NCT02779621

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

May 18, 2016

Last Update Submit

February 22, 2017

Conditions

Cervix Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    2 months since the recruitment

  • +1 more secondary outcomes

Study Arms (2)

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.

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

Procedure: Collection of cervical sample for routine cervical screening

Interventions

Self-collecting a vaginal sample with a swab for HPV testingPROCEDURE

The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.

Also known as: Copan Floq is used for self-sampling
Self-sampling
Collection of cervical sample for routine cervical screeningPROCEDURE

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)

Also known as: Routine cervical smear test
Routine smearSelf-sampling

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All cervical screening programme defaulters living in Coventry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Coventry & Warwickshire

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ceri Jones

    Head of Research, Development & Innovation, UHCW, Coventry

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 25, 2017

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)