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People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized
Vahe Khachadourian1, Nune Truzyan2, Arusyak Harutyunyan3
1School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. vahe.khachadourian@gmail.com.
Trials
|June 22, 2015
Summary
This study evaluated a new patient-centered strategy to improve tuberculosis treatment adherence and outcomes in Armenia. The innovative approach, including education and support, aims to enhance patient engagement and reduce disease spread.
Area of Science:
- Public Health
- Infectious Diseases
- Clinical Trials
Background:
- Tuberculosis (TB) poses a significant global health challenge, especially in low- and middle-income countries, due to high morbidity and mortality.
- Long treatment durations for TB necessitate strategies to improve patient adherence and outcomes.
- Patient empowerment, education, and community involvement are key to enhancing TB treatment success.
Purpose of the Study:
- To evaluate the effectiveness of an innovative, multicomponent, people-centered TB care strategy compared to usual care in Armenia.
- To assess the impact of the strategy on patient knowledge, stigma, quality of life, and treatment adherence.
- To provide evidence for adopting effective TB care models in similar healthcare settings.
Main Methods:
- A cluster randomized controlled trial involving drug-sensitive TB patients in Armenia.
- Intervention arm: Weekly educational sessions, weekly medication dispensing, daily SMS reminders, and daily phone calls.
- Control arm: World Health Organization-recommended directly observed treatment strategy with daily clinic visits.
Main Results:
- The primary outcome is physician-reported treatment outcome.
- Secondary outcomes include patient knowledge, depression, quality of life, stigma, social support, and self-reported adherence.
- The study aims to demonstrate improved adherence and treatment outcomes through the innovative strategy.
Conclusions:
- Improved adherence and treatment outcomes are crucial for strengthening TB control and preventing drug-resistant TB epidemics.
- Positive trial findings could support the adoption of this people-centered TB care approach in countries with similar healthcare and economic profiles.
- This strategy has the potential to significantly impact global tuberculosis control efforts.
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