Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

Conditions

• Cervical Carcinoma
• Human Papillomavirus Infection

Eligibility Criteria

Sex

FEMALE

Age

25 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of a cervical sample by clinician
• Cervical Biopsy — PROCEDURE
  Undergo cervical biopsy
• Colposcopy — PROCEDURE
  Undergo colposcopy
• Electronic Health Record Review — OTHER
  Ancillary studies
• Endocervical Curettage — PROCEDURE
  Undergo endocervical curettage
• Excision — PROCEDURE
  Undergo cervical excisional procedure
• HPV Self-Collection — PROCEDURE
  Undertake self-collection of vaginal sample
• Human Papillomavirus Test — PROCEDURE
  Undergo HPV testing of self-collected vaginal samples and cervical samples
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Nov 24, 2025

Status verified

Dec 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

500 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Prevention (self-collected and clinician-collected samples)
  Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Primary Outcome Measure

Clinical sensitivity for self-collected (SC) samples [ Time Frame: One-time, up to 60 days ]

Locations (18)

Find similar trials in Birmingham, AL

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