Innovative Approach in Tuberculosis Care in Armenia

NCT02082340 | Completed Results DMC

• 1 other identifier: S5 0399-01_GCC
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Armenia; Clinical trial; Directly Observed Therapy (DOT); Self-administered drug intake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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; Other: SMS text messages; Other: phone calls; Behavioral: Self-administered drug intake strategy; Behavioral: Educational leaflet

Control arm

NO INTERVENTION

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

Interventions

TB knowledge and socio-psychological counseling session BEHAVIORAL

TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse

Intervention arm

SMS text messages OTHER

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

Intervention arm

phone calls OTHER

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.

Intervention arm

Self-administered drug intake strategy BEHAVIORAL

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.

Intervention arm

Educational leaflet BEHAVIORAL

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of drug-sensitive TB
• Age 18 years old and above
• Understanding and reading in Armenian
• Completion of the intensive treatment phase

You may not qualify if:

• Involvement in the Home Based TB Treatment Program of the National TB Control Office

Sponsors & Collaborators

• Varduhi Petrosyan: lead
• Grand Challenges Canada: collaborator
• National Tuberculosis Control Center, Ministry of Health, Republic of Armenia: collaborator

Study Sites (1)

School of Public Health, American University of Armenia Fund

Yerevan, 0019, Armenia

Location

Related Publications (6)

• 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.

  PMID: 16546538 BACKGROUND

• 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

  BACKGROUND

• Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2001;(4):CD003343. doi: 10.1002/14651858.CD003343.

  PMID: 11687192 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32334553 DERIVED

• 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.

  PMID: 26093675 DERIVED

MeSH Terms

Conditions

Tuberculosis; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Harutyunyan
• Organization: American University of Armenia

aharutyunyan@aua.am

Study Officials

• Varduhi Petrosyan, MS, PHD

  American University of Armenia Fund

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MS, PHD

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Locations

AR (1)