Preventing cervical cancer with rapid HPV genotyping and same-day self-sampling
Official title: PROGRESS: Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling
Run by Atila Biosystems Inc. · NCT07232355 · Data updated 2026-11-12
This project tests whether a rapid HPV genotyping test on self-collected and provider-collected samples can quickly identify women at high risk so they can receive same-day screening and treatment in low-resource settings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 64 Years |
| Sex | Women only |
| Enrollment | 5000 (estimated) |
| Sponsor | Atila Biosystems Inc. Industry-sponsored |
| Locations | 4 sites (Sunnyvale, California and 3 other locations) |
| Status | Recruiting |
| Started | August 24, 2023 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07232355 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women who have a cervix, are not pregnant, have not had cervical cancer screening in the past two years, have no prior cervical cancer diagnosis or treatment, and can tolerate a speculum exam.
✕Probably not a fit
People who are pregnant, have had screening within the past two years, have prior cervical cancer or treatment, or cannot undergo a speculum exam are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study clinically validates a modified AmpFire® HPV genotyping platform that sorts positive results into four risk-based categories and can return the highest-risk result in under 20 minutes and others in under an hour. Investigators will collect both self- and provider-collected cervical samples from about 4,000 women and compare the test's performance (sensitivity, specificity) against current screening practices. The observational protocol is conducted with partner clinics in Honduras to assess feasibility, accuracy, and integration into same-day screening-and-treatment workflows. The objective is to determine whether this low-cost, rapid platform can expand access to effective cervical precancer screening in low- and middle-income settings.
Why it matters
Potential benefit: If successful, the test could enable affordable, same-day HPV screening and faster treatment referrals, helping reduce cervical cancer incidence in low-resource areas.
How similar studies have gone: Self-sampling and point-of-care HPV testing approaches have shown promise in prior research, but this specific modified AmpFire platform is being newly validated for rapid, risk-based genotyping in low-resource clinics.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of a cervix Exclusion Criteria: * Pregnancy * Cervical cancer screening in the past 2 years * Prior diagnosis or treatment of cervical cancer * Inability to tolerate a speculum exam
Where it's running
-
Atila Biosystems, Inc.
Sunnyvale, California, United States Recruiting -
Basic Health International
San Salvador, El Salvador Recruiting -
Centro de Salud Las Crucitas
Tegucigalpa, Honduras Recruiting -
Ciudad Mujer Kennedy
Tegucigalpa, Honduras Recruiting
Study contacts
- Study coordinator: Miriam L Cremer, MD MPH
- Email: mcremer@basichealth.org
- Phone: 216-312-0618
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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.