HPV Detection Using Self-Collected Menstrual Blood

This study is looking at a new way to test for Human Papillomavirus (HPV) using menstrual blood that you collect yourself at home. We want to see if HPV can be accurately found in these samples. You can join if you are a woman between 21 and 49 years old, have not gone through menopause, and have had a routine HPV test within the last 90 days. We will compare your self-collected menstrual blood sample, using the Endometrics Menstrual Blood Collection Kit, to your previous clinical HPV test result to see how well they match. The goal is to find out if this self-collection method could be a simple, non-invasive way to test for HPV. The study plans to enroll 50 participants, and its current status is unclear.

Study design: This is an interventional study with a planned enrollment of 50 participants. It is evaluating a device for self-collection of menstrual blood.
What's involved: You will collect a menstrual blood sample at home using a study-provided kit. This sample will be compared to a routine HPV test you had within the last 90 days.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, concordance of HPV detection, is measured at the completion of HPV testing, up to 75 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

HPV Detection Using Self-Collected Menstrual Blood

Not Yet Recruiting

NAAges 21–49InterventionalDiagnostic

Samantha Batman

~50 participants

Updated 2026-07-29 on ClinicalTrials.gov

What's tested:Endometrics Menstrual Blood Collection Kit

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing

Measured over At completion of HPV testing, up to 75 days

Conditions

Human Papillomavirus (HPV) Infection

Where it's being run

1 sites across 1 states

Virginia1

Who to contact

Samantha Batman, ND

[email protected]

434-466-9014

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 complete the required study procedures.

Are taking part in another research study or have another circumstance that, in the opinion of the study team, could affect study results or participant safety.

Are currently incarcerated.

What this trial measures

Concordance of HPV Detection Between Menstrual Blood and Clinical HPV TestingAt completion of HPV testing, up to 75 days
Agreement between high-risk HPV test results obtained from self-collected menstrual blood specimens and prior routine clinical cervical HPV test results. Concordance will be assessed for HPV16 positive, HPV18 positive, pooled high-risk HPV positive, and HPV negative categories. Supportive analyses may include positive percent agreement and negative percent agreement.

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