Clinical trial NCT02779621: The Potential for HPV Self-testing to Promote Participation in Cervical Screening
Official title: A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervix Diseases
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: Abbott
name: Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy
First posted: 2016-05-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: The total screening uptake rate in each arm
timeFrame: 2 months since the recruitment
Secondary outcomes:
measure: Proportion of HPV positive women who have subsequently had a smear test
timeFrame: 2 months since the HPV test result
measure: Proportion of smear positive women referred to colposcopy
timeFrame: 1 month since the smear result
measure: Proportion of women referred to colposcopy had attended colposcopy
timeFrame: 3 months since the smear result
measure: Proportion of women attended colposcopy had a CIN2+
timeFrame: 4 months since the smear result
measure: Assess the women's attitude towards self-sampling and its feasibility
timeFrame: 2 months since the recruitment
measure: Assess the women's attitude towards the feasibility of self-sampling
timeFrame: 2 months since the recruitment
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospital of Coventry & Warwickshire
state: Warwickshire
Study officials:
affiliation: Head of Research, Development & Innovation, UHCW, Coventry
name: Ceri Jones
role: STUDY_DIRECTOR
References: