Actively Recruiting
Self-Collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial as part of the NCI Cervical Cancer 'Last Mile' Initiative
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
500
Participants Needed
18
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating self-collected vaginal samples for human papillomavirus (HPV) testing compared to clinician-collected cervical samples in patients referred for colposcopy and/or cervical excisional procedures. The goal is to improve cervical cancer prevention by increasing access to screening, especially since many individuals are not screened enough or at all. This trial is part of the National Cancer Institute's Cervical Cancer 'Last Mile' Initiative, aiming to support regulatory review of self-collection methods as alternatives to clinician-collected samples. Participants first collect a vaginal sample themselves and then have a cervical sample collected by a clinician. They undergo standard of care colposcopy, possibly including biopsy, endocervical curettage, or cervical excisional procedures, as needed. Several self-collection devices and assays are being evaluated independently using a similar study design. During the one-time study visit, laboratory results from both self-collected and clinician-collected samples will be analyzed within 60 days. Researchers will assess clinical accuracy measures such as sensitivity, specificity, false positive and negative rates, and agreement between sample types. Additional questionnaires and health record reviews help evaluate usability and preferences related to self-collection, with safety monitoring included throughout participation.
CONDITIONS
Brief Title
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to provide documented informed consent
- Female aged 25 years or older
- Has an intact cervix
- Referred for colposcopy due to positive HPV test or abnormal cervical screening within the past 12 months, or referred for cervical excisional procedure
- Willing and able to undergo colposcopy and related cervical procedures if clinically indicated
You will not qualify if you...
- Pregnant at referral visit or gave birth within the past 3 months
- History of excisional or ablative therapy to the cervix in the last 12 months
- Complete or partial hysterectomy including removal of the cervix
- Medical conditions that prevent study participation as judged by investigator
- Previous participation in the SHIP Trial or another cervical cancer screening study within 12 months
- Experiencing unusual bleeding or pelvic pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - One-time, up to 60 days
Participants perform self-collection of a vaginal sample followed by clinician-collection of a cervical test sample. Participants then undergo standard of care colposcopy with or without cervical biopsy, endocervical curettage, and/or cervical excisional procedures as clinically indicated.
1 visit (in-person)
Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Louisiana State University
Lafayette, Louisiana, United States, 70503
Actively Recruiting
4
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
5
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
6
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
7
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
8
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States, 10461
Actively Recruiting
9
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
11
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
12
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73190
Actively Recruiting
13
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
15
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
16
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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