HPV Self-Collection for Human Papillomavirus

Overseen By Deanna Kepka

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: No cervix, Hospice, Palliative, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of HPV self-collection programs for women overdue for cervical cancer screening. The goal is to identify the best methods for offering these self-collection kits, either at home or in clinics, and to provide follow-up for those who test positive. Participants receive kits to collect samples themselves, offering an alternative to the traditional Pap test. Women or individuals with a cervix, aged 25-65, who haven't had a Pap test or HPV test in the recommended time (3.5 to 5.5 years) may be suitable candidates. The study aims to make cervical cancer screening more accessible and convenient. As an unphased trial, it offers participants the chance to contribute to research that could simplify and improve access to cervical cancer screening.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on screening methods rather than medication use.

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

Research shows that self-collection for HPV testing is a safe way for women to screen for cervical cancer. Studies have found that most women find this method easy and comfortable. No major problems have been reported with using these self-collection kits.

This method allows women to collect their own samples at home or in a clinic, which are then tested for HPV, a virus that can cause cervical cancer. The World Health Organization recommends this as an effective screening option.

Overall, self-collection for HPV testing is a safe and practical alternative to traditional methods like the Pap test.

Why are researchers excited about this trial?

Researchers are excited about HPV self-collection because it offers a convenient and private alternative to traditional cervical cancer screening methods like Pap smears. Unlike the standard procedure that requires a visit to a healthcare provider, this method allows individuals to collect samples themselves at home, which can increase accessibility and participation in screening programs. This approach could be especially beneficial for those who face barriers to accessing in-person healthcare services, ultimately leading to earlier detection and better outcomes for cervical cancer prevention.

What evidence suggests that HPV self-collection is effective for cervical cancer screening?

Research shows that HPV self-collection kits offer a promising method for cervical cancer screening. In this trial, participants will use these kits, which studies have found effective at detecting high-risk HPV, the virus that can lead to cervical cancer. This method increases screening access, particularly for women who are overdue for tests. Mailing these kits has raised testing rates among women who might not otherwise get tested. Additionally, this approach can save money, making it a practical option for screening large populations. Overall, HPV self-collection serves as an effective tool in the fight against cervical cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Deanna Kepka, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

The HPV Self-Collection Program is for women and individuals with a cervix, aged 24-64 who haven't had a Pap test in the last 3.5 years or those aged 30-65 without an HPV test in the past 5.5 years. Participants must be overdue for cervical cancer screening and have visited a participating clinic.

Inclusion Criteria

Qualifying visit to the participating clinic

I am between 25 and 65 years old.

I have missed my scheduled cervical cancer screening.

Exclusion Criteria

I do not have a cervix.

I am receiving comfort care for my illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of HPV self-collection program at clinics and homes, including protocol development and educational material distribution

12 months

Ongoing visits as needed for implementation

Follow-up

Participants with positive HPV tests are followed up for recommended care and further evaluation

12 months

Evaluation

Evaluation of the HPV self-collection program effectiveness, including surveys and interviews with healthcare team members and analysis of patient-level data

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HPV Self-Collection

Trial Overview This study aims to evaluate the effectiveness of mailing out HPV self-collection kits to women overdue for cervical cancer screening and offering them as an option at clinics. It focuses on implementing these programs rather than testing medical devices or safety.

How Is the Trial Designed?

Group I: HPV Self-Collection Experimental Treatment 1 Intervention

Patients at partnering clinics who are enrolled in the clinics' HPV self-collection program(s). The requirements for being enrolled in the program are based off of the American Cancer Society's recommendation for cervical cancer screening.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A study involving 93 women showed that a self-administered tampon for HPV testing had a concordance rate of 78.3% compared to 80.9% for physician-directed swabs, indicating similar effectiveness in detecting HPV.

The results suggest that self-collection devices like the tampon could be a feasible option for large-scale HPV screening in primary care, potentially increasing access to testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collection devices for human papillomavirus. Harper, DM., Hildesheim, A., Cobb, JL., et al.[2006]

Self-collected HPV testing demonstrated high sensitivity (88.7%) for detecting existing high-grade cervical lesions (CIN2+) and comparable performance to clinician-collected samples, suggesting it is a reliable method for cervical cancer screening.

