NCT06120205

Brief Summary

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays. Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
870

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2023Jun 2027

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

October 27, 2023

Last Update Submit

July 15, 2025

Conditions

HpvHPV 16 InfectionHPV InfectionHigh Risk HPV

Keywords

screeningself-collectHPVcervical cancer screening

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Detection of hrHPV in self-collect and clinician collect samples

    PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples

    Samples tested within 7 days of collection

  • Safety: SAE rate

    SAE rate is equivalent for both self-collect and clinician collect interventions

    6-14 days following collections

Study Arms (1)

Self-Collection / Clinician Collection

OTHER

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

Device: Teal Wand Self-Collection Device Group

Interventions

Teal Wand Self-Collection Device GroupDEVICE

Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.

Also known as: Clinician Collection
Self-Collection / Clinician Collection

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is 25 to 65 years of age and willing to provide informed consent.
  • Participant has an intact cervix.
  • Participant is 25 to 65 years of age and willing to provide informed consent.
  • Participant has an intact cervix.
  • One or more of the below:
  • Prior diagnosis of hrHPV within previous 6 months and/or
  • Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
  • Presenting for colposcopy/LEEP/excisional intervention

You may not qualify if:

  • Participant has impaired decision-making capacity or is unable to provide informed consent.
  • Participant has undergone partial or complete hysterectomy including removal of the cervix.
  • Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
  • Participant is pregnant (based on self-reporting).
  • Participant who reports or is experiencing menstrual bleeding.
  • Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
  • Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Birmingham OBGYN / Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Planned Parenthood Northern California

San Francisco, California, 94109, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Planned Parenthood Southern New England

New Haven, Connecticut, 06511, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Planned Parenthood St. Louis Region

St Louis, Missouri, 62208, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University Langone Hospital

Mineola, New York, 11501, United States

Location

Unified Women's Clinical Research Raleigh

Raleigh, North Carolina, 27607, United States

Location

Unified Women's Clinical Research - Lyndhurst

Winston-Salem, North Carolina, 27103, United States

Location

Planned Parenthood Gulf Coast

Houston, Texas, 77023, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53715, United States

Location

Related Publications (2)

  • Onabolu AO, Oluwole OS, Bokanga M. Loss of residual cyanogens in a cassava food during short-term storage. Int J Food Sci Nutr. 2002 Jul;53(4):343-9. doi: 10.1080/09637480220138151.

    PMID: 12090030BACKGROUND

  • Fitzpatrick MB, Behrens CM, Hibler K, Parsons C, Kaplan C, Orso R, Parker L, Memmel L, Collins A, McNicholas C, Crane L, Hwang Y, Sutton E, Coleman J, Kuroki L, Harshberger K, Williams S, Jennings A, Buccini F, Gillis L, Novetsky AP, Hawkes D, Saville M, Depel T, Aviki E, Sheth SS, Conageski C. Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511081. doi: 10.1001/jamanetworkopen.2025.11081.

    PMID: 40388167DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

November 20, 2023

Primary Completion

April 5, 2024

Study Completion (Estimated)

June 1, 2027

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

De-identified results only

Locations

US(15)