Solicitations - C-THAN
2020 Award Competition: Development of Point-Of-Care Testing for HIV and Co-Morbidities for Use in Low and Middle Income Countries
C-THAN Contact: Sally McFall, Ph.D., Director of Technology Development/Refinement Core
CHICAGO, IL – The Center for Innovation in Point-of-Care Technologies for HIV/AIDS 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 in low- and middle-income countries (LMIC). If successful, projects should be viable candidates for commercial development.
C-THAN was funded in 2018 for a 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.
HIV disproportionately impacts LMICs with the heaviest burden in sub-Saharan Africa. In 2017, 71% of people living with HIV/AIDS (PLWHA), 65% of new HIV infections and 75% of HIV-related deaths were from this region of the world. C-THAN was founded to support the development of vital POCT specifically designed for patient management of PLWHA in LMICs with emphasis on the diagnostic needs of sub-Saharan Africa. To improve care retention and clinical outcome for PLWHA, we need to use the most powerful robust and cost-effective tools available including highly sensitive and specific field-ready diagnostics. Adding services for HIV related co-morbidities such as POC tests for tuberculosis, hepatitis and AIDS-associated cancers through the same clinic network could improve outcomes and potentially reduce costs.
The focus of this solicitation is to develop POCTs that address one or more of the AIDS Office of Research High Priority Research Topics. The requirements for the test are summarized in the table below:
Design requirements for POCTs
The proposed project must focus on a specific need related to HIV prevention, treatment, or management in an LMIC setting and must show promise for improved health outcomes for those at high risk or living with HIV.
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.
Proposals focused on increasing patient access to HIV viral load monitoring which may include the development of novel viral load diagnostics, field testing of assays in development or implementation studies of current or near commercial tests are of specific interest, and assays and/or devices focused on POC HIV viral load testing will receive the highest priority.
Eligible applications must:
- 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 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, 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.