Mass Screening
Conditions
Interventions
This study is a population-based seroepidemiological survey (descriptive cross-sectional study) aimed at determining the prevalence of Chagas disease in the general population and specific groups, inc
E01.370.225.989
Sponsors
Centro de Pesquisas Gonçalo Moniz
Instituto Gonçalo Moniz
Eligibility
Age
9 Months to No maximum
Inclusion criteria
Inclusion criteria: Part A: Volunteers residing in the municipalities of Tremedal and Novo Horizonte, Bahia, with active registration in municipal health systems; both genders; and aged over nine months. Part B: Volunteers who tested positive with the Bio-Manguinhos Rapid Chagas Test, along with 10% of those who tested negative; both genders; and aged over nine months. Part C: Volunteers with laboratory-confirmed Chagas disease; both genders; aged under fifty years; and with a normal electrocardiogram (heart rate: 50-100 beats per minute, waves P and R (PR) interval = 200 milliseconds, waves Q, R, and S (QRS) complex = 120 milliseconds, and waves Q and T (QT) interval between 350-450 milliseconds)
Exclusion criteria
Exclusion criteria: Parts A and B: Volunteers residing in Novo Horizonte or Tremedal, Bahia, who are not registered with the local health systems will be excluded from the study, as will volunteers unable to undergo peripheral blood collection. Part C: Exclusion criteria include volunteers with signs of advanced chronic Chagas disease; diagnosis of HIV/AIDS, mental illness, or suicidal tendencies; any acute or chronic disease deemed contraindicated for treatment by the attending physician; history of alcoholism or drug use; known hypersensitivity to nitroimidazoles; and unavailability to comply with the procedures and visits outlined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prevalence of Chagas disease (CD) will be determined by the prevalence rate in the general population individuals residing in the municipalities of Tremedal and Novo Horizonte, Bahia;Validation of the TR-Chagas Bio-Manguinhos rapid test in a real-world setting;Efficacy and safety of antiparasitic treatments will be evaluated by determining the therapeutic failure rate in patients treated with benznidazole. Measurements will include the reduction of parasitic load by real-time PCR, decrease in anti-T. cruzi antibody titers, frequency of adverse events and serious adverse events, and the proportion of patients who discontinued treatment due to adverse events;Cost-effectiveness of the rapid test and projected costs of large-scale implementation in the Brazilian Unified Health System (SUS);Genotypic impact and biomarkers will be assessed through the genotyping of T. cruzi DTUs and their relationship with treatment efficacy. Additionally, the development and evaluation of predictive biomarkers for disease progression, therapeutic failure, and parasitological cure will be conducted;Implementation and acceptability of the rapid test;Epidemiological and clinical data will be collected through the establishment of a clinical and epidemiological database for future research, and the creation of a biobank for the storage of biological samples;Health policy recommendations will be developed based on evidence for the incorporation of the TR-Chagas Bio-Manguinhos test into the SUS and the improvement of diagnostic and treatment protocols for Chagas disease | — |
Secondary
| Measure | Time frame |
|---|---|
| The prevalence of Chagas disease (CD) in specific groups, including children, the elderly, women of childbearing age, pregnant women, and immunocompromised individuals, residing in the municipalities of Tremedal and Novo Horizonte, Bahia, will be determined. Additionally, the study will assess the risk of Trypanosoma cruzi infection and identify priority areas for interventions upon completion;Proportion of valid results obtained with the TR-Chagas Bio-Manguinhos test;Acceptability of the test among healthcare professionals and the general population | — |
Countries
Brazil
Contacts
Public ContactFred Santos
Instituto Gonçalo Moniz
Outcome results
None listed