HPV Self-Sampling for Cervical Cancer

(HPVselftest Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Positive HPV, Hysterectomy, Consent, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for women in Québec to self-screen for HPV (human papillomavirus), which can lead to cervical cancer. The goal is to determine if this self-sampling method is preferred and if it increases screening rates, particularly among women without a family doctor. Participants will be divided into four groups, each trying different methods to pick up and return their self-sampling kits. Women aged 25 to 65, who speak French and have internet access, may be suitable for this trial. The trial aims to make HPV screening easier and more accessible. As an unphased trial, this study offers a unique opportunity to contribute to more convenient and accessible cervical cancer screening for women in Québec.

What prior data suggests that HPV self-sampling is safe for cervical cancer screening?

Research has shown that HPV self-sampling is generally safe. One study found that samples collected by individuals for HPV testing are accurate and reliable, meaning the results can be trusted. Another study discovered that self-sampling for HPV is not only safe but also a good alternative to tests done in a clinic. Participants in various studies have found this method acceptable and easy to use.

Regarding side effects or negative outcomes, available data do not show any major safety concerns with self-sampling for HPV. Notably, self-sampling can make cervical cancer screening more accessible, especially for those who may not easily reach a doctor. Overall, evidence supports HPV self-sampling as a safe option for cervical cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to cervical cancer screening through HPV self-sampling. Unlike traditional Pap smears that require a visit to a healthcare provider, this method allows women to collect their samples in a more comfortable and convenient setting, whether at home, a pharmacy, or a clinic. This flexibility could increase screening rates by making the process less intimidating and more accessible. By reducing barriers to testing, this self-sampling method has the potential to catch high-risk HPV infections earlier, ultimately improving early detection and outcomes for cervical cancer.

What evidence suggests that HPV self-sampling is an effective screening method for cervical cancer?

Research has shown that self-testing for HPV effectively screens for cervical cancer. In this trial, participants will be divided into groups based on how they receive and return their self-sampling kits. One group will receive and return their kit by mail, another will pick up their kit from a community pharmacy and return it by mail, a third group will collect their kit from a family planning clinic and perform the self-sample on-site, and a fourth group will retrieve their kit and perform the self-sample at a vaccination center. In one study, over 90% of women who received a positive result from self-testing sought the necessary medical care. This method can increase screening, especially for those who might not visit a clinic. Evidence confirms that self-testing is safe and accurate, providing a good alternative to traditional clinic tests. Overall, it has proven to be a reliable way to reach more people and enhance screening efforts. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women aged 25-65 in Québec who are eligible for cervical cancer screening. It's designed to test if HPV self-sampling is an effective way to screen for cervical cancer, especially among those without a family doctor.

Inclusion Criteria

Have internet access (for completing the forms)

Have a valid mailing address, email address, and phone number

Have a CHUS medical record number

Exclusion Criteria

I have tested positive for HPV.

I have had my uterus removed.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-sampling

Participants receive self-sampling kits and perform HPV self-sampling

6 weeks

1 visit (self-sampling at home or designated location)

Result Notification

Participants receive their HPV test results and next steps via email

8-12 weeks after sample submission

Follow-up

Participants are monitored for safety and effectiveness after receiving results

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HPV self-sampling test

Trial Overview The study tests the feasibility of HPV self-sampling by dividing participants into four groups with different methods of kit distribution and return. The samples will be analyzed using the Cobas HPV test, and follow-up care pathways are planned based on results.

How Is the Trial Designed?

Group I: Vaccination center Experimental Treatment 1 Intervention

Finally, a fourth group will retrieve their kit and perform the self-sample at a vaccination center in Sherbrooke, with samples then transported by a local network.

Group II: Mail Experimental Treatment 1 Intervention

One group will receive and return their self-sampling kit by mail.

Group III: Family planning clinic Experimental Treatment 1 Intervention

A third group will collect their kit from a family planning clinic, perform the self-sample on-site, and it will be transported by a local courier network.

Group IV: Community pharmacy Experimental Treatment 1 Intervention

A second group will pick up their kit from a community pharmacy and return it by mail.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5008928/

Self-sampling for HPV to enhance uptake of cervical ... More than 90% of women with a positive HPV result in the self-sampling group complied with follow-up. As a result of this work, the Dutch screening program has ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834245

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00289-5/fulltext

Impact of mode of offer of self-sampling to people overdue ... The secondary outcome suggests those screened by self-sampling would not have been screened otherwise and contribute to increased screening ...

4. gocm.bmj.com gocm.bmj.com/content/4/3/e000059

the promise and future of self-sampling HPV testing Evidence from both high-income and low-income areas suggests that self-sampling HPV testing can effectively increase cervical cancer screening ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70041

Self‐collected vaginal specimens for human papillomavirus ... One systematic review reported that, in 40 of 42 studies, self-collected primary HPV testing increased the proportion of participants completing ...

6. dceg.cancer.gov dceg.cancer.gov/news-events/news/2025/self-collection-hpv-testing

New Guidelines for HPV Testing Using Self Collection - NCI New guidelines for clinicians performing cervical cancer screening advise on management of HPV test results from self-collected vaginal samples.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144659/

Self-Collection for Cervical Cancer Screening in a Safety- ... Overall, 84 of 609 participants (13.8%) had a positive high-risk HPV test result that required follow-up (77 with cytology and 7 with colposcopy) ...

8. journals.plos.org journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0005149

The acceptability, safety, and performance of primary cervical ... Self-collection for HPV-based cervical screening during pregnancy is highly acceptable, safe, and feasible, with performance comparable to the general ...