NIH Highlighted Topic: Advancing Prevention and Treatment of Bacterial Sexually Transmitted Infections in HIV-Affected Populations
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program focused on advancing prevention, diagnosis, treatment, and implementation strategies for bacterial sexually transmitted infections (STIs) in adolescent and maternal populations affected by HIV. NIH is particularly interested in technologies and interventions that address rising rates of syphilis, gonorrhea, and chlamydia among youth and pregnant populations living with or at elevated risk for HIV.
Despite significant progress in HIV treatment and prevention, bacterial STI rates continue to rise nationwide, particularly among adolescents, young women, and maternal populations. NIH is encouraging projects that improve STI diagnostics, clinical management, implementation science, prevention technologies, healthcare delivery systems, and workforce training related to HIV and bacterial STI care. Companies developing diagnostics, microbicidal technologies, AI-enabled epidemiology tools, digital health platforms, implementation science solutions, community health technologies, or novel therapeutics may be strong candidates for funding.
NIH is especially interested in projects involving innovative diagnostic modalities, alternative antimicrobial therapies, prevention technologies, post-exposure prophylaxis (PEP) access, maternal and adolescent care models, vaccine and immunotherapeutic development, and scalable service delivery systems. Research incorporating New Approach Methodologies (NAMs), implementation science, health equity strategies, and community-engaged care models is also encouraged.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Nursing Research (NINR), the Office of Research on Women’s Health (ORWH), the Office of Disease Prevention (ODP), and the Office of AIDS Research (OAR), all of which may give special consideration to high-impact applications advancing HIV prevention, STI diagnostics, maternal health, adolescent medicine, infectious disease management, and public health implementation strategies.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and healthcare solutions focused on bacterial sexually transmitted infections (STIs) and HIV-affected adolescent and maternal populations.
Eligible activities may include:
Development of innovative STI diagnostic technologies and point-of-care testing platforms
AI and machine learning tools for STI epidemiology, risk prediction, and clinical decision support
Novel antimicrobial therapies and alternative antibiotics for bacterial STIs
Microbicidal agents and multi-purpose prevention technologies integrating STI and HIV prevention
Digital health platforms supporting STI screening, prevention, treatment adherence, and patient engagement
Research improving access to HIV and STI post-exposure prophylaxis (PEP)
Maternal and adolescent healthcare delivery models focused on STI and HIV prevention
Community-based and implementation science approaches to increase prevention and treatment uptake
Workforce training platforms and clinical education technologies for HIV and STI care providers
Research evaluating cost-effectiveness, scalability, and sustainability of prevention programs
Vaccine and immunotherapeutic development related to bacterial STIs
Immune response studies supporting STI prevention and therapeutic innovation
Public health infrastructure and service delivery optimization technologies
Research focused on congenital syphilis prevention and maternal-fetal health outcomes
Validation studies, translational research, prototype development, and regulatory preparation activities
Commercialization planning and scale-up activities for diagnostics, therapeutics, and public health technologies
Funding may also support personnel, laboratory testing, software development, clinical data analysis, prototype fabrication, computational infrastructure, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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