Cervical CarcinomaNCT07186530
Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening
A study testing Best Practice, Communication Intervention and Electronic Health Record Review in people with Cervical Carcinoma and Human Papillomavirus Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial evaluates whether offering human papillomavirus (HPV) self-collection for cervical cancer screening at Mayo Clinic Express Care clinics improves uptake of cervical cancer screening and receipt of appropriate follow-up care. Read more about this study
- Who is it for?
- Ages 30 to 63 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma
- What is being tested?
- Best Practice, Communication Intervention and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 30 Sep 2030
- Phase
- Interventional
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 30 to 63 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ages 30-63 years old receiving primary care with a provider at Mayo Clinic in Rochester and who self-identify as asymptomatic (i.e., no pelvic pain, abnormal vaginal bleeding or abnormal vaginal discharge)
- Qualify for average risk cervical cancer screening per United States Preventive Services Task Force (USPSTF) guidelines but are overdue by >= 1 year, including those who have never been screened
- Must have an active Patient Online Services account (patient portal), approval for research contact status in portal/Epic and documentation of Minnesota (MN) research authorization, and health insurance coverage
Who cannot join
- History of hysterectomy
- Cervical cancer
- Cervical intraepithelial neoplasia (CIN) 2-3
- In utero diethylstilbestrol (DES) exposure
- HIV+
- Use of chronic immunosuppressant medication
- Known to be pregnant
- Medicare-covered women are NOT eligible as Medicare does not cover primary HPV testing by clinician-collection or self-collection [related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF]
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening
This clinical trial evaluates whether offering human papillomavirus (HPV) self-collection for cervical cancer screening at Mayo Clinic Express Care clinics improves uptake of cervical cancer screening and receipt of appropriate follow-up care. Cervical cancer is preventable through vaccination, screening, and treatment of pre-cancerous conditions. However, cervical cancer screening rates have declined over the past 25 years, and an estimated 25% of women are unscreened or overdue for screening. Usual care at Mayo Clinic currently includes annual portal or letter communications in the form of scheduled outreach to request scheduling an appointment for cervical cancer screening, as well as reminders from clinicians during clinic appointments. Cervical cancer screening at Mayo Clinic is most often done with a pelvic speculum exam with cervical swabs collected in the office by a clinician. HPV self-collection is Food and Drug Administration-approved and already used in clinical practice, but offering this method of screening in the novel setting of Express Care clinics that have expanded nighttime and weekend hours may improve rates of cervical cancer screening and receipt of appropriate follow-up care.
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma
- Being tested
- Best Practice, Communication Intervention, Electronic Health Record Review, HPV Self-Collection, Standard Follow-Up Care
- 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.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Communication InterventionOther
Receive portal message
Electronic Health Record ReviewOther
Also called Electronic Health Record (EHR) Review, EHR Review
EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated.
HPV Self-CollectionProcedure or surgery
Also called HPV Self Collection, Human Papillomavirus Self-Collection, HPV Self-Collection in a healthcare setting
Complete HPV self-collection
Standard Follow-Up CareProcedure or surgery
Receive standard follow-up care
| Study group | Role | What they receive |
|---|---|---|
| Arm I (HPV self-collection) | Experimental | Participants receive a portal message inviting them to schedule and complete cervical cancer screening via HPV self-collection at an Express Care clinic. Participants are also informed they can choose the usual care of a cervical cancer screening test with their primary care team in clinic instead. Participants who complete screening receive standard follow-up care. Receives: Other: Best Practice; Other: Communication Intervention; Other: Electronic Health Record Review; Procedure: HPV Self-Collection; Procedure: Standard Follow-Up Care |
| Arm II (usual care) | Active comparator | Participants receive usual care and standard follow-up care on study. Receives: Other: Best Practice; Other: Electronic Health Record Review; Procedure: Standard Follow-Up Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cancer screening test
Assessed by the number of participants who complete cervical cancer screening collection from invitation to complete a self-collected vaginal swab for HPV testing at Mayo Clinic Express Care clinics compared to the number of participants who complete screening with a clinician-collected cervical swab or self-collected vaginal swab at a primary care office.
Measured: Up to 6 months from trial enrollment
Secondary outcomes (1)
Follow-up of abnormal results
Assessed by the number of participants who complete follow-up for abnormal results obtained by self-collection or clinician-collection.
Measured: Up to 6 months from date of test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start7 Oct 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy L. Maclaughlin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186530
- Sponsor's protocol ID
- 25-000735
- Other IDs
- NCI-2025-05848
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No