In a study of 5109 women, self-collected HPV tests were significantly more effective than cytology in predicting new cases of CIN2+, with a sensitivity of 73.9%, highlighting its potential for earlier detection of cervical disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. Porras, C., Hildesheim, A., González, P., et al.[2022]

The study found that the swab-based self-collection method for detecting cervical HPV DNA was statistically equivalent to the standard clinical method, making it a reliable option for at-home testing.

In contrast, the tampon-based self-collection method produced a high rate of insufficient quality specimens (27%), indicating it is not a suitable alternative for HPV detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method. McLarty, JW., Williams, DL., Loyd, S., et al.[2020]

In a study involving over 16,000 women, HPV testing on self-collected samples showed similar accuracy to clinician-collected samples for detecting cervical lesions (CIN2+ and CIN3+), indicating that self-sampling could be a viable option for routine screening.

The study demonstrated that the sensitivity and specificity for detecting significant cervical lesions were not significantly different between self-collected and clinician-collected samples, supporting the use of self-sampling in organized screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. Polman, NJ., Ebisch, RMF., Heideman, DAM., et al.[2022]

A study involving 18 healthcare providers in Oregon revealed that while there are concerns and barriers to implementing HPV self-collection for cervical cancer screening, there is a strong willingness among providers to offer this option once it becomes available.

Providers believe that HPV self-collection is accepted by patients and emphasize the need for its inclusion in national screening guidelines to enhance cervical cancer screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. Bohn, JA., Fitch, KC., Currier, JJ., et al.[2023]

Self-collected vaginal samples for HPV testing showed lower sensitivity (72%) compared to physician-collected samples (92%), indicating that self-collection may not be as reliable for cervical cancer screening.

While self-collected PAP tests had a high positive predictive value, their sensitivity was only 52%, suggesting that self-collection might not improve screening efficiency in cervical cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-collection of test material. Supplement to cervical cancer screening]. Mangold, BR.[2022]

Self-collection of cervical samples for hr-HPV detection showed a significant error rate, with 9.1% of samples at UZ Ghent and 17.6% at AML failing to provide an internal control signal, indicating potential issues with sample quality.

Despite the high error rates, the prevalence of hr-HPV in the valid samples was 18.8%, suggesting that self-collection could still be a viable method for screening, but adjustments in testing protocols may be needed to account for differences in sample collection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. Verberckmoes, B., De Vos, T., Maelegheer, K., et al.[2023]

Self-collected vaginal samples (sHPV) showed a significantly lower positive detection rate for high-risk HPV compared to physician-collected samples (pHPV), with 40.4% versus 61.0% respectively, indicating that sHPV testing may not be as reliable for detecting cervical intraepithelial neoplasia (CIN) lesions.

While sHPV testing is well-accepted among participants and could help increase cervical cancer screening rates in Japan, its lower sensitivity for detecting CIN2+ lesions means it cannot yet replace traditional methods like pHPV testing or cytology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology. Aiko, KY., Yoko, M., Saito, OM., et al.[2017]

In a study involving over 30,000 women using self-collected samples for hrHPV testing, the accuracy for detecting severe cervical lesions (CIN3+) was found to be high, supporting the use of self-sampling as a primary screening method.

While self-collection showed slightly lower sensitivity compared to clinician-collected samples, it maintained high specificity, indicating that self-sampling is a viable option for cervical cancer screening, though workflow optimizations may enhance its clinical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study. Inturrisi, F., Aitken, CA., Melchers, WJG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11939108/

Self-Collected Vaginal Specimens for HPV Testing Human papillomavirus testing of self-collected vaginal specimens expands cervical cancer screening options and has potential to increase access ...

2. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(23)00076-2/fulltext

Effect of HPV self-collection kits on cervical cancer ... Mailed HPV self-collection testing has potential to increase uptake of cervical cancer screening among under-screened women. Mailed at-home HPV ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839517

Cost-Effectiveness of HPV Self-Testing Options for Cervical ... This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...

4. journals.lww.com journals.lww.com/jlgtd/fulltext/2025/04000/self_collected_vaginal_specimens_for_hpv_testing_.6.aspx

Self-Collected Vaginal Specimens for HPV Testing:... DISCUSSION. Use of self-collected vaginal specimens for primary HPV screening is an effective approach to expand access to cervical cancer screening.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524001207

Performance of a vaginal self-collection device versus ... This study aims to validate the performance of the vaginal self-sampling device (Vitroveil®) to detect high risk human papillomavirus (hrHPV) in comparison to ...