NCT07538050 Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)
| NCT ID | NCT07538050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Cervical Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2026-04-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In high-income countries, prevention strategies have led to declines in cervical cancer rates by more than 75% in high-income countries. In contrast, low- and middle-income countries (LMICs) carry the global burden of cervical cancer with about 85% of new cases and 90% mortality. Screening is an essential component of effective prevention to reduce this disease burden. The World Health Organization recommends human papillomavirus (HPV) testing as the most effective screening method. However, HPV testing can be expensive and complex to implement. Most tests require central laboratory processing, which means women must come back for a different visit to obtain results and potential treatment. In LMICs, this often results in high loss to follow up because many women face transportation and other challenges. The development of new, low-cost HPV tests that can be processed locally as the potential to improve adherence in screening programs. In this study, the research team will assess the feasibility of a same-day screen-and-treat approach compared to the standard two-visit regime in the context of the cervical cancer prevention program in El Salvador. This will be a cross-sectional study that will enroll 1,000 women in remote areas of the country over 10-15 weeks. The hypothesis is that at least 10% fewer women lost to follow-up at six months using the single visit approach compared to the \>20% historical loss to follow-up using the standard two-visit approach.
Eligibility 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
Contact & Investigator
Miriam Cremer, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07538050 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 59 Years, studying Cervical Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07538050 currently recruiting?
Yes, NCT07538050 is actively recruiting participants. Contact the research team at cremerm@ccf.org for enrollment information.
Where is the NCT07538050 trial being conducted?
This trial is being conducted at San Salvador, El Salvador.
Who is sponsoring the NCT07538050 clinical trial?
NCT07538050 is sponsored by The Cleveland Clinic. The principal investigator is Miriam Cremer, MD at The Cleveland Clinic. The trial plans to enroll 1,000 participants.
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