Human Papillomavirus Infection Clinical Trial
Official title:
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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