HPV Detection Using Self-Collected Menstrual Blood

Conditions

• Human Papillomavirus (HPV) Infection

Eligibility Criteria

Sex

FEMALE

Age

21 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Endometrics Menstrual Blood Collection Kit — DEVICE
  Investigational self-collection menstrual blood sampling kit used to collect menstrual blood specimens for HPV testing and concordance assessment with prior routine clinical HPV test results.

Study Details

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.

Key Dates

First listed

Jul 29, 2026

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Menstrual Blood Self-Collection

Primary Outcome Measure

Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing [ Time Frame: At completion of HPV testing, up to 75 days ]

Central Contacts

• Samantha Batman, ND
  434-466-9014
  [email protected]

Locations (1)

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