Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Purpose

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

Eligibility

Eligible Ages
Between 25 Years and 65 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Are age 25-65 - Has an intact cervix - Self-reports that they have not been screened for cervical cancer within the last 3 years - Has a smartphone - 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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).
  • Behavioral: 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.
  • Behavioral: 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.
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.
  • Behavioral: 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).
  • Behavioral: 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.

Recruiting Locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Michelle Silver, PhD, ScM
314-454-7903
michelle.silver@wustl.edu

More Details

NCT ID
NCT07453459
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Michelle Silver, PhD, ScM
314-454-7903
michelle.silver@wustl.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center