Trial Outcomes & Findings for TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes (NCT NCT04221789)

NCT ID: NCT04221789

Last Updated: 2025-05-21

Results Overview

Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 555 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-05-21

Participant Flow

Between November 2020 and May 2023, a total of 555 individuals were enrolled across four public reference hospitals in Argentina. Of the 1017 individuals assessed for eligibility, 380 were excluded mostly due to retreatment

Participant milestones

Measure	Intervention: TB Treatment Assistant Patients receiving instructions to use phone application TB treatment assistant: Cell phone app to support self administered treatment and monitor adherence	Control Patients receiving instructions for usual care self administered treatment
Overall Study STARTED	277	278
Overall Study COMPLETED	255	270
Overall Study NOT COMPLETED	22	8

Reasons for withdrawal

Measure	Intervention: TB Treatment Assistant Patients receiving instructions to use phone application TB treatment assistant: Cell phone app to support self administered treatment and monitor adherence	Control Patients receiving instructions for usual care self administered treatment
Overall Study deviation from protoco	22	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention: TB Treatment Assistant n=277 Participants Patients receiving instructions to use phone application	Control n=278 Participants Patients receiving instructions for usual care self administered treatment	Total n=555 Participants Total of all reporting groups
Age, Continuous	32.5 years STANDARD_DEVIATION 12.97 • n=277 Participants	33.7 years STANDARD_DEVIATION 13.66 • n=278 Participants	33.1 years STANDARD_DEVIATION 13.31 • n=555 Participants
Sex: Female, Male Female	145 Participants n=277 Participants	135 Participants n=278 Participants	280 Participants n=555 Participants
Sex: Female, Male Male	132 Participants n=277 Participants	143 Participants n=278 Participants	275 Participants n=555 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 months

Population: No differences

Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months

Outcome measures

Measure	Intervention: TB Treatment Assistant n=255 Participants Patients receiving instructions to use phone application	Control n=270 Participants Patients receiving instructions for usual care self administered treatment
Number of Participants With Treatment Success	208 Participants	201 Participants

SECONDARY outcome

Timeframe: 6 months

Abandonment of treatment for at least 2 months

Outcome measures

Measure	Intervention: TB Treatment Assistant n=255 Participants Patients receiving instructions to use phone application	Control n=270 Participants Patients receiving instructions for usual care self administered treatment
Treatment Default	44 Participants	66 Participants

Adverse Events

Intervention: TB Treatment Assistant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Fernando Rubinstein

IECS

Phone: 01147778767

Email: frubinstein@iecs.org.ar

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place