Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
Public ClinicalTrials.gov record NCT01582711. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection (LTBI) Treatment With 12 Doses of Once Weekly Rifapentine (RPT) and Isoniazid (INH) Given as Self-administered (SAT) Versus Directly-observed Therapy (DOT): iAdhere.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01582711
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,002 participants
Conditions and interventions
Conditions
Interventions
- Self Administered Therapy (SAT) Behavioral
- SMS reminders Behavioral
- isoniazid and rifapentine Drug
Behavioral · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2012
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Mar 12, 2025
2012 – 2014
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94110 | — |
| Denver Public Health Department | Denver | Colorado | 80204 | — |
| Washington DC Veterans Affairs Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Columbia University College of Physicians and Surgeons and New York City Department of Health | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27713 | — |
| Vanderbilt University Medical Center and Nashville Metro Public Health Department | Nashville | Tennessee | 37232-0146 | — |
| University of North Texas Health Science Center at Fort Worth | Fort Worth | Texas | 76104-4802 | — |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229-4404 | — |
| South Texas - Department of State Health Services | San Antonio | Texas | 78229-4404 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01582711, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01582711 live on ClinicalTrials.gov.