Overview

CHICAGO, IL – The Center for Innovation in Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Disease at Northwestern University (C-THAN) seeks collaborative research projects to develop novel point-of-care technologies aimed at improving diagnosis and treatment monitoring of HIV/AIDS, HIV-associated co-morbidities, or emerging infectious diseases in low-resource settings. If successful, projects should be viable candidates for commercial development.  

About C-THAN

C-THAN was initially funded in 2018 for a five-year period and renewed in 2023 for five more years by the Point-of-Care Technologies Research Network (POCTRN+), National Institutes for Health. C-THAN’s mission is to support the development and facilitate commercialization of a pipeline of point-of-care technologies designed to meet the clinical needs of people at high-risk or living with HIV/AIDS or impacted by emerging infectious diseases in low-resource settings.  

Background

HIV disproportionately impacts settings and areas with limited medical resources and/or infrastructure with the heaviest disease burden in sub-Saharan Africa. As of the end of 2023, an estimated 39.9 million people were living with HIV/AIDS (PWH) worldwide with approximately two-thirds of PWH, half of new infections, and over half of HIV-related deaths occurring in low-resource settings. C-THAN supports the development of point-of-care technologies specifically designed for local needs in the diagnosis and management of HIV, HIV-associated co-morbidities, or emerging infectious diseases.

We seek to support projects designed for settings with limited medical resources and infrastructure including restricted access to electricity, refrigeration, and/or central water supply. Relevant projects considered for funding include, but are not limited to, diagnostic assays or technologies for HIV/AIDS disease and its associated comorbidities (e.g., tuberculosis, viral hepatitis, related cancers, related cardiovascular diseases), treatment-related diagnostics, technologies that can be self-administered for either diagnosis or treatment monitoring, technologies that improve or enable point-of-care test performance and emerging infectious diseases highly relevant to individuals with HIV (such as Mpox) or emerging infectious diseases impacting people in low-resource settings (e.g., Marburg, Lassa fever, Ebola). 

Solicitation Priorities, Eligibility and Design Requirements

The proposed project must focus on a specific need related to HIV (or associated co-morbidity) prevention, diagnosis, or treatment that address one or more of the National Institutes of Health Priority Areas in low-resource settings; or emerging infectious disease prevention, diagnosis, or treatment in low-resource settings.  Proposed point-of-care technology features and low-resource setting environmental factors that must be considered are listed in the table below: 

For the current solicitation, we are prioritizing proposals that focus on HIV viral load monitoring which may include the development of novel viral load diagnostics, technology that enables sample collection and/or plasma separation, field testing of assays in development, or implementation studies of current or near commercial tests. We are also prioritizing proposals from teams consisting of investigators based or working in low-resource settings; however, the use of such a technology would be beneficial for patients globally, including high income countries such as the United States. 

To be considered responsive to this solicitation:  

• Co-morbidity disease areas must be clearly associated with HIV and propose technologies focusing on prevention, diagnosis, and treatment among HIV populations as per National Institutes of Health high priority areas. 
• Emerging infectious disease proposals must focus on prevention, diagnosis, or treatment of these infections among populations in low-resource settings. 

The proposed project may consist of one or more product development activities including: developing and/or refining technology, testing or assay development using banked clinical samples, clinical field testing, establishing test characteristics, obtaining feedback on user steps from end users, obtaining end user assessments, conducting market research on product concepts, or working prototypes with distributors, implementers, procurement agencies, policy makers, or other relevant stakeholders, evaluating test implementation, and assessing feasibility. 

Relevant technologies that will be considered for funding include, but are not limited to, in vitro diagnostic assays or technologies, treatment-related diagnostic technologies, technologies that can be self-administered, and/or technologies that improve or enable point-of-care test performance. Microfluidic and nanotechnology platforms that are capable of multiplex testing to measure multiple analytes are welcomed.  

