An interventional study of Electronic DOT and In-person DOT in Tuberculosis, Drug-resistant Tuberculosis and Adherence, Medication, sponsored by Centers for Disease Control and Prevention. Completed at 4 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Health services research
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be implemented to evaluate traditional directly observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment. The trial will assess whether eDOT that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best intervention proven to be successful when it comes to TB patients' adherence to therapy (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT, health departments and other clinicians might be able to provide eDOT to certain populations of TB patients in a more flexible and potentially cost-saving manner.
Tuberculosis (TB) is among the most common infectious diseases and cause of death worldwide. The bacteria that causes TB, Mycobacterium tuberculosis (Mtb), is spread when a person with TB disease of the lungs or throat coughs, speaks, or sings. These bacteria can float in the air for several hours, depending on the environment. Persons who breathe in the air containing these TB bacteria can become infected.
The World Health Organization (WHO) estimates that 9.6 million became ill with TB in 2014. Among this group, approximately 480,000 persons became ill with multidrug-resistant TB (MDR TB), which is TB caused by bacteria that are resistant to at least isoniazid and rifampin, the two most potent TB drugs used to treat persons with TB disease. Extensively drug resistant (XDR) strains of TB were reported by 105 countries in 2015. As such, the National Strategy for Combatting Antibiotic Resistant Bacteria (CARB) has designated Mtb a SERIOUS threat level pathogen.
Completion of treatment by persons with TB disease represents the optimal path to the prevention of morbidity and mortality, cure of the patient, interruption of transmission, and prevention of acquired drug resistance. The single best intervention in this regard has proven to be directly observed therapy (DOT).
DOT provides frequent interactions between the patient and the patient's healthcare team. This enables better monitoring and efficient response to medication side effects. This is especially important as medication side effects are among the top reasons patients are lost to follow-up during treatment therapy.
Experience in the U.S. in the 1990s demonstrated the efficacy of this intervention in the prevention and control of drug-resistant tuberculosis.Studies in the past 15 years in international settings have challenged the utility of DOT, but have been criticized for imperfect to poor design or implementation.
DOT entails a trained "observer" acceptable to both the patient and the health system being present to monitor treatment adherence as patients swallow anti-TB drugs. In the United States, DOT remains a cornerstone of TB control. While DOT represents the treatment standard, the implementation of DOT has been modified by some programs in an effort to reduce costs and conserve program resources. In the U.S., efforts recently have sought to utilize advances in communication technology to facilitate the implementation of DOT.
This study will evaluate traditional approaches to DOT compared to DOT by electronic methods. The study will be based within, and primarily conducted by the New York City Department of Health and Mental Hygiene (NYC DOHMH), Bureau of Tuberculosis Control (BTBC) clinics. This will enable the study to be to be conducted in a programmatic setting and reflect "real-life" situations.
Hypothesis: Directly observed therapy (DOT) that employs electronic communication methods (eDOT) is a non-inferior approach to monitor treatment adherence, compared to traditional forms of DOT, in which a trained person is in the physical presence of patients as anti-TB drugs are ingested (ipDOT).
Design: This will be a U.S.-based, 1 site (with 4 clinic settings), randomized, cross-over, 2-arm, non-inferiority trial with randomization to either traditional in-person DOT (ipDOT) or electronic DOT (eDOT)*, at the time outpatient treatment begins within participating health department clinics.
*Secondary analyses will evaluate DOT conducted in "real time" or "live" (eDOT-live) compared to DOT that uses a recorded video (eDOT-recorded).
Population:Patients newly diagnosed with drug-sensitive or non-rifamycin resistant TB.
Site: Four clinics of the New York City Department of Health and Mental Hygiene, Bureau of Tuberculosis Control.
Study Duration: Duration per participant is approximately 6 months.
Description of Intervention: After providing written informed consent, participants will be randomly assigned to one of the following DOT study group assignments: (1) traditional in-person DOT (ipDOT) or (2) electronic DOT (eDOT).
Note: Patients and their providers will discuss and choose the type of eDOT they will use. The two options are: (2a) eDOT conducted "live" in which TB program staff interact with patients in real-time via a computer or phone application as they ingest their medication (eDOT-live), and (2b) eDOT in which patients record themselves ingesting their TB medication using "time-stamped, recorded" videos for TB program staff to review within 1 business day (24 hours), and verify that patients ingested their medication doses as scheduled (eDOT-recorded).
