Over-the-Counter / Home Use Platforms for HIV Detection and Antiretroviral Therapy Monitoring

Overview

The FY 2026–2030 NIH Strategic Plan for HIV and HIV-Related Research, coordinated by the NIH Office of AIDS Research (OAR), guides the largest public investment in HIV research, building on scientific progress and opportunities for advancing research to end the HIV pandemic. Despite scientific advances, HIV remains a major public health challenge, with persistent disparities in access and outcomes. According to UNAIDS estimates, in 2025 an estimated 41.0 million people worldwide were living with HIV, and 1.2 million people newly acquired HIV.

In the United States, CDC estimated that approximately 1.2 million adults and adolescents were living with HIV at the end of 2022, including approximately 13 percent who were unaware of their status. CDC’s provisional 2024 care-continuum data show that, among people living with diagnosed HIV, 77 percent received some HIV medical care, 56 percent were retained in care, and 69 percent achieved viral suppression. These gaps persist despite substantial federal investment through the Ending the HIV Epidemic in the U.S. (EHE) initiative, which has sought to accelerate progress through four core strategies—diagnose, treat, prevent, and respond—with a goal of reducing new HIV infections by at least 90 percent by 2030. As federal HIV efforts evolve, sustaining and building on the infrastructure, partnerships, and lessons developed through EHE will be important to maintaining progress toward ending the HIV epidemic in the United States. Significant work also remains to achieve the 95–95–95 targets, retained in the UNAIDS Global AIDS Strategy 2026–2031: 95 percent of people living with HIV know their HIV status, 95 percent of people living with HIV who know their status receive treatment, and 95 percent of people living with HIV who are on treatment have a suppressed viral load. These targets support the goal of ending HIV as a public health threat by 2030. Key steps include increasing testing and status awareness, improving access to treatment, strengthening laboratory infrastructure, developing better viral load monitoring technologies, and taking a holistic, whole-person health approach to care.

At-home and near person HIV testing can expand access to early detection by offering privacy, convenience, and flexibility while reducing barriers related to stigma, transportation, and access to healthcare. It may help individuals receive more timely diagnoses and linkages to care. Current at-home HIV tests do not replace confirmatory diagnostic testing or laboratory-based viral load monitoring, which quantitatively measures HIV RNA and assesses treatment response. Integrating home and near person testing with timely diagnosis, treatment, and ongoing monitoring can strengthen HIV care and improve health outcomes.

The only over-the-counter (OTC) HIV tests currently available in the U.S. market are antibody-only tests, which generally have a detection window of 1–3 months after HIV acquisition and typically cost between $25–$40 at retail. Although additional HIV self-testing options are available in some countries outside the United States, neither molecular nor antigen/antibody tests are currently available for OTC use in the United States. Molecular tests can generally detect the virus as early as ten days after acquisition, and antigen/antibody tests can detect HIV two weeks after acquisition. As a result, U.S. consumers lack OTC options for earlier HIV detection.

Once diagnosed with HIV, antiretroviral therapy (ART) has been demonstrated across multiple NIH-funded clinical trials to suppress HIV replication, improve health outcomes, and enable people with HIV to achieve and maintain viral suppression. Viral load monitoring is an essential component of HIV care as it assesses treatment response, identifes an inadequate response or viral rebound, and guides timely clinical intervention. After ART initiation, viral load measurements help clinicians monitor the early decline in viral replication. Subsequent monitoring confirms sustained viral suppression and can identify potential treatment failure or adherence challenges before complications develop.

Viral load monitoring also supports HIV prevention. Sustained viral suppression prevents sexual transmission of HIV, a principle supported by clinical evidence and known as Undetectable = Untransmittable (U=U). If someone’s viral load is no longer suppressed, clinical evaluation and interventions are needed to restore effective treatment and avoid onward transmission. Accessible viral load testing can support individual health and enhance efforts to reduce HIV transmission.

Viral load testing often relies on centralized laboratories, which can delay access to results, particularly in resource-limited settings and communities with limited healthcare infrastructure. There is a significant unmet need for sensitive, reliable, affordable, and easy-to-use OTC technologies for rapid viral load assessment which could expand access to treatment monitoring, identify inadequate treatment response or viral rebound earlier, and support clinical decisions. These technologies could improve treatment outcomes and help sustain viral suppression.

In collaboration with OAR, the National Institute of Nursing Research (NINR), and the National Institute of Mental Health (NIMH), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is soliciting proposals through its Rapid Acceleration of Diagnostics (RADx®) program to advance technologies for HIV detection and/or ART monitoring that address specific unmet domestic OTC use scenarios.

The U.S. market offers limited options for OTC HIV testing. Affected communities have expressed a need for more private, accessible tests to support personal healthcare decisions. Priorities include early or low-cost HIV detection, qualitative and quantitative viral load monitoring, identification of treatment failure or the need to adjust ART, and support for pre-exposure prophylaxis (PrEP) initiation and monitoring.

