Trial · NCT01582711
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
NCT01582711, Phase 3, Completed, Centers for Disease Control and Prevention; results first posted 2025-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT. Trials, record NCT01582711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01582711
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
- NCT number
- NCT01582711
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,002 participants, actual
- Lead sponsor
- Centers for Disease Control and Prevention
- Conditions
- Latent Tuberculosis Infection
- Interventions
- Self Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
- First posted
- 2012-04-23
- Last updated
- 2025-03-13
- Results first posted
- 2025-03-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Completion Rate. | Up to 16 weeks from start of treatment. | To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation. |
| Secondary | Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders | Up to 16 weeks from start of treatment. | To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders |
| Secondary | The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | Up to 16 weeks from start of treatment. | The number and proportion of participants who adhered (completed treatment) based on pill count and self-report, considered to be standard of care (SOC) vs. the number of participants who completed treatment based on SOC plus MEMS cap. |
| Secondary | Availability and Acceptability | Up to 16 weeks from start of treatment. | To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study. |
| Secondary | Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death | Up to 16 weeks from start of treatment. | 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) |
| Secondary | Number and Percentage of Participants Reason for Failure to Complete Treatment | Up to 16 weeks from start of treatment. | To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms (both combined and individually) including discontinuation due to: * non-adherence * any adverse event (AE) * a diagnosis of active TB * other reasons |
| Secondary | Patient-specific Cost | Up to 20 weeks from start of treatment. | To collect patient-specific cost data related to the DOT and SAT arms |
| Secondary | Antituberculosis Drug Resistance | Up to 16 weeks from start of treatment. | To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Completion Rate. | Up to 16 weeks from start of treatment. | Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from treatment completion analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders | Up to 16 weeks from start of treatment. | Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from treatment completion analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | Up to 16 weeks from start of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Availability and Acceptability | Up to 16 weeks from start of treatment. | 'Proportion of Participants willing to use SMS (Acceptability) (eSAT arm ONLY)' analysis was only done in '3HP SAT with SMS Reminders'. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death | Up to 16 weeks from start of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number and Percentage of Participants Reason for Failure to Complete Treatment | Up to 16 weeks from start of treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient-specific Cost | Up to 20 weeks from start of treatment. | This analysis was conducted in 81 (DOT-40, SAT-41) participants from 7 study sites. As pre-specified in the protocol, DOT cost maybe prohibitive to TB programs, and SAT cost may provide a cost-effective alternative. Data was collected and analyzed to assess DOT costs vs SAT costs, such that the distinction between SAT and eSAT arms were not appropriate. As a result, participants in the SAT arms were combined to find total cost. | U.S. Dollar | MEDIAN |
| SECONDARY | Antituberculosis Drug Resistance | Up to 16 weeks from start of treatment. | Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from drug resistance analyses. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Completion Rate. | 3HP Directly Observed Therapy (DOT) | 294 | Participants | ||
| Treatment Completion Rate. | 3HP Self Administered Therapy (SAT) | 248 | Participants | ||
| Treatment Completion Rate. | 3HP SAT With SMS Reminders | 250 | Participants | ||
| Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders | 3HP Self Administered Therapy (SAT) | 248 | Participants | ||
| Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders | 3HP SAT With SMS Reminders | 250 | Participants | ||
| The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | 3HP Directly Observed Therapy (DOT) | Treatment completion proportion based on pill count/self-report | 294 | Participants | |
| The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | 3HP Self Administered Therapy (SAT) | Treatment completion proportion based on pill count/self-report | 271 | Participants | |
| The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | 3HP SAT With SMS Reminders | Treatment completion proportion based on pill count/self-report | 266 | Participants | |
| The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | 3HP Directly Observed Therapy (DOT) | Treatment completion proportion based on pill count/self-report and MEMS cap | 294 | Participants | |
| The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS | 3HP Self Administered Therapy (SAT) | Treatment completion proportion based on pill count/self-report and MEMS cap | 248 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3HP Directly Observed Therapy (DOT) | 337 | |
| Overall Study | STARTED | 3HP Self Administered Therapy (SAT) | 337 | |
| Overall Study | STARTED | 3HP SAT With SMS Reminders | 328 | |
| Overall Study | COMPLETED | 3HP Directly Observed Therapy (DOT) | 337 | |
| Overall Study | COMPLETED | 3HP Self Administered Therapy (SAT) | 337 | |
| Overall Study | COMPLETED | 3HP SAT With SMS Reminders | 328 | |
| Overall Study | NOT COMPLETED | 3HP Directly Observed Therapy (DOT) | 0 | |
| Overall Study | NOT COMPLETED | 3HP Self Administered Therapy (SAT) | 0 | |
| Overall Study | NOT COMPLETED | 3HP SAT With SMS Reminders | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Systemic Drug Reaction | General disorders | 3HP Directly Observed Therapy (DOT) | 13 | 337 | 13 |
| other | Systemic Drug Reaction | General disorders | 3HP Self Administered Therapy (SAT) | 15 | 337 | 15 |
| other | Systemic Drug Reaction | General disorders | 3HP SAT With SMS Reminders | 14 | 328 | 14 |
| other | Hepatitis | General disorders | 3HP Directly Observed Therapy (DOT) | 1 | 337 | 1 |
| other | Hepatitis | General disorders | 3HP Self Administered Therapy (SAT) | 3 | 337 | 3 |
| other | Hepatitis | General disorders | 3HP SAT With SMS Reminders | 5 | 328 | 5 |
| other | Thrombocytopenia | General disorders | 3HP Directly Observed Therapy (DOT) | 0 | 337 | 0 |
| other | Thrombocytopenia | General disorders | 3HP Self Administered Therapy (SAT) | 0 | 337 | 0 |
| other | Thrombocytopenia | General disorders | 3HP SAT With SMS Reminders | 1 | 328 | 1 |
| other | Neutropenia | General disorders | 3HP Directly Observed Therapy (DOT) | 1 | 337 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3HP Directly Observed Therapy (DOT) | 0 | 337 |
| Total, all-cause mortality | 3HP Self Administered Therapy (SAT) | 0 | 337 |
| Total, all-cause mortality | 3HP SAT With SMS Reminders | 1 | 328 |
| Total, other adverse events | 3HP Directly Observed Therapy (DOT) | 42 | 337 |
| Total, other adverse events | 3HP Self Administered Therapy (SAT) | 54 | 337 |
| Total, other adverse events | 3HP SAT With SMS Reminders | 56 | 328 |
| Total, serious adverse events | 3HP Directly Observed Therapy (DOT) | 11 | 337 |
| Total, serious adverse events | 3HP Self Administered Therapy (SAT) | 5 | 337 |
| Total, serious adverse events | 3HP SAT With SMS Reminders | 6 | 328 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 3HP Self Administered Therapy (SAT) vs 3HP SAT With SMS Reminders: Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01582711
GET https://conductscience.org/api/trials/v1/NCT01582711/results?page=2