Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT (NCT01582711) | Clinical Trial Compass
CompletedPhase 3
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
United States, China, South Africa1,002 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ison…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two ways of taking the same 3HP medication — self-administered therapy (SAT) versus directly observed therapy (DOT) — so which approach did the results show led to better treatment completion rates, and which one might be more realistic for my own situation?
2Since this was a Phase 3 trial that has already completed, has the data from this study actually changed how doctors decide between SAT and DOT for latent TB treatment, and does it affect how you would recommend I take my medication?
3The 3HP regimen means taking medication once a week for 3 months — given my schedule and daily responsibilities, would self-administered therapy be a safe and practical option for me, or would you recommend I come in for observed doses?
4Are there specific patient characteristics — like my age, other health conditions, or living situation — that the results of this study suggest might make one approach work better than the other for someone like me?
5Before considering a treatment approach studied in this trial, should I first make sure I've been fully evaluated to confirm I actually have latent rather than active TB infection, and does that change which treatment path my doctor would recommend?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Completion Rate.
Timeframe: Up to 16 weeks from start of treatment.