Innovative Approach in Tuberculosis Care in Armenia

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Behavioral: TB knowledge and socio-psychological counseling session; Other: SMS text messages; Other: phone calls; Behavioral: Self-administered drug intake strategy; Behavioral: Educational leaflet

• Registration Number: NCT02082340
• Lead Sponsor: Varduhi Petrosyan

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2019-07-16
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Results First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	SMS text messages	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
Intervention arm	phone calls	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
Intervention arm	TB knowledge and socio-psychological counseling session	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
Intervention arm	Self-administered drug intake strategy	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
Intervention arm	Educational leaflet	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

Primary Outcome Measures

Name	Time	Method
TB Treatment Success Rates Defined by the World Health Organization (WHO)	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).

Secondary Outcome Measures

Name	Time	Method
Knowledge About TB Infection	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)	Knowledge about TB infection will be measured by surveys
Stigma Level Towards TB Patients	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 will be measured by surveys
Family Support Towards TB Patients	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)	Change in family support towards TB patients will be measured by surveys
TB Treatment Adherence	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 will be measured by surveys
Depression Status of TB Patients	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 will be measured by surveys
Quality of Life of TB Patients	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 will be measured by surveys

Trial Locations

Locations (1)

School of Public Health, American University of Armenia Fund; 🇦🇲 Yerevan, Armenia