Self-Collection HPV Testing for Cervical Cancer Prevention

Not currently recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate whether individuals can collect their own vaginal samples for HPV testing, a common virus linked to cervical cancer, instead of having a doctor do it. The goal is to determine if self-collected samples are as accurate as doctor-collected ones, potentially making cervical cancer screening easier and more comfortable for many. This approach could improve cancer prevention by encouraging more people to get screened, especially those who avoid traditional exams. Eligible participants are individuals referred for a colposcopy, a closer examination of the cervix, after abnormal HPV or cervical screening results in the past year. As an unphased trial, this study offers a unique opportunity to contribute to potentially groundbreaking research in cervical cancer prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that collecting one's own vaginal sample for HPV testing is generally safe and easy. In a study, most participants successfully returned their self-collection kits, and the majority tested negative for high-risk HPV types. Only a few tested positive for HPV-16, which is linked to a higher cancer risk. This indicates that the test can identify those who might be at risk.

Self-sampling can be more comfortable than a doctor-administered collection. This method is considered a good option for primary HPV screening, especially for those who might avoid traditional screening methods. No major issues have been reported with the self-collection process, suggesting it is a safe alternative for HPV testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HPV self-collection method for cervical cancer prevention because it offers a more accessible and less invasive way for women to collect samples for HPV testing. Unlike the standard procedure, which requires a clinician to collect cervical samples, this method allows women to collect vaginal samples themselves, potentially increasing screening rates by providing convenience and privacy. This approach could significantly improve early detection of HPV, especially in communities with limited access to healthcare facilities, ultimately enhancing cervical cancer prevention efforts.

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

Research has shown that using self-collected vaginal samples for HPV testing effectively assesses the risk of cervical cancer. In this trial, participants will both self-collect a vaginal sample and have a clinician collect a cervical test sample. Studies have found that self-collection methods encourage more people to get screened, especially those who might not otherwise participate. This approach is cost-effective and reliably detects HPV, which can lead to cervical cancer if untreated. By collecting their own samples, individuals may feel more at ease and have easier access to screening. This method offers a practical alternative to samples collected by a healthcare provider. ^{4 6 7 8 9}

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 who need a colposcopy or cervical excisional procedure and are interested in self-collecting vaginal samples for HPV testing to prevent cervical cancer. It's part of an initiative to make screening more accessible, especially for those who avoid traditional pelvic exams.

Inclusion Criteria

I am 25 years old or older.

I am willing and able to sign a consent form.

I was referred for a colposcopy or cervical procedure due to abnormal cervical cancer screening results in the last year.

Exclusion Criteria

I have had surgery or treatment to remove part of my cervix in the last year.

I have had a hysterectomy.

Previous participation in the SHIP Trial

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 or without 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 on self-collected vaginal samples versus clinician-collected cervical samples. The goal is to inform FDA regulatory reviews of self-collection methods as alternatives for cervical cancer screening.

How Is the Trial Designed?

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

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without 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

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-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]

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]

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]

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-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-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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524653/

Cost-effectiveness of human papillomavirus (HPV) self ... Our findings show that employing HPV self-collection was both affordable and effective in increasing cervical cancer screening uptake among underscreened, ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06676150

Self-collection for HPV Testing to Improve Cervical Cancer ... This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or ...

4. 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 ...

5. 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.

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/PMC11939108/

Self-Collected Vaginal Specimens for HPV Testing Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2835169

Self-Collection for Cervical Cancer Screening in a Safety ... Among participants who returned a self-collection kit, 491 (80.6%) had a negative high-risk HPV test result; 7 (1.2%) had positive HPV-16 or HPV ...

9. roche.com roche.com/stories/clinicians-perspective-HPV-self-collection

An OB-GYN's perspective on HPV self-collection Self-collection is the option for patients to collect their own vaginal samples for HPV testing. At the moment in the U.S., self-collection is ...