Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT

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.

Conditions

• Latent Tuberculosis Infection

Interventions

BEHAVIORAL

Self Administered Therapy (SAT)

Self Administered Therapy (SAT)

BEHAVIORAL

SMS reminders

Short Message Service (SMS) text reminders

DRUG

isoniazid and rifapentine

rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Andrey S Borisov, MD, MPH · U.S. Centers for Disease Control and Prevention (CDC), Atlanta, USA.

• Robert Belknap, MD · Division of Infectious Diseases, University of Colorado, Denver, USA.

• Robert Belknap, MD · Division of Infectious Diseases, University of Colorado, Denver, USA.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States
• China
• South Africa
• Spain

Study Locations