HPV Testing for Cervical Cancer

Overseen By Peter MacDowell, BA, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Past hysterectomy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Cervical cancer screening in the Emergency Department

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment HPV Testing for cervical cancer?

Research shows that HPV testing, when combined with other screening methods, can significantly reduce the rates of advanced cervical cancer and related deaths. It is more sensitive than traditional Pap tests, meaning it is better at detecting high-grade lesions that could lead to cancer. ^{1 2 3 4 5}

Is HPV testing for cervical cancer safe for humans?

HPV testing is generally safe for humans, but there can be psychological and possible physical harm if positive results are not managed properly. Most HPV infections are harmless, and overreacting to positive results can lead to unnecessary stress and medical interventions. ^{6 7 8 9 10}

How is HPV testing different from other treatments for cervical cancer?

HPV testing is unique because it is used primarily as a screening tool to identify women at risk of cervical cancer, rather than as a treatment. It can be combined with Pap smears to increase the sensitivity of screening and can be done through self-sampling, which offers more flexibility compared to traditional methods. ^{5 11 12 13 14}

Eligibility Criteria

This trial is for individuals who visit the emergency department and may be at risk of cervical cancer or human papillomavirus (HPV) infection. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

I am a cisgender woman or a transgender/non-binary person with a cervix.

I can make my own decisions about joining a study.

I am between 25 and 65 years old.

Exclusion Criteria

I have had a hysterectomy that included the removal of my cervix.

I have been diagnosed with HIV.

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

Participants are instructed on self-sampling for HPV during their ED visit

1 day

1 visit (in-person)

Follow-up

Participants receive a follow-up call to assess uptake of cervical cancer screening

150 days

1 call (virtual)

Treatment Details

Interventions

• HPV Testing

Trial Overview The study is testing the feasibility and effectiveness of conducting HPV testing as a method for cervical cancer screening in an emergency department setting.

Participant Groups

Group I: Intervention Arm - testing Experimental Treatment 1 Intervention

Participants in this arm will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by the 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 vial of transport media, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A comparison of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and surface plasmon resonance for genotyping of high-risk human papillomaviruses. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Combining human papillomavirus testing or cervicography with cytology to detect cervical neoplasia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Chapter 13: Primary screening of cervical cancer with human papillomavirus tests. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus testing and molecular markers of cervical dysplasia and carcinoma. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of the Anyplex II HPV28 assay with the Hybrid Capture 2 assay for the detection of HPV infection. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Overuse of Cervical Cancer Screening Tests Among Women With Average Risk in the United States From 2013 to 2014. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Introduction of human papillomavirus DNA screening in the world: 15 years of experience. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus testing in primary cervical screening and abnormal Papanicolaou management. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

False positive cervical HPV screening test results. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

HPV-based Tests for Cervical Cancer Screening and Management of Cervical Disease. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison between the Hybrid Capture 2 and the hpVIR real-time PCR for detection of human papillomavirus in women with ASCUS or low grade dysplasia. [2019]

12. Romania pubmed.ncbi.nlm.nih.gov

Human papilloma virus infection and cervical dysplasia. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus screening and cervical cancer prevention. [2017]

14. United States pubmed.ncbi.nlm.nih.gov

Self-collected human papillomavirus testing acceptability: comparison of two self-sampling modalities. [2015]