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A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02785289
Enrollment
120
Registered
2016-05-27
Start date
2016-06-30
Completion date
2016-09-30
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Infection

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).

Interventions

Vaginal cell collection will be performed with the two types of indicated swab.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Flow cytometric analysis1 weekNumber of epithelial cells
Real-time PCR analysis1 monthHPV positivity

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026