Following 20 observable medication doses under an initial DOT study group assignment participants will be assigned (crossed-over) to the opposite DOT method to collect data on another 20 observable medication doses. Specifically, participants who initially received ipDOT will switch to eDOT. Participants initially assigned to eDOT will switch to ipDOT.
At the conclusion of this Cross-Over Period with 40 observable medication doses, participants will continue treatment using their preferred DOT method.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 216 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet the following inclusion criteria in order to participate in this study:
Exclusion Criteria:
An individual meeting any of the following exclusion criteria at the time of enrollment will be excluded from study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following 20 observable medication doses under an initial DOT study group assignment of in-person DOT (ipDOT), patients will be assigned (crossed-over) to electronic DOT (eDOT) to collect data on another 20 observable medication doses.
Other: Electronic DOT · Other: In-person DOT
Following 20 observable medication doses under an initial DOT study group assignment of electronic DOT (eDOT), patients will be assigned (crossed-over) to in-person DOT (ipDOT) to collect data on another 20 observable medication doses.
Other: Electronic DOT · Other: In-person DOT
Electronic DOT is the use of electronic communication methods to observe patients swallow anti-TB drugs and monitor for medication side effects. This study will use two variations of electronic communication methods, referred to as "electronic directly observed therapy" or "eDOT". This includes: (1) eDOT conducted "live" in which TB program staff interact with patients via a computer or phone application as they ingest their medication (eDOT-live), and (2) eDOT conducted using "time stamped, recorded" videos in which TB program staff log into an electronic system and review videos recorded by patients in order to verify that patients ingested their medication doses as scheduled (eDOT-recorded).
Also known as: eDOT, Video DOT (VDOT)
A trained person is in the physical presence of patients as anti-TB drugs are ingested.
Also known as: ipDOT, Traditional DOT
"Percentage of Medication Doses Directly Observed (Modified ITT Analysis)"
The proportion of observable medication doses directly observed by staff during in-person DOT and electronic DOT, analyzed using the modified intention-to-treat (Modified ITT) population. The unit of analysis is medication doses.
Time frame: Time frame varied based on the participant's prescribed treatment regimen and phase of treatment; 20 doses of medication would require 8 to 13 weeks.
Percentage of Medication Doses Directly Observed (Empirical Analysis)
The proportion of observable medication doses directly observed by staff during in-person DOT and electronic DOT, analyzed using the empirical analysis population. The unit of analysis is medication doses.
Time frame: Cross-over period; 20 observable medication doses per DOT method (approximately 8 to 13 weeks depending on treatment regimen).
Reporting of Medication Side Effects
Time, measured in days, in which participants experience initial symptoms of medication side effects to when they receive medical attention for the medication side effects they are experiencing, either through consultation with a physician, urgent care or emergency room visits, or hospital admission across DOT methods.
Time frame: Time frame varied based on the participant's prescribed treatment regimen and phase of treatment; 20 doses of medication would require 8 -13 weeks.
Number of Medication Doses Not Directly Observed
Number of scheduled, observable medication doses that were not directly observed by staff. Participants contributed medication-dose observations during the cross-over period and, when applicable, the continuation period through treatment completion. The unit of analysis is medication doses.
Time frame: During the cross-over period and continuation period, from treatment initiation until completion of tuberculosis treatment (approximately up to 6 months, depending on the prescribed treatment regimen).
Patients' Demographic, Social, and Medical Characteristics Associated With Treatment Adherence
Number of participants by gender, race, ethnic origin, country of birth, primary language spoken, and employment who adhere to TB treatment. Additionally, the number of patients with a history of contact with persons diagnosed with multi-drug resistant TB, incomplete treatment for latent TB infection, diabetes, renal disease, immunosuppression, hepatitis, a history of homelessness, a history of substance abuse, a history of incarceration, a history of a prior TB diagnosis who adhere to TB treatment.
Time frame: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).
Treatment Outcomes
Compare the proportion of participants completing treatment to those lost to follow-up or refused further treatment, transfer or move, experience treatment failure, or expire (with death attributable to tuberculosis) across DOT methods.
