Real time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda

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Principal Investigator(Last, First, Middle): Musiimenta, Angella PROJECT SUMMARY With an estimated 60,000 people diagnosed with TB annually, Uganda holds the 16th position of the 22 countries with highest cases of TB in the world. The Uganda national target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat 85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6% TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda. Causes of non-adherence to TB medication include lack of patient follow-up, patients’ lack of transport to go to the clinics to pick up drugs, patients’ forgetfulness. There is evidence that real time adherence monitoring linked with SMS reminders and social support notifications can address barriers to sustained ART adherence. Such novel interventions addressing TB medication adherence challenges in low resource settings to date are limited. The prevailing SMS-based studies for TB medication adherence report mixed results, do not strategically link interventions with missed doses, and have largely been implemented in developed countries. To date, little is known about the use of real-time adherence monitoring technologies for TB medication adherence in resource-limited settings. Through the ART adherence studies, I have gained experience in electronic adherence monitoring technologies, which I would like now to expand to TB medication. For this K43 award, my goal is to investigate the use of real time adherence monitoring technology linked with SMS reminders and notifications for TB medication adherence in rural southwestern Uganda. I will carry out a formative qualitative study to identify optimal SMS reminders, notifications, and initial feasibility of real time adherence monitoring. I will recruit 20 TB patients and 10 healthcare providers in a TB clinic in Mbarara Regional Referral Hospital (MRRH). Drawing from the Unified Theory of Acceptance and Use of Technology, and the Model of Healthcare Utilization, I will use semi-structured interviews to assess the optimal intervention in terms of the preferred language of SMS reminders, length, content, timing (number, frequency, schedule), strategies to protect confidentiality and patient privacy, predicted barriers to appropriate response to SMS messaging, preferences of social support, perceptions of using social supporters, patient understanding of messages and usage of the electronic adherence monitor, barriers to adoption of real time adherence monitoring intervention linked to SMS reminders and notifications, as well as barriers and motivators to medication adherence. The purpose will be to inform the development the technology necessary to conduct a real-time intervention involving a wireless monitor and SMS reminders and notifications. I will develop and Test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. I will develop and quantitatively test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. I will randomize participants (1:1:1) to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months. I will build on my experience in the study conducted with Dr. Haberer (R34MH100940) using the Wisepill device, and utilize the CommConnect platform and Yo! Voice Solutions as a gateway (see letters of collaboration). The primary outcome will be percent adherence. Secondary outcomes will include gaps in adherence, TB cure rate, treatment completion rate, treatment success rate, clinic appointment attendance, and mortality. I will determine the mechanisms of effect and context of an integrated adherence monitoring, SMS reminders and social support interventions. I will explore experiences of participants in the intervention arm (20 participants and 20 social supporters) through qualitative interviews. The goal of the interviews is to elicit detailed qualitative data on the experiences of participants and social supporters with special emphasis on understanding mechanisms of effects of the SMS reminders, forms and dynamics of support, experiences with the SMS reminders/notifications, and technical problems encountered. I will then determine the types of SMS (daily versus linked SMS), and the nature of social support that show the most promise for real time intervention on anti-TB medication adherence and cure, which will fully be evaluated through an R01 supported randomized control trial. The portfolio of research and training proposed for this K43 award will draw on my existing skills in electronic adherence monitoring, and global health program implementation. It will enable me to work with a multidisciplinary team of mentors from Harvard Medical School University, Yale School of Public Health, and Mbarara University, and ultimately become a productive and influential independent investigator focused on using technology-assisted interventions to improve medication adherence in resource limited settings. Project Description