Implementation Research on Efficacy of Pill-in-Hand Adherence Monitoring for Tuberculosis
Implementation Research on Efficacy of Pill-in-Hand Adherence Monitoring for Tuberculosis
Year: November 2021
Collaborators: Gates Foundation and World Health Partners
Team: Sirisha Papineni, Kamalkant Sharma, Samayita Ghosh, Deepali Verma, Pratima Jandhyala, Abhiyan Chaudhri, Reshma Kaur, Rajat Kumar, Avish Sethi
Background
India accounts for nearly a quarter of the world’s TB burden. Irregular adherence to TB increases the risk of disease relapse, death, and acquired drug resistance for TB. However, numerous socioeconomic, clinical, and psychosocial factors make patients prone to non-adherence, resulting in treatment failure. With high disease burden and low healthcare worker to patient ratio, India requires effective adherence management strategies. Multiple adherence monitoring methods have been deployed in different geographies, which indicate variable results. This study aims to evaluate the effectiveness of different adherence management methods (Refill Monitoring, 99Dlite and MERM) implemented by the National Tuberculosis Elimination Program on clinical outcomes and adherence in multiple districts in Punjab.
About the Study
The study aims to evaluate three adherence monitoring methods---Refill Monitoring, 99Dlite, and MERM---from healthcare workers and patients’ perspective to:
i) Quantify the impact of these monitoring methods on patients’ medication adherence and clinical outcomes.
ii) Identify the underlying mechanisms and pathways (“the how”) of the impact of these monitoring methods.
iii) Optimise the effect of these monitoring methods on the workflow processes of frontline workers.
iv) Estimate the programmatic costs of their implementation and scale-up.
Methodology
The study is a randomized controlled trial embedded in mixed-methods operational research, guided by economics and behavioural sciences that evaluates the efficacy of pill-in hand adherence monitoring method. Additionally, a qualitative study, informed by behavioural sciences, investigates the differentiated TB care model by exploring the conceptualization and dynamic assessment and management of risk for non-adherence, while also assessing to what extent digital adherence technologies (DAT) facilitate these processes to improve treatment adherence and outcomes. The study also includes the estimation of the programmatic cost to assess the relative cost-effectiveness of the various monitoring methods using Time-driven Activity-based costing. Advanced analytic methods will be used to recommend optimal use of health worker capacity.
Intended Outcome
The study aims to generate rigorous evidence to guide national decision-making on the scale-up of digital adherence management and implementation protocols along with their cost effectiveness and budget impact.