Innovative Approach in Tuberculosis Care in Armenia

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia, 0019
    • School of Public Health, American University of Armenia Fund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; 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; TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse; Other: SMS text messages; 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; Other: phone calls; 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.; Behavioral: Self-administered drug intake strategy; 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.; Behavioral: Educational leaflet; 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
NO_INTERVENTION: Control arm; patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Varduhi Petrosyan
• Collaborators: Grand Challenges Canada; National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
• Investigators: Principal Investigator: Varduhi Petrosyan, MS, PHD, American University of Armenia Fund

Publications and helpful links

General Publications

• Newell JN, Baral SC, Pande SB, Bam DS, Malla P. Family-member DOTS and community DOTS for tuberculosis control in Nepal: cluster-randomised controlled trial. Lancet. 2006 Mar 18;367(9514):903-9. doi: 10.1016/S0140-6736(06)68380-3.
• Raza S, Sarfaraz M, Ahmad M. Practice of family and non-family based directly observed treatment for tuberculosis in Pakistan: A retrospective cohort study. The Health 2012; 3(2): 39-44
• Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2003;(1):CD003343. doi: 10.1002/14651858.CD003343.
• Truzyan N, Harutyunyan T, Koshkakaryan M, Petrosyan V. Household TB Infection Control Pilot Project: Counseling for TB Patients and Their Family Members. American University of Armenia School of Public Health, Center for Health Services Research and Development, Yerevan, Armenia, 2013
• Khachadourian V, Truzyan N, Harutyunyan A, Petrosyan V, Davtyan H, Davtyan K, van den Boom M, Thompson ME. People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial. BMC Pulm Med. 2020 Apr 25;20(1):105. doi: 10.1186/s12890-020-1141-y.
• Khachadourian V, Truzyan N, Harutyunyan A, Thompson ME, Harutyunyan T, Petrosyan V. People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 22;16:281. doi: 10.1186/s13063-015-0802-2.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (ESTIMATE): March 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Tuberculosis; Clinical trial; Directly Observed Therapy (DOT); Armenia; Self-administered drug intake
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: S5 0399-01_GCC