Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2) (NCT07538050)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ministry of Health Clinics — San Salvador, Oriente
Age range: 30 Years to 59 Years
🧪 Interventions in This Study
- Same day screen and treat (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Ministry of Health Clinics — San Salvador, Oriente
📞 Contact the Study Coordinator
Phone: (216) 213-6460
Email: cremerm@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cervical Cancer Screening
- Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer — Duarte, California
- Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women — Tallahassee, Florida
- Developing and Implementing HPV SCREENED — New Brunswick, New Jersey
- A Mobile Web App Intervention to Promote Cervical Cancer Screening — Lake Andes, South Dakota
- Personalized Risk-based Follow-up of Cervical Cancer Screening in Practice, RCT — Boston, Massachusetts
- Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection — Atlanta, Georgia
Explore by condition: All Cervical Cancer Screening clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.