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Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)

NCT07538050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • Cervical Cancer Screening

Interventions

BEHAVIORAL

Same day screen and treat

Women will self collect samples for a low cost genotyping HPV test and be offered same day treatment if applicable

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Miriam Cremer, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538050 on ClinicalTrials.gov