Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs

Not Applicable

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Compare different self-obtained specimen for HPV identification

• Registration Number: NCT01316120
• Lead Sponsor: University Hospital, Geneva

Brief Summary

Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.

Detailed Description

High-risk human papillomavirus (HR-HPV) infections in women are clinically important because they have been associated with nearly all cases of preinvasive and invasive cervical neoplasia1. Genital HR-HPV related infection is common, affecting approximately 10-25% of women, depending on the population and age-groups studied2-4.

With the advance in our understanding of HPV biology and the development of technologies for HPV detection together with the poor sensitivity of a single Pap test, there has been now a growing interest concerning the potential use of HPV DNA testing as a screening tool for cervical cancer5.

Currently, there is no consensus on which sampling method is the most effective for HPV DNA testing. These last years, studies have reported that samples provided by women themselves were suitable for DNA testing and support the feasibility of self-collection for HPV DNA testing6-8. Data from these studies support that it is acceptable for the women and demonstrated that a fairly high concordance rate between the self- and physicians testing method has been achieved.

Potential advantage of self-collection is that it could improve access to health care, reduce healthcare costs and save time for patients and providers. Available data have been reported with the use of specimen transport medium (STM), but the use of dry vaginal swab may potentially offer similar reliability than standard STM. Small studies suggest that HPV test (PCR) sampled by physicians using dry vaginal swab seems to be as accurate as those performed in a standard medium for HPV detection9,10. Dry vaginal swab offers potential advantages in terms of being more convenient for collection and is less expensive than a vaginal swab placed in a transport medium.

The aim of our study is to assess the performance of self-obtained v-DRY versus "standard" v-STM and its acceptability.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Primary Completion: 2011-08
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

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

Inclusion Criteria

• 20 years or older,
• First consultation in our colposcopy unit,
• Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF).

Exclusion Criteria

• Previous hysterectomy,
• Pregnant,
• Virgin,
• Not able to comply with the protocol study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV Dry first	Compare different self-obtained specimen for HPV identification	Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests
HPV standard transport medium	Compare different self-obtained specimen for HPV identification	Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests

Primary Outcome Measures

Name	Time	Method
To assess sensibility and specificity of dry swabs for HPV diagnosis	day 1	Agreement between collection methods in terms of HPV risk categories will be measured using the kappa statistic ( ) with a precision of 10% (95% confidence interval). This measure of agreement is 0 when the amount of agreement is what would be expected by chance and 1 when there is perfect agreement.

Secondary Outcome Measures

Name	Time	Method
Preference about HPV self-collection	day 1	Women will complete a self administered questionnaire on demographics and preference for sampling method (Dry versus standard)
Sensitivity and specificity of specimen transport medium (STM)	day 1	Sensitivity and specificity to detect high-risk HPV using v-STM as gold standard will be reported.