Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01) (SHIP-A-S01)

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Carcinoma; Human Papillomavirus Infection
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Other: Electronic Health Record Review; Procedure: Cervical Biopsy; Procedure: Colposcopy; Procedure: Endocervical Curettage; Procedure: Excision; Procedure: HPV Self-Collection; Procedure: Human Papillomavirus Test; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)

EXPLORATORY OBJECTIVES:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one time), laboratory results available within 30 days are collected for study analysis purposes.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Cancer Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Science Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University/Sidney Kimmel Cancer Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Cancer Center
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Einstein Campus
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center-UC Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-Magee Womens Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU Massey Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• GROUP A: Willingness and ability to provide a documented informed consent
• GROUP A: Is 25 years or older
• GROUP A: Has an intact cervix
• GROUP A: Has had a referral for colposcopy or cervical excisional procedure 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
• GROUP A: 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
• GROUP B: Willingness and ability to provide a documented informed consent
• GROUP B: Is 25 years or older
• GROUP B: Has an intact cervix
• GROUP B: Eligible for regular cervical cancer screening by current national guidelines

Exclusion Criteria:

• GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
• GROUP A: 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
• GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP A: Is experiencing unusual bleeding or pelvic pain
• GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
• GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
• GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
• GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (self-collected and clinician-collected samples); Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Procedure: Cervical Biopsy; Undergo cervical biopsy conducted by clinician; Procedure: Colposcopy; Undergo colposcopy conducted by clinician; Other Names: CP; Procedure: Endocervical Curettage; Undergo endocervical curettage conducted by clinician; Procedure: Excision; Undergo cervical excisional procedure conducted by clinician; Other Names: Abscission; Extirpation; Surgical Removal; Procedure: HPV Self-Collection; Undertake self-collection of vaginal samples; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection; Procedure: Human Papillomavirus Test; Undergo HPV testing of self-collected vaginal samples and cervical samples; Other Names: HPV Assay; HPV Test; Human Papillomavirus; Procedure: Biospecimen Collection; Undergo collection of cervical samples by clinician; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection
Experimental: Group B (self-collected and clinician-collected samples); Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Procedure: Cervical Biopsy; Undergo cervical biopsy conducted by clinician; Procedure: Colposcopy; Undergo colposcopy conducted by clinician; Other Names: CP; Procedure: Endocervical Curettage; Undergo endocervical curettage conducted by clinician; Procedure: Excision; Undergo cervical excisional procedure conducted by clinician; Other Names: Abscission; Extirpation; Surgical Removal; Procedure: HPV Self-Collection; Undertake self-collection of vaginal samples; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection; Procedure: Human Papillomavirus Test; Undergo HPV testing of self-collected vaginal samples and cervical samples; Other Names: HPV Assay; HPV Test; Human Papillomavirus; Procedure: Biospecimen Collection; Undergo collection of cervical samples by clinician; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical sensitivity for self-collected (SC) samples (Group A)	Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia [CIN]2+). Will report point estimate and 95% confidence intervals (CIs).	One-time, up to 30 days
Clinical sensitivity for clinician-collected (CC) samples (Group A)	Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs.	One-time, up to 30 days
Sensitivity ratio for SC versus CC samples (Group A)	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 30 days
Difference in clinical sensitivity between SC and CC samples (Group A)	Will report point estimate and 95% CIs.	One-time, up to 30 days
Clinical specificity for SC samples (Group A)	Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.	One-time, up to 30 days
Clinical specificity for CC samples (Group A)	Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.	One-time, up to 30 days
Specificity ratio for SC versus CC samples (Group A)	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 30 days
Difference in clinical specificity between SC and CC samples (Group A)	Will report point estimate and 95% CIs.	One-time, up to 30 days
False positive rate (FPR) for SC samples (Group A)	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 30 days
FPR for CC samples (Group A)	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 30 days
FPR ratio for SC versus CC samples (Group A)	The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs.	One-time, up to 30 days
Difference in FPR ratio between SC and CC samples (Group A)	Will report point estimate and 95% CIs.	One-time, up to 30 days
False negative rate (FNR) for SC samples (Group A)	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 30 days
FNR for CC samples (Group A)	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 30 days
FNR ratio for SC versus CC samples (Group A)	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 30 days
Difference in FNR ratio between SC and CC samples (Group A)	Will report point estimate and 95% CIs.	One-time, up to 30 days
Positive percent agreement (Group A)	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 30 days
Negative percent agreement (Group A)	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 30 days
Positive percent agreement (Group A and Group B)	Will report point estimate and 95% CIs.	One-time, up to 30 days
Negative percent agreement (Group A and Group B)	Will report point estimate and 95% CIs.	One-time, up to 30 days
Cohen's Kappa (Group A and Group B)	Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs.	One-time, up to 30 days
Test positivity rates (Group A and Group B)	Will report point estimate and 95% CIs.	One-time, up to 30 days
Rate of invalid test results (Group A and Group B)	Will report point estimate and 95% CIs.	One-time, up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human factors affecting usability	Will be assessed by questionnaire data.	One-time, up to 30 days
Human factors affecting acceptability	Will be assessed by questionnaire data.	One-time, up to 30 days
Human factors affecting references for self-collection	Will be assessed by questionnaire data.	One-time, up to 30 days

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Uterine Cervical Neoplasms; Papillomavirus Infections; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Urogenital Surgical Procedures; Genetic Techniques; Gynecologic Surgical Procedures; Obstetric Surgical Procedures; Diagnostic Techniques, Obstetrical and Gynecological; Molecular Diagnostic Techniques; Specimen Handling; Colposcopy; Human Papillomavirus DNA Tests
• Other Study ID Numbers: NCI-2024-05879 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); LMI-001-A-S01 (Other Identifier: DCP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No