Human Papillomavirus (HPV) InfectionNCT07733557
HPV Detection Using Self-Collected Menstrual Blood
A study testing Endometrics Menstrual Blood Collection Kit in people with Human Papillomavirus (HPV) Infection, run by Samantha Batman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women only
- Conditions the study is for
- Human Papillomavirus (HPV) Infection
- What is being tested?
- Endometrics Menstrual Blood Collection Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Samantha Batman, MD, 434-466-9014, TSH5ME@uvahealth.org
About this study
Official title: Concordance of HPV Detection Using Self-Collected Menstrual Blood
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.
- Conditions
- Human Papillomavirus (HPV) Infection
- Being tested
- Endometrics Menstrual Blood Collection Kit
- Medical subject headings
- Papillomavirus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrics Menstrual Blood Collection KitDevice
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 group | Role | What they receive |
|---|---|---|
| Menstrual Blood Self-Collection | Experimental | Not described Receives: Device: Endometrics Menstrual Blood Collection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing
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.
Measured: At completion of HPV testing, up to 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samantha Batman
- Sponsor type
- University, hospital or other
- Collaborators
- Endometrics
- Responsible party
- Sponsor-investigator, Samantha Batman, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733557
- Sponsor's protocol ID
- 303596
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of HPV Detection Using Self-Collected Menstrual Blood
- ClinicalTrials.gov ID
- NCT07733557
- Acronym / sponsor ID
- 303596
- Conditions
- Human Papillomavirus (HPV) Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samantha BatmanUniversity, hospital or other
- Collaborators
- Endometrics
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menstrual Blood Self-Collection | Experimental | Device: Endometrics Menstrual Blood Collection Kit |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrics Menstrual Blood Collection KitInvestigational 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. | Device | Menstrual Blood Self-Collection |
Primary outcome
Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing
Time frame: At 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrics Menstrual Blood Collection Kit in people with Human Papillomavirus (HPV) Infection, run by Samantha Batman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Batman, ND (434-466-9014, TSH5ME@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.