Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

NCT07453459 | Recruiting

• 1 other identifier: 202602185
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Cervical cancer screening; Self-collection; At-home HPV test

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Proportion of participants with positive results who completed follow-up

  Up to eight weeks after results available

Study Arms (2)

Aim 1: Standard instructions

ACTIVE COMPARATOR

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; Behavioral: Virtual Visit Standard Instructions

Aim 1: Standard instructions + in-person guidance

EXPERIMENTAL

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; Behavioral: Virtual Visit Standard Instructions + In-Person Registration Navigation

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).

Aim 1: Standard instructions; Aim 1: Standard instructions + in-person guidance

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.

Aim 1: Standard instructions

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.

Aim 1: Standard instructions + in-person guidance

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Teal Health, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Silver, PhD, ScM

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Silver, PhD, ScM

CONTACT

314-454-7903; michelle.silver@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)