Can people collect their own vaginal sample for HPV testing as well as clinician collection for comparison?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The pivotal study assesses the Mia by XytoTest self-collection device for obtaining vaginal samples suitable for the cobas HPV test. It compares diagnostic agreement between Mia self-collected specimens and clinician-collected samples for detecting high-risk HPV. The study also checks safety and whether end users from diverse populations can use the device safely and effectively. Residual samples may be used for additional assays to explore other biomarkers. The goal is to support FDA marketing authorization for the Mia device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Group 1: General Population Group

1. Participants are 25 to 65 years of age and willing to provide informed consent.
2. Participants have an intact cervix.

Group 2: Enriched Population Group

1. Participants are 25 to 65 years of age and willing to provide informed consent.
2. Participants have an intact cervix.
3. 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; and/or presenting for colposcopy/LEEP/excisional intervention.

Exclusion Criteria:

Apply to all groups:

1. Impaired decision-making capacity or inability to provide informed consent.
2. History of partial or total hysterectomy, including removal of the cervix.
3. Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
4. Current pregnancy (based on self-reporting).
5. Active menstruation at time of specimen collection.
6. Vaginal bleeding within 48 hours.
7. Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
8. Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
9. Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Where it's running

• ASR Arizona CGA
  Phoenix, Arizona, United States Recruiting
• Integrated Clinical Research
  Sherman Oaks, California, United States Recruiting
• Altus Clinical Research
  Lake Worth, Florida, United States Recruiting
• Zenacare Research
  North Miami Beach, Florida, United States Recruiting
• ASR Idaho CGI
  Boise, Idaho, United States Recruiting
• Boeson Research - Great Falls
  Great Falls, Montana, United States Recruiting

Study contacts

• Study coordinator: Liliana Montes
• Email: l.montes@xytotest.com
• Phone: 305 335 6162

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Two-probe thermal ablation for cervical precancer in HIV+ women in Kenya

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• Self-swab versus clinician-collected HPV screening for vulnerable women in Reunion

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  Recruiting at 2 sites Centre Hospitalier Universitaire de la Réunion · Saint-Paul and 1 other locations · NCT07438080

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.