Trial Outcomes & Findings for Innovative Approach in Tuberculosis Care in Armenia (NCT NCT02082340)

Results Overview

The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

392 participants

Primary outcome timeframe

Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months

Results posted on

2020-02-18

Participant Flow

Between 12 March and 26 December 2014, we identified and contacted eligible TB patients from the intervention TB out-patient clinics as well as the control TB out-patient clinics.

Participant milestones

Participant milestones
Measure	Intervention Arm The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.	Control Arm Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.
Overall Study STARTED	194	198
Overall Study COMPLETED	193	197
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.	Control Arm Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Innovative Approach in Tuberculosis Care in Armenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=194 Participants The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet.	Control Arm n=198 Participants Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO.	Total n=392 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 15.9 • n=5 Participants	47.8 years STANDARD_DEVIATION 14.9 • n=7 Participants	46.8 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	48 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	150 Participants n=7 Participants	305 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months

The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).