HPV Self-Collection for Cervical Cancer Prevention (SHIP-A-S01 Trial)
Palo Alto (17 mi)Overseen byVikrant V Sahasrabuddhe
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
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.
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.24579
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.1351112
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.5681012
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.
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 was referred for a colposcopy or cervical procedure after an abnormal cervical cancer screening in the last year.
I am 25 years old or older.
My cervix has not been removed.
Exclusion Criteria
I have had a hysterectomy, either partial or complete.
I am experiencing unusual bleeding or pelvic pain.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Prevention (self-collected and clinician-collected samples)Experimental Treatment10 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
The University of North Carolina at Chapel HillChapel Hill, NC
Emory University Hospital/Winship Cancer InstituteAtlanta, GA
University of Alabama at Birmingham Cancer CenterBirmingham, AL
UCSF Medical Center-ParnassusSan Francisco, CA
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. [2022]High-risk human papillomavirus (hr-HPV) detection will become an important tool in the screening for cervical cancer. Self-sampling is an inexpensive and well-accepted method for HPV detection that will increase participation of nonresponders in current screening programs. Even more, because self-collected samples are as good as physician-collected samples for HPV detection, self-sampling might be a suitable method for future primary cervical cancer screening.
Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. [2022]HPV testing has emerged as an effective cervical cancer screening test. The use of HPV self-testing has the potential to address many barriers to screening and reach at-risk women through engagement in screening. However, there is a need to examine the evidence for whether offering self-collected HPV testing in practice increases screening compliance. The objective of this review is to determine to what extent providing self-collected HPV testing increases screening participation in women who are never or underscreened for cervical cancer.
[Self-collection of test material. Supplement to cervical cancer screening]. [2022]Recent studies have reported high sensitivity of human papillomavirus (HPV) testing from self-collected vaginal specimens. These results suggest the possibility of introducing self-collection of samples for cervical cancer screening to increase overall participation. The current study compared test results from self-collected and physician-collected specimens.
Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. [2022]Screening for human papillomavirus (HPV) infection is more effective in reducing the incidence of cervical cancer than screening using Pap smears. Moreover, HPV testing can be done on a vaginal sample self-taken by a woman, which offers an opportunity to improve screening coverage. However, the clinical accuracy of HPV testing on self-samples is not well-known. We assessed whether HPV testing on self-collected samples is equivalent to HPV testing on samples collected by clinicians.
Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. [2022]Self-collected human papillomavirus (HPV) testing could reduce barriers to cervical cancer screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica.
Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology. [2017]The aim of this study was to assess the accuracy of self-collected vaginal samples compared with physician-collected cervical samples for high-risk human papillomavirus (HPV) testing in Japanese women with abnormal cervical cytology. We also assessed the acceptability of self-collected HPV (sHPV) testing using a questionnaire.
Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. [2020]Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals.
Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. [2022]Objective: Women without regular health care providers or a medical home routinely fail to complete recommended cervical cancer screening. At-home self-collection of samples to test for high-risk strains of human papillomavirus (hrHPV) can improve screening rates. This study documents acceptability and feasibility of community lay navigator (LN)-facilitated at-home self-collection for underscreened women in Appalachian Virginia. Materials and Methods: This study used mixed methods in three phases. Phase I involved focus groups of LNs to ensure cultural acceptability of self-collection, and to enhance recruitment of medically underserved women. An environmental scan of community resources and climate was created in Phase II. During Phase III, underscreened women in Appalachian Virginia (the far southwest corner of Virginia) were recruited to complete hrHPV testing using LN-provided self-collection kits. Results: LN-facilitated at-home self-collection for HPV testing was deemed culturally acceptable and feasible to participants in this community-based pilot study. Self-kit training included 64 LNs, of which 35 engaged in the study and were provided 77 kits and instructions. A total of 59 self-kits were returned, of which 42 were correctly completed with valid HPV results, yielding a 16.6% hrHPV rate. Conclusions: Over a quarter of the women LNs recruited had no medical home, indicating this delivery model may have potential to reach women at increased risk of being underscreened for cervical cancer. Research is needed to identify optimal approaches to increase LN participation in outreach self-collection interventions.
Self-Collection for Cervical Screening Programs: From Research to Reality. [2020]In 2018, there were an estimated 570,000 new cases of cervical cancer globally, with most of them occurring in women who either had no access to cervical screening, or had not participated in screening in regions where programs are available. Where programs are in place, a major barrier for women across many cultures has been the requirement to undergo a speculum examination. With the emergence of HPV-based primary screening, the option of self-collection (where the woman takes the sample from the vagina herself) may overcome this barrier, given that such samples when tested using a PCR-based HPV assay have similar sensitivity for the detection of cervical pre-cancers as practitioner-collected cervical specimens. Other advantages of HPV-based screening using self-collection, beyond the increase in acceptability to women, include scalability, efficiency, and high negative predictive value, allowing for long intervals between negative tests. Self-collection will be a key strategy for the successful scale up of cervical screening programs globally in response to the WHO call for all countries to work towards the elimination of cervical cancer as a public health problem. This review will examine self-collection for HPV-based cervical screening including the collection devices, assays and possible routine laboratory processes considering how they can be utilized in cervical screening programs.
Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. [2021]Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening.
HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023]Polymerase chain reaction based human papilloma virus (HPV) self-collection for cervical cancer screening is well established. It is utilized worldwide, accepted by patients, is cost-effective, has comparable sensitivity to provider-collected samples, and increases screening rates, however clinical practice in the United States has not shifted to include HPV self-collection. This study sought to examine provider knowledge and attitudes to better understand why HPV self-collection is not being utilized.
Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]Self-collection of cervical samples to detect high-risk human papillomavirus (hr-HPV) is a trending topic in primary cervical cancer screening. This study evaluates the applicability of a self-sampling device to routine molecular procedures for hr-HPV detection.