of women attended colposcopy had a CIN2+
Measured: 4 months since the smear result
Assess the women's attitude towards self-sampling and its feasibility
Analysing data of user questionnaires
Measured: 2 months since the recruitment
Assess the women's attitude towards the feasibility of self-sampling
Analysing data of user questionnaires
Measured: 2 months since the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2016 (estimated)
- Primary completionJan 2017 (estimated)
- Study completion25 Jan 2017
Why it stopped: Due to Chief Investigator relocating out of the United Kingdom.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy
- Responsible party
- Sponsor
- Investigators
- Ceri Jones, Study director, Head of Research, Development & Innovation, UHCW, Coventry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779621
- Sponsor's protocol ID
- 203560
- Acronym
- PROMOTER
- Status last verified
- Feb 2017
- First submitted
- 18 May 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial
- ClinicalTrials.gov ID
- NCT02779621
- Acronym / sponsor ID
- PROMOTER / 203560
- Conditions
- Cervix Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to Chief Investigator relocating out of the United Kingdom.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Abbott, Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy
- Study start
- Jan 2016 (estimated)
- Primary completion
- Jan 2017 (estimated)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-sampling | Experimental | Procedure: Self-collecting a vaginal sample with a swab for HPV testing, Procedure: Collection of cervical sample for routine cervical screening(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. |
| Routine smear | Active comparator | Procedure: Collection of cervical sample for routine cervical screening(Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All cervical screening programme defaulters living in Coventry
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-collecting a vaginal sample with a swab for HPV testingAlso: Copan Floq is used for self-samplingThe vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay. | Procedure or surgery | Self-sampling |
| Collection of cervical sample for routine cervical screeningAlso: Routine cervical smear testThis is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse) | Procedure or surgery | Routine smear, Self-sampling |
Primary outcome
The total screening uptake rate in each arm
Time frame: 2 months since the recruitment
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.
6 secondary outcomes
Proportion of HPV positive women who have subsequently had a smear test
Time frame: 2 months since the HPV test result
Proportion of smear positive women referred to colposcopy
Time frame: 1 month since the smear result
Proportion of women referred to colposcopy had attended colposcopy
Time frame: 3 months since the smear result
Proportion of women attended colposcopy had a CIN2+
Time frame: 4 months since the smear result
Assess the women's attitude towards self-sampling and its feasibility
Time frame: 2 months since the recruitment
Assess the women's attitude towards the feasibility of self-sampling
Time frame: 2 months since the recruitment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceri Jones study director
Head of Research, Development & Innovation, UHCW, Coventry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-collecting a vaginal sample with a swab for HPV testing and Collection of cervical sample for routine cervical screening in people with Cervix Diseases, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total screening uptake rate in each arm (time frame: 2 months since the recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.