Delivering Community-based Interventions and Disease Management Tools Across a Digital Platform in Order to Increase TB Treatment Adherence in LMICs

Tuberculosis (TB) is the deadliest infectious disease in the world. The latest estimates suggest there were 10.4 million cases in 2015 and 1.8 million TB deaths. Despite the availability of highly effective medications for treating TB in the developing world, lack of adherence to the treatment regimen remains the driving influence leading to multi-drug resistant (MDR) TB, morbidity and mortality. Conventional treatment is a lengthy process which depends heavily on patient adherence in seeking and then carrying out the prescribed treatment. Recognizing this challenge, the World Health Organization has developed a protocol for treating TB called Direct Observation of Treatments, Short-course (DOTS), but it is expensive and difficult to institute on a large-scale in resource-constrained regions, evidenced by its use in only 30% of all cases. This protocol also further burdens TB patients who are already some of the most marginalized individuals in society by requiring them to take time off from work in order to travel to the TB clinic for treatment verification. The patient may find this embarrassing if there is a stigma surrounding the disease in the community, or at the least, an unwelcomed intrusion into one's privacy. There is therefore great need for the development of alternative protocols, which reduce the costs of treatment and burden of adherence, and more effectively motivate patients to adhere to the program.

TB is spread through the air when people who are sick with TB excrete the causative bacillus, Mycobacterium tuberculosis mainly through coughing. Left untreated, a single patient can infect between 12 and 15 persons per year, a stark contrast to an Ebola patient who will only infect between 1.5 and 2.5 persons. When a patient adheres to the treatment regime, she makes it less likely that others will become sick, contributing to the health of her family and community. Adherence is thus a contribution to a public good--a personally costly action that benefits others. A substantial and growing literature in the social sciences demonstrates the potential of behavioral interventions for generating large increases in contributions to public goods, yet this potential has largely been left untapped in the treatment of TB. Keheala taps into this underutilized potential by developing a powerful, cost-effective platform for better engaging patients' sense of responsibility to their community in order to increase adherence.

Keheala is a feature-phone and Internet-based digital platform that uses text message-like interactions to deliver behavioral interventions that have been demonstrated as remarkably effective in the social sciences literature on altruism. A patient who participates in the program is assigned a support-sponsor who receives alerts about the patient's adherence, allowing a dialogue of support or problem solving. For the pilot RCT, these support-sponsors will be hired and trained by Keheala. An automated system sends motivational messages and regular prompts for patients to self-verify their treatment. Messages include reminders about the community benefits of adherence and a measure of the patient's adherence performance relative to successful peers. If a patient fails to correctly verify her compliance, the system automatically alerts the support-sponsor, who then intervenes with a supportive dialogue. Clinicians can view individual or aggregate patient histories to leverage limited resources. Combining powerful behavioral interventions with the functionality needed to lessen the burden of disease on everyday life, Keheala uniquely and comprehensively overcomes the barriers to appropriate treatment adherence.

Problem Statement TB treatment adherence rates suffer due to the burdensome six-month duration of treatment. During this period, patients endure severe side effects from drug cocktails, while regular clinical visits often necessitate distant, time-consuming travel and absenteeism from work. However, non-adherence not only threatens the individuals' health--70% of those who aren't treated will die within 10 years --it is also a public health concern: adherence reduces the risk of transmission, usually to nearly zero within less than two weeks, whereas treatment cessation can lead to recurrence and high transmission rates, threatening the well-being of affected communities. Keheala's goal is to increase adherence for the benefit of the infected individual and the community as a whole.

Justification The Keheala solution is based on extensive primary and secondary research. Interviews with relevant and experienced stakeholders ensured that the functionality provided is what actually is needed in order to overcome the social drivers of failed treatment adherence. Additionally, the functionality is designed with principles from the social sciences literature showing the potent impact invoking an individual's sense of responsibility to her community can have on affecting behavior. These principles are well-supported and understood in other contexts, however, exactly how effective these principles can be at invoking treatment adhering behavior in the resource-constrained TB context remains to be tested.