Development of a Self-collection Device for Cervical Cancer Screening

Study Overview
=================
Brief Summary
-----------------
Evaluation of a novel self-collection device for cervical cancer screening.

Detailed Description
-----------------
The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Official Title
-----------------
Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening

Conditions
-----------------
Human Papilloma Virus, Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18

Intervention / Treatment
-----------------
* Device: Teal Health Self-Collection Device Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Inclusion Criteria - General Population Group Subject is 25 to 65 years of age and willing to provide informed consent. Subject with intact cervix. Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group) Subject is 25 to 65 years of age and willing to provide informed consent. Subject with intact cervix. Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy. Exclusion Criteria: Subject who reports current menstruation. Subject is pregnant (based on self-reporting). Subject has impaired decision-making capacity or unable to provide informed consent. Subject is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study. Subject has undergone partial or complete hysterectomy including removal of the cervix. Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products. Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teal Health Self-Collection Device Group<br>This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology. | Device: Teal Health Self-Collection Device Group<br>* Participants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: SAEs | Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection | Acute - immediately after self-collection procedure | 
| Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | Detection of high risk HPV in self-collected as compared to clinician-collected sample results. | Up to 30 days | 
| Primary Effectiveness: Sample Inadequacy Rate | Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer. | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Survey | Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually) | Immediately After Self-collection Procedure | 
| Satisfaction and Needs Survey | Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually) | Immediately After Self-collection Procedure | 
| Rate of sample adequacy for liquid-based cytology analysis | Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis | Up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer screening, high risk HPV, hrHPV