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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Other: Compare different self-obtained specimen for HPV identification
* Other: Compare different self-obtained specimen for HPV identification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Dry first<br>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 | Other: Compare different self-obtained specimen for HPV identification<br>* Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.<br>|
| Experimental: HPV standard transport medium<br>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 | Other: Compare different self-obtained specimen for HPV identification<br>* Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess sensibility and specificity of dry swabs for HPV diagnosis | 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. | day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Self-collected vaginal samples, HPV self-obtained sample, HPV specimen transport medium