Funding Opportunity

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 (POCT) aimed at improving diagnosis and treatment monitoring of HIV/AIDS or the detection of emerging or reemerging infectious disease in low- and middle-income countries (LMIC). If successful, projects should be viable candidates for commercial development.

About C-THAN

C-THAN was funded initially funded in 2018 for a five-year period and renewed in 2023 for an additional five-year period by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technologies Research Network (POCTRN), Fogarty International Center (FIC) and the Office of AIDS Research. C-THAN’s mission is to support the development and facilitate commercialization of a pipeline of POCT designed to meet the clinical needs of people who live with HIV/AIDS in LMIC. In this funding cycle, we have increased the scope of projects eligible for funding to include emerging and reemerging infectious disease.

Background

HIV disproportionately impacts low- and middle-income countries (LMICs) with the heaviest burden in sub-Saharan Africa. In 2022, 65.6% of people living with HIV/AIDS (PLWHA), 50.7% of new HIV infections and 57.5% of HIV-related deaths were from this region of the world. C-THAN was founded to support the development of vital point-of-care technologies (POCT) specifically designed for patient management of PLWHA in LMICs and emerging infectious disease with an emphasis on the diagnostic needs of sub-Saharan Africa. 

We seek to support projects designed for settings with limited medical 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 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 POC test performance and emerging infectious diseases highly relevant to PLWHA (such as Mpox) and other emerging or reemerging infectious diseases impacting people in LMICs.

The focus of this solicitation is to develop POCTs that address one or more of the AIDS Office of Research Priority Areas summarized in the table below and emerging and reemerging infectious diseases impacting people living in LMICs.

Design Requirements for POCTs 

The proposed project must focus on a specific need related to HIV prevention, treatment, or management in an LMIC setting or an emerging or reemerging infectious disease and must show promise for improved health outcomes for people living in LMICs. 

The proposed project may consist of one or more product development activities including: developing and/or refining technology, 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 POC 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 LMICs will have priority. Minimum preferred maturity levels in the four product development cycle domains:

• Technology: proof of concept (3) or preferably proof of feasibility (4) 
• Regulatory: proof of concept (3) or preferably proof of feasibility (4)
• Marketing/Business: proof of concept (3) or preferably proof of feasibility (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- and middle-income countries either independently or in collaboration with developers in high resource countries are encouraged to apply. Teams consisting solely of applicants from low- and middle-income countries will be given special consideration. 

Justification

Our mission is to support the development and facilitate commercialization of a pipeline of POCT designed to meet the clinical needs of PLWHA and to aid in pandemic preparedness in LMICs. 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 LMICs. 

Applicants are encouraged to contact C-THAN to discuss potential collaborations within the 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 and/or its co-morbidities or emerging infectious disease in LMICs
• 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 LMIC 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: portability, operable in locations with limited or no medical infrastructure (limited access to electricity or uneven electrical supply, 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 LMIC or in HIV/AIDS priority topics and describe the proposed approach to resolution of these limitations.

We are specifically seeking proposals focused on increasing patient access to 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.

Application Instructions

Award applications are solicited and evaluated in two stages. Applicants must submit pre-proposals (called Expressions of Interest), which will undergo review by C-THAN, NIBIB, and FIC scientific staff. A subset of the applicants who submitted pre-proposals will be invited to submit full proposals. Further details are provided below.

• Applications from all sources will be considered including domestic or foreign, public or private, or non-profit or for-profit. Applicants from low- and middle-income countries either independently or in collaboration with developers in high resource countries are encouraged to apply. Teams consisting solely of applicants from low- and middle-income countries will be given special consideration.
• 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. 
• Pre-proposals must be submitted through the POCTRN online system at and are due no later than 11:59PM ET on Sunday, March 31, 2024.
• The anticipated performance period is twelve months.  
• 4-6 awards of up $50,000-$100,000 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.

Unique Review Criteria for C-THAN

• Proposals will be evaluated on whether the device/test is applicable to LMIC settings with limited access to electricity, land-line communication, refrigeration, or central clean water supply.
• Each project must address one or more of the AIDS Office of Research priority areas or address an emerging or reemerging infectious disease.
• In the event of two or more applications having equivalent scores, preference will be given to application teams consisting of members from LMICs.
• Applicants will be notified by Monday, April 29, 2024 as to whether they are invited to submit a full proposal.
• Invitations will be sent by email both to the PI and to the administrative contact listed in the pre-proposal. Invited full proposals must be received by 11:59PM ET June 3, 2024. Proposals must be submitted through the online proposal submission system. Instructions for navigating and completing the full-proposal submission system will be sent with the notification to individuals from whom full proposals are requested.
• Each full proposal will be peer-reviewed on a confidential basis. All applicants will be informed of review decisions by July 29, 2024.