Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Same day screen and treat.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Screening. Basic parameters: 30 years — 59 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- El Salvador
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- 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
Primary outcome measures
- Proportion of lost to follow-up at 6-months [Time frame: 6-months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
El Salvador · 1 center
- Ministry of Health Clinics — San Salvador
Identifiers
NCT: NCT07538050 · 24-105