Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes: a RCT

Tuberculosis (TB) is the world's deadliest infectious disease. Each year, 10.4 million new individuals are diagnosed with TB, and 1.7 million are killed. 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. After some time, the antibiotics typically eliminate symptoms of the disease, but the antibiotics themselves can make individuals feel quite ill. Additionally, individuals lack information, support, and suffer from a powerful community stigma. Stigma avoidance has been shown to drive work absenteeism, community outcasting and distant travel for health services. Because of these burdens, individual will become ill again - it also increases the risk that others will be infected, and that an antibiotic-resistant strain will evolve. 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 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, as well as in our proof of concept randomized controlled trial (RCT) administered in Kenya. Building on these early findings, the investigators now seek to: 1) Implement a large-scale, four-sided randomized controlled trial (RCT) that investigates large-scale, programmatic implementation across diverse and heavily burdened regions of Kenya, 2) compare cost-effectiveness with three practical alternative protocols, 3) assess the long-term social impact of the intervention and 4) link self-reported adherence with verifiable markers of medication consumption.

Justification:

Evidence of mobile interventions improving TB treatment outcomes falls short of expectations. There is need for more powerful and cost-effective interventions, for higher quality evidence of the impact of these interventions on treatment outcomes, and for studies specifically on TB. Keheala has been demonstrated in a large-scale RCT to substantially reduce the unsuccessful treatment outcomes of TB patients at 17 clinical sites around Nairobi County. Policy makers and funders now seek to 'stress-test' the Keheala intervention at scale across diverse and challenging environments, through its programmatic implementation and by comparing its cost-effectiveness to alternative protocols. The alternative protocols, an SMS-reminder intervention and a fully-automated, behaviorally informed mobile health intervention, are thought to be effective, less expensive and more easily scaled. Keheala is frequently compared to these interventions in conversation, but any evidence that suggests a benefit over the other is unsubstantiated today. Accordingly, the investigators propose a large-scale RCT, the gold standard for evidence-based research, to rigorously investigate questions of scalability and cost-effectiveness.