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

Trial Summary

What is the purpose of this trial?

The objective of the study is to develop, pilot, and analyze the effectiveness of HPV self-collection programs which will be used to follow up among women overdue for cervical cancer screening. The investigators will develop protocols for in-clinic and home-based HPV-self-collection programs and follow-up system for HPV-positive tests for community health centers and/or clinics. The program is meant to mail HPV-self-collection kits to women who are due and/or overdue for cervical cancer screening and the program is also meant to present women seen in clinic with a self-collection option for screening alongside a Pap test option. The research team will develop related informational resources on how to complete the test as well as information on screening options. The study will neither experiment nor test the effectiveness of the self-collection process nor the assay of specimens for HPV and high-risk HPV strains. It is not a clinical investigation to assess the safety or effectiveness of a medical device. The study is implementation science and seeks to find optimal ways to implement this World Health Organization recommended screening option.

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 data supports the effectiveness of the treatment HPV Self-Collection for Human Papillomavirus?

Research shows that HPV testing on self-collected samples is as effective as testing on samples collected by healthcare providers. It is well accepted by patients, cost-effective, and can increase screening rates for cervical cancer. ^{1 2 3 4 5}

Is HPV self-collection safe for humans?

The research does not specifically address safety concerns, but HPV self-collection is generally considered safe as it involves collecting a sample from the body without invasive procedures. ^{4 5 6 7 8}

How does HPV self-collection differ from other treatments for HPV detection?

HPV self-collection allows individuals to collect their own samples at home for HPV testing, which can be more convenient and accessible compared to traditional methods where a clinician collects the sample during a pelvic exam. This method can help increase participation in cervical cancer screening by reducing barriers such as the need for a clinical visit. ^{2 4 5 8 9}

Research Team

Deanna Kepka, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023]

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

Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology. [2017]

7. England 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. [2022]

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

Collection devices for human papillomavirus. [2006]

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

Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method. [2020]