Trial Outcomes & Findings for An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment (NCT NCT03266003)
NCT ID: NCT03266003
Last Updated: 2026-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
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.
Results posted on
2026-07-02
Participant Flow
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.
A total of 216 persons were screened, enrolled, and randomized. Following randomization, yet prior to the start of the crossover period, among those randomized to Group 1, 4 withdrew. Reasons were: Late exclusion, TB Diagnosis ruled out (n=1) Moving (n=1) Consent withdrawn (n=1) Other (n=1). Among those randomized to Group 2, 1 participant was withdrawn due to death.
Participant milestones
| Measure |
Group 1: ipDOT Followed by eDOT
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
Group 2: eDOT Followed by ipDOT
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
|---|---|---|
|
First Intervention (20 Observed Doses)
STARTED
|
109
|
102
|
|
First Intervention (20 Observed Doses)
COMPLETED
|
95
|
78
|
|
First Intervention (20 Observed Doses)
NOT COMPLETED
|
14
|
24
|
|
Second Intervention (20 Observed Doses)
STARTED
|
95
|
78
|
|
Second Intervention (20 Observed Doses)
COMPLETED
|
95
|
78
|
|
Second Intervention (20 Observed Doses)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: ipDOT Followed by eDOT
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
Group 2: eDOT Followed by ipDOT
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
|---|---|---|
|
First Intervention (20 Observed Doses)
Physician Decision
|
1
|
2
|
|
First Intervention (20 Observed Doses)
Lost to Follow-up
|
1
|
2
|
|
First Intervention (20 Observed Doses)
Withdrawal by Subject
|
2
|
5
|
|
First Intervention (20 Observed Doses)
Late Exclusion - Ruled out TB
|
4
|
6
|
|
First Intervention (20 Observed Doses)
Late Exclusion: Hospitalized more than 5 days
|
2
|
3
|
|
First Intervention (20 Observed Doses)
Late Exclusion: Drug Resistance Identified
|
2
|
3
|
|
First Intervention (20 Observed Doses)
Participant moved or relocated
|
2
|
3
|
Baseline Characteristics
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
Baseline characteristics by cohort
| Measure |
Group 1: ipDOT Followed by eDOT
n=113 Participants
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
Group 2: eDOT Followed by ipDOT
n=103 Participants
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.
Electronic 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).
In-person DOT: A trained person is in the physical presence of patients as anti-TB drugs are ingested.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
41-50 years
|
20 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Age, Continuous
|
38 years
n=20 Participants
|
44 years
n=20 Participants
|
42 years
n=40 Participants
|
|
Age, Customized
16-20 years
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Customized
21-30 years
|
35 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
57 Participants
n=40 Participants
|
|
Age, Customized
31-40 years
|
18 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Age, Customized
51-60 years
|
20 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
|
Age, Customized
61-70 years
|
8 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Age, Customized
71-80 years
|
4 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Age, Customized
81-90 years
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=20 Participants
|
72 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
African American / Black, Non-Hispanic
|
20 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian/ Pacific Islander/ Hawaiian
|
37 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
43 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other / Multiple
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=20 Participants
|
103 participants
n=20 Participants
|
216 participants
n=40 Participants
|
|
Access to Video Device Prior to Enrollment
Yes
|
78 Participants
n=20 Participants
|
71 Participants
n=20 Participants
|
149 Participants
n=40 Participants
|
|
Access to Video Device Prior to Enrollment
No
|
35 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Primary Language Spoken
English
|
29 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
55 Participants
n=40 Participants
|
|
Primary Language Spoken
Spanish
|
34 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
56 Participants
n=40 Participants
|
|
Primary Language Spoken
Chinese (Cantonese, Fujianese, Mandarin)
|
9 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Primary Language Spoken
French, Creole, Pidgins, French-based Other
|
9 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Primary Language Spoken
Other
|
30 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
60 Participants
n=40 Participants
|
|
Primary Language Spoken
Unknown
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Educational Attainment
No formal schooling
|
8 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Educational Attainment
Primary school (Grades 1-5)
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Educational Attainment
Middle school (Grades 6-8)
|
14 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Educational Attainment
Secondary school (Grades 9-12)
|
40 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
84 Participants
n=40 Participants
|
|
Educational Attainment
College+
|
34 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Educational Attainment
Unknown / Refused to Answer
|
13 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
TB Disease, Pulmonary (Yes)
|
100 Participants
n=20 Participants
|
90 Participants
n=20 Participants
|
190 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Participants included in the Modified ITT and Empirical Analyses
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.
