At-home HPV self-collection kits for cervical cancer screening
Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening
We are testing different ways to give at-home HPV self-collection kits to under-screened people aged 25–65 to see if more of them complete cervical cancer screening and follow-up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07453459 on ClinicalTrials.gov |
What this trial studies
This equity-focused, community-based project compares the feasibility of different distribution methods for at-home HPV self-collection kits among under-screened individuals with a cervix. Participants use a smartphone and the Teal Health app and join virtual visits; some arms add in-person registration and navigation. The study collects qualitative interviews and measures kit return and adherence to follow-up after abnormal results. Activities are centered through Washington University School of Medicine with virtual and some in-person components.
Who should consider this trial
Good fit: People aged 25–65 with an intact cervix who report no cervical cancer screening in the past 3 years, have a smartphone and internet access, and can read and speak English are ideal candidates.
Not a fit: Those who are currently pregnant or recently postpartum, have abnormal vaginal bleeding, a history of reproductive system cancer, a compromised immune system, prior DES exposure, recent treatment for cervical precancer, are already up-to-date on screening, or lack a smartphone/internet access are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could increase screening uptake and timely follow-up, helping detect precancers earlier in under-screened populations.
How similar studies have performed: Previous research has shown that mailed or home HPV self-sampling can increase screening uptake in under-screened groups, so this approach builds on promising evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Silver, PhD, ScM — Washington University School of Medicine
- Study coordinator: Michelle Silver, PhD, ScM
- Email: michelle.silver@wustl.edu
- Phone: 314-454-7903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.