Tuberculosis, Pulmonary
Conditions
Interventions
This is an open-masked clinical trial with 3 arms. The intervention carried out consists of the use of the Tuberculosis Treatment Video Telemonitoring System (VDOT) to supervise the taking of Tubercul
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: Managers from different levels (federal, state, regional, and municipal) will be included. Health and social assistance professionals who have worked in healthcare and/or health surveillance for at least six months, starting from September 2019, due to their prior experience before the pandemic context. Representatives of social movements and health councils (national, state, municipal, and local) who have at least six months of experience will also be interviewed. All cases and deaths from tuberculosis (TB) reported in the Notifiable Diseases Information System (SINAN) from 2015 to 2022 and cases and deaths from COVID-19 from 2020 to 2022 available on the Coronavirus Panel will be considered. The population for this study phase will consist of people undergoing treatment for TB. No gender criteria apply. Professionals who are part of the health team responsible for Directly Observed Treatment (DOT). Managers of the units (Primary Health Care (PHC) coordinators and/or coordinators of PHC units in the municipalities and units previously selected)
Exclusion criteria
Exclusion criteria: Serão excluídos gestores ou profissionais que não respondam a três contatos seguidos. Só serão considerados os casos e óbitos notificados como causa básica tuberculose ou COVID-19 dentro do período citado; outras doenças ou notificações fora do período serão excluídas. Serão excluídas pessoas que não estejam fazendo tratamento para tuberculose (TB) no momento e profissionais de saúde que não atuem no Tratamento Diretamente Observado (TDO), exceto gestores das unidades
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome considered in the study is the success of the treatment or adherence efficacy, expressed by the proportion of participants who completed the treatment since randomization. It is expected to find a high adherence rate, verified through the monitoring of participants, by observing the proportion of those who completed the treatment. Secondary outcomes will be measured by considering the percentage of side effects reported and addressed by health services. It is expected to identify a variation in side effects, verified through health reports, by observing the percentage of side effects reported and addressed. Additionally, the participants' willingness to continue treatment will be evaluated. It is expected to find a high rate of willingness to continue, verified through questionnaires administered to participants, by observing the percentage expressing this willingness. Another secondary outcome is the importance of the treatment for TBD or TBI as reported by participants. It is expected to find a positive perception of the treatment's importance, verified through interviews, by observing the percentage of participants reporting this importance. Other aspects such as satisfaction, costs, stigma, and privacy will also be assessed. It is expected to find variations in these aspects, verified through interviews and questionnaires, by observing satisfaction indexes, incurred costs, stigma perception, and privacy concerns. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactRicardo Arcêncio
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed