Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT (iAdhere)
Latent Tuberculosis Infection
About this trial
This is an interventional prevention trial for Latent Tuberculosis Infection focused on measuring LTBI, LTB, Latent TB, TB infection
Eligibility Criteria
Inclusion Criteria:
- Males and non-pregnant, non-nursing females
- Age > 18 years
- Weight > 45kg and considered appropriate to receive RPT 900mg and INH 900mg once weekly by the local site investigator
- Willingness to provide signed informed consent.
- Clinical indication for LTBI treatment such as: 1) persons with a positive tuberculin skin test (TST) as defined by CDC criteria or a positive interferon-gamma release assay (IGRA) defined per the manufacturers' guidelines AND one of the following: close contact to someone with culture confirmed TB, HIV infection, or > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of TB treatment; 2) TST or IGRA converters defined as a documented change from negative to positive within a two-year period; 3) Persons with any other clinical indication for LTBI treatment as locally defined including persons with a negative TST and/or IGRA (e.g. HIV-infected close contacts to an active pulmonary TB cases)
Exclusion Criteria:
- Confirmed or suspected active TB
- Contacts to a source case with known resistance to isoniazid or rifampin
- Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB, regardless of whether the course was completed, because adherence may be different in people who previously took TB treatment
- Persons who are not considered candidates for SAT by the local investigator
- History of sensitivity or intolerance to isoniazid or rifamycins
- Serum alanine aminotransferase (ALT, SGPT) > 5x upper limit of normal among persons in whom an ALT is determined
- Persons with HIV-infection who 1) have a CD4 < 350 or 2) are currently receiving or planning to receive antiretroviral therapy in the first 120 days after study initiation (e.g., HIV-1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors)
Sites / Locations
- University of California, San Francisco
- Denver Public Health Department
- Washington DC Veterans Affairs Medical Center
- Columbia University College of Physicians and Surgeons and New York City Department of Health
- Duke University
- Vanderbilt University Medical Center and Nashville Metro Public Health Department
- University of North Texas Health Science Center at Fort Worth
- Audie L. Murphy VA Hospital
- South Texas - Department of State Health Services
- TB and Chest service of Hong Kong
- Wits Health Consortium
- Agencia de Salut Publica - Barcelona, Spain and UNTHSC
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
3HP Directly Observed Therapy (DOT)
3HP Self Administered Therapy (SAT)
3HP SAT with SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.