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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for screening cervical cancer in the Emergency Department using HPV testing, which detects human papillomavirus, a potential cause of cervical cancer. Participants can collect their own sample during their visit, following simple instructions from the study staff. The trial seeks cisgender women and transgender or non-binary individuals with a cervix, aged 25 to 65, who have not undergone a hysterectomy that removed the cervix. As an unphased trial, it offers participants the chance to contribute to innovative screening methods that could enhance early detection of cervical cancer.

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 prior data suggests that HPV testing is safe for cervical cancer screening?

Research has shown that HPV testing is a safe and well-tolerated method for cervical cancer screening. Studies have found that undergoing an HPV test every five to eight years after a negative result is as safe as more frequent testing. This approach reduces the risk of developing cervical cancer compared to older methods like microscopic cell examination.

Additionally, HPV testing has led to a significant drop in early signs of cervical cancer. From 2008 to 2022, cases among young women who were screened decreased by 79%. Women who underwent HPV-based screenings had a 28% lower chance of developing serious cervical cancer compared to those using the older cell examination method.

Overall, these findings demonstrate that HPV testing is a safe and effective way to detect cervical cancer early and reduce the risk of serious health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HPV testing method being studied for cervical cancer because it offers a unique approach to early detection. Unlike traditional Pap smears that require clinical sampling, this method allows individuals to self-sample for HPV, increasing accessibility and privacy. This could lead to higher participation rates in screening programs, especially for those who may avoid clinical settings. By enabling more people to conveniently test themselves, this approach has the potential to improve early detection and ultimately reduce cervical cancer rates.

What evidence suggests that HPV testing is effective for cervical cancer screening?

In this trial, participants can self-sample for HPV during their ED visit. A previous study found that testing for HPV (human papillomavirus) is the most effective and affordable method for checking cervical cancer. Research has shown that screening for HPV is more effective at preventing serious cervical cancer than other methods. Between 2008 and 2022, cases of early cervical cancer dropped by 79% among women aged 20 to 24 who were screened. Another study found an 80% decrease in more severe early cervical cancer in the same group. These findings suggest that HPV testing is a strong tool for lowering the risk of cervical cancer. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10719104/

Benefits, harms and cost-effectiveness of cervical screening ... Assuming 70% coverage, we found that primary human papillomavirus (HPV) screening approaches were the most effective and cost-effective, ...

2. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7406a4.htm

Trends in Cervical Precancers Identified Through ... During 2008–2022, cervical precancer incidence decreased 79% and higher-grade precancer incidence decreased 80% among screened women aged 20–24 years.

3. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(24)00218-4/fulltext

Human papillomavirus-based cervical screening and long- ... This randomised policy trial found HPV-based screening to be superior for preventing invasive cervical cancer in the real-world setting.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837443

Cervical Cancer Screening, HPV Vaccination, and ... This decision analytical model study examines how different strategies for Papanicolaou testing, human papillomavirus (HPV) testing, and HPV ...

5. academic.oup.com academic.oup.com/jnci/article/116/9/1525/7687058

Primary human papillomavirus testing vs cotesting: clinical ... These data suggest that cotesting confer an unfavorable benefit-to-harm ratio over primary HPV testing.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881993/

Screening for Cervical Cancer - PMC Testing using HPV assays at 5-year intervals results in a lower risk of cancer and precancer than cytology testing at 3-year intervals. Sequential negative HPV ...

7. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/hpv-testing-for-cervical-cancer-may-be-safe-at-longer-intervals-than-what-current-guidelines-recommend/

HPV Testing for Cervical Cancer May Be Safe at Longer ... HPV testing eight years after a negative result instead of the recommended five was found comparable to standard cytology screening.

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21628

Cervical cancer screening for individuals at average risk: 2020 ... The evidence from RCTs and other studies showed that HPV-based cervical cancer screening has superior sensitivity and long-term negative ...