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Vaginal Self-sampling for Non-attenders

NCT03252769 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1950

Last updated 2018-10-04

No results posted yet for this study

Summary

Cervical cytology screening coverage in Northern Ireland (the proportion of eligible women, aged 25-64 years who have had a test result recorded in the previous five years) has increased steadily since 2005 to 78% in 2012/2013; almost reaching the 80% coverage target. The uptake of cervical screening among women in the 25-29 year age group in Northern Ireland however, has remained consistently lower (70-73%) than all other age groups except for the 60-64 year age group where the coverage rate is similar. The main barriers preventing women from attending for cervical screening are: embarrassment; inconvenience; time and discomfort associated with obtaining cervical samples. Studies have shown that offering women the opportunity to collect a vaginal self-sample to test for HPV (the main risk factor for cervical cancer) could increase screening coverage. Non-attenders in the Western and Belfast Health and Social Care Trust area, aged 25-29 years, will be identified by GPs. Letters with information relating to the study and collection devices will be sent to women giving them two options: 1. inviting them to book a normal screening appointment; 2. inviting them to collect a self-sample for HPV testing with either a swab or brush collection device. Participants for receipt of swab or brush will be randomised. Acceptance to participate in the study will be indicated by signed consent. Returned self-collected samples will be HPV tested. If a sample is negative, no further investigation is required and the woman will be encouraged to accept her next screening invitation. If a sample is positive the woman will be encouraged to book a screening appointment. The study will evaluate: impact on screening uptake, acceptance of self-sampling for both devices, practicality and cost-effectiveness of the intervention.

Conditions

Interventions

OTHER

Self-sampling

Sponsors & Collaborators

  • Western Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Mary McMenamin · WHSCT

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252769 on ClinicalTrials.gov