HPV Self-Collection for Cervical Cancer Prevention

(SHIP-A-S01 Trial)

Recruiting at 25 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: Unknown

520 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, but please consult with the trial coordinators for confirmation.

What data supports the idea that HPV Self-Collection for Cervical Cancer Prevention is an effective treatment?

The available research shows that HPV Self-Collection is effective because it performs similarly to samples collected by doctors in detecting early signs of cervical cancer. It also increases participation in screening programs, especially among women who are less likely to attend regular screenings. This method helps overcome barriers like the need for a clinical visit, making it easier for more women to get tested and potentially reducing the number of cervical cancer cases. ^{1 2 3 4 5}

What safety data exists for HPV self-collection for cervical cancer prevention?

The studies reviewed focus on the performance, accuracy, and acceptability of self-collected HPV samples for cervical cancer screening. They indicate that self-collected samples have comparable performance to clinician-collected samples in detecting high-risk HPV and precursor lesions. The studies also highlight the acceptability and feasibility of self-collection, particularly in underserved populations, suggesting it is a safe and effective method to increase screening coverage. However, specific safety data, such as adverse effects or complications, is not directly addressed in these abstracts. ^{2 6 7 8 9}

Is HPV Self-Collection a promising treatment for cervical cancer prevention?

Yes, HPV Self-Collection is a promising treatment for cervical cancer prevention. It allows people to collect their own samples at home, making it easier and more comfortable to get tested. This method is as effective as samples collected by doctors, and it can help increase the number of people who participate in cervical cancer screening. It is also cost-effective and widely accepted by patients. ^{2 8 10 11 12}

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. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal 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. 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.

Research Team

Vikrant V Sahasrabuddhe

Principal Investigator

National Cancer Institute Division of Cancer Prevention

Eligibility Criteria

The SHIP Trial is for individuals who need a colposcopy or cervical excisional procedure and are interested in self-collecting vaginal samples for HPV testing. This trial aims to improve cervical cancer prevention by offering an alternative to traditional pelvic exams.

Inclusion Criteria

I am willing to undergo detailed cervical exams and possibly treatments if needed.

I am willing and able to sign a consent form.

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

Exclusion Criteria

Known medical conditions that, in the opinion of the investigator, preclude study participation

I had surgery or treatment on my cervix within the last year.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

The emphasis in the pilot phase of the study will be on streamlining and refining study procedures and clinical and operational workflows.

Up to 90 days

Sample Collection and Testing

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

One-time

Follow-up

Participants are monitored for safety and effectiveness after sample collection and testing. Laboratory results are collected for study analysis purposes.

Up to 90 days

Treatment Details

Interventions

• HPV Self-Collection

Trial Overview This study tests the clinical accuracy of HPV testing on self-collected vaginal samples versus those collected by clinicians. It's part of efforts to increase access to screening and inform FDA reviews of self-collection methods for detecting cervical cancer risks.

Participant Groups

Group I: Prevention (self-collected and clinician-collected samples) Experimental Treatment 10 Interventions

Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with 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+

Findings from Research

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]

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]

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]

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 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-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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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. Australia pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. 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]

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

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

11. Germany pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

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