Outcome measures
| Measure |
Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy
n=3192 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing in-person DOT could choose to meet with health department staff at the TB clinic or at a mutually agreed-upon location in the community.
|
Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy
n=3244 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing electronic DOT could choose live videoconferencing (Skype for Business), which allowed TB program staff to interact with participants in real-time, or recorded (asynchronous) videos using a software application that automatically uploaded timestamped videos to a secure cloud-based server (SureAdhere Mobile Technology, Inc), and which TB program staff reviewed the following workday.
|
|---|---|---|
|
"Percentage of Medication Doses Directly Observed (Modified ITT Analysis)"
|
2783 Medication Doses
|
2913 Medication Doses
|
PRIMARY outcome
Timeframe: Cross-over period; 20 observable medication doses per DOT method (approximately 8 to 13 weeks depending on treatment regimen).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.
Outcome measures
| Measure |
Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy
n=2979 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing in-person DOT could choose to meet with health department staff at the TB clinic or at a mutually agreed-upon location in the community.
|
Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy
n=3457 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing electronic DOT could choose live videoconferencing (Skype for Business), which allowed TB program staff to interact with participants in real-time, or recorded (asynchronous) videos using a software application that automatically uploaded timestamped videos to a secure cloud-based server (SureAdhere Mobile Technology, Inc), and which TB program staff reviewed the following workday.
|
|---|---|---|
|
Percentage of Medication Doses Directly Observed (Empirical Analysis)
|
2601 Medication Doses
|
3091 Medication Doses
|
SECONDARY outcome
Timeframe: Time frame varied based on the participant's prescribed treatment regimen and phase of treatment; 20 doses of medication would require 8 -13 weeks.Population: In accordance with TB program protocols, all study participants were educated about symptoms of medication side effects at their first in-person clinic appointment and instructed to report these side effects and any health-related concerns during each DOT session. 57 participants reported medication side effects or health concerns during the study's crossover periods. Among the 57 participants, data specific to time frame were unavailable for seven participants.
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.
Outcome measures
| Measure |
Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy
n=23 Participants
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing in-person DOT could choose to meet with health department staff at the TB clinic or at a mutually agreed-upon location in the community.
|
Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy
n=27 Participants
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing electronic DOT could choose live videoconferencing (Skype for Business), which allowed TB program staff to interact with participants in real-time, or recorded (asynchronous) videos using a software application that automatically uploaded timestamped videos to a secure cloud-based server (SureAdhere Mobile Technology, Inc), and which TB program staff reviewed the following workday.
|
|---|---|---|
|
Reporting of Medication Side Effects
|
1.0 Days
Interval 0.5 to 2.0
|
1.0 Days
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 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).Population: Overall Number of Participants Analyzed reflects the number of participants contributing data to each intervention. Overall Number of Units Analyzed reflects the total number of medication doses included in the analysis. Participants could contribute multiple medication-dose observations beyond the initial 20 observable doses per intervention because DOT observations continued through treatment completion.
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.
Outcome measures
| Measure |
Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy
n=4692 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing in-person DOT could choose to meet with health department staff at the TB clinic or at a mutually agreed-upon location in the community.
|
Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy
n=15405 Medication Doses
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing electronic DOT could choose live videoconferencing (Skype for Business), which allowed TB program staff to interact with participants in real-time, or recorded (asynchronous) videos using a software application that automatically uploaded timestamped videos to a secure cloud-based server (SureAdhere Mobile Technology, Inc), and which TB program staff reviewed the following workday.
|
|---|---|---|
|
Number of Medication Doses Not Directly Observed
|
798 medication doses
|
2794 medication doses
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).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.
Outcome measures
| Measure |
Percentage of Doses Staff Observed Participants Ingest With In-person Directly Observed Therapy
n=173 Participants
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing in-person DOT could choose to meet with health department staff at the TB clinic or at a mutually agreed-upon location in the community.
|
Percentage of Doses Staff Observed Participants Ingest With Electronic Directly Observed Therapy
All nonholiday, weekday doses scheduled in advance for DOT were designated scheduled and observable, and an outcome was documented for each dose.
