Human Papilloma Virus, Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18
Conditions
Keywords
cervical cancer screening, high risk HPV, hrHPV
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.
Interventions
DEVICETeal Health Self-Collection Device Group
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.
Sponsors
Teal Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Group 1: Inclusion Criteria - General Population Group 1. Subject is 25 to 65 years of age and willing to provide informed consent. 2. Subject with intact cervix. Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group) 1. Subject is 25 to 65 years of age and willing to provide informed consent. 2. Subject with intact cervix. 3. Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.
Exclusion criteria
1. Subject who reports current menstruation. 2. Subject is pregnant (based on self-reporting). 3. Subject has impaired decision-making capacity or unable to provide informed consent. 4. 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. 5. Subject has undergone partial or complete hysterectomy including removal of the cervix. 6. 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. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: SAEs | Acute - immediately after self-collection procedure | Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection |
| Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | Up to 30 days | Detection of high risk HPV in self-collected as compared to clinician-collected sample results. |
| Primary Effectiveness: Sample Inadequacy Rate | Up to 30 days | Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability Survey | Immediately After Self-collection Procedure | Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually) |
| Satisfaction and Needs Survey | Immediately After Self-collection Procedure | 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) |
| Rate of sample adequacy for liquid-based cytology analysis | Up to 30 days | Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis |
Countries
United States
Outcome results
None listed