Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)

Background Substance use, including misuse of opioids, is a high-risk behavior associated with immediate and long-term health consequences. Understandably, multiple initiatives to address the opioid crisis in the United States aim to improve pain management, access to medication-assisted treatment, and use of overdose-reversing medications. Moreover, public health experts have also long recognized the impact of social determinants on health outcomes. According to the World Health Organization (WHO), “the social determinants of health are the conditions in which people are born, grow, live, work and age. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels.” Growing research is demonstrating that social determinants of health (SDH) play a far greater role in health outcomes than previously expected. The health of people with SUD is inextricably bound to their social environment. Drug-taking and drug-use risk behaviors are affected by social processes, and, in this situation, health is a product of both drug-use behaviors and social determinants. Social determinants can directly shape health risk behaviors. SDH can be manifested in the living conditions and resources that indirectly exacerbate the consequences of drug use. For example, inadequate housing can increase the likelihood of infectious disease transmission, while the stable social relationships can offer protective financial and emotional resources, and more cohesive neighborhoods can have a greater likelihood of providing appropriate support and care. Although illicit drugs are used by people of all income ranks, drug-related morbidity and mortality are disproportionately higher among lower income groups. Numerous studies have shown the existence of a social gradient, in which rates of morbidity and mortality decrease directly and proportionately with each increase in level of income or education. Factors such as poor access to risk-reduction information and differences in quality of information received may play a role in stratifying the health risks. People with lower socioeconomic status experience difficulties with receiving the appropriate preventive care, have limited access to medical care, and frequently receive substandard medical care. People affected by SUD or drug use make up a significant proportion of the homeless in the United States. 10%-25% of homeless people are estimated to have substance use disorders, with estimates of lifetime prevalence of 25%- 63%. Drug-attributable mortality rates in homeless are reported to be 8 to 17 times higher than those in general population. Homelessness influences the well-being of this population because of associated high-risk behavior, inadequate access to medical care, and failure/inability to comply with treatment regimens. In general, regular attendance of a drug treatment program, such as methadone maintenance treatment, is associated with significant reductions in drug use. The lack of basic information about the drug treatment program locations, treatment options, and access to the program, including limited access to logistics and technology as well as financial literacy, impedes access to medical care. Enrollment in methadone programs is thus inversely associated with homelessness. Effects of incarceration on health relate to the cycle of incarceration (release and reentry), which increases morbidity and mortality for incarcerated drug users and limits their access to health resources. According to the Bureau of Justice Statistics, 58 % of people incarcerated in state prisons and 63 % of the sentenced population in local jails meet criteria for persons with substance use disorders. Injection drug-use rates for prisoners are about 20 times higher than for the general population. Longer incarceration episodes are associated with increased injection drug use. Limited availability of housing, benefit programs, and preventive and treatment services in these communities upon release compounds their health problems. Incarceration is thus a risk for disease amplification both within prisons and in the communities where the inmates come from and return to. Research evidence warns about a high likelihood of drug-related death immediately after prison release, with mortality from overdose that is up to 8 times higher in the first 2 weeks after release than in the next 10 weeks and the relative risk of death from drug overdose is more than 120 times higher in this population. Overall, the mortality of former prisoners during the first year after release was up to 40 times the age-adjusted rate in the general population. The likely factors associated with this high mortality include loss of tolerance to opiates while in prison, the increased opportunity for drug use, and other high-risk behavior but also the limited scope of employment and psychological stress associated with re-entry into the community. Research Objectives A full spectrum of interventions encompassing both social determinants of health and individual-level factors (behavioral interventions, medications for treatment of the Opioid Use Disorder (MOUD)) should be considered in order to fully address the drug use epidemic in the Unites States. Digital technology-based solutions can offer a new path forward in addressing SDH in drug addiction, as these solutions focus on providing evidence-based, continuous and accessible experiences for individuals affected by drug use or living with SUD. The advantages of digital technology also lie in its capacity to accommodate the changing context and environments that contribute to the 21st century SDH: new communication means, mobility, cultural contexts, new consumer behaviors, family and community dynamics, etc. NIDA supports the research and development of the tech-forward solutions to provide evidence-based medical care