Concordance of HPV Detection Using Self-Collected Menstrual Blood
Samantha Batman
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.
Eligibility
- Age range
- 21–49 years
- Sex
- Female
- Healthy volunteers
- No
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, includi…
Interventions
- DeviceEndometrics Menstrual Blood Collection Kit
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.
Location
- University of VirginiaCharlottesville, Virginia