Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07453459
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Qualitative Interview — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 17, 2026
Status verified
Apr 2026
Primary completion
Nov 15, 2027
Completion
Jan 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Proportion of participants who returned HPV samples [ Time Frame: Up to eight weeks after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Michelle Silver, PhD, ScM
[email protected]
314-454-7903
Ashley Housten, OTD, MSCI (SUB_INVESTIGATOR)
Lindsay Kuroki, MD, MSCI (SUB_INVESTIGATOR)
Meera Muthukrishnan, PhD, MPH (SUB_INVESTIGATOR)
Trena Depel, VP (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Washington University School of Medicine· St Louis, MO

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