Innovative Approach in Tuberculosis Care in Armenia

Varduhi Petrosyan

Status: Completed

Conditions: Tuberculosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02082340

S5 0399-01_GCC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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

Treatment:

Behavioral: Educational leaflet

Behavioral: Self-administered drug intake strategy

Other: SMS text messages

Other: phone calls

Behavioral: TB knowledge and socio-psychological counseling session

Control arm

No Intervention group

Description:

patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO