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OpenTrials
Completed

NCT Number: NCT02698423

Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care

The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.

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Key information

Conditions

Cancer of the Uterine Cervix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No previous cervical cancer screening test in the last three years

Exclusion criteria

  • pregnancy
  • previous hysterectomy

Treatment and study plan

Cobas HPV DNA Test

Device

Women will receive a home-sent sample for HPV self-testing

Papanicolau test

Other

Women will be invited to come in for a physician-performed Pap test

Primary outcomes

  1. Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing

    Time frame: 1 year

    Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.

Secondary outcomes

  1. Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.

    Time frame: 1 year

    Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial

Acronym: DEPIST

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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