A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

University Hospitals (UH)

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Device: Vaginal swab

Study type: Interventional

Funder types: Other

Identifiers

NCT02785289

2016-00412

Details and patient eligibility

About

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

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Flocked

Experimental group

Description:

Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.

Treatment:

Device: Vaginal swab

Coton

Experimental group

Description:

Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.

Treatment:

Device: Vaginal swab