Recruiting

Cervical Cancer Screening

Sponsor:

Washington University School of Medicine

Code:

NCT07453459

Conditions

Cervical Cancer

HPV Infection

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Qualitative Interview

Virtual Visit Standard Instructions

Virtual Visit Standard Instructions + In-Person Registration Navigation

Study Details

Brief summary:

This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened.

Conditions

Cervical Cancer

HPV Infection

Study ID

NCT07453459

Start date

Apr 17, 2026

Status verified date

Jul, 2026

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are age 25 or older
  • Has an intact cervix
  • Self-reports that they have not been screened for cervical cancer within the last 3 years for 25-64, 5 years for 65 or older
  • Has a cellphone that can receive texts (including verification codes) and an email account
  • Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview
  • Can read, speak, write and understand English well enough to take a survey and complete an interview

Exclusion Criteria:

  • Abnormal vaginal bleeding or discharge
  • A history of cancer of the reproductive system
  • A compromised immune system
  • Prior Diethylstilbestrol (DES) exposure
  • Currently pregnant or are within 6 weeks of giving birth
  • Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Aim 1: Standard instructions

Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.

experimental: Aim 1: Standard instructions + in-person guidance

Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.

Interventions

Qualitative Interview

Participants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B).

Virtual Visit Standard Instructions

Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit.

Virtual Visit Standard Instructions + In-Person Registration Navigation

Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. Participants will scan the QR code and complete the registration process onsite with a study coordinator, leaving the event with a scheduled date and time for their telehealth appointment.

Primary outcome measure

  • Proportion of participants who returned HPV samples [ Time Frame: Up to eight weeks after enrollment ]
  • Proportion of participants with completed referral visits [ Time Frame: Up to eight weeks after enrollment ]
  • Time to sample return [ Time Frame: Up to eight weeks after enrollment ]
  • Time to referral [ Time Frame: Up to eight weeks after enrollment ]
  • Thematic findings addressing opportunity [ Time Frame: Eight weeks after enrollment ]
  • Thematic findings addressing capability [ Time Frame: Eight weeks after enrollment ]
  • Thematic findings addressing motivation [ Time Frame: Eight weeks after enrollment ]
  • Thematic findings addressing behavior [ Time Frame: Eight weeks after enrollment ]

Central Contacts and Locations

Central contacts

Michelle Silver, PhD, ScM

314-454-7903michelle.silver@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michelle Silver, PhD, ScM

314-454-7903michelle.silver@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Cervical cancer screening
  • Self-collection
  • At-home HPV test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-27.