Project Lead(s): Varduhi Petrosyan
Tuberculosis (TB) is one of the world’s major public health problems.
Armenia is among the countries with the highest rates of multi-drug resistant (MDR) TB: 9.4% of newly diagnosed cases and 43% of previously treated TB cases were MDR.
Lack of adherence to TB treatment contributes to the high number of MDR TB cases in Armenia and the traditional direct-observed treatment (DOT) using health professionals is not very effective.
The Innovative Approach in TB Care in Armenia (IATCA) project sought to enable 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.
To assess the effectiveness of the strategy, a cluster randomized controlled trial was conducted with a group of TB patients treated according to the new strategy and a control group receiving traditional DOT.
The alternative, multi-component TB outpatient care strategy among pulmonary drug-sensitive TB patients in their continuation phase of TB treatment included:
1) Training and psychological counselling for TB patients and their family members
2) Weekly TB outpatient centre visits to see TB providers and receive medication
3) Self-administered drug-intake, supervised by a trained family member
4) Daily morning SMS reminders to TB patients
5) Daily phone calls to supporting family members or the patient (if a supporting family member did not exist) as additional reminders to ensure daily drug intake and to monitor for potential side effects from TB medication.
The project sent approximately 36,357 daily text messages (SMS) to 195 TB patients from the 26 intervention outpatient TB centres during the course of the study. Approximately 35,897 daily phone calls were made to family members (or TB patients).
The evidence from the analysis demonstrated that clinical outcome (treatment success) from the alternative approach was as good as regular DOTs.
While not superior, as hoped, the results suggest that this cheaper, more efficient approach (one weekly visit versus six) and a more socially empowering alternative strategy could lead to equally successful clinical results, while substantially reducing TB provider workload, patient time and financial resources.
A summary of treatment outcomes for the 1194 intervention TB patients and 198 control TB patients showed:
- Intervention arm: 92.7% (176) treatment success; 6.7% (13) lost to follow-up; 0.5% (1) treatment failed; 1.5% (3) died, and 0.5% (1) not evaluated
- Control arm: 92.9% (184) treatment success; 5.1% (10) lost to follow-up; 0 treatment failed; 1.5% (3) died, and 0.5% (1) not evaluated.
There was no statistically significant difference between the intervention and control arms regarding the treatment outcome. For the study’s primary outcome, the two strategies achieved similar clinical effectiveness.
The evidence from the analysis of the study’s secondary outcomes (knowledge about TB, patients’ depression status, stigma within family, and self-reported adherence to TB treatment) demonstrated that the alternative strategy was better than the regular DOTs.
There are plans to scale-up the project to the entire population of Armenia, partnering with the Ministry of Health of the Republic of Armenia, the National TB Control Center, the World Health Organization Country Office in Armenia and other important TB stakeholders in the country. The Bill & Melinda Gates Foundation and the Armenian Medical Fund will be approached for matched funding to scale up the project.
Results of the study have been presented at conferences, including the 46th Union World Conference on Lung Health, Cape Town, South Africa, and the 8th European Public Health Conference, Milan, Italy, in 2015. The protocol of the study has been published in the open access journal Trials. The study team was working on the manuscript on the main findings to publish in an open access journal.