A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

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

Detailed Description
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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).

Official Title
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A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Device: Vaginal swab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flocked<br>Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab. | Device: Vaginal swab<br>* Vaginal cell collection will be performed with the two types of indicated swab.<br>|
| Experimental: Coton<br>Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab. | Device: Vaginal swab<br>* Vaginal cell collection will be performed with the two types of indicated swab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow cytometric analysis | Number of epithelial cells | 1 week | 
| Real-time PCR analysis | HPV positivity | 1 month |