An estimated one-third of the world's population is infected with M. tuberculosis, resulting in 9.2 million cases of tuberculosis (TB) and 2.2 million deaths annually. Without good compliance with treatment regimens lasting =6 months, illness progresses, patients remain contagious, and mutations form rendering the bacteria resistant to anti-TB medications. So great are the individual and community level impacts of poor adherence that health agencies worldwide recommend that, whenever feasible, patients should be observed taking each dose of medication, referred to as directly observed therapy (DOT). However, DOT is resource intensive, restrictive to patients, and unavailable to patients who live far from DOT providers. The purpose of this study is to develop and pilot test a flexible and cost-effective method of providing remote DOT via video cellular phones, which patients will use to video themselves taking their medications and transfer the videos to DOT workers for review. Advantages of video cell phone DOT (VCP-DOT) include the fact that videos can be taken from any location at any time and DOT workers can manage larger case loads by reviewing videos at their convenience. Our long term goal is to provide TB control programs in developed and developing countries with improved methods of effectively treating TB.
The aims of this Exploratory/Developmental R21 research study are to;1) identify modifiable barriers and facilitators to VCP-DOT delivery among patients and providers;2) determine the acceptability and feasibility of VCP-DOT and estimate treatment adherence rates compared to in-person DOT;and 3) characterize patient experiences with VCP-DOT to identify program components that could impact adherence and patient satisfaction. We hypothesize that VCP-DOT is acceptable to patients and achieves greater treatment adherence at a lower cost than in-person DOT. To address these aims we will conduct a series of focus groups to identify facilitators and barriers to VCP-DOT elicited from TB healthcare providers and patients. Focus groups will first be conducted in San Diego to identify major themes, and then in Tijuana to identify cultural and setting-specific differences. This information will be used to fine-tune the intervention before it is pilot tested among 40 patients in San Diego and 10 patients in Tijuana to assess its feasibility, acceptability, cost and potential efficacy compared to existing DOT programs. The pilot might also reveal technical strengths and weaknesses of the intervention. Findings will be used to propose a sufficiently powered randomized controlled trial to test the efficacy and cost-effectiveness of VCP-DOT in international settings. This study will take place in the US/Mexico border cities of San Diego and Tijuana, because their high TB incidence rates and close proximity allow us to cost-effectively develop and pilot test VCP-DOT in two areas with vastly different TB control systems. If effective, VCP-DOT could dramatically reduce the burden and cost of TB treatment to patients and their providers, thereby increasing treatment adherence and expanding treatment options globally including among patients who live beyond the reach of in-person DOT.

Public Health Relevance

Until TB treatment duration is significantly reduced from the current 6-plus months, novel methods are needed to cost-effectively assure high levels of treatment adherence to cure the patient and avoid development of anti- TB drug resistance. This Exploratory/Developmental study will evaluate the use of video-camera cell phones to deliver directly observed TB therapy. This study is responsive to the U.S. Federal TB Task Force's recommendation for """"""""identifying alternatives and adjuncts to currently used treatment protocols through behavioral research to improve adherence to therapy (domestic and international)"""""""".

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Exploratory/Developmental Grants (R21)
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Clinical Research and Field Studies of Infectious Diseases Study Section (CRFS)
Program Officer
Parker, Tina M
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University of California San Diego
Internal Medicine/Medicine
Schools of Medicine
La Jolla
United States
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Bojorquez, Ietza; Salazar, Irais; Garfein, Richard S et al. (2018) Surveillance or support: The experience of direct observation during tuberculosis treatment. Glob Public Health 13:804-818
Garfein, R S; Collins, K; Muñoz, F et al. (2015) Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study. Int J Tuberc Lung Dis 19:1057-64