Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial
NCT Number: NCT06498661
Acronym: SHIP-A-S01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Carcinoma|Human Papillomavirus Infection
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Cervical Biopsy|PROCEDURE: Colposcopy|PROCEDURE: Endocervical Curettage|PROCEDURE: Excision|PROCEDURE: HPV Self-Collection|PROCEDURE: Human Papillomavirus Test|OTHER: Questionnaire Administration|OTHER: Survey Administration
Sponsor: National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-26
Completion Date: 2025-03-14
Locations: Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

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.

Primary Outcome Measures: Clinical sensitivity, Will be defined as the probability of a testing human papillomavirus (HPV) positive on self- collected (SC) (or clinician collected \[CC\]) sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (Cis)., One-time, up to 90 days|Clinical specificity, Will be defined as the probability of testing HPV negative on SC (or CC) sample given \< CIN2. Will report point estimate and 95% Cis., One-time, up to 90 days|False positive ratio (FPR), Will be defined as the probability of testing HPV positive on SC (or CC) sample given \< CIN2. Will report point estimate and 95% CIs ., One-time, up to 90 days|False negative ratio (FNR), Will be defined as the probability of testing a HPV negative on SC (or CC) given CIN2+. Will report point estimate and 95% CIs., One-time, up to 90 days|Sensitivity ratio, 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, 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|FPR ratio, The FPR 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|FNR ratio, The FNR 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 for CC, expressed as a percent. Will report point estimate and 95% Cis., One-time, up to 90 days
Other Outcome Measures: Human factors affecting usability, Will be assessed by questionnaire data., One-time, up to 90 days|Human factors affecting acceptability, Will be assessed by questionnaire data., One-time, up to 90 days|Human factors affecting references for self-collection, Will be assessed by questionnaire data., One-time, up to 90 days