Maturity: Applicants with a working prototype or an existing assay/device (not necessarily used for the proposed application) and preliminary data to demonstrate its potential for detection, diagnosis, or treatment guidance for HIV and/or its co-morbidities in low-resource settings will have priority. Minimum preferred maturity levels in the four product development cycle domains: 

1. Technology:  proof of concept (3) or preferably proof of feasibility (4)  
2. Regulatory: proof of concept (3) or preferably proof of feasibility (4)  
3. Marketing/Business: proof of concept (3) or preferably proof of feasibility (4)  
4. Clinical: proof of concept (3) or preferably proof of feasibility (4)  

Applicant Eligibility: Applications from all sources will be considered including domestic or foreign, public, or private, or non-profit or for-profit. Applicants from low resource settings either independently or in collaboration with developers in high resource settings are highly encouraged to apply.  

Justification: Our mission is to support the development and facilitate commercialization of a pipeline of point-of-care technology designed to meet the clinical needs of individuals at high-risk or living with HIV or emerging infectious diseases in low-resource settings. To achieve our goals, we will support projects from both US and foreign institutions with preference for those with collaborations/connections that could facilitate eventual field testing, implementation evaluations, and manufacturing within low-resource settings.  

Applicants are encouraged to contact C-THAN early to discuss whether their proposal is responsive to this solicitation, and to connect with potential collaborations within the C-THAN network. 

Preferred applications will: 

• Be based upon a working prototype (for new technologies) or an existing device (which will serve as the base for adaptation)  
• Generate preliminary data to demonstrate its potential for detection, diagnosis, or treatment guidance for HIV, HIV-associated co-morbidities, or emerging infectious disease in low-resource settings 
• Demonstrate test characteristics such as clinical sensitivity and specificity, feasibility, or usability for a chosen clinical need comparable to an existing technology, device, or assay in clinical practice. 

General characteristics: usable for patient management in low-resource setting clinic conditions, non- to minimally invasive, low cost (the cost of test should be comparable to or lower than the local median daily income, the local cost of HIV medication dose, etc.) user friendly (can be operated by health care workers that receive local training in its operation and maintenance). 

Specific attributes: affordability, rapid, robust when exposed to power fluctuations, portability, operable in locations with limited or no medical infrastructure (limited access to electricity, land-line communication, refrigeration, or central water supply). 

C-THAN is also receptive to proposals from industry with commercially available testing devices that have not been optimized to address the requirements listed above. The application must detail the limitations of the currently available system relative to use in low-resource settings or in HIV/AIDS priority topics and describe the proposed approach to resolution of these limitations. 

Application Instructions

Point-of-Care Technology Innovation Award applications will undergo review by C-THAN, POCTRN, and NIH scientific staff. Further details are provided below. 

• Awards under this solicitation may be made only to NIH-eligible applicants. Details regarding specific requirements can be found in the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards
• Applications must be submitted through the POCTRN online system and are due no later than 11:59pm EST on June 6, 2025.  
• The earliest anticipated start date for funding for those full proposals selected for funding is expected to be in November 2025 (if funds are received from the Federal government and all necessary IRB and IACUC approvals are in place). 
• The anticipated performance period is twelve months.  
• 3 awards of up $150,000 combined direct and indirect costs will be made. Indirect costs will be provided at your institution’s Federally negotiated rate. Funding will be determined based upon the statement of work and the money required to accomplish the project milestones. 
• Point-of-Care Technology Awards Review Criteria will guide the selection of proposals. Unique review criteria for C-THAN: 
  • Proposals will be evaluated on whether the device/test is applicable to low resource settings with limited access to electricity, land-line communication, refrigeration, or central clean water supply. 
  • Each project must address one or more of the National Institutes of Health Priority Areas in low-resource settings OR address an emerging infectious disease in low-resource settings. 
  • In the event of two or more applications having equivalent scores, as detailed above, priority will be given to applications proposing HIV viral load technologies and teams with investigators based or working in low-resource settings. 
  • To be considered responsive to this solicitation: 
    • Co-morbidity disease areas must be clearly associated with HIV and propose technologies focusing on prevention, diagnosis, and treatment among HIV populations as per National Institutes of Health high priority areas (see table above). 
    • Emerging infectious disease proposals must focus on prevention, diagnosis, or treatment of these infections among populations in low-resource settings 
• Each proposal will be peer-reviewed on a confidential basis. All applicants will be informed of review decisions beginning August 15, 2025.