Mass Screening for Chagas Disease Among University Entrants as a Strategy to Improve Access to Diagnosis and Treatment in the Province of Salta, Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,568
- 试验地点
- 3
- 主要终点
- Prevalence of Trypanosoma cruzi infection.
研究概览
简要总结
The goal of this observational study is to improve access to diagnosis and treatment for chronic Trypanosoma cruzi infection among university students of all ages and genders at the National University of Salta (UNSa), Argentina. The main questions it aims to answer are:
- What is the seroprevalence and geographic distribution of T. cruzi infection in UNSa students?
- Can voluntary point-of-care tests performed at university serve as an effective opportunity for timely diagnosis and linkage to care for Chagas disease?
Participants will:
- Be offered a RDTs (WL Check Chagas, Wiener Lab) during their regular activities in the university.
- If RDT is positive, be referred to the health system for confirmatory testing and treatment.
- Receive follow-up support by trained staff via phone. A subgroup of RDT-negative students will have serum samples preserved and analyzed later via ELISA to verify RDT accuracy.
详细描述
Background and Rationale Chagas disease is a parasitic infection caused by Trypanosoma cruzi, endemic in Latin America and primarily transmitted by triatomine insects. In Argentina, where vector control has reduced transmission, vertical transmission has become the predominant route. The disease often remains asymptomatic for years but can cause serious cardiac and digestive damage during the chronic phase. Specific treatment is available, especially effective if administered early or before pregnancy in women of childbearing age.
Despite the availability of effective therapy, access to diagnosis and treatment remains limited due to both health system and patient-related barriers. The reported prevalence in Salta province is high: around 5% in blood banks and up to 8% among pregnant women.
The Universidad Nacional de Salta (UNSa), with nine campuses across the province, requires all incoming students to complete a medical check-up. This project leverages that existing requirement to offer rapid diagnostic testing (RDT) for T. cruzi, aiming to identify cases early, link positive individuals to care, and indirectly reach affected families.
The study will be implemented by a multidisciplinary team including researchers in medicine, biology, biochemistry, anthropology, and public health, with institutional support from the Universidad Nacional de Salta, Fundación Mundo Sano, and Salta's Ministry of Public Health.
Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Member of the university community (e.g., student, faculty, administrative staff, or other personnel).
- •Aged 18 years or older.
- •Of any sex or gender.
- •Able and willing to provide informed consent.
排除标准
- •- Prior confirmed diagnosis of Trypanosoma cruzi infection.
结局指标
主要结局
Prevalence of Trypanosoma cruzi infection.
时间窗: One year.
Proportion of individuals who tested positive for Trypanosoma cruzi infection among the total number of individuals tested, using Rapid Diagnostic Test (RDT). This outcome reflects the overall frequency of infection within the study population at the time of testing.
Distribution of Trypanosoma cruzi infection.
时间窗: One year
Prevalence of T. cruzi infection disaggregated by university campus. This outcome captures the proportion of individuals who tested positive at each participating site, allowing for comparison of infection rates across different geographical locations. The distribution complements the overall prevalence by highlighting site-specific patterns of infection.
Field verification of the RDT
时间窗: One year
Diagnostic performance of the RDT for detecting Trypanosoma cruzi infection, assessed in comparison to the reference standard. This outcome reflects the accuracy of the RDT under real-world field conditions in the study population.
次要结局
- Acceptability of the RDT-based testing strategy in a non-health setting(One year)
- Feasibility of implementing RDT-based testing in a non-health setting(One year)
- Treatment outcomes among participants with confirmed Trypanosoma cruzi infection(18 months)
研究者
Adriana Echazu
Project Director
Mundo Sano Foundation