HPV Self-Collection for Cervical Cancer Prevention

Recruiting at 24 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Pregnancy, Recent birth, Hysterectomy, 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: 2

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

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's best to discuss this with the trial coordinators or your doctor.

Is HPV self-collection safe for humans?

The studies on HPV self-collection for cervical cancer screening do not report any safety concerns, suggesting it is generally safe for human use. ^{1 2 3 4 5}

How is HPV Self-Collection different from other treatments for cervical cancer prevention?

HPV Self-Collection is unique because it allows individuals to collect their own samples at home for HPV testing, which can increase participation in cervical cancer screening by reducing barriers and is as effective as samples collected by healthcare providers. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment HPV Self-Collection for cervical cancer prevention?

Research shows that self-collected HPV testing is as effective as clinician-collected samples in detecting cervical pre-cancers. It also increases participation in cervical cancer screening, especially among women who are less likely to attend regular screenings. ^{1 9 10 11 12}

Who Is on the Research Team?

Vikrant V Sahasrabuddhe

Principal Investigator

National Cancer Institute Division of Cancer Prevention

Are You a Good Fit for This Trial?

This trial is for individuals referred for colposcopy or cervical excisional procedures to prevent cervical cancer. Participants will use self-collection kits for HPV testing, which could offer more comfort and flexibility than traditional clinic-based tests.

Inclusion Criteria

I am 25 years old or older.

My cervix has not been removed.

I was referred for a colposcopy or cervical procedure after an abnormal cervical cancer screening in the last year.

Exclusion Criteria

Is pregnant when presenting for the referral visit or gave birth within the past 3 months

I have had a hysterectomy, either partial or complete.

Previous participation in the SHIP Trial. Participation is defined as completing the self-collection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants undergo self-collection of a vaginal sample and clinician-collection of a cervical test sample

One-time

1 visit (in-person)

Standard of Care Procedures

Participants undergo standard of care colposcopy with cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated

One-time

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection and procedures

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• HPV Self-Collection

Trial Overview The SHIP Trial evaluates the clinical accuracy of HPV testing using self-collected vaginal samples versus clinician-collected cervical samples. It aims to inform FDA regulatory reviews of these self-collection methods for cervical cancer screening.

How Is the Trial Designed?

Group I: Prevention (self-collected and clinician-collected samples) Experimental Treatment 9 Interventions

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

HPV Self-Collection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as HPV Self-Collection for:

• Cervical cancer screening
• Cervical cancer prevention

Approved in European Union as HPV Self-Testing for:

• Cervical cancer screening
• Cervical cancer prevention

Approved in Canada as Self-Collected HPV Sampling for:

• Cervical cancer screening
• Cervical cancer prevention

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

HPV testing on self-collected samples detected 76% of cervical intraepithelial neoplasia grade 2 (CIN2) or worse and 84% of CIN3 or worse, indicating it is a viable option for screening, especially for women who may not participate in regular screenings.

However, the sensitivity and specificity of HPV testing on self-samples were lower compared to clinician-taken samples, suggesting that while self-sampling can improve access, clinician sampling is still recommended for more accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Arbyn, M., Verdoodt, F., Snijders, PJ., et al.[2022]

A study involving 429 women aged 30 to 65 showed that mailing self-collection kits for HPV testing resulted in a 64% return rate, with 15% of samples testing positive for HPV, indicating a feasible method to increase screening among those overdue for Pap tests.

Women who tested positive for HPV were more likely to follow up with Pap tests (82%) compared to those who tested negative (51%), suggesting that self-testing can effectively encourage further screening and improve overall cervical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. Smith, JS., Des Marais, AC., Deal, AM., et al.[2020]

Self-collection for HPV-based cervical screening can significantly increase participation rates among women, especially in regions where traditional screening methods are culturally challenging due to the requirement of a speculum examination.

Self-collected samples have been shown to have similar sensitivity for detecting cervical pre-cancers as those collected by healthcare practitioners, making it a viable and effective option for improving cervical cancer screening globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Collection for Cervical Screening Programs: From Research to Reality. Hawkes, D., Keung, MHT., Huang, Y., et al.[2020]

A systematic review of 10 studies, mostly from Europe and North America, found that HPV self-testing significantly increased cervical cancer screening participation among women who were never or underscreened, with a relative compliance rate of 2.14 compared to traditional Pap testing.

The results suggest that offering self-collected HPV testing can effectively engage at-risk women in screening programs, indicating a need for new delivery methods as HPV testing becomes a primary screening tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Racey, CS., Withrow, DR., Gesink, D.[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]

Self-collected cervico-vaginal swabs showed a higher positivity rate for high-risk HPV (76%) compared to provider-collected samples (70%), indicating that self-collection could enhance cervical cancer screening coverage.

HPV-16 was the most prevalent genotype in both sample types and had the highest positive predictive value for detecting cervical intraepithelial neoplasia (CIN) grade 2 or higher, suggesting that while self-collection is effective, it may lead to increased referrals for colposcopy due to higher HPV-16 detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. Rohner, E., Edelman, C., Sanusi, B., et al.[2021]

At-home self-collection for hrHPV testing, facilitated by community lay navigators, was found to be culturally acceptable and feasible for underscreened women in Appalachian Virginia, indicating a promising approach to improve cervical cancer screening rates.

In this pilot study, 59 self-collection kits were returned, with a 16.6% rate of high-risk HPV detected, highlighting the potential of this method to reach women who lack regular healthcare access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. Mitchell, EM., Lothamer, H., Garcia, C., et al.[2022]

High-risk human papillomavirus (hr-HPV) detection is crucial for cervical cancer screening, and self-sampling is an effective and cost-efficient method that can boost participation among those who typically do not respond to traditional screening.

Self-collected samples for HPV detection are as reliable as those collected by physicians, suggesting that self-sampling could be a viable option for primary cervical cancer screening in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. Schmeink, CE., Bekkers, RL., Massuger, LF., 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]

Citations

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

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

2. England pubmed.ncbi.nlm.nih.gov

Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. [2022]

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

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Collection for Cervical Screening Programs: From Research to Reality. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. [2022]

6. 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]

7. Australia pubmed.ncbi.nlm.nih.gov

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

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

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. [2021]

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

Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. [2022]

11. England pubmed.ncbi.nlm.nih.gov

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

12. Germany pubmed.ncbi.nlm.nih.gov

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