University-Based Chagas Testing in Salta Province, Argentina

NCT07033325 | Enrolling By Invitation

• 1 other identifier: 5/2024-SCRTI-UNSa
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chagas Disease; Trypanosoma Cruzi Infection; Chronic Chagas Disease

Keywords

Chagas; Chagas Rapid Diagnostic Test; Trypanosoma cruzi; Salta; Argentina

Outcome Measures

Primary Outcomes (3)

• Prevalence of Trypanosoma cruzi infection.

  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.

  One year.

• Distribution of Trypanosoma cruzi infection.

  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.

  One year

• Field verification of the RDT

  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.

  One year

Secondary Outcomes (3)

• 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

Interventions

Rapid diagnostic test (RDT) for Trypanosoma cruzi infection. DIAGNOSTIC_TEST

Rapid diagnostic tests (RDTs) for the detection of Trypanosoma cruzi infection are performed in university facilities, outside of a clinical care setting, using a point-of-care approach. The study population includes adult male and female participants from the university community. This intervention differs from most existing strategies that target exclusively women of reproductive age and/or newborns to control vertical transmission; instead, it focuses on broader population-based screening and linkage to care for chronic infections.

Also known as: Immunochromatography., Chagas Rapid Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Salta is a province in northwestern Argentina where Chagas disease remains endemic. While vectorial transmission has declined in recent years due to control efforts, it has not been fully eliminated. Vertical transmission continues to be a major route of infection. Seroprevalence data indicate that 5% of blood donors and 8% of pregnant women in Salta test positive for Trypanosoma cruzi infection. The study population includes incoming students at the Nationional University of Salta (UNSa), across its nine campuses located throughout the province. According to UNSa records, in 2023, around 8,000 students began their studies. UNSa is the only public university in Salta, attracting students from across both urban centers and rural areas. First-year students are required to undergo a routine health check, which provides an opportunity for offering Chagas screening. While incoming students are the primary target population, other members of the university are also eligible to participate.

You may qualify if:

• 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.

You may not qualify if:

• \- Prior confirmed diagnosis of Trypanosoma cruzi infection.

Sponsors & Collaborators

• Mundo Sano Foundation: lead
• Universidad Nacional de Salta: collaborator

Study Sites (2)

Universidad Nacional de Salta

Orán, Salta Province, 4530, Argentina

Location

Universidad Nacional de Salta

Salta, 4400, Argentina

Location

Related Publications (4)

• Lopez-Albizu C, Danesi E, Piorno P, Fernandez M, Garcia Campos F, Scollo K, Crudo F. Rapid Diagnostic Tests for Trypanosoma cruzi Infection: Field Evaluation of Two Registered Kits in a Region of Endemicity and a Region of Nonendemicity in Argentina. J Clin Microbiol. 2020 Nov 18;58(12):e01140-20. doi: 10.1128/JCM.01140-20. Print 2020 Nov 18.

  PMID: 32938737 BACKGROUND

• OPS. Organización Panamericana de la Salud. Guía para el diagnóstico y el tratamiento de la enfermedad de Chagas. Washington, D.C. OPS; 2018. 2018. 1-172 p.

  BACKGROUND

• Ministerio de Salud de la Nación. Enfermedad de Chagas. Guía para la atención al paciente infectado con Trypanosoma cruzi. 2018. 96 p.

  BACKGROUND

• WHO Expert Committee. Control of Chagas disease. World Health Organ Tech Rep Ser. 2002;905:i-vi, 1-109, back cover.

  PMID: 12092045 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples will be retained temporarily for the purpose of diagnostic test validation (comparison with recombinant ELISA). No whole blood or DNA will be preserved or extracted. All serum specimens will be properly discarded after testing is completed.

MeSH Terms

Conditions

Chagas Disease

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Adriana Echazu, PhD

  Mundo Sano Foundation

  STUDY DIRECTOR

• Ruben O Cimino, PhD

  Instituto de Investigaciones de Enfermedades Tropicales, Univeridad Nacional de Salta

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: September 11, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The individual participant data (IPD) will be made available following the completion of the study and the publication of the main results. The anticipated availability period is from December 2025 to June 2026.
• Access Criteria: Other researchers will be able to access the IPD information if they need it for scientific purposes and make a formal request describing their objectives.

Locations

AR (2)