This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.
Aged ≥13 years and body weight ≥ 30 kg;
Currently attending junior / senior high school or university students;
School staff members;
Teachers/students sharing the same classroom or dormitory with the index case;
Current active TB disease (clinically or bacteriologically confirmed);
Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case;
Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for >14 consecutive days within the past 2 years;
Prior completion of full-course of treatment for ATB or LTBI;
Parallel
isoniazid and rifapentine
Drug12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks
Rifampin and Isoniazid
Drug3HR regimen of isoniazid and rifampicin once daily for three months
Cumulative incidence of active tuberculosis (TB) over 24 months
The primary endpoint is a composite of bacteriologically confirmed or clinically diagnosed active TB within 24 months after randomization. Bacteriologically confirmed TB is defined as M. tuberculosis detection by sputum culture and/or molecular assay (e.g., GeneXpert MTB/RIF). Clinically diagnosed TB requires the presence of ≥2 objective clinical symptoms (cough ≥2 weeks, fever, night sweats, weight loss \>10%, or hemoptysis) plus chest imaging findings highly suggestive of active TB, after exclusion of alternative diagnoses. This measure will be used to assess the non-inferiority of the 1H3P3 regimen compared to the 3HR regimen.
Proportion of participants with adverse events (AEs) and serious adverse events (SAEs)
To compare the safety profiles between the 1H3P3 and 3HR regimens. All AEs and SAEs will be documented, and group differences in AE proportions will be analyzed. Severity will be graded per the Division of AIDS (DAIDS) table.
Incidence of treatment discontinuation attributable to AEs
To compare the treatment discontinuation rates due to AEs between the 1H3P3 and 3HR regimens
Treatment completion rate.
Defined as the proportion of participants who complete ≥90% of scheduled doses within 110% of the planned treatment duration (≥11 doses within 6 weeks for 1H3P3 group and ≥81 doses within 16 weeks for 3HR group)
All-cause mortality.
Death from any cause during the 24-month follow-up period.
Patient-Reported Outcome (PRO) - Health-related Quality of Life (Exploratory)
Health state utility and EuroQol visual analogue scale (EQ VAS) values will be measured using the EuroQol 5-Dimensions 3-Level (EQ-5D-3L) questionnaire. This exploratory endpoint was introduced via a protocol amendment and will be administered only to participants enrolled after the amendment effective date. Assessments occur at baseline and at each on-treatment visit.
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