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AN DIEGO — In this vast border region, tuberculosis control is a high-stakes game of chase. Some patients infected with the disease frequently cross into Mexico for work or to visit family, slipping off the radar of public health workers who must verify they are taking their medicines. It is through these cracks in surveillance that the disease sometimes escapes, like a thief through a back-alley exit.

In the past few years, however, a new weapon has emerged that’s proved difficult even for mutating airborne bacteria to shake: the omnipresent smartphone.

Mobile technologies devised by researchers at the University of California, San Diego, and Johns Hopkins are allowing patients to use their phones to record daily medication intake. The encrypted videos are sent to public health workers who can watch them from their cubicles, instead of traveling long distances every day to visit patients at their homes or workplaces.

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It is a simple but elegant solution to a central challenge of controlling TB, one of the world’s deadliest diseases and a killer of 1.7 million people globally in 2016. Patients infected with the disease must be carefully monitored for a minimum of six months, and often much longer, to ensure they are not missing doses that could allow the infection to survive, mutate into drug-resistant strains, and spread across highly populated areas.

“It gives patients a lot more autonomy,” said Richard Garfein, founder of San-Diego-based SureAdhere and a pioneer in the use of mobile-phone technology to monitor TB patients. “It has made their lives a lot easier and illuminated some of the barriers they face.”

Garfein’s work to develop the monitoring product showcases both the potential of modern technology to improve treatment of serious diseases, as well as the challenge of tailoring even relatively simple digital solutions for use on sick patients. His team had to conduct studies of the tool’s impact on medication adherence, train health workers and patients to use the technology, and carefully monitor patients to ensure they used it properly.

The video app may eventually prove most impactful in developing countries, where TB incidence rates are much higher and governments lack the resources to effectively treat people, let alone verify they are taking their medicines. The Centers for Disease Control and Prevention and the World Health Organization have published handbooks to support the use of video observation to improve medication adherence, but both have emphasized that its use should be calibrated carefully. For example, it may not be a viable solution for transient populations or those in poorer countries without access to the technology and reliable internet access.

“It doesn’t have to be an all-or-nothing approach,” said Dr. Philip LoBue, director of the CDC’s Division of TB Elimination. “It may work for some patients, but not all, and it may work for some parts of treatment, but not all.”

Uptake of the technology is accelerating in the U.S., where studies have shown that video observation produced high adherence rates as well as cost savings for public health departments. Agencies have adopted SureAdhere and similar products made by Emocha Mobile Health and AiCure, extending the technology to large cities such as San Francisco and New York, as well as rural and urban counties in Texas, Colorado, and elsewhere.

“Some of the counties we have are vast geographically and often underserved as far as the public health presence,” said Peter Dupree, director of Colorado’s TB control program. “It makes sense for us to use video [observation] to save a lot of time for overstretched workers and hopefully see the patients feeling more comfortable and not having a state vehicle pulling up every day.”

sureAdhere is a a smart-phoned based tech to monitor medication use by TB patients.
Garfein founded SureAdhere, which is one of several companies offering video monitoring smartphone apps to ensure TB patients take medications daily. Sandy Huffaker for STAT

A challenge at the border

Garfein, a 56-year-old infectious disease epidemiologist and UCSD professor who previously worked for the CDC, said the idea for video observation emerged about a decade ago when he began talking with San Diego public health workers about the unique challenges of controlling TB along the border.

It is a region where TB incidence is elevated because of a thicket of interlocking reasons: higher rates of the disease in Mexico, poverty, and lack of access to medical care in some places. San Diego’s rate of TB in 2016 was 7.8 cases per 100,000 people, compared to an average rate of 2.9 across the United States.

For many decades, the standard of care for treating active cases in the U.S. has been directly observed therapy, in which public health workers visit with patients each day to watch them swallow a battery of antibiotics. Failure to do so often results in missed doses that can allow the airborne illness to survive and spread.

But that method is exceedingly challenging in San Diego County, which sprawls across 4,500 square miles and has many residents whose lives straddle the border. “We have patients … that spend a couple days in Tijuana and a couple days up here every week,” said Garfein. “It’s impossible to monitor them.”

He and colleagues at UCSD began brainstorming solutions. They considered an app that would allow real-time video monitoring of patients. But that had limitations, such as shaky cell signals and other problems associated with on-the-spot remote monitoring. Then they landed on what’s known as asynchronous observation. Patients could use the phone to record themselves at any time, in any location, and upload the videos to a secure server where they could be viewed every day by a public health worker.

In 2010, Garfein’s group began a two-year study of video-monitored observation of 52 patients in San Diego and Tijuana that ultimately confirmed its efficacy: 93 percent and 96 percent of patients in those cities, respectively, adhered to their drug regimens while using video monitoring over an average of 5.5 months. Those rates are comparable to those of patients monitored through in-person therapy. A separate study in New York City reported an adherence rate of 95 percent for patients using video monitoring, compared with 91 percent for patients who received in-person visits.

