This version may be subject to change during the production process.

This version may be subject to change during the production process.

Background Tuberculosis (TB) is an urgent global health threat and the world’s deadliest infectious disease despite being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of the disease and development of drug-resistant disease. Mobile health interventions hold promise to provide the required adherence support to improve TB treatment outcomes. Objective This study aims to evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success and default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TSTs implementation. Methods The TB-TSTs study is an open-label, randomized controlled trial with 2 parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Participants will be recruited on a rolling basis from 4 clinical sites in Argentina. The intervention consists of a smartphone progressive web app, a treatment supporter (eg, TB nurse, physician, or social worker), and a direct adherence test strip engineered for home use. Intervention group participants will report treatment progress and interact with a treatment supporter using the app and metabolite urine test strip. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patients’ and providers’ perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share the results with stakeholders and policy makers. Results Enrollment began in November 2020, with a delayed start due to the COVID-19 pandemic, and complete enrollment is expected by approximately July 2022. Data collection and follow-up are expected to be completed 6 months after the last patient is enrolled. Results from the analyses based on the primary end points are expected to be submitted for publication within a year of data collection completion. Conclusions To our knowledge, this randomized controlled trial will be the first study to evaluate a patient-centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on the effectiveness, implementation, and adoption of mobile health tools. The findings have broader implications not only for TB adherence but also more generally for chronic disease management and will improve our understanding of how to support patients facing challenging treatment regimens. Trial Registration ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789. International Registered Report Identifier (IRRID) DERR1-10.2196/28094

IMPACT: Recognizing Interdisciplinary Collaborative Research in Promotion and Tenure Processes OBJECTIVES/GOALS: Academic institutions have traditionally focused on individual achievements for promotion. We present our effort on identifying and measuring attitudes on promotion and tenure (PT) criteria that values and rewards interdisciplinary research (IR). We have developed a toolkit to facilitate the recognition of IR in PT processes. METHODS/STUDY POPULATION: Our group reviewed appointment, promotion and tenure (APT) policies from each of the six Health Science Schools and the College of Engineering at the University of Washington (UW) to assess language of objective criteria and attributes of IR to guide APT committees in the evaluation of interdisciplinary researchers. We surveyed faculty about their attitudes relating to IR within the context of promotion and tenure. Interviews of department chairs and administrators about institutional policies and infrastructure that supports or inhibits IR, and current best practices, were conducted. We have developed toolkits for junior faculty, department chairs, external reviewers, and APT committees to facilitate rewarding IR at promotion. RESULTS/ANTICIPATED RESULTS: Review of APT policies found criteria that recognizes IR for APT in three schools. 118 faculty responded to the survey (44% Professor, 26% Associate, and 37% eligible for APT committees). The majority of faculty reported they were currently conducting IR (95%), considered IR important (98%), and believed the UW faculty code should encourage IR (85%). Although a vast majority considered their units supportive of IR (>80%), less than half (43%) reported that their APT criteria provided examples that included participation in IR. Our survey also found that APT committees were challenged about best practices to reward IR, APT external reviewers struggle to evaluate individual vs team contributions, and individual faculty are challenged to describe contributions for APT within context of an interdisciplinary team. DISCUSSION/SIGNIFICANCE OF FINDINGS: IR is conducted and valued by UW faculty; however, current structures, policies, and APT code do not facilitate IR for promotion and tenure. We have developed a toolkit for promotion-eligible faculty, chairs, external reviewers, and APT committees to facilitate IR. Our goal is to modify UW faculty code and unit APT criteria to recognize and reward IR.

OBJECTIVES/GOALS: Our goal is to explore and collaboratively identify the team science competencies essential for Clinical Research Professionals at all experience levels and how these competencies relate to the Joint Task Force for Clinical Translational Research Professionals Competencies. METHODS/STUDY POPULATION: Team science competencies for clinical research professionals are poorly defined. The JTF Clinical Trial Competencies lack sufficient emphasis on team science, though it is briefly included in two JTF competency domains: Leadership & Professionalism, and Communication & Teamwork. The competencies primarily focus on tasks related to clinical research and basic knowledge of product development; however, a conceptual model for applying the competencies using a team science lens is needed. Currently, the JTF competency figure is often thought of as sequential, given the competencies are numbered, creating the misconception that the last competencies are less important. We support a new figure showing the permeability of team science across competencies and the connectedness and equality of the competencies. RESULTS/ANTICIPATED RESULTS: Our anticipated results are to show the integral nature of team science in clinical research professional communities of practice. Once complete, we will have identified measurable team science competency-based skills essential for clinical research professionals at various levels of expertise. Understanding the multi-dimensional team science competencies will inform targeted team science education and training for clinical research professionals. Our revised competency framework provides an improved team science conceptual model for clinical translational science. DISCUSSION/SIGNIFICANCE: Our work will define team science competencies as related to clinical research professionals at all experience levels. The interdependence of teams across clinical trial activities necessitates a consideration of an improved conceptual framework for clinical translational team science competencies.

BACKGROUND Tuberculosis (TB) is an urgent global health threat and the world’s deadliest infectious disease despite it being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of disease and the development of drug resistant disease. Mobile health (mHealth) interventions hold promise to provide the needed adherence support to improve TB treatment outcomes. OBJECTIVE To evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success, default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TST implementation. METHODS The TB-TSTs study is a randomized controlled trial (RCT) with two parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Intervention group participants will report treatment progress and interact with a treatment supporter using an innovative interactive smartphone App and a paper-based drug metabolite urine test strip engineered for home use. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patient and provider perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share results with stakeholders and policymakers. RESULTS We anticipated the start of enrollment in November 2020, a delayed start due to the COVID-19 pandemic and complete enrollment by approximately July 2022. Data collection and follow-up is expected to be completed six months after the last patient is enrolled. Results from the analyses based on the primary endpoints are expected to be submitted for publication within a year of data collection completion. CONCLUSIONS This RCT will be the first to our knowledge to evaluate a patient centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on effectiveness, implementation, and adoption of the mHealth tools. Findings have broader implications not only for TB adherence but also chronic disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens. CLINICALTRIAL ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789