Tuberculosis (TB) remains a leading cause of preventable infectious disease deaths worldwide. In the United States, a total of 9,029 new cases of TB were reported in 2018, and it is estimated that up to 13 million individuals are living with latent TB infection. Multidrug resistant TB is a growing global threat and, while still relatively rare in the U.S., is classified as a serious threat in CDC’s 2019 Antibiotic Resistance Threats in the United States report. Its treatment is expensive, time consuming, and has potentially life-threatening side effects. Resistance is more likely to emerge from the mismanagement of the drugs used to treat TB, and directly observed therapy (DOT) is the most effective strategy for ensuring individuals adhere to and complete treatment. Given the barriers to implementing DOT, which can include the time, cost, and potential for stigma and impact on patients, more and more local health department TB programs are exploring the use of video directly observed therapy (VDOT).
Dr. Richard Garfein, MPH, PhD and colleagues conducted a study funded by the California Health Care Foundation to examine the feasibility, acceptability and potential efficacy of VDOT by five jurisdictions in California. The study compared adherence between patients using VDOT and in-person DOT, conducting pre- and post-treatment patient surveys to assess patients’ perceptions of their treatment and using records to monitor treatment outcomes and doses observed. The researchers applied multivariable linear regression to identify associations between sociodemographic characteristics, risk behaviors, and treatment experience with adherence. NACCHO had the opportunity to speak with Dr. Garfein about the study and its implications for local public health TB programs.
Can you talk a bit about the anticipated benefits and challenges of VDOT compared to DOT?
The benefits of VDOT compared to DOT mainly entail decreasing the burden of medication monitoring for the patient and reducing staff time and travel costs for the TB program. In California, even though DOT is done for most patients in their homes or other convenient location, in-person DOT means that the patient must be at the location at an agreed-upon time to meet with the DOT worker, which can be disruptive to daily living. In addition, DOT typically occurs during business hours, which might not correspond with the patient’s preferred time to take their medications (e.g., with a meal or at bedtime to minimize medication adverse effects). VDOT allows patients to take their medications from any location at any time by making and sending a confidential video. Anecdotally, nurses told me that patients who frequently missed doses on DOT would become highly adherent after switching them to VDOT. They also described patients who could not be observed using DOT because of their work schedule or because they frequently traveled but could be observed taking every dose after switching to VDOT.
For TB programs, the benefits come in the form of saving travel costs, increasing staff safety by minimizing exposure to auto accidents or dangerous environments, and giving staff more time to focus on patients who need additional support to manage their therapy. Staff still maintain frequent contact with their patients on VDOT, but the interactions emphasize caring for patients rather than monitoring adherence. In terms of costs, our study showed that VDOT costs less than DOT even when the costs of phones and phone service were included.
Despite these benefits, VDOT has some challenges. Technology is one. Patients must use a smartphone (their own or one provided to them) to record and send videos. They must also know how to use a smartphone and be able to keep it safe and charged so that it is available when it is time to take their medications. Since smartphone manufacturers are highly invested in making their devices intuitive to use, and VDOT program developers try to simplify the steps to using their apps, we found that nearly all patients, regardless of age, literacy or prior smartphone use, could be taught how to use VDOT. Network connectivity is another potential problem if patients live or travel to areas without cellular or WiFi access. However, asynchronous (store-and-forward) VDOT is designed to store patient videos securely on the device until a network is detected and the videos are automatically uploaded. In some cases, this can cause a delay in observing medication doses, but ultimately every dose can be observed and counted. Patient concern over confidentiality and stigma is another important consideration, and other options should be available for patients who refuse to use VDOT. However, our research shows that 98% of study participants thought VDOT was “the same or more confidential” than DOT, 96% reported that VDOT was “very or somewhat easy to perform,” and only 3% would choose DOT over VDOT if they had to repeat treatment.
Through your study, what did you learn about the types of patients who benefited from the VDOT option?
One of the most reassuring findings from our research is that, not only was adherence very high among participants who used VDOT, we did not identify any participant characteristics that predicted adherence to treatment. In designing our study eligibility criteria, some TB program staff suggested that we include an upper age limit because older patients might have trouble with technology. However, we were pleased to observe that patients as old as 86 who never used a smartphone before were able to learn how to use the VDOT app and record every medication dose. The implications of these findings for TB programs are that they can offer VDOT to all patients who are willing to use it given that program staff monitor their adherence and are prepared to switch to an alternative, such as DOT, if adherence wanes.
Considering the results of your study and the different jurisdictions you worked with, what do you see as the implications for local TB programs?
By conducting this study in both rural and urban health jurisdictions, we found high adherence rates in both settings (94.2% and 92.8%, respectively). In a separate study that tested VDOT in San Diego, San Francisco and New York City, we found similarly high rates of adherence and patient satisfaction across three major metropolitan cities (In Press, International Journal of Tuberculosis and Lung Disease). These findings indicate that VDOT may be applied across a range of TB programs. Further VDOT research is currently ongoing in several high-burden, low-income countries to see if these findings can be generalized to those settings as well. The most important implication of this study and others is that TB program staff now have access to a new tool for managing their patients and providing patient-centered care. Through VDOT videos, providers maintain the high-fidelity evidence of medication ingestion previously limited to DOT, while honoring patient autonomy by allowing them to take their medications when and where it best suits them. By decreasing the treatment burden on patients and providers, patients are better able to adhere to their treatment regimens and providers can more efficiently support their patients through to completion of treatment.