Not Yet RecruitingNot Applicable

HPV Detection Using Self-Collected Menstrual Blood

United States50 participantsStarted 2026-07

Plain-language summary

This study is evaluating whether human papillomavirus (HPV) can be accurately detected from self-collected menstrual blood samples. Participants who have had routine clinical HPV testing within the previous 90 days will collect a menstrual blood sample at home using a study-provided collection kit. The HPV test result from the menstrual blood sample will be compared with the participant's prior clinical HPV test result to assess agreement between the two methods. The goal is to determine whether menstrual blood collection may provide a feasible, noninvasive approach for HPV testing.

Who can participate

Age range

21 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Are 21 to 49 years old. * Are female, have not yet gone through menopause, and expect to have a menstrual period during the study. * Have a cervix (have not had a hysterectomy that removed the cervix). Had a routine high-risk HPV (human papillomavirus) test within the past 90 days and received a valid result (positive or negative). * Receive medical care at the participating clinic and have been identified by the study team as a possible candidate for the study. * Can read, understand, and communicate in English. * Are willing and able to follow study procedures, including using a menstrual blood collection kit and returning the sample for testing. * Are willing to provide informed consent before any study procedures are performed. * May be of any race or ethnicity. Exclusion Criteria: * Had an HPV test in the past 90 days, but the result was unclear, invalid, or could not be interpreted. * Are currently pregnant. * Have had a hysterectomy that removed the cervix. * Are not currently having menstrual periods or are unable to provide a menstrual blood sample during the study period. * Have a medical, mental health, cognitive, social, or other condition that, in the opinion of the study doctor, could make it difficult to safely participate or complete the study procedures. * Are unable to understand the study requirements, use the collection kit, or return the sample for testing. * Do not wish to participate, withdraw consent, or are unwilling to comple…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing

Timeframe: At completion of HPV testing, up to 75 days

Trial details

NCT IDNCT07733557

SponsorSamantha Batman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07

Contact for this trial

Samantha Batman, ND

434-466-9014 TSH5ME@uvahealth.org

View on ClinicalTrials.gov More Human Papillomavirus (HPV) Infection trials