RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis infection (TBI) under routine programmatic conditions in Kazakhstan.
The study enrolls three cohorts: patients with DS-TB receiving the 4-month isoniazid-rifapentine-moxifloxacin-pyrazinamide regimen (2HPMZ/2HPM), patients with DS-TB receiving the standard 6-month isoniazid-rifampicin-pyrazinamide-ethambutol regimen (2HRZE/4HR), and individuals with TBI receiving the 1-month rifapentine-isoniazid regimen (1HP). Participants include people living with and without HIV.
The study is conducted across four regions of Kazakhstan and is funded through the Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB (WEEPI) grant. Findings will inform national TB policy and contribute to global evidence on programmatic implementation of rifapentine-based regimens.
Age 18 years or older
Bacteriologically confirmed drug-susceptible pulmonary tuberculosis
Newly diagnosed, not previously treated (or treated less than 1 month)
Willing and able to provide written informed consent
Confirmed or suspected drug-resistant tuberculosis (rifampicin-resistant tuberculosis (RR-TB) or multidrug-resistant tuberculosis (MDR-TB))
Extrapulmonary tuberculosis as the sole manifestation
Pregnancy or breastfeeding at time of enrollment
Severe hepatic impairment (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3x upper limit of normal)
Adults aged 18 years and older with drug-susceptible tuberculosis or tuberculosis infection, including people living with and without HIV, enrolled at tuberculosis facilities in four regions of Kazakhstan.
Cohort
Prospective
Not listed
Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)
Proportion of patients with drug-susceptible tuberculosis who achieve a favourable treatment outcome, defined as "cured" or "treatment completed" without recurrence, within 12 months of treatment initiation. Compared between 2HPMZ/2HPM and standard 2HRZE/4HR cohorts.
Cumulative Incidence of Serious Adverse Events
Cumulative incidence rate, timing of onset, severity, and outcomes of all serious adverse events recorded during treatment in the 2HPMZ/2HPM and 1HP cohorts. Treatment duration is up to 4 months for 2HPMZ/2HPM and up to 1 month for 1HP.
Treatment completion rate
Percentage of participants who complete the full assigned regimen (2HPMZ/2HPM or 1HP) without premature discontinuation, measured from treatment initiation through the end of the assigned regimen.
Programmatic operability
Descriptive documentation of reasons for treatment non-initiation or premature discontinuation across the 2HPMZ/2HPM and 1HP cohorts, assessed from treatment initiation through the end of the assigned regimen.
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Public Union "Kazakhstan Association of Phthisiopulmonologists"
Lead sponsor
The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
Collaborator
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