NIH Highlighted Topic: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions
Highlighted Topic 99 | Lead Office: NIH Office of AIDS Research (OAR) | Posted July 28, 2026 | Expires July 28, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).
Executive Summary
NIH has designated HIV-associated co-occurring conditions as a formal Highlighted Topic, and sixteen NIH Institutes, Centers, and Offices have attached their own stated interests to it. For a small business, this is one of the most cross-cutting priority signals NIH has published in the HIV space, because it opens the door to funding from cancer, cardiopulmonary, aging, metabolic, mental health, substance use, oral health, musculoskeletal, and integrative health budgets at the same time, all through a single application to the standard SBIR or STTR omnibus.
The science being requested is a shift in framing. Antiretroviral therapy has turned HIV into a manageable chronic condition, and the unsolved problem is no longer viral suppression. It is that people with HIV develop comorbidities earlier, carry more of them at once, experience treatment-related toxicities, and navigate mental health, substance use, and structural barriers that disease-specific care models were never designed to handle. NIH wants to fund work that treats those conditions as an interconnected system rather than a list of separate diseases, and it wants that work to reach patients through care models that actually get implemented.
For companies, the commercially relevant openings are concentrated in a handful of places: multi-condition risk prediction and early screening, point-of-care and decentralized diagnostics for comorbidities and coinfections, digital therapeutics and adherence technologies that address HIV alongside substance use or mental health, biomarkers of accelerated aging and organ injury, drug interaction and polypharmacy decision support, and platforms that let a single clinic deliver integrated care without adding staff.
There is no dedicated pot of money and no separate application form. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the normal NIH SBIR or STTR omnibus, you compete against every other small business application in that cycle, and NIH states plainly that applying in a Highlighted Topic area will not affect how your application is referred or reviewed. What the topic does give you is unusually specific intelligence about what sixteen ICOs want to buy, plus named program staff to call before you write a word. Two participating Institutes, NHLBI and NIDA, state they may dedicate funds to this topic area, and three, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in it.
Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through July 28, 2028.
One timing change matters more here than almost anywhere else in the NIH portfolio: HHS eliminated dedicated AIDS-specific SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies that built their calendars around the legacy AIDS cycles need to rebuild them around the standard September, January, and April dates.
A Quick Note on the NIH SBIR and STTR Program
The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. There is no equity, no repayment, and no board seat.
The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in a single application, and Direct to Phase II lets companies that have already established feasibility skip Phase I entirely. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as clinical validation, manufacturing scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.
For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).
Everything below is specific to this Highlighted Topic.
What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?
This distinction trips up nearly every first-time applicant, so it is worth being precise.
A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and in most cases its own set-aside funding. You apply to it directly.
A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package. It has no guaranteed funding. You cannot apply to it. Instead, you apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating Institutes and Centers currently want to fund inside their existing budgets.
NIH is explicit about the practical consequences:
Apply through an appropriate parent announcement or other broad NIH opportunity.
Reach out early to the listed scientific contacts to discuss alignment.
If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.
Applying in a Highlighted Topic area will not affect NIH referral or review of your application.
That last point is the one to internalize. The topic does not give you a scoring advantage. What it gives you is a map. Sixteen ICOs have each written down, in their own words, what they would fund in this space and who to call about it. That intelligence is worth considerably more than a modest scoring bump, because the single most common reason strong small business applications fail at NIH is misalignment with the Institute that ends up holding the application.
Highlighted Topics replaced the older Notice of Special Interest (NOSI) model for this purpose. If you have applied to NIH before and are looking for a notice number to enter into the Agency Routing Identifier field, there is not one for a Highlighted Topic. The practical approach is to make the alignment explicit in your cover letter and in your Specific Aims, and to confirm handling with the program officer at your target Institute before you submit.
What Are They Looking For? A Detailed Overview
The Core Scientific Problem
NIH frames the problem in terms that any founder in this space will recognize from the clinic.
Antiretroviral therapy transformed HIV into a manageable chronic condition. But people with HIV still face high risk and early onset of comorbidities, adverse effects from ART itself, and a set of medical, psychosocial, and structural challenges that are tangled together rather than separable. The burden extends beyond people living with HIV: NIH specifically calls out HIV-exposed but uninfected children, who may carry elevated risks of immune, metabolic, and developmental problems compared with unexposed peers, particularly in low and middle-income settings.
The stated knowledge gaps are where the fundable work lives:
Mechanistic gaps. How do HIV, ART, and psychosocial stressors interact to drive the early onset and progression of comorbidities? This is the question underneath accelerated aging, chronic inflammation, and immune activation.
Shared-pathway gaps. Many comorbidities intersect and share risk factors before diverging into disease-specific trajectories. NIH gives two examples directly: metabolic syndrome raising risk for diabetes, cardiovascular disease, and chronic kidney disease at once; and certain coinfections raising cancer risk. The implication is a real product thesis. If you can identify or intervene on a shared upstream factor, you address multiple outcomes with one technology, and that is a much stronger commercial story than a single-indication tool.
Model gaps. Traditional disease-specific models do not capture shared factors, and they do not capture the multilevel determinants that decide whether an intervention actually gets implemented in a real health system.
Care delivery gaps. NIH wants whole-person care that links infectious diseases, endocrinology, psychiatry, nursing, pharmacy, and community health, with emphasis on early screening, lifestyle-based prevention, and sustained engagement in HIV care, all while accounting for local context and health system constraints.
The Stated Purpose
The topic aims to catalyze interdisciplinary research on HIV-associated co-occurring conditions and to expand multidisciplinary teams that can develop and deliver preventive strategies improving health and quality of life across the lifespan. Three emphases are named:
Shared factors and multi-organ effects, to inform early preventive strategies.
Implementation science approaches to identify barriers and facilitators, optimize multidisciplinary care, and deliver scalable, sustainable care models.
Multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise, cross-NIH alignment, and use of existing NIH resources.
Meaningful community engagement is strongly encouraged throughout.
Alignment With the Make America Healthy Again Initiative
This topic is being issued as part of the Make America Healthy Again (MAHA) initiative, and NIH lists the specific MAHA workstreams it aligns with. This matters strategically, because it tells you which vocabulary and which framings currently carry institutional weight. The named alignments include:
The NIH MAHA Chronic Disease Initiative, which aligns existing NIH chronic disease research and aims to generate actionable results for diseases arising in childhood and adulthood.
The Whole-Person-Health approach to chronic disease prevention, including metabolic health at all stages of life.
Prescribing patterns and impact on mental health, including evaluation of prescription patterns and overprescription trends.
Food for Health, studying food and lifestyle interventions and their effect on outcomes and cost.
Nutrition, including dietary patterns that support metabolic health and precision nutrition.
The oral health and systemic disease connection, including oral microbiome relationships with gut health and immune function.
The Gut Microbiome Research Initiative, on the microbiome's role in chronic disease development and progression.
Longitudinal research for chronic disease prevention, leveraging existing NIH cohorts including All of Us, ABCD, HBCD, and ECHO.
Clinical trial networks, strengthening existing networks through engagement with large public and private hospital systems including the VA.
Mental health and addiction research, with focus areas including screen time in children and adolescents.
If your technology touches metabolic health, nutrition, the microbiome, polypharmacy, or prevention, there is language here you should be borrowing.
Participating Institutes, Centers, and Offices, and What Each One Wants
This is the section to read closely. Your application will be assigned to one Institute, that Institute's budget will pay for it, and that Institute's priorities will determine whether it gets funded after review. Below is what each participating ICO has stated for this topic.
Office of AIDS Research (OAR), lead office. OAR is interested in facilitating interdisciplinary research, including implementation science, to advance understanding of the common factors underlying HIV-associated co-occurring conditions, supporting early prevention, integrated whole-person care, and improved health and quality of life across the lifespan. OAR does not award grants. Your application must be relevant to at least one participating Institute or Center that does. OAR is the central scientific contact for the topic overall, and Geetanjali Bansal, PhD, is the ICO scientific contact.
National Cancer Institute (NCI). NCI wants to advance understanding of the risks, development, progression, prevention, diagnosis, and treatment of cancer in people with HIV, and to test and implement bundled cancer and HIV interventions. NCI notes that people with HIV have increased incidence of certain cancers, are diagnosed at earlier ages and higher stages, have worse overall and cancer-specific survival, and are less likely to receive cancer treatment. Named example topics: characterizing how HIV infection contributes to the development and pathogenesis of HIV-related tumors; discovering and developing new biomarkers, diagnostics, and therapeutics to improve prevention, diagnosis, treatment, and outcomes; and identifying factors that drive cancer disparities for people with HIV, including work to improve adoption, implementation, and sustainment of effective interventions. Contact: Rebecca Liddell Huppi, PhD.
National Heart, Lung, and Blood Institute (NHLBI). NHLBI is interested in mechanisms and pathways behind HIV-associated heart, lung, blood, and sleep (HLBS) comorbidities, and in interventions that improve care, including implementation research. Stated priorities: combined effects of aging, HIV, and ART on HLBS conditions; aging- and HIV-related changes in hematopoiesis, including hematopoietic stem cells and their niche; the impact of sleep deficiency and sleep-disordered breathing on HIV-associated cardiopulmonary and cardiometabolic disease; vascular contributions to cognitive impairment and dementia; implementation strategies that improve uptake and sustainability of evidence-based HLBS interventions; mechanistic studies to reduce the effects of HIV and aging on HLBS comorbidities, including traditional risk factors and sex differences; and novel methods to detect subclinical HIV-related HLBS conditions plus strategies to mitigate clinical disease. NHLBI states it may dedicate available funds to applications in this topic area, subject to funds, the number of meritorious applications, and competing priorities.
National Institute on Aging (NIA). NIA supports projects addressing HIV-associated co-occurring conditions in midlife and older age, spanning the NIH Stage Model from basic science (Stage 0) through intervention development and refinement (Stage 1) to implementation (Stage V). Areas of interest: the etiologies and pathogenesis of these conditions, including the roles of chronic immune activation and antiretroviral and other drug toxic effects; optimizing medications, care coordination, and behavioral and social interventions to improve outcomes, function, and quality of life; and developing, testing, implementing, and scaling evidence-based interventions that address poor outcomes. Contact: Marcel E. Salive, MD, MPH.
National Institute on Drug Abuse (NIDA). NIDA seeks interdisciplinary research on how drug use, addiction, and HIV interact across the lifespan. Named examples: how HIV, ART, and polysubstance use affect brain function, behavior, mood, sleep, pain, and cognition; molecular, neurochemical, cellular, and circuit functions underpinning HIV and co-occurring substance use disorders; shared pathways linking substance use, HIV, stress, trauma, and mental health conditions; individual and community factors affecting HIV prevention, care engagement, and ART adherence, with focus on improving access in underserved populations; integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions; and basic, clinical, and translational research on treatment of SUD and overdose in people with HIV. NIDA states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it.
National Institute of Mental Health (NIMH). NIMH is interested in interdisciplinary biological and behavioral approaches to the neuropsychiatric mechanisms behind central nervous system comorbidities in people with HIV across the lifespan; how HIV biology, treatment exposures, and psychosocial burden converge on shared pathways driving neurocognitive and mental health disorders, in order to inform early intervention and scalable whole-person care models; and multidisciplinary implementation research identifying barriers to neurocognitive and mental health diagnosis and treatment in people with HIV, with emphasis on community engagement and sustainable care delivery. Contacts: Vasudev Rao, MBBS, MS, and Teri Senn, PhD. Note that NIMH's standing small business program already names technologies addressing basic, behavioral, and implementation science related to people living with HIV as an interest area, which makes it an unusually natural home for an SBIR application under this topic.
National Institute of Allergy and Infectious Diseases (NIAID). NIAID is interested in coinfections affecting people with HIV across the lifespan, from infant through adult, and encourages multidisciplinary applications addressing the impact of stigma and other intersecting behavioral, biological, and health system factors on diagnosis, prevention, and treatment. The named coinfections are tuberculosis, viral hepatitis, and sexually transmitted infections. Contact: Robin E. Huebner, PhD, MPH.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK supports basic, clinical, and implementation science examining the impact of HIV on organs, tissues, and biological systems, including person-oriented comorbidity research. Priorities include enteropathy and gastrointestinal homeostasis; liver diseases and viral hepatitis coinfections; digestive diseases, nutrition, obesity, diabetes, and related complications; and kidney, urologic, and hematologic diseases that may present differently or follow altered clinical courses in the context of HIV. On the clinical side, NIDDK wants work that improves implementation and delivery of evidence-based care and develops strategies to improve HIV diagnosis and progression. Studies addressing social, behavioral, and environmental factors influencing HIV and comorbidities in diabetes, digestive, and kidney disease are named as high priority, particularly regarding disease severity and treatment adherence. Contacts: Deepak Nihalani, Khoa Nguyen, and Minnjuan Flournoy Floyd.
National Institute on Alcohol Abuse and Alcoholism (NIAAA). NIAAA notes that heavy alcohol use, including alcohol use disorder, interacts with both behavioral risk and organ pathophysiology in people living with HIV, accelerating physiological and physical vulnerability, affecting medication adherence and toxicities, and complicating care. Research should improve understanding of the pathophysiology of alcohol-associated comorbidities; develop biomedical and behavioral approaches to restore alcohol-induced organ dysfunction; and implement interventions addressing alcohol and associated mental health, substance use, comorbidities, coinfections, and complications in vulnerable populations. Named complications include cardiovascular disease, metabolic disorders, neurocognitive impairment, and cellular and immune dysfunction. Contact: Kendall Bryant, PhD.
National Center for Complementary and Integrative Health (NCCIH). NCCIH supports research on complementary and integrative health approaches for symptom management in people living with HIV, framing HIV as a chronic multisystem condition with complex symptoms including pain, fatigue, and neurocognitive and mental health challenges that suit a Whole Person Health approach. Priorities: testing complementary and integrative interventions such as mind-body approaches and natural products to address symptom clusters and improve function and quality of life; elucidating biological, behavioral, and psychosocial mechanisms including inflammation, neuroimmune, and stress pathways, and identifying biomarkers and patient characteristics; integrating these approaches into HIV care through pragmatic and hybrid effectiveness-implementation studies and scalable delivery models; and evaluating risks such as drug and herb interactions, synthesizing evidence, and developing guidance for informed decision-making. NCCIH states it may give special consideration to meritorious applications in this topic area. Contact: Lanay Mudd, PhD.
National Institute of Dental and Craniofacial Research (NIDCR). NIDCR supports interdisciplinary research on shared risk factors influencing the onset and progression of HIV-associated comorbidities in the oral and craniofacial complex across the lifespan. Areas of interest: mechanisms of HIV-related oral disease, including immune dysregulation, inflammation, and ART effects; biological, behavioral, and contextual risk factors linking oral and systemic comorbidities and coinfections, including HPV-associated cancer and metabolic and inflammatory diseases; interdisciplinary preventive, diagnostic, and treatment approaches, including probiotics, mucosal immunity modifiers, early cancer detection, and management of oral and salivary gland complications; and integration of oral health into the multidisciplinary HIV care continuum. NIDCR states it may give special consideration to meritorious applications in this topic area. Contact: NIDCR Division of Extramural Research.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). NIAMS seeks research on HIV-associated comorbidities affecting the musculoskeletal system, skin, and systemic rheumatic diseases, and encourages studies of how HIV infection, ART, and host or viral factors contribute to early onset, acceleration, or worsening of NIAMS-relevant comorbidities. Named conditions include musculoskeletal pain; muscle diseases such as sarcopenia and cachexia; cartilage degeneration and osteoarthritis; osteoporosis, osteopenia, and fractures; arthritis and other rheumatic diseases; and dermatologic manifestations. NIAMS supports basic, translational, and clinical research characterizing the burden, trajectory, and risk of these conditions across the lifespan, and states that priority is given to implementation science projects that develop, test, and scale multidisciplinary whole-person care models integrating musculoskeletal, rheumatic, and skin health into HIV prevention and treatment settings. Contact: Heiyoung Park, PhD. Important operational note for small businesses: NIAMS does not accept clinical trial applications under the SBIR parent announcement.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). NICHD is listed as a participating ICO with a scientific contact, Sonia Lee, PhD, but has not published a topic-specific scope statement. Given the topic's explicit attention to HIV-exposed uninfected children and to outcomes across the lifespan, pediatric, maternal, and developmental angles are clearly in play, but this is an Institute where a pre-submission conversation is not optional.
Office of Behavioral and Social Sciences Research (OBSSR). Participating, with Cathy Maulsby, PhD, as contact. OBSSR does not award grants.
Office of Disease Prevention (ODP). ODP is particularly interested in innovative prevention research using rigorous study design, measurement, and analysis methods to test interventions, implementation strategies, and multidisciplinary care approaches that prevent co-occurring conditions in people with HIV across the lifespan. ODP does not award grants. Contact: JoyAnn Courtney, PhD.
Office of Research on Women's Health (ORWH). ORWH is interested in research projects addressing HIV-associated co-occurring conditions in women. ORWH does not award grants. Contact: Balkissa Ouattara, MD, PhD, MPH.
Tribal Health Research Office (THRO). Participating, with Sheila Caldwell, PhD, and Christopher Barnhart, PhD, as contacts. THRO does not award grants.
Email addresses for every contact are published on the NIH topic page. Note carefully that five of the sixteen participating ICOs are offices that cannot fund anything. Your application still has to land on the mission of an Institute or Center that writes checks.
Where Does a Small Business Actually Fit?
This is the honest part, and it is the question a founder should ask before spending 150 hours on an application.
A large share of what this topic describes is classic investigator-initiated academic research: mechanistic biology, cohort analyses, implementation science trials in health systems. Much of that is better suited to an R01 than to an SBIR. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service. If the deliverable at the end of your project is a paper and a set of findings rather than something a customer buys, an SBIR reviewer will say so.
The good news is that this topic contains an unusual density of genuine product opportunities, because "shared factors, multi-organ effects, early screening, and scalable care models" is a description of things that get built and sold. The strongest small business fits:
Multi-condition risk prediction and early screening. The topic's central scientific bet is that shared upstream factors drive several downstream comorbidities. A validated tool that stratifies risk across cardiometabolic, renal, hepatic, neurocognitive, and oncologic outcomes at once maps directly onto NHLBI, NIDDK, NIA, and NCI interests simultaneously, and onto the MAHA prevention framing.
Point-of-care and decentralized diagnostics. Coinfection detection for TB, viral hepatitis, and STIs sits squarely in NIAID's stated scope. Oral and salivary diagnostics sit in NIDCR's. Detection of subclinical HLBS disease is a named NHLBI priority.
Biomarkers of accelerated aging, immune activation, and organ injury. NIA names chronic immune activation and drug toxic effects explicitly. NHLBI names hematopoietic changes. NCCIH names inflammation, neuroimmune, and stress mechanisms plus biomarker identification.
Digital therapeutics and integrated behavioral health. NIDA's interest in integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions is one of the clearest commercial openings in the entire topic, and NIDA is one of the two Institutes signaling possible dedicated funds. NIMH's interest in scalable whole-person care models points the same direction.
Adherence, polypharmacy, and interaction safety. ART adherence is named by NIDA. Medication optimization is named by NIA. Drug and herb interaction risk is named by NCCIH. Prescribing patterns are a named MAHA workstream. Clinical decision support that manages ART alongside comorbidity medications and supplements has an unusually broad set of sponsors.
Care coordination and integration platforms. Nearly every ICO in the topic asks for something that in practice requires software: integrating oral health into the HIV care continuum, integrating musculoskeletal and skin health, bundling cancer and HIV interventions, coordinating care across infectious disease, endocrinology, psychiatry, pharmacy, and community health. Note that NIAMS explicitly prioritizes implementation science for exactly this, which is rare.
Biosensors and wearables. NIAAA's standing small business priorities already include transdermal and wearable alcohol monitoring, which lands directly on this topic's alcohol and organ dysfunction thread.
Therapeutics. Treatments targeting shared inflammatory or metabolic pathways, or targeting a specific comorbidity in the HIV context, fit multiple Institutes. This is the longest and most capital-intensive path, and Fast-Track or Direct to Phase II with a clear regulatory strategy is usually the right structure.
One structural constraint to plan around. The topic repeatedly references low and middle-income settings and global context. The SBIR parent announcement does not permit foreign subawards or subcontracts, and applications involving them will not be considered for funding. If your work is genuinely LMIC-facing, the research plan has to be structured so that the funded work happens domestically, with international relevance argued rather than internationally performed. This is a common and avoidable reason HIV-focused SBIR applications get administratively withdrawn.
STTR is worth a hard look here. This topic asks for multidisciplinary teams with complementary expertise and meaningful community engagement, which is exactly what the STTR mechanism is built for. Under STTR, a formal collaboration with a university or nonprofit research institution is required, and the Principal Investigator may be primarily employed by either the company or the research partner. For a company that needs an academic HIV clinician, an implementation scientist, or a community-engaged research partner in order to be credible, STTR (PA-27-102) is often the stronger vehicle than SBIR.
How Much Funding Would I Receive?
There is no funding amount attached to the Highlighted Topic itself. Budgets are set by the parent announcement you apply through and by the Institute that funds you.
Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:
Phase I: up to $323,090, typically over one to two years
Phase II: up to $2,153,927, typically over two to three years
Fast-Track: combines Phase I and Phase II in one application and one review
Direct to Phase II: available under SBIR for companies that have already established feasibility
Phase IIB (PA-27-101): follow-on funding beyond Phase II, with budgets that can run substantially larger
Commercialization Readiness Pilot: late-stage, milestone-driven support, up to the SBA statutory maximum of $4,191,495 at NCI, with amounts varying by Institute
Several Institutes participating in this topic hold approval to exceed the standard caps. NIA allows up to $700,000 for Phase I and $3 million for Phase II on Alzheimer's disease and AD-related dementias, and up to $500,000 and $2.5 million for other projects in its mission space, which is directly relevant given the topic's inclusion of neurocognitive comorbidity and vascular contributions to dementia. NIGMS allows Phase IIB budgets up to $3 million, or $4 million for Strategic Breakthrough awards involving clinical trials. NCI supports CRP projects up to the statutory maximum plus up to $500,000 for technical assistance.
Cost sharing is not required. Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II generally requires at least 50 percent.
Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.
What Could I Use the Funding For?
Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute or Center. Allowable costs include personnel, materials, prototype fabrication, assay development, validation studies, testing, intellectual property protection, and other direct R&D expenses.
Phase II, Phase IIB, and CRP funds may additionally cover scale-up, clinical validation, regulatory preparation including IND and IDE-enabling studies, and commercialization activities.
Whether you can run a clinical trial depends entirely on which Institute funds you. Most ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK, all of which participate in this topic. NIAMS and NIDCR, which also participate in this topic, do not accept clinical trials under the SBIR parent announcement. If your project involves human subjects, confirm your target Institute's specific policy before you build the research plan around it.
What Is the Timeline?
Highlighted Topic dates
Posted: July 28, 2026
Expires: July 28, 2028
SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)
September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.
January 5, 2027
April 5, 2027
The same September, January, and April cycle continues into 2027 and 2028 while the topic remains active. September 5, 2027 falls on a Sunday ahead of Labor Day, so that cycle effectively closes Tuesday, September 7, 2027.
All applications are due by 5:00 PM local time of the applicant organization.
Review and award timeline for the September 2026 cycle
Scientific merit review: November 2026
Advisory council review: January 2027
Earliest project start date: April 2027
Review and award timeline for the January 2027 cycle
Scientific merit review: March 2027
Advisory council review: May 2027
Earliest project start date: July 2027
Review and award timeline for the April 2027 cycle
Scientific merit review: July 2027
Advisory council review: August 2027
Earliest project start date: December 2027
Two timing changes that specifically affect HIV-focused applicants
First, HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies previously had access to a separate offset schedule that routed applications into AIDS-specific review. That is gone. You now compete on the standard small business calendar, which makes Institute alignment and cycle selection more consequential than before.
Second, NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Plan to submit early enough to resolve eRA Commons validation errors before the deadline, not after it.
Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not already complete. SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must be finished before you can submit anything. For a first-time applicant, expect 120 to 200 hours of total effort on a competitive submission.
Who Is Eligible to Apply?
Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:
Organized for profit with a place of business located in the United States
At or below 500 employees, including affiliates
More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination
For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution.
Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.
Are There Restrictions I Should Know About?
Only U.S. small business concerns are eligible; foreign organizations are not.
Applications involving foreign subawards or subcontracts will not be considered for funding. This is the single most important constraint to plan around given the topic's global framing.
Your application must be relevant to at least one participating Institute or Center that awards grants. Five of the participating offices in this topic, OAR, OBSSR, ODP, ORWH, and THRO, do not.
Clinical trials are not accepted by every Institute. Among the ICOs in this topic, NIAMS and NIDCR do not accept them under the SBIR parent announcement.
Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.
Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.
Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 reauthorization tightened foreign risk management and due diligence review, and this screening now sits inside the review critical path rather than beside it.
Cost sharing is not required.
Applying under a Highlighted Topic does not change referral or review, and does not guarantee that any funds have been set aside.
What Kind of Application Is Likely to Win Here?
NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, four things separate the competitive applications from the rest.
One: you picked the right Institute, and you picked it before you started writing. Sixteen ICOs participating means sixteen possible framings of the same technology, and the framing determines which study section reviews you and which budget pays for you. A cardiometabolic risk tool assigned to NHLBI is a different application than the same tool assigned to NIDDK. Email the named contact, describe the technology in a paragraph, and ask directly whether it fits and which mechanism they would suggest. That conversation is free and it is the highest-return hour you will spend.
Two: you actually addressed shared factors, not one disease. The intellectual center of this topic is that comorbidities in people with HIV intersect and share upstream drivers. An application that addresses a single condition in people with HIV is responsive to that Institute's general mission but not distinctively responsive to this topic. An application that shows how one intervention affects multiple outcomes through a shared mechanism is.
Three: you took implementation seriously. NIH says outright that traditional disease-specific models insufficiently capture multilevel implementation determinants, and NIAMS goes further by prioritizing implementation science outright. For a company, this translates into concrete asks: who delivers this, in what clinic, paid for by whom, fitting into what workflow, sustained how after the grant ends. Applications that treat adoption as somebody else's problem read as naive here.
Four: your team is genuinely multidisciplinary, and your community engagement is real. Multiple Program Directors and Principal Investigators with complementary expertise are strongly encouraged. Meaningful community engagement is strongly encouraged. Reviewers in this space are well practiced at spotting a letter of support from a community organization that has no role in the actual research plan.
Frequently Asked Questions
Is this a Notice of Funding Opportunity I can apply to directly?
No. This is an NIH Highlighted Topic, which is a published statement of scientific priority rather than a solicitation. There is no application package and no separate deadline. You apply through a broad NIH funding opportunity, and for small businesses that means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.
How much funding is available under this Highlighted Topic?
The topic itself carries no funding amount. Your budget is governed by the parent announcement you apply through: under standard guidelines, up to $323,090 for SBIR Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. NHLBI and NIDA both state they may dedicate available funds to this topic area, subject to available funds, the number of meritorious applications, and competing priorities.
Does applying under this Highlighted Topic improve my chances?
Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. Three participating ICOs, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in this topic area, and two, NHLBI and NIDA, state they may dedicate funds. The real advantage is informational: sixteen ICOs have documented what they want and named the staff to call about it.
What are the deadlines?
The topic is open from July 28, 2026 through July 28, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, with the cycle continuing while the topic remains active. Because September 5, 2026 falls on a Saturday before Labor Day, that cycle accepts submissions through Tuesday, September 8, 2026. All applications are due by 5:00 PM local time of the applicant organization.
Are there separate AIDS-specific due dates for HIV-related SBIR applications?
Not anymore. HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies now submit on the standard small business schedule and compete within it.
Which NIH Institutes participate in this topic?
Sixteen ICOs: the Office of AIDS Research as lead, plus NCCIH, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIMH, OBSSR, ODP, ORWH, and THRO. Five of those, OAR, OBSSR, ODP, ORWH, and THRO, are offices that do not award grants, so your application must also be relevant to a participating Institute or Center that does.
Who is eligible to apply?
For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.
My work focuses on low and middle-income settings, which the topic specifically mentions. Can SBIR fund that?
Only with careful structuring. The topic references low and middle-income settings and HIV-exposed uninfected children in those settings, but the SBIR parent announcement prohibits foreign subawards and subcontracts. The funded research has to be performed domestically. Global relevance can be argued in the significance and commercialization sections; it cannot be delivered through an international subaward under this mechanism.
Can I run a clinical trial with this funding?
It depends on the Institute. Most participating ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK. NIAMS and NIDCR, both participating in this topic, do not accept clinical trials under the SBIR parent announcement. Confirm your target Institute's policy before designing the project.
Should I apply for SBIR or STTR?
SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Given that this topic explicitly asks for multidisciplinary teams and community engagement, STTR is often the better structural fit, and STTR allows the Principal Investigator to be primarily employed by either the company or the research partner.
Where do I reference the Highlighted Topic in my application?
Unlike a Notice of Special Interest, a Highlighted Topic has no notice number to enter in the Agency Routing Identifier field. Make the alignment explicit in your cover letter and in your Specific Aims, and confirm handling with the program officer at your target Institute before you submit.
What does NIH mean by "shared factors" and why does it matter commercially?
NIH's point is that many comorbidities in people with HIV intersect and share risk factors before diverging into disease-specific trajectories, using metabolic syndrome raising diabetes, cardiovascular, and kidney disease risk as one example and coinfection-driven cancer risk as another. Commercially this is favorable, because a technology addressing an upstream shared factor has a larger addressable market and a stronger clinical value proposition than a single-indication tool, and it can be framed to fit several Institutes at once.
How long will it take me to prepare an application?
For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before submission.
What happens if I miss the deadline?
Nothing good. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window. Build in time to fix validation errors before the deadline rather than after it.
Is this topic connected to a broader federal initiative?
Yes. NIH issued it as part of the Make America Healthy Again initiative, and the topic page names the specific MAHA workstreams it aligns with, including the NIH Chronic Disease Initiative, the Whole-Person-Health approach, prescribing patterns and mental health, Food for Health, nutrition and metabolic health, the oral health and systemic disease connection, the Gut Microbiome Research Initiative, longitudinal cohort research, clinical trial networks, and mental health and addiction research. Framing your significance section in that vocabulary is a low-cost, high-signal move.
How Can BW&CO Help?
BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and we specialize in exactly the problem this topic creates: a broad scientific priority with sixteen possible sponsors, no dedicated money, and no obvious front door.
We can:
Identify the right Institute and the right mechanism for your technology, Phase I, Phase II, Fast-Track, Direct to Phase II, Phase IIB, or CRP, and position you with the program officer who controls that budget.
Triple your likelihood of success through proven strategy and insider-aligned proposal development.
Reduce your time spent on the proposal by 50 to 80 percent, so your team stays focused on the technology and the company.
Structure the research plan so that foreign collaboration, clinical trial sequencing, and registration timelines do not sink an otherwise fundable application.
