Innovative Technologies for HIV Behavioral and Social Science Research (R41/R42 Clinical Trial Optional)

Background

Technology-enabled HIV research has emerged in the past decade as a dynamic field that offers potential to bring HIV prevention and treatment efforts to scale. Technological innovations can help to reach vulnerable and at-risk populations such as minorities, adolescents, older adults, and individuals from rural settings who have challenges accessing conventional prevention and treatment services. The goal of this funding opportunity announcement (FOA) is to support the development of new technologies for HIV prevention or treatment, or the application of existing technologies to behavioral and social science HIV research in these domains. For guidance on high priority scientific areas in this domain, applicants are encouraged to review the NIH HIV/AIDS Research Priorities, and the NIMH Division of AIDS Research programs and priorities. The Small Business Technology Transfer (STTR) program supports small businesses in developing technologies that can advance the mission of NIMH/DAR and represents support for the research and development of technologies that corresponds to these identified research priorities. 

Applicants are encouraged to target the technological innovations to individuals who are most vulnerable to HIV acquisition or those who are living with HIV with poor health outcomes (e.g., adolescents, older adults, pregnant and post-partum women, and people with mental health issues). Applicants may consider reaching participants in a range of different venues and settings (e.g., Mental Health clinics, communities, schools, emergency rooms, criminal justice settings, via social media, etc.). Applicants may consider harnessing technical innovations to enhance objective assessment of neurocognitive abilities or functional impairments; expansion of diagnostic/testing technology for vulnerable populations; and development of tools to objectively measure mental health associated with HIV infection.

Emerging communication technologies may offer many opportunities for HIV/AIDS research, such as: (1) collecting data in an adaptive way and allowing for more frequent, accurate, and inclusive assessments outside the clinical research environment; (2) bringing delivery of interactive content to scale; (3) covering broad geographic areas; (4) delivering technologies in highly tailored ways; and (5) providing tools to empower vulnerable populations to engage in healthy preventive behaviors. In the past five years, mobile technology platforms for adjunct delivery of behavioral interventions and health status monitoring have widely proliferated, enabling supplemental support to in-person behavioral treatments for improved health outcomes. Despite this growth, few mHealth interventions or applications have undergone systematic and rigorous usability evaluation prior to their dissemination. For broader impact and to fully achieve their potential, these technologies must be optimized through feedback from intended end-users and through the development of scalable platforms and processes to enable broad dissemination and incorporation into regular clinical practice. Further, leveraging existing software platforms and applications for the treatment and/or prevention of HIV is cost effective and contributes to resource sharing efforts.

Specific Areas of Interest

Research themes for mobile health applications in HIV prevention and care include:

• Patient-care focused applications, such as health behavior change;
• Health system-focused applications, such as reporting and data collection;
• Population health-focused applications, including HIV awareness and testing campaigns; and
• Provider-focused applications to improve HIV provider knowledge and patient-provider communication

Applicants are asked to address the general considerations below, as they relate to implementation of  technological innovations through behavioral and social science research approaches.  It may be helpful to consult the behavioral and social science research agenda of DAR priorities as reflected in current NIMH AIDS initiative (see AIDS-related FOAs). 

• Methodology:  To address methodological rigor, technological innovations should assess impact on data quality and/or biases in sampling approaches, and allow for transparency of research methods and results (https://grants.nih.gov/reproducibility/index.htm);      
• Barriers:  Technology developments must address barriers to successful uptake and adherence using these technology-delivered treatments/interventions which may include issues such as  stigma, perceived risk perception, availability and access, and misinformation.
• Theoretical framework:  A theory-driven framework should be utilized in the consideration of behavior change mechanisms since technology can improve outcomes in many ways.
• Development:  Technology enabled interventions should be tailored to the developmental stage of the at-risk or HIV-positive individual.

Based upon the priorities and considerations highlighted above, this FOA encourages STTR phase I applications for (a) proof-of-concept testing and development of new technologies when needed and novel approaches to move useful technologies from non-commercial laboratories into the commercial marketplace, and (b) adaptation and application of existing technological innovations for products that are relevant to behavioral and social science research for HIV prevention and treatment.

This FOA also encourages STTR phase II applications for the iterative refinement and development of opportunities for manufacture of emergent technologies and approaches that have already demonstrated their potential through initial proof-of-concept testing in the phase I STTR.

Small businesses that are primarily interested in research and development (and not commercialization) should consider other grant mechanisms at NIH, rather than the STTR program. Program staff at NIMH/DAR can help identify the most appropriate grant mechanism to use. Research topics encouraged by this FOA include but are not limited to the development and testing of:

• Innovative technologies to improve outreach, recruitment, and retention of hard-to-reach populations for HIV prevention and treatment research;
• Innovative technologies to assess HIV medication adherence through wireless technologies, remote sensing devices, or other novel methods; 
• Innovative technologies for objective and reliable measurement of neurocognitive and mental health abnormalities associated with HIV;
• Technologies to better capture and harmonize mental health and HIV associated data to facilitate secondary or meta-analyses and modelling;
• Tools, curricula, and strategies to reduce documented disparities in HIV infection including racial/ethnic, gender, age-related and others;
• Innovative technologies to improve HIV provider knowledge and practice in low resource and rural settings.
• Innovative technologies to be used with rapid home-based HIV self-testing kits, to address repeat testing and increase linkage and engagement in HIV care for those testing positive; 
• Innovative online HIV prevention programs for raising awareness, knowledge promotion, and uptake of HIV prevention services and tools;
• Innovative interactive technologies to deliver training programs for health care staff, including physicians, home care aids, and long-term care service providers – particularly focused on reducing disparities of care between diverse racial and ethnic groups;
• Innovative technology and tools designed to facilitate the effective use and implementation of biomedical HIV prevention methods and include biomarker outcomes when appropriate;
• Innovative technologies designed to improve HIV treatment outcomes by rapidly linking individuals diagnosed with HIV to care, enhancing patient readiness for initiation of antiretroviral medications, improving and sustaining patient adherence to antiretroviral medications, and/or improving patient retention in medical car

Research themes for mobile health applications in HIV prevention and care include:

• Patient-care focused applications, such as health behavior change;
• Health system-focused applications, such as reporting and data collection;
• Population health-focused applications, including HIV awareness and testing campaigns; and
• Provider-focused applications to improve HIV provider knowledge and patient-provider communication

See Section VIII. Other Information for award authorities and regulations.