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“The intervention worked really well and we got a lot of positive feedback from the patients,” Garfein said of the study in San Diego and Tijuana. “Some of the things they said to us were, ‘It’s nice to be able to take my meds [on video] and be on my way, instead of having to have a conversation and be cordial and clean up my home.’”

In other words, it provided them with greater control and more privacy — eliminating hurdles that had undermined medication adherence and created opportunities for drug-resistant TB to spread. Seven participants were eventually returned to in-person monitoring, however, and another six lost their phones or had them broken or stolen.

Video monitoring spreads rapidly

The positive results opened the floodgates. Public health officials around the country began expressing interest: Not only could the technology support medication adherence, it could also save time and money spent sending public health workers on daily journeys to meet with patients.

San Diego County continued to use the technology after completion of the study, although it eventually switched to a similar product sold by Emocha, a Baltimore-based company that submitted a lower bid.

“It allows our staff to do other things, instead of spending all day driving to people’s homes,” said Krystal Liang, a nurse supervisor with the county’s public health department. She said more resources could be used for broader education and prevention activities to help lower infection rates.

“It gives patients a lot more autonomy. It has made their lives a lot easier and illuminated some of the barriers they face.”

Richard Garfein, founder of SureAdhere

Liang said the vast majority of TB patients prefer to use video monitoring, although some still prefer in-person visits because of a lack of familiarity with smartphone technology and other lifestyle concerns.

The technology has been adopted by communities with much lower incidences of TB. In Williamson County, Texas, where the disease rate is about 2 per 100,000 people, TB program manager Lori Eitelbach said a public health worker can spend 20 to 30 minutes watching a handful of videos instead of crisscrossing the county every day. That level of efficiency easily justifies the $32-per-patient subscription cost charged by SureAdhere, she said. It also gives much greater latitude to patients.

“We’ve had people take it on vacation, people doing it in their cars, in the break room at the office,” Eitelbach said. “The people who are using [remote monitoring] don’t ever want to go off it.”

The state of Colorado is also making it available to local public health departments. A study from El Paso County, located in the central portion of the state, found that use of video monitoring reduced the cost per dose to about $1.50, down from $37 per dose when health workers were meeting with patients in person.

“They were seeing a huge costs savings as well as being able to funnel resources, and highly trained employees, to cover other public health needs,” said Dupree, the director of the state’s TB program.

He said the state still advises that patients start treatment with in-person visits before transitioning to video, to ensure they are following their regimens and capable of using the technology. Dupree also noted that, while adherence rates are high with video observation, it does not solve all the problems associated with tracking TB cases. Many patients are homeless and suffer from substance abuse problems that remain significant impediments to effective care.

“For a subset of people, TB is the least of their worries,” he said. “It’s how are they going to feed their kids, or where are they sleeping tonight, or where are they getting their next fix,” he said. “It’s not a panacea for everybody.”

Hope for a global impact

The video technology may have a much larger impact in developing countries where resources to control TB are lacking and public health officials are scrambling to combat strains resistant to most treatments.

India, for example, recorded 2.7 million cases of the disease in 2016, a rate of 211 cases per 100,000 residents. By contrast, the U.S. had just 9,272 cases that year.

The biggest worry is extensively drug-resistant TB, known as XDR-TB, which involves resistance to at least four of the core anti-TB drugs, including the two most powerful medicines, isoniazid and rifampicin. By the end of 2016, 490,000 XDR-TB cases had been identified worldwide, although that accounts for only a small proportion of the cases because many poorer countries lack the capacity to diagnose drug resistance, according to the WHO.

Global health officials have said mobile technology could more efficiently connect patients to care in places where culture and geography erect large barriers. In 2017, the WHO published a handbook for the use of mobile health technologies in various health care settings, citing Garfein’s study in Tijuana and San Diego as part of the emerging body of evidence to support the use of video observation for TB patients.

“As various digital health products have been developed in support of various components of TB programmes … it is important to validate the appropriateness of these products, as well as optimize their uptake on a larger scale,” the handbook states.

Garfein said the first challenge to reducing drug resistance in places like India and China is ensuring that patients get access to effective medicines. Next comes the challenge of increasing adherence beyond the 50 to 60 percent levels reported currently. He said he hopes to bring the video technology even to places where patients and governments lack the funding to pay for it.

“In India, the cost of a whole course of [TB] treatment is about $12, so we can’t come in there and say, ‘We’ll charge you $36 a month for this,’” he said. “It would be more like a couple of bucks. If we could offset the cost of implementing it with resources from other places, that could start to make a big difference.”

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