R01AI162888

Video Dot and Economic Incentives to Promote Adherence to LTBI Therapy

Tuberculosis (TB), a highly contagious disease caused by Mycobacterium tuberculosis, remains a major public health concern in the United States. Identifying and treating individuals with latent TB is a key strategy to achieve the goal of TB elimination in the US. However, there are many challenges to achieving this goal. In Baltimore, where this research will be conducted, more than one-third of non-US-born individuals have latent TB, and they are disproportionately affected by co-morbidities that increase the risk of progression to active TB, such as diabetes and HIV.

Socioeconomic factors such as poverty, access to care, health literacy, and language or cultural barriers present obstacles to treatment. Treatment for an asymptomatic condition, such as latent TB, is rarely a priority for patients with many other competing needs. The length of treatment (several months for standard "short-course" regimens) is also problematic, particularly for patients experiencing housing or financial instability. Therefore, the majority of individuals infected with latent TB do not complete treatment.

We propose to evaluate novel and scalable smartphone-enabled interventions to promote completion of treatment for latent TB. Video-Directly Observed Therapy (VDOT) provides multi-faceted adherence support by allowing real-time monitoring of adherence coupled with case-management feedback. It is available in patients' preferred languages and delivers electronic reminders. Likewise, behavior economic (financial) incentives, in which patients receive incentives contingent on ingesting prescribed medications, could mitigate financial stress associated with medical care and lost wages, a common concern among many patients with latent TB infection.

Adults with latent TB (N=399) will be randomized to a usual care control, or VDOT, or a VDOT plus incentives group. Usual care control participants will receive standard care for latent TB. VDOT participants will receive the same usual care but will use smartphones and a commercially available application to receive electronic reminders, submit video-observations to document adherence, and receive case-management real-time feedback. VDOT plus incentives participants will receive further support through contingent financial incentives (up to $35 per week) for taking prescribed medications under the VDOT system.

The primary outcome measure, completion of treatment for latent TB, will be assessed for all participants through MEMS CAPS (AIM 1). We will also determine the costs, budgetary impact, and incremental cost-effectiveness of the VDOT and VDOT plus incentives interventions (AIM 2). If this intervention is effective in promoting completion of treatment for latent TB and is economically sound, it could prove to be a scalable and effective intervention to promote completion of treatment for latent TB in high-risk populations in Baltimore and in other populations around the world.

The Johns Hopkins University

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Baltimore, Maryland 212051832 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the End Date has been extended from 06/30/26 to 06/30/27 and the total obligations have increased 300% from $811,650 to $3,246,780.