Time frame: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT) during the cross-over period, they will be asked to report which DOT method they prefer, and the reasons for their preference.
Time frame: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).
Patient Opinion Questionnaire
After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT), participants will be asked to complete the Patient Opinion Questionnaire to assess their perceptions of the quality of care across DOT methods and satisfaction with patient-staff relationships/rapport.
Time frame: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).
Enrollment began July 2017 and ended October 2019. Recruitment was conducted through 4 chest clinics operated by the New York City Department of Health and Mental Hygiene, Bureau of Tuberculosis Control. Non-English-speaking participants were recruited using bilingual staff, contracted interpreters, and translated data collection forms.
| Milestone | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT |
|---|---|---|
| Started | 109 | 102 |
| Completed | 95 | 78 |
| Not completed | 14 | 24 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 5 |
| Withdrew: Late exclusion - ruled out tb | 4 | 6 |
| Withdrew: Late exclusion: hospitalized more than 5 days | 2 | 3 |
| Withdrew: Late exclusion: drug resistance identified | 2 | 3 |
| Withdrew: Participant moved or relocated | 2 | 3 |
| Milestone | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT |
|---|---|---|
| Started | 95 | 78 |
| Completed | 95 | 78 |
| Not completed | 0 | 0 |
The proportion of observable medication doses directly observed by staff during in-person DOT and electronic DOT, analyzed using the modified intention-to-treat (Modified ITT) population. The unit of analysis is medication doses.
| Medication Doses | Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy | Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy |
|---|---|---|
| "Percentage of Medication Doses Directly Observed (Modified ITT Analysis)" | 2783 | 2913 |
The proportion of observable medication doses directly observed by staff during in-person DOT and electronic DOT, analyzed using the empirical analysis population. The unit of analysis is medication doses.
| Medication Doses | Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy | Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy |
|---|---|---|
| Percentage of Medication Doses Directly Observed (Empirical Analysis) | 2601 | 3091 |
Time, measured in days, in which participants experience initial symptoms of medication side effects to when they receive medical attention for the medication side effects they are experiencing, either through consultation with a physician, urgent care or emergency room visits, or hospital admission across DOT methods.
| Days | Medication Doses to be Observed With In-person Directly Observed Therapy. | Medication Doses to be Observed With Electronic Directly Observed Therapy |
|---|---|---|
| Reporting of Medication Side Effects | 1.0 (0.5 to 2.0) | 1.0 (0.0 to 2.0) |
Number of scheduled, observable medication doses that were not directly observed by staff. Participants contributed medication-dose observations during the cross-over period and, when applicable, the continuation period through treatment completion. The unit of analysis is medication doses.
| medication doses | In-person Directly Observed Therapy (ipDOT) | Electronic Directly Observed Therapy (eDOT) |
|---|---|---|
| Number of Medication Doses Not Directly Observed | 798 | 2794 |
Number of participants by gender, race, ethnic origin, country of birth, primary language spoken, and employment who adhere to TB treatment. Additionally, the number of patients with a history of contact with persons diagnosed with multi-drug resistant TB, incomplete treatment for latent TB infection, diabetes, renal disease, immunosuppression, hepatitis, a history of homelessness, a history of substance abuse, a history of incarceration, a history of a prior TB diagnosis who adhere to TB treatment.
Results for this outcome have not been posted.
Compare the proportion of participants completing treatment to those lost to follow-up or refused further treatment, transfer or move, experience treatment failure, or expire (with death attributable to tuberculosis) across DOT methods.
Results for this outcome have not been posted.
After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT) during the cross-over period, they will be asked to report which DOT method they prefer, and the reasons for their preference.
| Participants | Participants' DOT Preferences for the Remainder of Treatment |
|---|---|
| Preferred to continue treatment with live-video electronic DOT | 73 |
| Preferred to continue treatment with recorded-video electronic DOT | 73 |
| Preferred to continue treatment with community-based in-person DOT | 9 |
| Preferred to continue treatment with clinic-based in-person DOT | 1 |
| Elected to self-administer medications | 6 |
| No preference recorded | 11 |
After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT), participants will be asked to complete the Patient Opinion Questionnaire to assess their perceptions of the quality of care across DOT methods and satisfaction with patient-staff relationships/rapport.