Participants undergoing electronic DOT could choose live videoconferencing (Skype for Business), which allowed TB program staff to interact with participants in real-time, or recorded (asynchronous) videos using a software application that automatically uploaded timestamped videos to a secure cloud-based server (SureAdhere Mobile Technology, Inc), and which TB program staff reviewed the following workday.
|
|---|---|---|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
Preferred to continue treatment with live-video electronic DOT
|
73 Participants
|
—
|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
Preferred to continue treatment with recorded-video electronic DOT
|
73 Participants
|
—
|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
Preferred to continue treatment with community-based in-person DOT
|
9 Participants
|
—
|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
Preferred to continue treatment with clinic-based in-person DOT
|
1 Participants
|
—
|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
Elected to self-administer medications
|
6 Participants
|
—
|
|
Participants' Preferred DOT Method at the Conclusion of the Cross-over Period.
No preference recorded
|
11 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cross-Over Period (40 observable medication doses total; approximately 8 weeks for daily regimens and 13 weeks for intermittent regimens).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.
Outcome measures
Outcome data not reported
Adverse Events
Adverse Events (AE) Reported While Using Electronic DOT (eDOT)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 31 deaths
Adverse Events (AE) Reported While Using In-person DOT (ipDOT)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Adverse Events (AE) Reported While Using Electronic DOT (eDOT)
n=198 participants at risk
Electronic directly observed therapy (eDOT): Participants ingested anti-TB medications while treatment adherence was monitored using electronic communication methods. eDOT included live video interactions with TB program staff or recorded videos reviewed by staff to verify medication ingestion.
|
Adverse Events (AE) Reported While Using In-person DOT (ipDOT)
n=191 participants at risk
In-person directly observed therapy (ipDOT): Participants ingested anti-TB medications in the physical presence of TB program staff trained to monitor treatment adherence.
|
|---|---|---|
|
Gastrointestinal disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or above
|
1.5%
3/198 • Number of events 3 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.00%
0/191 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Skin and subcutaneous tissue disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or Above
|
0.51%
1/198 • Number of events 1 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.00%
0/191 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
General disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or above
|
0.00%
0/198 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.52%
1/191 • Number of events 1 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Musculoskeletal and connective tissue disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or above
|
0.51%
1/198 • Number of events 1 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.00%
0/191 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Cardiac disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 3 or above
|
1.0%
2/198 • Number of events 2 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.52%
1/191 • Number of events 1 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
Other adverse events
| Measure |
Adverse Events (AE) Reported While Using Electronic DOT (eDOT)
n=198 participants at risk
Electronic directly observed therapy (eDOT): Participants ingested anti-TB medications while treatment adherence was monitored using electronic communication methods. eDOT included live video interactions with TB program staff or recorded videos reviewed by staff to verify medication ingestion.
|
Adverse Events (AE) Reported While Using In-person DOT (ipDOT)
n=191 participants at risk
In-person directly observed therapy (ipDOT): Participants ingested anti-TB medications in the physical presence of TB program staff trained to monitor treatment adherence.
|
|---|---|---|
|
Gastrointestinal disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
6.1%
12/198 • Number of events 12 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
4.7%
9/191 • Number of events 9 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Skin and subcutaneous tissue disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
3.5%
7/198 • Number of events 7 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
4.2%
8/191 • Number of events 8 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
General disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
0.00%
0/198 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.52%
1/191 • Number of events 1 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Musculoskeletal and connective tissue disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
1.0%
2/198 • Number of events 2 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
3.1%
6/191 • Number of events 6 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Cardiac disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
1.0%
2/198 • Number of events 2 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.00%
0/191 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
|
Eye disorders
National Cancer Institute Common Terminology Criteria for Adverse Events - Grade 1 or 2
|
1.0%
2/198 • Number of events 2 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
0.00%
0/191 • 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.
All study participants were educated about symptoms of medication side effects at their first clinic appointment, and instructed to report these side effects and any health-related concerns during each DOT session. Any unfavorable change in health was reported as an adverse event. For ipDOT and LVDOT, staff inquired about AEs at each session start. For RVDOT, participants were instructed to report any AEs at the beginning of each recording, which staff reviewed by the following business day.
|
Additional Information
Joseph Burzynski, MD, MPH
Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene
Phone: 718-786-5510
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place