Abstract:
Introduction Tuberculosis (TB) is a leading infectious cause
of death globally. It is the most common opportunistic infection
in people living with HIV, and the most common cause of their
morbidity and mortality. Following TB treatment, surviving
individuals may be at risk for post-TB lung disease. The TB
Sentinel Research Network (TB-SRN) provides a platform for
coordinated observational TB research within the International
epidemiology Databases to Evaluate AIDS (IeDEA) consortium.
Methods and analysis This prospective, observational cohort
study will assess treatment and post-treatment outcomes
of pulmonary TB (microbiologically confirmed or clinically
diagnosed) among 2600 people aged ≥15 years, with and
without HIV coinfection, consecutively enrolled at 16 sites in 11
countries, across 6 of IeDEA’s global regions. Data regarding
clinical and sociodemographic factors, mental health, health-
related quality of life, pulmonary function, and laboratory and
radiographic findings will be collected using standardised
questionnaires and data collection tools, beginning from the
initiation of TB treatment and through 12 months after the end
of treatment. Data will be aggregated for proposed analyses.
Ethics and dissemination Ethics approval was obtained at
all implementing study sites, including the Vanderbilt University
Medical Center Human Research Protections Programme.
Participants will provide informed consent; for minors, this
includes both adolescent assent and the consent of their parent
or primary caregiver. Protections for vulnerable groups are
included, in alignment with local standards and considerations
at sites. Procedures for requesting use and analysis of TB-SRN
data are publicly available. Findings from TB-SRN analyses
will be shared with national TB programmes to inform TB
programming and policy, and disseminated at regional and
global conferences and other venues
