Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.
The innovative treatment approach integrates several educational, technological, and social evidence-based components. The aim of this study is to pilot the innovative approach for drug-sensitive TB patients during the outpatient phase of tuberculosis treatment. To test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. The intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, TB patient and family member training (including distribution of a leaflet about TB) and psychological counseling, reminder text messages to TB patients, and reminder phone call to TB patient family members. The control arm will include drug-sensitive tuberculosis patients that receive the regular Directly Observed Therapy recommended by the World Health Organization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
392
TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse
TB patients will receive SMS text messages every morning (except Sunday) during the whole ambulatory TB treatment phase as a reminder for taking the TB medication prescribed and provided by the TB physician
Family members of the TB patients will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.
School of Public Health, American University of Armenia Fund
Yerevan, Armenia
TB Treatment Success Rates Defined by the World Health Organization (WHO)
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).
Time frame: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
Knowledge About TB Infection
Knowledge about TB infection will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Stigma Level Towards TB Patients
Stigma level towards TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Family Support Towards TB Patients
Change in family support towards TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
TB Treatment Adherence
TB treatment adherence will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
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Once a week TB patients will receive the TB medication from their local outpatient TB centers and will use the medication every day (six days a week, except Sunday according to the TB treatment protocol) at home under supervision of a family member in charge.
Educational leaflet containing information on TB infection; infection control measures; importance of TB treatment adherence and family support will be provided to all TB patients at the end of the counselling session
Depression Status of TB Patients
Depression status of TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Quality of Life of TB Patients
Quality of life of TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)