Low-cost HPV test that gives same-day results and treatment in women 30-59
Official title: Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)
Run by The Cleveland Clinic · NCT07538050 · Data updated 2026-11-12
A low-cost HPV test done on the same day as a self-collected sample is being tested to see if it can reliably screen for cervical cancer and enable immediate treatment in women aged 30-59 in San Salvador.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 59 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (San Salvador, Oriente) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07538050 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 30-59 who are willing to perform HPV self-sampling and do not meet exclusion criteria.
✕Probably not a fit
Women outside the age range, those with a prior hysterectomy, recent HPV testing within 5 years, or a history of invasive cancer may not benefit from this testing approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a low-cost, locally processable HPV test (ScreenFire) for cervical cancer screening. The trial uses a same-day screen-and-treat approach, allowing immediate follow-up actions if needed. Eligible participants are women aged 30-59 who agree to self-collect an HPV sample; those with prior hysterectomy or recent HPV testing are excluded. The study is conducted at Ministry of Health clinics in San Salvador, led by The Cleveland Clinic, to determine efficacy and potential cost-effectiveness in LMIC settings.
Why it matters
Potential benefit: If successful, the approach could simplify screening, reduce loss to follow-up, and enable earlier detection and treatment of cervical abnormalities.
How similar studies have gone: Prior studies suggest that point-of-care, low-cost HPV testing with same-day treatment can improve adherence, though this exact approach in LMIC settings is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between 30-59 years of age * Willing to conduct HPV self-sampling Exclusion Criteria: * Prior hysterectomy * HPV testing in at least 5 years * Previous diagnosis or treatment of invasive cancer
Where it's running
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Ministry of Health Clinics
San Salvador, Oriente, El Salvador Recruiting
Study contacts
- Principal investigator: Miriam Cremer, MD — The Cleveland Clinic
- Study coordinator: Miriam Cremer, MD
- Email: cremerm@ccf.org
- Phone: 216-213-6460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.