Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home 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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; HPV Infection
• Intervention / Treatment: Behavioral: Qualitative Interview; Behavioral: Virtual Visit Standard Instructions; Behavioral: Virtual Visit Standard Instructions + In-Person Registration Navigation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Silver, PhD, ScM; Phone Number: 314-454-7903; Email: michelle.silver@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Ashley Housten, OTD, MSCI
      • Contact: Michelle Silver, PhD, ScM; Phone Number: 314-454-7903; Email: michelle.silver@wustl.edu
      • Sub-Investigator: Lindsay Kuroki, MD, MSCI
      • Sub-Investigator: Meera Muthukrishnan, PhD, MPH
      • Sub-Investigator: Trena Depel, VP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who returned HPV samples	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.	Up to eight weeks after enrollment
Proportion of participants with completed referral visits	Outcome will be reported via Pearson's chi-square test.	Up to eight weeks after enrollment
Time to sample return	Outcome will be analyzed by nominal regression model.	Up to eight weeks after enrollment
Time to referral	Outcome will be analyzed by nominal regression model.	Up to eight weeks after enrollment
Thematic findings addressing opportunity	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?	Eight weeks after enrollment
Thematic findings addressing capability	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?	Eight weeks after enrollment
Thematic findings addressing motivation	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?	Eight weeks after enrollment
Thematic findings addressing behavior	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?	Eight weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with positive results who completed follow-up	Outcome will be reported via Pearson's chi-square test.	Up to eight weeks after results available

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Teal Health, Inc.
• Investigators: Principal Investigator: Michelle Silver, PhD, ScM, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cervical cancer screening; Self-collection; At-home HPV test
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: 202602185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes