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. 2014 Nov 18;2014(11):CD006594. doi: 10.1002/14651858.CD006594.pub3

NCT02082340.

Trial name or title Innovative approach in tuberculosis care in Armenia
Methods Study design: Randomized, efficacy study, parallel assignment, open label
Inclusion criteria:
  1. Diagnosis of drug‐sensitive TB.

  2. Age 18 years old and above.

  3. Understanding and reading in Armenian.

  4. Completion of the intensive treatment phase.


Exclusion criteria:
  1. Involvement in the home‐based TB treatment programme of the National TB Control Office.

Participants Target sample size: 400 participants; age minimum: 18 years; age maximum: N/A; gender: both
Interventions Self‐administered drug intake strategy, TB knowledge and socio‐psychological counselling session, SMS text messages, phone calls, educational leaflet
Outcomes Primary:
  1. TB treatment success rates (time frame: patients will be followed for the duration of ambulatory phase of treatment, an expected average of 4 months).


Secondary:
  1. Depression status of TB patients.

  2. Family support towards TB patients.

  3. Knowledge about TB infection.

  4. Quality of life of TB patients.

  5. Stigma level towards TB patients.

  6. TB treatment adherence.


Time frame: At baseline, 1, and 3 months after starting the ambulatory phase of the treatment and upon completion of the treatment (an expected average of 4 months after starting the ambulatory phase of the treatment)
Starting date Date of registration: 4 March 2014
Date of first enrolment: March 2014
Last refreshed on: 31 March 2014
Recruitment status: Active, not recruiting
Contact information URL:http://clinicaltrials.gov/show/NCT02082340
Varduhi Petrosyan
American University of Armenia Fund
Notes Study ID: NCT02082340
 Register: ClinicalTrials.gov
Location: Armenia
 Source of funding: Grand Challenges Canada