Feasibility of Delphi Screener for Cervical Cytology

Study Overview
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Brief Summary
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The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions. The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.

Official Title
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The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City

Conditions
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Cervical Neoplasia

Intervention / Treatment
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* Device: Delphi Screener


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Valid Pap smear in last 1-3 months obtained at participating clinic 18 years or older Self-report being able to read in English and/or Spanish Willing to sign informed consent Exclusion Criteria: Used vaginal product (douche, spermicide, antifungal) in last 48 hours Last menses started ≤ 4 days prior to enrollment visit No uterus / history of hysterectomy Self-report currently pregnant Self-report currently breastfeeding

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm study<br>Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample) | Device: Delphi Screener<br>* Self-sampling device for cervical vaginal lavage<br>* Other names: Mermaid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints. | 1-3 months between 2 specimen collections | 
| Kappa Coefficient | Kappa comparing clinician-collected cytology result to self-lavage cytology result | 1-3 months between 2 specimen collections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome: Acceptability of Device | On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening | cross-sectional - asked at time of Screener use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cytology, Pap smear, self-sampling, abnormal, normal