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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer Screening
• Intervention / Treatment: Behavioral: Same day screen and treat

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montserrat Soler, PhD; Phone Number: 619-980-0157; Email: solerm@ccf.org
• Study Contact Backup: Name: Miriam Cremer, MD; Phone Number: 216-213-6460; Email: cremerm@ccf.org

Study Locations

• El Salvador
  • Oriente
    • San Salvador, Oriente, El Salvador, 000000000
      • Recruiting
      • Ministry of Health Clinics
      • Principal Investigator: Karla Alfaro, MD
      • Contact: Karla Alfaro, MD, MPH; Phone Number: 503-7854-7746; Email: kalfaro@basichealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV testing; Women will self collect samples for a low cost genotyping HPV test and same day treatment if applicable	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Miriam Cremer, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Complex Mixtures; Tars; Coal Tar
• Other Study ID Numbers: 24-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No