Program Description

NIH has assembled a national network of technical, clinical, manufacturing, quality systems, and regulatory experts to provide individualized project support. NIBIB plans to support technology de-risking, including third-party analytical and preclinical confirmation of device performance. These efforts will help to facilitate accelerated production and commercialization of OTC HIV tests in the United States.

Proposals will be reviewed by an external panel of experts for technical, clinical, commercialization and regulatory feasibility based on the Project Review Criteria stated below. NIH will make the final determination about which proposals will advance to the Deep Dive review stage for work package development based on stated criteria and potential for commercialization.

Projects selected for further consideration will be assigned a team with healthcare and commercialization expertise, who over the course of multiple meetings will perform a Deep Dive review into the project with the applicants. The Deep Dive review will identify key risk factors that may impede the validation and prototyping of the proposed solution, as well as ways to mitigate these risks. In addition, the team will identify additional resources needed to accelerate the project. Depending on the maturity of each proposed solution, this process will take from a few days to a few weeks.

The outcome of the Deep Dive review will be a proposed work package for the 10-12 month performance period. An external panel of experts will evaluate the proposed work package for technical, clinical, commercialization and regulatory feasibility based on the Project Review Criteria stated below. NIH will make the final determination about which proposals will advance to the work package stage, with funding provided in a milestone-based contract, and approved work beginning as soon as possible.

A RADx® project team will continue to support funded projects, and RADx® and its partners will provide milestone-driven financial and in-kind resources to maximally accelerate progress. The work package will cover the full range of activities needed to derisk, prototype, and validate the technology so that project teams will be in a competitive position for further NIH funding based on progress in the work package and milestone achievements.

Solicitation Requirements

This solicitation seeks over-the-counter (OTC) technologies that fit one or more of the following target product profiles:

1. Qualitative whole blood assay to detect HIV infection and support prophylaxis (PrEP) initiation and/or monitoring
   1. Molecular test
   2. 4th generation Ag/Ab LFA test
   3. Low-cost antibody test
2. Quantitative or semi-quantitative (≤1000 copies/ml required; preferred ≤200 copies/ml) whole blood assay for ART monitoring

Responsive proposals must address at least one specified target product profile and demonstrate a measurable improvement relevant to that profile. Applicants must identify the intended users and testing setting(s), describe the specimen collection and testing workflow, provide evidence of current performance, and explain the proposed advantage over relevant alternatives. Proposals must also describe how results will connect users to appropriate confirmatory testing or clinical follow-up. The ability of the proposed solution to serve and be deployed to underserved, hardly-reached communities, including those <18yrs old, is highly desired.

Proposals for low-cost antibody tests are considered responsive if they demonstrate meaningful reduction in cost barriers even without demonstrating earlier detection, provided performance is appropriate for the intended use. Support for pre-exposure prophylaxis (PrEP) initiation or monitoring is optional for specified approaches. Applicants proposing a PrEP-related indication must describe the intended role in HIV testing before or during PrEP, any additional testing required for that use scenario, and the evidence supporting the proposed indication.

Quantitative or semi-quantitative whole blood assays for HIV viral load monitoring in people receiving ART must demonstrate performance better than 1000 copies/ml, with preferred performance ≤200 copies/ml.  Applicants must distinguish the limit of detection, limit of quantitation, and any clinical classification threshold, as applicable. Proposals must specify the specimen matrix, whether reported concentrations represent whole blood or plasma-equivalent values, and performance near the relevant decision thresholds. Semi-quantitative assays must define the result categories reported to the user and the clinical purpose of each category.

Submission and Review Process

Project proposals will be accepted and reviewed online via Cimit’s CoLab platform. Innovators can access the online portal here.

To register, applicants must establish an account in the portal.  Once registered, applicants will be asked to provide a submission Title and Executive Summary, the latter of which should include a brief description of the technology and how it will improve detection of HIV and/or ART monitoring. Do not include any proprietary or confidential information in the Title and Executive Summary sections as they may be publicly shared if selected.  Applicants will then need to respond to a series of specific prompts across different evaluation criteria that will include details of technical capability and readiness, clinical impact, and commercialization pathway.

Applications must address all the following:

• Highlight how the proposed technology will advance personal healthcare solutions in detection of HIV infection and/or ART monitoring OTC.
• Describe how users will interpret results and obtain appropriate follow-up, including confirmatory diagnostic testing, clinician assessment, or repeat testing, as applicable.
• Detail the limitations of the currently available solutions and describe how the proposed approach will advance upon current technology.
• Provide proof-of-concept data supporting the proposed intended use
• Describe sample collection, preparation, and processing from whole blood.
• Demonstrate consideration for the cost of goods for the technology and suggest whether it appears feasible that the test could be implemented in OTC settings.
• Describe the approach for manufacturing and distributing high-quality in vitro diagnostic tests.
• Provide an estimated budget and proposed high-level milestones for the project to reach an advanced prototype, ready for third party validation during the work package.

Responsive applications may also pivot and refine existing technologies toward new intended uses in OTC settings. Applicants with technology that could eventually be adapted for multiplex detection of common co-occurring infections (e.g., Mycobacterium tuberculosis, hepatitis B and C viruses, human papillomavirus, and other sexually transmitted infections) are strongly encouraged to apply. 

Applicants are highly encouraged to use people-first language consistent with the NIAID HIV Language Guide. This guide includes person-centered language suggestions for communicating about HIV and related topics. The guide was designed to help those working in HIV-related research to communicate about their work using empowering rather than stigmatizing language, especially as it relates to HIV.

Applications will NOT be considered for:

• Technologies that do not significantly advance upon the state of the art or reduce cost barriers.
• Animal model development: all in vivo models must be well established and characterized, and available to the applicant.
• Efforts to develop technology for fundamental study of HIV.
• Fundamental/basic research projects.
• Technologies that are not intended for use according to the FDA’s regulatory authority.

Project Review Criteria

Each application will be reviewed by an independent external expert panel to assess the potential of the proposed solution to meet each of the following applicable criteria:

• Applicants must have a permanent U.S. address.
• Technology fulfills an unmet US domestic need (as described above), including how the approach improves upon the state of the art.
• Technology uses sample volumes and workflow compatible with OTC use case scenarios.
• Data demonstrates proof-of-concept of the proposed solution.
• Quantitative and semi-quantitative technologies must achieve a viral load cutoff of 1000 copies/ml or better, and ideally ≤200 copies/ml.
• The projected cost for the platform is not a barrier to its implementation in OTC settings and the proposed product offers a price advantage over alternatives.
• Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostic tests under an established Quality Management System.
  • Viable plans are provided for eventual production including forecasts, timeline, milestones, supply chain needs, product cost, and other ramp-up considerations.
  • Critical commercial partners, contractors, vendors, and service providers have been identified or secured.
• Innovators should be mindful of 21 CFR 866.3956, 21 CFR 866.3957, and 21 CFR 866.3958 and how their technology will comply with the applicable instructions.

The same organization is permitted to submit multiple applications to this solicitation, but must conform to the following conditions: 

• Each application must be distinct and focused on a different target product profile.
• No organization may propose both a quantitative and semi-quantitative viral load platform. Should a single organization propose both types of viral load platforms, the quantitative viral load application will be the only application evaluated.
• Any personnel proposed for more than one project must have the bandwidth and proposed hours to successfully perform all tasks may not exceed 40 hrs/week.

Timeline and Award Information

Applications must be submitted by January 15, 2027, 11:59pm Eastern Time. It is anticipated that proposal review will occur in Jan/Feb 2027 with one or more awards announced shortly thereafter. Up to eight organizations will be selected to advance to a Work Package based upon the Project Review Criteria. Each of the advancing organizations will receive a milestone-based fixed-price award of up to $700,000.00 total cost. Final budgets and detailed milestones to be negotiated at time of award. Contingent upon the performance of Work Packages and the technologies’ commercialization potential, NIH may consider advancing up to four technologies with additional resources applied for acceleration towards market readiness and pre-clinical testing.

FAQs about this program can be found here.

For other programmatic or technical questions please contact RADxNIBIB@mail.nih.gov. For all emails, in the subject line include: Inquiry about OTC/At-Home HIV Funnel.

About National Institute of Biomedical Imaging and Bioengineering (NIBIB)

The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care.

About Office of AIDS Research (OAR)

OAR is part of the NIH Office of the Director and works in partnership with the NIH Institutes, Centers, and Offices to coordinate the NIH HIV research program, ensuring that HIV research is aligned with the NIH Strategic Plan for HIV and HIV-Related Research. OAR does not award grants but co-funds HIV-related applications and research projects that have received an award from NIH Institutes and Centers. Projects must align with at least one of the strategic goals and objectives outlined in the FY 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research.

NIH provides the largest public investment in HIV research globally. As HIV crosses nearly every area of medicine and scientific investigation, the response to the HIV pandemic requires a multi-institute, multidisciplinary, global research program. OAR provides scientific coordination and management of this research program. The vision of the NIH OAR is to advance research to end the HIV pandemic and improve health outcomes for people with HIV.

About National Institute of Nursing Research (NINR)

NINR leads nursing research to solve pressing health challenges and inform practice and policy, optimizing health for all. NINR believes that nursing research is the key to unlocking the power and potential of nursing by leveraging nursing’s strengths and unique knowledge and perspectives inherent to the discipline to the benefit of all people.

About National Institute of Mental Health (NIMH)

NIMH is the lead federal agency for research on mental disorders. NIMH seeks to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

About Cimit

Cimit is a nonprofit health impact accelerator dedicated to efficiently advancing groundbreaking solutions for complex health challenges. They do so by working to identify the best ideas, facilitate teams in developing them, and providing their partner organizations with transformative solutions to difficult health challenges.

About VentureWell 

VentureWell is a global organization that catalyzes science and technology solutions by activating and connecting innovators. Working with public and private partners, VentureWell accelerates the path from lab to market through custom interventions and proven program models.