Key Dates

Related Announcements

•  July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230
•  July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231
•  July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232

Issued by

National Institute of Mental Health (NIMH)

Sexual and Gender Minority Research Office (SGMRO)

Purpose

Background

Emerging digital health technologies in HIV research is a growing and dynamic field that has the potential to bring HIV prevention and treatment efforts to scale. Innovations in technology can assist in reaching high-incidence populations, such as racial or ethnic minority communities, sexual and gender minority groups, adolescents and young adults, and individuals from rural settings who face challenges in accessing conventional prevention and treatment services. The aim of this Notice of Special Interest (NOSI) is to support the development of new technologies for the prevention or treatment of HIV, or the application of existing technologies to behavioral and social science HIV prevention or treatment research. 

Applicants are encouraged to focus their technological innovations on populations that are most at risk for HIV, those living with HIV who are not currently accessing HIV care or fully benefiting from antiretroviral treatment, or other populations that experience HIV health disparities (e.g., racial or ethnic minority communities, sexual and gender minority groups, adolescents and young adults, older adults, pregnant and post-partum women, and people with mental health disorders). To reach these populations, applicants may consider utilizing a variety of venues and settings (e.g., mental health clinics, pharmacies, communities, schools, emergency rooms, criminal justice settings, and social media). Additionally, applicants may consider harnessing technological innovations to enhance objective assessment of Central Nervous System (CNS) complications for people living with HIV using the Research Domain Criteria (RDoC) framework; expansion of HIV diagnostic/testing technology for vulnerable populations; development of tools or platforms to screen for mental health disorders in people living with HIV (PLWH) and address mental health associated with HIV, and other areas identified below.

Emerging digital health technologies can provide opportunities to support HIV research and care, such as: (1) collecting data in an adaptive way and allowing for more frequent, accurate, and inclusive assessments outside the clinical research environment; (2) fostering the delivery of interactive and personalized/tailored content; (3) scaling interventions to cover broad geographic areas; and (4) providing tools to empower populations to engage in healthy preventive behaviors. 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 clinical practice. Furthermore, 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  

Areas of interest for use of digital health technology in HIV prevention and care include:

• Patient-focused applications such as dynamically tailored interventions to promote health behavior change and maintenance;
• Provider-focused applications to improve HIV provider clinical workflows and patient-provider communication
• Health system-focused applications, such as reporting and data collection; and
• Population health-focused applications, including HIV awareness and testing and linkage (prevention or treatment) campaigns.

Other research topics encouraged by this NOSI include but are not limited to the development and testing of:

• Innovative technologies to improve outreach, recruitment, and retention of populations experiencing HIV disparities for HIV prevention and treatment research;
• Technologies to assess and monitor HIV medication adherence that provide important innovations relative to existing tools and approaches; 
• Innovative technologies for objective and reliable measurement of CNS complications, including mental health disorders associated with HIV using the RDoC framework;
• New technologies to make mental health treatment more available, accessible, and acceptable to people living with HIV;
• Technologies to better capture and harmonize mental health and HIV associated data to facilitate secondary data analysis including meta-analytic and modelling studies;
• Tools, curricula, and strategies to reduce documented disparities in HIV including racial/ethnic, gender, age-related, geographic and other disparities;
• 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 and promoting uptake of HIV prevention services and tools;
• Innovative interactive technologies to deliver health equity training programs for health care providers and staff – particularly focused on reducing stigma, discrimination, and HIV care disparities across diverse racial and ethnic groups;
• Novel tools and technologies to aid mutual patient-provider decision-making around the expanding set of oral and injectable HIV prevention or treatment options
• 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 clinical care, improving and sustaining patient adherence to antiretroviral medications, and/or improving patient retention in medical care.
• New technologies and tools to reduce intersectional stigma at the patient, provider, health system, and population levels. 
• Innovative technologies or tools to integrate and harmonize multi-level data that captures the social and structural determinants of health with behavioral, clinical, and social HIV data. 

Applicants are encouraged to address the below considerations, as they relate to implementation of technological innovations through behavioral and social science research approaches.  It may be helpful to consult Division of AIDS Research (DAR)  priorities as reflected in current NIMH DAR Notices of Special Interest (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 of 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 individual.

Based upon the priorities and considerations highlighted above, this NOSI encourages SBIR phase I applications for (a) proof-of-concept testing and development of  technologies and novel approaches to move 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.

For guidance on high priority scientific areas in this domain, applicants are encouraged to review the NIH Strategic Plan for HIV and HIV-Related Research, and NIH Research Priorities by NIH Office of AIDS Research. Small businesses that are primarily interested in research and development (and not commercialization) should consider other grant mechanisms at NIH, rather than the SBIR program. Applicants are encouraged to contact NIMH Division of AIDS research Program officers for consultations prior to submission for NOSI-related questions. 

Award Budget

Total funding support (direct costs, indirect costs, fee) normally may not exceed $295,924 for Phase I awards and $1,972,828 for Phase II awards. The Small Business Administration (SBA) has approved waivers to allow businesses to exceed the overall budget caps on their award for particular topic areas the current list of approved topics can be found at https://seed.nih.gov/sites/default/files/HHS_Topics_for_Budget_Waivers.pdf.    Applicants are strongly encouraged to contact NIH program officials prior to submitting any application.

For applications responding to topics in this Notice of Special Interest, budgets up to $450,000 total funding support for Phase I awards, and $750,000 total funding support per year, up to three years for Phase II awards, and $1,000,000 total funding support per year, up to three years for Phase IIB awards may be requested.  

Application and Submission Information

This notice applies to due dates on or after September 5, 2023 and subsequent receipt dates through January 6, 2027. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

• PA-23-230 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-23-231 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-23-232 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
•  

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-MH-23-200” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Vasudev R. Rao, MBBS, MS.
National Institute of Mental Health (NIMH)
Telephone: 240-669-5609
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Financial/Grants Management Contact(s)

Maggie Paolini
National Institute of Mental Health (NIMH)
Phone: 301-443-2746
Email: [email protected]