Cervical CancerNCT07453459
Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening
A study testing Qualitative Interview, Virtual Visit Standard Instructions and Virtual Visit Standard Instructions + In-Person Registration Navigation in people with Cervical Cancer and HPV Infection, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, HPV Infection
- What is being tested?
- Qualitative Interview, Virtual Visit Standard Instructions and Virtual Visit Standard Instructions + In-Person Registration Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Michelle Silver, PhD, ScM, 314-454-7903, michelle.silver@wustl.edu
Ashley Housten, OTD, MSCI
About this study
Official title: 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.
- Conditions
- Cervical Cancer, HPV Infection
- Being tested
- Qualitative Interview, Virtual Visit Standard Instructions, Virtual Visit Standard Instructions + In-Person Registration Navigation
- Keywords
- Cervical cancer screening, Self-collection, At-home HPV test
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewBehavioural
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 InstructionsBehavioural
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 NavigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Qualitative Interview; Behavioral: Virtual Visit Standard Instructions + In-Person Registration Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to eight weeks after enrollment
Proportion of participants with completed referral visits
Outcome will be reported via Pearson's chi-square test.
Measured: Up to eight weeks after enrollment
Time to sample return
Outcome will be analyzed by nominal regression model.
Measured: Up to eight weeks after enrollment
Time to referral
Outcome will be analyzed by nominal regression model.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: Eight weeks after enrollment
Secondary outcomes (1)
Proportion of participants with positive results who completed follow-up
Outcome will be reported via Pearson's chi-square test.
Measured: Up to eight weeks after results available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start17 Apr 2026
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Teal Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle Silver, PhD, ScM, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453459
- Sponsor's protocol ID
- 202602185
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT07453459
- Acronym / sponsor ID
- 202602185
- Conditions
- Cervical Cancer, HPV Infection
- Keywords
- Cervical cancer screening, Self-collection, At-home HPV test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Teal Health, Inc.
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Standard instructions | Active comparator | Behavioral: Qualitative Interview, Behavioral: Virtual Visit Standard InstructionsParticipants 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. |
| Aim 1: Standard instructions + in-person guidance | Experimental | Behavioral: Qualitative Interview, Behavioral: Virtual Visit Standard Instructions + In-Person Registration NavigationParticipants 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative InterviewParticipants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B). | Behavioural | Aim 1: Standard instructions, Aim 1: Standard instructions + in-person guidance |
| Virtual Visit Standard InstructionsParticipants 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. | Behavioural | Aim 1: Standard instructions |
| Virtual Visit Standard Instructions + In-Person Registration NavigationParticipants 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. | Behavioural | Aim 1: Standard instructions + in-person guidance |
Primary outcome
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.
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.
Time to sample return
Time frame: Up to eight weeks after enrollment
Outcome will be analyzed by nominal regression model.
Time to referral
Time frame: Up to eight weeks after enrollment
Outcome will be analyzed by nominal regression model.
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?
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?
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?
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?
1 secondary outcome
Proportion of participants with positive results who completed follow-up
Time frame: Up to eight weeks after results available
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Silver, PhD, ScM principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Interview, Virtual Visit Standard Instructions and Virtual Visit Standard Instructions + In-Person Registration Navigation in people with Cervical Cancer and HPV Infection, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Silver, PhD, ScM (314-454-7903, michelle.silver@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who returned HPV samples (time frame: Up to eight weeks after enrollment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.