Vaginal Self-sampling for Non-attenders

NCT03252769 | Unknown

• 1 other identifier: WT 15/15
• Study Type: interventional
• Target: 1,950
• Locations: 1 country
• Sites: 1

Brief 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

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• The uptake rate of cervical screening in response to the intervention

  The uptake rate of cervical screening in response to the intervention

  4 weeks - 6 months

Study Arms (1)

Self-sampling

OTHER

Invitation to self-sample

Other: Self-sampling

Interventions

Self-sampling OTHER

Self-sampling

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 25-29y and 55-64y

You may not qualify if:

• Aged below 25y; between 30-54y or aged over 64y

Sponsors & Collaborators

• Western Health and Social Care Trust: lead

Study Sites (1)

WHSCT

Londonderry, Northern Ireland, BT476SB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mary McMenamin

  WHSCT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary McMenamin

CONTACT

02871345171; mary.mcmenamin2@westhealth.n-i.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)