Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach

2 countries

14 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Progress72%

Sep 2024Dec 2026

Study Start

First participant enrolled

September 13, 2024

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

September 24, 2024

Last Update Submit

April 28, 2026

Conditions

Cervical Carcinoma Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (14)

Clinical sensitivity for self-collected (SC) samples
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
One-time, up to 90 days
Clinical sensitivity for clinician-collected (CC) samples
Will be defined as the probability of testing HPV positive on CC sample given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
Clinical specificity for SC samples
Will be defined as the probability of testing HPV negative on SC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
Clinical specificity for CC samples
Will be defined as the probability of testing HPV negative on CC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
False positive rate (FPR) for SC samples
Will be defined as the probability of testing HPV positive on SC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
FPR for CC samples
Will be defined as the probability of testing HPV positive on CC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 90 days
False negative rate (FNR) for SC samples
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
FNR for CC samples
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 90 days
Sensitivity ratio for SC versus CC samples
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
Specificity ratio for SC versus CC samples
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
False positive (FP) ratio for SC versus CC samples
The FP ratio is the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
False negative (FN) ratio for SC versus CC samples
The FN ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
One-time, up to 90 days
Positive percent agreement
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.
One-time, up to 90 days
Negative percent agreement
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.
One-time, up to 90 days

Other Outcomes (3)

Human factors affecting usability
One-time, up to 90 days
Human factors affecting acceptability
One-time, up to 90 days
Human factors affecting preferences for self-collection
One-time, up to 90 days

Study Arms (1)

Prevention (self-collected and clinician-collected samples)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionProcedure: Cervical BiopsyProcedure: ColposcopyOther: Electronic Health Record ReviewProcedure: Endocervical CurettageProcedure: ExcisionProcedure: HPV Self-CollectionProcedure: Human Papillomavirus TestOther: Questionnaire AdministrationOther: Survey Administration