Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT,
SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients
diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The
primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly
rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to
self-administered therapy (SAT). The secondary objectives:
- To compare the treatment completion rates between participants randomized to SAT without
reminders versus SAT with weekly SMS reminders
- To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among
participants who complete treatment and those who discontinue therapy prior to
completion.
- To determine the availability and acceptability of using SMS reminders among all
patients consenting to participate in the study.
- To determine the toxicity and tolerability by comparing the rates of any drug-related
grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined
and individually)
- To compare the frequency, timing, and causes for failure to complete treatment between
the DOT arm and the SAT arms
- To collect patient-specific cost data related to the 3 treatment arms
- To describe the pattern of antituberculosis drug resistance among Mycobacterium
tuberculosis strains cultured from participants who develop active TB.