HPV study: Rovers Cervex-Brush
Official title Comparative Self-collection for Cervical Cancer Screening Pivotal Study
ClinicalTrials.gov ID: NCT07758140
What this study is testing
- What it's testing
- The study wants to see if people can correctly use the Mia self‑collection kit and get a good sample, and whether the self‑collected results match those from a clinician’s sample for detecting high‑risk HPV.
- Who it's for
- Adults who are due for cervical cancer screening and meet the study’s health criteria.
- What's involved
- Participants will use the Mia self‑collection device to take a vaginal sample at home or in the clinic, follow written instructions, and also have a clinician collect a cervical sample. Both samples will be tested for high‑risk HPV.
- Time commitment
- A single visit (or home collection) with two sample collections and the required follow‑up testing.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix. Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
You likely can't join if
- Impaired decision-making capacity or inability to provide informed consent.
- History of partial or total hysterectomy, including removal of the cervix.
- Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
- Current pregnancy (based on self-reporting).
- Active menstruation at time of specimen collection.
- Vaginal bleeding within 48 hours.
See the full eligibility criteria
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix. Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months
- Impaired decision-making capacity or inability to provide informed consent.
- History of partial or total hysterectomy, including removal of the cervix.
- Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
- Current pregnancy (based on self-reporting).
- Active menstruation at time of specimen collection.
- Vaginal bleeding within 48 hours.
- Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
- Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
- Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Sherman Oaks, California, United States
- Lake Worth, Florida, United States
- North Miami Beach, Florida, United States
- Boise, Idaho, United States
- Great Falls, Montana, United States
- Raleigh, North Carolina, United States
- Wilmington, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Houston, Texas, United States
- Lynnwood, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Sherman Oaks, California, United States; Lake Worth, Florida, United States; North Miami Beach, Florida, United States; Boise, Idaho, United States; Great Falls, Montana, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.