NCT00977392

Brief Summary

RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect a self-sample for human papillomavirus testing. PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo routine cervical screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 7, 2013

Status Verified

September 1, 2009

Enrollment Period

8 months

First QC Date

September 12, 2009

Last Update Submit

August 6, 2013

Conditions

Health Status UnknownPrecancerous Condition

Keywords

human papilloma virus infectionhealth status unknown

Outcome Measures

Primary Outcomes (1)

  • Comparison of the percentages of women responding to the invitation to return a self-sampling kit vs responding to an invitation for a cervical smear

Secondary Outcomes (2)

  • Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test)

  • Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening

Interventions

compliance monitoringBEHAVIORAL
cervical Papanicolaou testOTHER
educational interventionOTHER
screening questionnaire administrationOTHER
survey administrationOTHER
colposcopyPROCEDURE

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears * No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP) * No women who are not due for routine screening as part of the NHSCSP PATIENT CHARACTERISTICS: * Not pregnant * Have been sexually active PRIOR CONCURRENT THERAPY: * No prior total abdominal hysterectomy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barts and the London School of Medicine

London, England, SW15 5PN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Precancerous ConditionsPapillomavirus Infections

Interventions

Vaginal SmearsEarly Intervention, EducationalColposcopy

Condition Hierarchy (Ancestors)

NeoplasmsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, Obstetrical and GynecologicalSurgical Procedures, OperativeInvestigative TechniquesChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Anne Szarewski, MD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2009

First Posted

September 15, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

August 7, 2013

Record last verified: 2009-09

Locations

GB(1)