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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07538050
Acronym
SCALE AIM 2
Enrollment
1000
Registered
2026-04-20
Start date
2026-04-16
Completion date
2027-12-31
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Screening

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.

Interventions

BEHAVIORALSame 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

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of lost to follow-up at 6-months6-monthsWomen will self collect HPV samples for same day screening and treatment if applicable. Rates of lost to follow-up will be compared to historical data.

Countries

El Salvador

Contacts

CONTACTMiriam Cremer, MD
cremerm@ccf.org216-213-6460
CONTACTMontserrat Soler, PhD
solerm@ccf.org619-980-0157
PRINCIPAL_INVESTIGATORMiriam Cremer, MD

The Cleveland Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026