Clinical trial NCT02082340: Innovative Approach in Tuberculosis Care in Armenia
Official title: Innovative Approach in Tuberculosis Care in Armenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Armenia
Clinical trial
Directly Observed Therapy (DOT)
Self-administered drug intake
Lead sponsor: American University of Armenia Fund
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
First posted: 2014-03-10
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: TB Treatment Success Rates Defined by the World Health Organization (WHO)
timeFrame: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
Secondary outcomes:
measure: Knowledge About TB Infection
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
measure: Stigma Level Towards TB Patients
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
measure: Family Support Towards TB Patients
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
measure: TB Treatment Adherence
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
measure: Depression Status of TB Patients
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
measure: Quality of Life of TB Patients
timeFrame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: School of Public Health, American University of Armenia Fund
Study officials:
affiliation: American University of Armenia Fund
name: Varduhi Petrosyan, MS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2003;(1):CD003343. doi: 10.1002/14651858.CD003343.
citation: 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
citation: 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.
citation: 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.