Innovative Approach in Tuberculosis Care in Armenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Innovative Approach in Tuberculosis Care in Armenia

Conditions
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Tuberculosis

Intervention / Treatment
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* Behavioral: TB knowledge and socio-psychological counseling session
* Other: SMS text messages
* Other: phone calls
* Behavioral: Self-administered drug intake strategy
* Behavioral: Educational leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of drug-sensitive TB Age 18 years old and above Understanding and reading in Armenian Completion of the intensive treatment phase Exclusion Criteria: Involvement in the Home Based TB Treatment Program of the National TB Control Office

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>The intervention includes the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet | Behavioral: TB knowledge and socio-psychological counseling session<br>* TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse<br>Other: SMS text messages<br>* 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<br>Other: phone calls<br>* 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.<br>Behavioral: Self-administered drug intake strategy<br>* 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.<br>Behavioral: Educational leaflet<br>* 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<br>|
| No Intervention: Control arm<br>patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge About TB Infection | Knowledge about TB infection will be measured by surveys | 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 | 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 | 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 | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | 
| Depression Status of TB Patients | Depression status of TB patients will be measured by surveys | 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 | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Armenia, Clinical trial, Directly Observed Therapy (DOT), Self-administered drug intake