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

NCT07538050 | Not Yet Recruiting

• 1 other identifier: 24-105
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Proportion of lost to follow-up at 6-months

  Women 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.

  6-months

Study Arms (1)

HPV testing

EXPERIMENTAL

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

Behavioral: Same day screen and treat

Interventions

Same day screen and treat BEHAVIORAL

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

HPV testing

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: Cervical pre-cancer screening.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 30-59 years of age and willing to conduct HPV self-sampling

You may not qualify if:

• Hysterectomy, HPV testing in at least 5 years, and previous diagnosis or treatment of invasive cancer.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Ministry of Health Clinics

San Salvador, Oriente, 000000000, El Salvador

Location

MeSH Terms

Interventions

Coal Tar

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Miriam Cremer, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Cremer, MD

CONTACT

216-213-6460; cremerm@ccf.org

Montserrat Soler, PhD

CONTACT

619-980-0157; solerm@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)