A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection
• Interventions: Device: Vaginal swab

• Registration Number: NCT02785289
• Lead Sponsor: University Hospital, Geneva

Brief Summary

The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

Detailed Description

Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an efficient method cover hard-to reach populations in developing countries. While the recent cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection, recent studies have questioned their efficacy by reporting the superiority of the more expensive flocked swabs.

The objective of this study is to compare the performance of cotton vs flocked swabs for cellular retrieval and HPV DNA quantification after vaginal self-sampling.

A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of age or older, attending the colposcopy clinic, understanding the study procedures and able to comply with the study protocol. Pregnant women, those having previously had a total hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect two different vaginal self samples: one with the cotton swab and one with the flocked swab. Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic evaluation for specimen adequacy will be run on each sample. Agreement between the two methods will be calculated using the kappa statistic (κ).

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2016-06
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• attending the colposcopy clinic
• accepts voluntarily to take part to the study and signs the informed consent form

Exclusion Criteria

• pregnancy
• previous hysterectomy
• ongoing menstruations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flocked	Vaginal swab	Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.
Coton	Vaginal swab	Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.

Primary Outcome Measures

Name	Time	Method
Flow cytometric analysis	1 week	Number of epithelial cells
Real-time PCR analysis	1 month	HPV positivity

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland