Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

This study is looking at different ways to help women get screened for cervical cancer, especially those who haven't been screened recently. It's testing if giving out at-home HPV (Human Papillomavirus) self-collection kits is a good way to improve screening rates and follow-up care. You would participate in an interview and receive information about how to get an at-home cervical cancer screening kit through Teal Health. The study wants to see how many people return their HPV samples and complete follow-up visits within eight weeks. To join, you must be a woman aged 25 or older, have an intact cervix, and not have been screened for cervical cancer in the last 3-5 years. You also need a cellphone, email, and internet access. The study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
You will participate in a semi-structured interview and receive information about how to get an at-home cervical cancer screening kit. You will then use a QR code to register with Teal and request a telehealth appointment to receive your kit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to eight weeks after enrollment to measure sample return and completion of referral visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07453459

Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Recruiting
NAAges 25+InterventionalHealth services
Washington University School of Medicine
~100 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Qualitative InterviewVirtual Visit Standard InstructionsVirtual Visit Standard Instructions + In-Person Registration Navigation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who returned HPV samples
Measured over Up to eight weeks after enrollment
+7 more outcomes measured
Cervical Cancer
HPV Infection
1 sites across 1 states
Missouri1
  • Michelle Silver, PhD, ScM · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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.
  • Proportion of participants who returned HPV samplesUp 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.

  • Proportion of participants with completed referral visitsUp to eight weeks after enrollment

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

  • Time to sample returnUp to eight weeks after enrollment

    Outcome will be analyzed by nominal regression model.

  • Time to referralUp to eight weeks after enrollment

    Outcome will be analyzed by nominal regression model.

  • Thematic findings addressing opportunityEight 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?

  • Thematic findings addressing capabilityEight 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?

  • Thematic findings addressing motivationEight 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?

  • Thematic findings addressing behaviorEight 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?