TB YOUTH - One-month Ultra-short Tuberculosis Preventive Treatment Regimen Compared to Three-month Treatment for School Contacts

What this Trial Is About

Adolescents and school staff are at risk of tuberculosis (TB), with many cases going undiagnosed and contributing to the spread of TB in school settings. This clinical trial aims to compare the effectiveness of a new one-month ultra-short tuberculosis preventive treatment (TPT) regimen called 1H3P3 against the standard three-month 3HR regimen in preventing active TB among close contacts of school TB cases. The study is a prospective, multi-center, open-label, cluster randomized controlled trial conducted within the national tuberculosis control program in China. Participants diagnosed with latent tuberculosis infection (LTBI) through active screening will be randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. The trial will follow participants for two years to assess the incidence of active TB and treatment outcomes. This study also aims to inform future TB prevention policies for adolescents. Throughout the two-year follow-up, participants will undergo regular assessments including culture or GeneXpert MTB/RIF testing to confirm active TB cases or clinical evaluation for suspected TB. The study will monitor treatment completion rates, withdrawals, mortality, and drug resistance development. Participants' health will be closely observed to evaluate the safety and tolerability of the treatment regimens, supporting a comprehensive approach to TB prevention in schools.

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts