Tuberculosis. Latent Tuberculosis. Tuberculosis, Pulmonary. Transients and Migrants. Refugees
Conditions
Interventions
This is a pragmatic study, based on implementation science, whose scope is based on the systematic approach to research problems. The study will be carried out in the five Brazilian cities with the hi
Sponsors
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals over 18 years old; both gender; international migrants, refugees, and stateless persons diagnosed through the verification of induration (greater than 5 mm) 72 hours after the application of the Tuberculin Test (TT), applied intradermally on the forearm and/or use of the Interferon-Gamma Release Assay (IGRA) in situations where the use of TT is not possible, and according to the protocols of the World Health Organization (WHO); migrants, refugees, and stateless persons with drug-resistant tuberculosis (DR-TB) identified through project screening and/or spontaneous demand at health services, diagnosed according to the protocols of the Ministry of Health (MoH), based on the Rapid Molecular Test (RMT), sputum smear microscopy, or sputum cultur
Exclusion criteria
Exclusion criteria: Lack of familiarity or difficulty using a smartphone; individuals under 18 years old; Brazilians; migrants, refugees, and stateless persons not residing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find treatment success or adherence efficacy, expressed by the proportion of participants who completed the treatment since randomization. Using adherence tracking and recording methods, the adherence efficacy will be verified by the proportion of participants who complete the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Conduct semi-structured interviews with participants from the three study groups (VDOT, TDO, and TA). Five participants will be randomly selected from each group. The interview approach will use a question guide based on the Behavior Change Wheel (BCW) framework. This theoretical framework addresses key aspects of accepting and adhering to currently prescribed treatments by health services, based on Capability, Opportunity, and Motivation.;Evaluate the incidence of side effects reported and attended to by health services, using medical records and follow-up reports. The percentage of side effects will be measured and compared between study groups. ;Measure satisfaction, costs, stigma, and privacy, using specific questionnaires administered to participants. These parameters will be analyzed and compared between study groups.;Assess the willingness to continue treatment, determined through questionnaires administered to participants at the end of the study period. The percentage of participants who express willingness to continue treatment will be recorded and analyzed.;Evaluate the perception of the importance of treatment for Drug-Resistant Tuberculosis (DR-TB) or Latent Tuberculosis Infection (LTBI), through semi-structured interviews with participants. The percentage of participants who report the importance of the treatment will be quantified. | — |
Countries
Brazil
Contacts
Public ContactRicardo Arcêncio
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed