The Public Health Impact of the Wirelessly Observed Therapy Program Funded by the Alliance Healthcare Foundation.

Eradication of Mycobacterium tuberculosis (MTB) has been for decades a major policy goal of the Centers for Disease Control (CDC), US Public Health, the Global Alliance on TB and the World Health Organization (WHO). Poor adherence to therapy has long been the recognized barrier to effective treatment of tuberculosis infection. Inconsistent and interrupted treatment, in combination with HIV co-infection, has led to rising numbers of MTB cases and the emergence of drug resistant MTB. One third of the world’s population (~2 billion people) are infected with MTB, over 9 million people a year develop active tuberculosis, and mortality approaches 2 million deaths annually.

Treatment of active MTB requires 6-12 months of combined therapy. Public health authorities in all countries recommend MTB treatment be administered by short course Directly Observed Therapy (DOTS), in which a healthcare worker observes medication ingestion events and provides written verification of treatment adherence and completion. While highly reliable when performed appropriately, DOTS is resource intensive, time consuming, and represents the largest single cost to MTB treatment. Thus, while DOTS is the World Health Organization’s recommended MTB treatment standard, and all US Public Health Departments aim to use it, DOTS implementation has been attenuated, even in the United States, due to its cost. In the US, DOTS is not consistently applied; “Modified DOTS”, or self-administered therapy, is implemented in more and more patients as budget shortfalls grow. Some MTB programs in the U.S. do not use DOTS at all because they can’t afford it, or use DOTS for high risk patients only and a portion of patients with MTB are provided treatment in the private sector with self– administered therapy being the rule rather than the exception. Bi-and tri-weekly dosing of anti-tuberculous therapy was introduced for the continuation phase of treatment to save DOTS cost, despite evidence that daily dosing of MTB medication is superior. In the absence of DOTS there is no method of reliably determining when and if patients actually ingest their medication.

Proteus Digital Health have developed an edible sensor to provide Wirelessly Observed Therapy (WOTS) as a reliable, efficient, scalable and cost-effective alternative to DOTS for sharing complete and accurate medication data in real-time among patients, prescribing physicians, public health workers, pharmacists and other health care providers. The System represents a potential new paradigm for MTB therapy monitoring, which can be utilized by public health workers and participating outreach workers to provide confirmation of MTB treatment. The ultimate goal of the this Alliance Healthcare Foundation funded program entitled ‘Wirelessly Observed Therapy’ is to utilize WOTS as an alternative to DOTS for daily real-time assessment of MTB medication adherence in Public Health ambulatory care settings, providing individualized mobile health care, using prompt, targeted feedback for the management of MTB infected patients.

The Public Health impact of this program is potentially groundbreaking and substantial. This project will provide San Diego County Public Health with a first in the leadership of medically integrated Mobile Health Technology. The design of our program will integrate this new mobile technology seamlessly into San Diego County (including North Coastal San Diego County, North Central San Diego County, North Inland San Diego County, Central San Diego County, East San Diego County, South San Diego County) & Imperial County Public Health MTB treatment infra-structure. Given the airborne transmission of MTB this program will actually have an impact on the health and safety of the entire population in San Diego and Imperial Counties. If we focus specifically on the number of people infected with MTB, including both active and latent cases, those at risk through contact with actively infected cases or with high likelihood of exposures, we estimate that this program will potentially impact the health of approximately 100,000 members of the public in San Diego and Imperial Counties. The program as designed and implemented in San Diego County Public Health will be scalable throughout the US, and thus has the potential to substantially contribute to Public Health Systems throughout the US. Further, the program provides a blueprint for TB treatment globally. Many countries cannot afford DOTS; WOTS may provide the first opportunity for reliable MTB treatment monitoring for the underserved worldwide. WOTS adapted to HIV/AIDS clinics will be applicable and scalable to all State and National HIV clinics, as well as multiple other Chronic Diseases like Diabetes and Heart Failure. The team will publish results of the Alliance Health Care Funded Program internationally providing data for agencies like the CDC, Health and Human Services Agency, the Aids Clinical Trials Group and the Gates Foundation.