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NCT Number: NCT07453459

Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

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.

Recruiting

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Key information

Conditions

Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Ashley Housten, OTD, MSCI

SUB_INVESTIGATOR

Lindsay Kuroki, MD, MSCI

SUB_INVESTIGATOR

Meera Muthukrishnan, PhD, MPH

SUB_INVESTIGATOR

Michelle Silver, PhD, ScM

CONTACT

[email protected]

314-454-7903

Trena Depel, VP

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of participants who returned HPV samples

    Time frame: Up to eight weeks after enrollment

    Feasibility of the distribution methods between groups will be measured by the return rate of at home, self-collected HPV samples. Outcome will be reported via Pearson's chi-square test.

  2. Proportion of participants with completed referral visits

    Time frame: Up to eight weeks after enrollment

    Outcome will be reported via Pearson's chi-square test.

  3. Time to sample return

    Time frame: Up to eight weeks after enrollment

    Outcome will be analyzed by nominal regression model.

  4. Time to referral

    Time frame: Up to eight weeks after enrollment

    Outcome will be analyzed by nominal regression model.

  5. Thematic findings addressing opportunity

    Time frame: Eight weeks after enrollment

    Will be assessed during semi-structured interviews with participants and analyzed according to the Capability, Opportunity, Motivation, Behavior (COM-B) model. Questions during the semi-structure interview will follow a guide. Answers to the questions will be analyzed for thematic findings.

    The following questions on the guide asked to the returners of kits:

    • What was your reaction for when you were offered the Teal kit?
    • How did the support from event staff, the virtual care visit, or people in your life influence your decision about using the kit?

    The following questions on the guide asked to the non-returners of kits:

    • What, if any, were the barriers that prevented you from completing it?

    *Probe: For example, finding the time to use the kit or understanding the instructions

    • Was there anything that changed between the time you enrolled in the study and receiving the kit that made you decide to not complete the kit?

  6. Thematic findings addressing capability

    Time frame: Eight weeks after enrollment

    Will be assessed during semi-structured interviews with participants & analyzed according to the COM-B model. Questions during the semi-structure interview will follow a guide. Answers will be analyzed for thematic findings.

    The following will be asked to returners of kits:

    • How confident are you in the results you received? Do you trust them? Why/why not?
    • Did you feel like you received enough information when you got the kit to know what to do?
    • How did you feel about your ability to correctly use the self-sampling kit?
    • Were there any physical difficulties or health issues that made it challenging for you to use the kit? If so, can you describe them?
    • Do you have any recommendations for improving access to Teal kits for at-home cervical cancer screening?

    The following will be asked to non-returners of kits:

    • What suggestions/changes do you think would make it easier for you to use the kit in the future?

  7. Thematic findings addressing motivation

    Time frame: Eight weeks after enrollment

    Will be assessed during semi-structured interviews with participants & analyzed according to COM-B model. Questions will follow a guide. Answers will be analyzed for thematic findings.

    The following will be asked to returners of kits:

    • Feelings about cervical cancer screening?
    • Previous pap smear/HPV test for cervical cancer screening? Describe the experience.
    • Any concerns/uncertainties you had about using the kit?
    • What made you decide to use the kit?
    • What did you like/not like about using the kit?
    • What things got in the way of using the kit or made it easier?
    • Would you recommend the kit to a friend?
    • Would you use the kit in the future?
    • Thoughts on the importance/urgency of completing the kit?
    • Explanation of your beliefs about the potential benefits/downsides of using the kit?

    The following will be asked to non-returners of kits:

    -Can you describe any situations/experiences/barriers that influenced your decision not to complete & return the kit?

  8. Thematic findings addressing behavior

    Time frame: Eight weeks after enrollment

    Will be assessed during semi-structured interviews with participants and analyzed according to the COM-B model. Questions during the semi-structure interview follow a guide. Answers to the questions will be analyzed for thematic findings.

    The following questions on the guide asked to all participants:

    -Before receiving the kit, what were some of the reasons you were overdue for cervical cancer screening?

Secondary outcomes

  1. Proportion of participants with positive results who completed follow-up

    Time frame: Up to eight weeks after results available

    Outcome will be reported via Pearson's chi-square test.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Silver, PhD, ScM

CONTACT

[email protected]

314-454-7903

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Teal Health, Inc.

Registry information

Official study title

Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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