and treatment through multiple funding opportunities published elsewhere. Through this FOA, NIDA seeks research applications for commercializable digital products that aim at positively influencing the fundamental social and environmental conditions that are risk factors for the populations affected by the use of drugs, including opioids. In the context of this FOA, product is any source of value for the end-users and customers. Services, subscriptions, software as a service (SaaS), physical/tangible products (e.g. apps, digital platforms), aggregations, and similar could all provide value and thus be considered the eligible products. The proposed product could be the result of novel scientific research, repurposing an existing technology for a new use, extending a research observation into SUD area, devising a new business model or distribution/delivery channel that unlocks value currently concealed, or simply bringing a product or service to previously underserved set of customers. This FOA focuses on development of digital solutions for the states, families, schools, employers, landlords, and patients, especially, the 90% of people with addiction who do not receive treatment. The FOA's aspiration is to incentivize the small businesses and startups to explore the digital tech's great opportunity of reaching the disenfranchised populations: the unemployed, the uninsured, the incarcerated, etc. The eligible small businesses can submit the grant applications focusing on transforming family, housing, employment, justice and educational determinants of drug addiction. The proposed products should offer the most far-reaching and promising opportunities for the intended customers and end-users to meaningfully contribute to addressing the drug addiction and opioid crisis. Illustrative topics could include, but are not limited to: Research, design and validation of novel digital tools and approaches to address food and housing insecurities; Research and design of novel tools to enable impactful housing programs that promote health (for example, the innovative housing programs that can co-locate employment, education, and behavioral health services); Design and validation of curriculum for “soft skills” development for addiction treatment providers; Novel educational tools/novel educational delivery systems to foster compassion and eliminate stigma associated with SUD; Research and design of preventive systems for families to promote healthy behaviors, social skills, community opportunities, and productive social involvement; Novel educational tools/novel didactic delivery systems focused on social stability (community, tradition, faith, family), and self-regulation and resilience; Novel educational tools/novel didactic delivery systems to focus on happiness, wellbeing, belonging, positive and fruitful communal life; Design and validation of technologies that help create and enhance productive social support networks facilitating recovery, engagement with care, and/or access to needed services; Research and design of tools and technologies to help facilitate continuity of care, access to services, and successful community reintegration for people re-entering communities following a period of incarceration; Development of technology to facilitate data sharing among organizations that serve justice- involved individuals with the goal of increasing coordination of services, enhancing service quality, and/or increasing engagement with effective services; Research, design and validation of novel approaches for job training (e.g. in entrepreneurship, literacy and financial literacy, IT skills), especially, delivered in recovery housing or while incarcerated; Development and validation of the best approaches for employer education and support to allow employers to hire, retain, and facilitate treatment for employees seeking help for SUD. Applications focusing solely on the Social Determinants of Health in the context of Alcohol Use Disorders will be deemed non-responsive and will be returned without review. The SBIR/STTR program is a phased program. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. An overall objective of the SBIR and STTR programs is to increase private sector commercialization of innovations derived from federally supported research and development. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Three types of applications are accepted in response to this FOA: Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to proceeding to Phase II. Fast-Track (Phase I/ Phase II) applications should include clear rationale of feasibility of the proposed approach and/ or technology application in SUD area; demonstrate a high probability of commercialization; propose clear, appropriate, meaningful and measurable goals (milestones) to be achieved prior to initiating Phase II; and indicate potential Phase III support/interest (non SBIR/STTR) from future commercialization partners. An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. Phase II. The objective of Phase II (as a part of Fast Track applications) is to continue the R&D efforts initiated in Phase I to advance technologies to potential commercialization. Projects proposed for Phase II are based on the results achieved in Phase I (or equivalent) and aim to demonstrate scientific and technical merit and commercial potential. NIDA seeks to determine that both technical feasibility and commercial feasibility are established in Phase I before making the decision about proceeding to Phase II. Applications solely focused on the research and development of the solutions to provide medical care and/or treatment will be deemed non-responsive and will be returned without review. Applications solely focused on the Social Determinants of Health in the context of Alcohol Use Disorders will be deemed non-responsive and will be returned without review.