Results for this outcome have not been posted.
Collected over Adverse event data was collected from the time each participant enrolled in the study until the conclusion of the crossover period, an approximate duration of 8-13 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events (AE) Reported While Using Electronic DOT (eDOT) | 31/198 (15.7%) | 5/198 (2.5%) | 26/198 (13.1%) |
| Adverse Events (AE) Reported While Using In-person DOT (ipDOT) | 26/191 (13.6%) | 2/191 (1%) | 24/191 (12.6%) |
| Event | Adverse Events (AE) Reported While Using Electronic DOT (eDOT) | Adverse Events (AE) Reported While Using In-person DOT (ipDOT) |
|---|---|---|
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveGastrointestinal disorders | 3/198 | 0/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveCardiac disorders | 2/198 | 1/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveGeneral disorders | 0/198 | 1/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or AboveSkin and subcutaneous tissue disorders | 1/198 | 0/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveGeneral disorders | 1/198 | 0/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveGeneral disorders | 1/198 | 0/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or aboveMusculoskeletal and connective tissue disorders | 1/198 | 0/191 |
| Event | Adverse Events (AE) Reported While Using Electronic DOT (eDOT) | Adverse Events (AE) Reported While Using In-person DOT (ipDOT) |
|---|---|---|
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2Gastrointestinal disorders | 12/198 | 9/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2Skin and subcutaneous tissue disorders | 7/198 | 8/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2General disorders | 2/198 | 6/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2Musculoskeletal and connective tissue disorders | 2/198 | 6/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2General disorders | 5/198 | 5/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2General disorders | 1/198 | 2/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2General disorders | 2/198 | 2/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2General disorders | 2/198 | 2/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2Cardiac disorders | 2/198 | 0/191 |
| National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2Eye disorders | 2/198 | 0/191 |
| Age, Continuous(years) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| Median | 38 (16 to 86) | 44 (18 to 76) | 42 (16 to 86) |
| Age, Customized(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| 16-20 years | 6 | 4 | 10 |
| 21-30 years | 35 | 22 | 57 |
| 31-40 years | 18 | 14 | 32 |
| 41-50 years | 20 | 18 | 38 |
| 51-60 years | 20 | 21 | 41 |
| 61-70 years | 8 | 13 | 21 |
| 71-80 years | 4 | 11 | 15 |
| 81-90 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| Female | 45 | 31 | 76 |
| Male | 68 | 72 | 140 |
| Race/Ethnicity, Customized(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| African American / Black, Non-Hispanic | 20 | 23 | 43 |
| Asian/ Pacific Islander/ Hawaiian | 37 | 43 | 80 |
| Hispanic | 43 | 28 | 71 |
| Other / Multiple | 9 | 4 | 13 |
| White, Non-Hispanic | 4 | 5 | 9 |
| Region of Enrollment(participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| United States | 113 | 103 | 216 |
| Access to Video Device Prior to Enrollment(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| Yes | 78 | 71 | 149 |
| No | 35 | 32 | 67 |
| Primary Language Spoken(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| English | 29 | 26 | 55 |
| Spanish | 34 | 22 | 56 |
| Chinese (Cantonese, Fujianese, Mandarin) | 9 | 15 | 24 |
| French, Creole, Pidgins, French-based Other | 9 | 7 | 16 |
| Other | 30 | 30 | 60 |
| Unknown | 2 | 3 | 5 |
| Educational Attainment(Participants) | Group 1: ipDOT Followed by eDOT | Group 2: eDOT Followed by ipDOT | Total |
|---|---|---|---|
| No formal schooling | 8 | 4 | 12 |
| Primary school (Grades 1-5) | 4 | 5 | 9 |
| Middle school (Grades 6-8) | 14 | 13 | 27 |
| Secondary school (Grades 9-12) | 40 | 44 | 84 |
| College+ | 34 | 28 | 62 |
| Unknown / Refused to Answer | 13 | 9 | 22 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Jan 2020, 29 months.
Results were first posted in Jul 2026, 6 years 5 months after primary completion.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 29 months is above that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centers for Disease Control and Prevention →