NCT07281430 · National Cancer Institute (NCI)
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of a cervical sample by clinician
PROCEDURE
Cervical Biopsy
Undergo cervical biopsy
PROCEDURE
Colposcopy
Undergo colposcopy
OTHER
Electronic Health Record Review
Ancillary studies
PROCEDURE
Endocervical Curettage
Undergo endocervical curettage
PROCEDURE
Excision
Undergo cervical excisional procedure
PROCEDURE
HPV Self-Collection
Undertake self-collection of vaginal sample
PROCEDURE
Human Papillomavirus Test
Undergo HPV testing of self-collected vaginal samples and cervical samples
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Clinical sensitivity for self-collected (SC) samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a positive SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
Clinical sensitivity for clinician-collected (CC) samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a positive CC sample given CIN2+. Will report point estimate and 95% CIs.
Clinical specificity for SC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a negative SC sample given \< CIN2. Will report point estimate and 95% CIs.
Clinical specificity for CC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a negative CC sample given \< CIN2. Will report point estimate and 95% CIs.
False positive rate (FPR) for SC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a positive SC sample given \< CIN2. Will report point estimate and 95% CIs.
FPR for CC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a positive CC sample given \< CIN2. Will report point estimate and 95% CIs.
False negative rate (FNR) for SC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a negative SC sample given CIN2+. Will report point estimate and 95% CIs.
FNR for CC samples
Time frame: One-time, up to 60 days
Will be defined as the probability of a negative CC sample given CIN2+. Will report point estimate and 95% CIs.
Sensitivity ratio for SC versus CC samples
Time frame: One-time, up to 60 days
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Specificity ratio for SC versus CC samples
Time frame: One-time, up to 60 days
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
False positive (FP) ratio for SC versus CC samples
Time frame: One-time, up to 60 days
Will be defined as the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
False negative (FN) ratio for SC versus CC samples
Time frame: One-time, up to 60 days
Will be defined as the FNR of SC divided by the FBR of CC. Will report point estimate and 95% CIs.
Positive percent agreement
Time frame: One-time, up to 60 days
Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
Negative percent agreement
Time frame: One-time, up to 60 days
Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Willingness and ability to provide a documented informed consent
- Is 25 years or older
- Has an intact cervix
- Has had a referral for colposcopy in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit, and/or for cervical excisional procedure
- Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
Exclusion criteria
- Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
- Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- Known medical conditions that, in the opinion of the investigator, preclude study participation
- Previous participation in the SHIP Trial or another cervical cancer screening study within the past 12 months. Participation is defined as completing the self-collection
- Is experiencing unusual bleeding or pelvic pain
Where
- Birmingham, Alabama
- Atlanta, Georgia
- Lafayette, Louisiana
- New Orleans, Louisiana
- Minneapolis, Minnesota
- Albuquerque, New Mexico
- The Bronx, New York
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations