NIH Highlighted Topic: Implementation Science to Optimize HIV Prevention and Treatment
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 encouraging innovative research proposals focused on implementation science strategies that improve the delivery, adoption, scale-up, and sustainability of HIV prevention and treatment interventions across real-world healthcare and community settings. This highlighted topic supports multidisciplinary projects aimed at closing the gap between proven HIV interventions and their successful implementation in diverse populations and care environments.
NIH is particularly interested in projects that optimize uptake of biomedical HIV prevention and treatment tools, including long-acting therapies, behavioral interventions, telehealth solutions, integrated care delivery models, and evidence-based HIV care practices. Companies developing digital health platforms, AI-enabled care coordination systems, remote monitoring technologies, patient engagement platforms, implementation analytics tools, telehealth infrastructure, or community-based healthcare technologies may be strong candidates for funding.
Areas of interest include HIV prevention implementation, treatment adherence, viral suppression strategies, aging with HIV, HIV and cancer care coordination, substance use disorder interventions, women’s health, rural healthcare delivery, behavioral health integration, healthcare systems optimization, implementation scalability, and community-led intervention models. NIH is also encouraging projects leveraging artificial intelligence, machine learning, natural language processing (NLP), electronic health records, geospatial technologies, and predictive analytics to improve care delivery and public health outcomes.
Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and implementation impact.
This highlighted topic is supported by numerous NIH Institutes and Offices including OAR, NIAID, NIMH, NLM, NIDA, NIA, NCI, NINR, ORWH, NIDDK, NIDCR, NIMHD, and others, all of which are seeking scalable innovations that improve HIV prevention, treatment adherence, integrated care delivery, and long-term health outcomes in real-world settings.
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, implementation, and commercialization of HIV prevention technologies, digital health systems, implementation science platforms, and integrated care delivery solutions.
Eligible activities may include:
Digital health and telehealth platforms for HIV prevention and treatment
AI and machine learning systems for treatment adherence and care optimization
Long-acting HIV therapeutic delivery and monitoring technologies
Remote patient monitoring and wearable health systems
Clinical decision support and healthcare workflow management platforms
Community-based HIV prevention and care coordination technologies
Behavioral health and substance use disorder intervention systems
HIV implementation science analytics and scalability platforms
EHR integration, interoperability, and health data exchange tools
Natural language processing (NLP) and predictive analytics for HIV care
Patient engagement and viral suppression support technologies
Women’s health and female-specific HIV prevention technologies
Rural healthcare delivery and mobile care platforms
HIV and oncology integrated care coordination systems
Community-led and multi-sector intervention delivery platforms
Population health analytics and implementation research infrastructure
Prototype development, implementation trials, and translational studies
Commercialization planning, regulatory preparation, and scale-up activities
Funding may also support personnel, software engineering, cloud infrastructure, AI model development, clinical implementation research, health systems integration, telehealth deployment, community engagement, data analytics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or digital health 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:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
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Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
