HPVNCT07345897
Emergency Department-based Cervical Cancer Screening Through Self-sampling
A study testing Cervical Cancer Screening in people with HPV and HPV Associated Cancers, run by University of Rochester at 1 site in United States.
Trial summary
This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, HPV Associated Cancers, HPV Cancers
- What is being tested?
- Cervical Cancer Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to Jan 2028
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cisgender women and transgender/non-binary individuals with a cervix,
- Age 30 - 65 years, and demonstrating decisional capacity to consent to participate with no known exclusion criteria present.
Who cannot join
- Past hysterectomy with cervical removal
- Known infection with HIV (as screening recommendations for people with HIV differ from the general population)
- Inability to consent (e.g., lacking decisional capacity, intoxicated, or in distress)
- Current pregnancy or in the three months after giving birth
- Use of vaginal ovules, creams or washes, vaginal contraceptives or condoms within past 3 days
- Sexual intercourse or transvaginal ultrasound scans or gynecological examinations within past 2 days
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, 1 recruiting
- Recruiting
University of Rochester Strong Memorial Hospital
Rochester, New York, 14642
Beau Abar, PHD MS, 5852758143, beau_abar@urmc.rochester.edu
Peter MacDowell, 5852741509, peter_macdowell@urmc.rochester.edu
About this study
Official title: Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.
Read the detailed description
This is a single-arm pilot trial with a prospectively enrolled sample. The participants who complete the screening survey and are determined to be adherent (n ~ 600) will be notified that they appear to be adherent with current screening guidelines, and their participation ends at this point. These participants will be considered screen failures for study purposes. Women and transgender/non-binary individuals with a cervix, aged 30-65, will be recruited from a high-volume urban ED. Follow-up will occur at 150 days to determine CC screening activity, perceived and concrete barriers to care, and participant experiences with the intervention. Electronic Health Record (EHR) review will be conducted to corroborate participants' reports of screening activities and assess completion of clinic-based testing and clinical endpoints.
- Conditions
- HPV, HPV Associated Cancers, HPV Cancers, Cervical Cancer Screening, Cervical Cancer (Early Detection)
- Being tested
- Cervical Cancer Screening
- Keywords
- HPV Screening, Cervical cancer screening, HPV, Cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Cancer ScreeningDiagnostic test
Subjects will perform self sampling for cervical cancer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by study staff on how to self-sample using a defined instructional script written at an elementary reading level, (2) provided with a packaged swab, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms. Once self sampling has been completed, the study staff will then transfer the swab to a vial of transport media and forward the specimens to the laboratory for analysis. Participants recruited to the intervention arm that subsequently decline to or are unable to self-sample in the ED will remain in the study and will receive referral for clinic-based screening. Receives: Diagnostic Test: Cervical Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of cervical cancer screening from self-sampling in the ED
Number of subjects referred for additional screening who follow through with next steps in the screening process.
Measured: In about 150 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start13 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beau Abar, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345897
- Sponsor's protocol ID
- 00011046
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made to share individual participant data however there is no current plan to share on an individual basis.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
- ClinicalTrials.gov ID
- NCT07345897
- Acronym / sponsor ID
- 00011046
- Conditions
- HPV, HPV Associated Cancers, HPV Cancers, Cervical Cancer Screening, Cervical Cancer (Early Detection)
- Keywords
- HPV Screening, Cervical cancer screening, HPV, Cervical cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jan 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 project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.
Detailed description
This is a single-arm pilot trial with a prospectively enrolled sample. The participants who complete the screening survey and are determined to be adherent (n ~ 600) will be notified that they appear to be adherent with current screening guidelines, and their participation ends at this point. These participants will be considered screen failures for study purposes. Women and transgender/non-binary individuals with a cervix, aged 30-65, will be recruited from a high-volume urban ED. Follow-up will occur at 150 days to determine CC screening activity, perceived and concrete barriers to care, and participant experiences with the intervention. Electronic Health Record (EHR) review will be conducted to corroborate participants' reports of screening activities and assess completion of clinic-based testing and clinical endpoints.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Diagnostic Test: Cervical Cancer ScreeningParticipants will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by study staff on how to self-sample using a defined instructional script written at an elementary reading level, (2) provided with a packaged swab, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms. Once self sampling has been completed, the study staff will then transfer the swab to a vial of transport media and forward the specimens to the laboratory for analysis. Participants recruited to the intervention arm that subsequently decline to or are unable to self-sample in the ED will remain in the study and will receive referral for clinic-based screening. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cisgender women and transgender/non-binary individuals with a cervix,
- Age 30 - 65 years, and demonstrating decisional capacity to consent to participate with no known exclusion criteria present.
Key exclusion criteria (6 listed)
- Past hysterectomy with cervical removal
- Known infection with HIV (as screening recommendations for people with HIV differ from the general population)
- Inability to consent (e.g., lacking decisional capacity, intoxicated, or in distress)
- Current pregnancy or in the three months after giving birth
- Use of vaginal ovules, creams or washes, vaginal contraceptives or condoms within past 3 days
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 |
|---|---|---|
| Cervical Cancer ScreeningSubjects will perform self sampling for cervical cancer. | Diagnostic test | Intervention Arm |
Primary outcome
Uptake of cervical cancer screening from self-sampling in the ED
Time frame: In about 150 days of enrollment
Number of subjects referred for additional screening who follow through with next steps in the screening process.
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 4 May 2026.
- Individual participant dataSharing planned: Undecided. No decision has been made to share individual participant data however there is no current plan to share on an individual basis.
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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 Cervical Cancer Screening in people with HPV and HPV Associated Cancers, run by University of Rochester 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 May 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 Research Administrator (585-274-1509, peter_macdowell@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of cervical cancer screening from self-sampling in the ED (time frame: In about 150 days of enrollment). 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 4 May 2026.