Solicitations - C-THAN

Solicitations

2022 Award Competition: Point-of-Care Technologies for HIV/AIDS in Low- and Middle-Income Countries

In 2020, an estimated 37.7 million people were living with HIV/AIDS (PLWHA) worldwide with low- and middle-income countries (LMICs) disproportionately impacted. The heaviest burden of HIV remains in sub-Saharan Africa with more than two-thirds of PLWHA.  The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) was founded to support the development of vital point-of-care technologies (POCT) specifically designed for patient management of PLWHA in LMICs with 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, and/or technologies that improve or enable POC test performance.

Funds available

$450,000

Number of projects anticipated

4-6 awards of $50,000 to $100,000 for 12 months. The funding will be determined based upon the statement of work and the money required to accomplish the project milestones.

Timeline

Solicitation Release

January 19, 2022

Expressions of Interest Due

February 28, 2022

Invitation of Full Proposals

April 4, 2022

Proposals Due

May 16, 2022

Review Notification to All Applicants

July 25, 2022

Contracting and Awards

July 25-August 29, 2022

 
Clinical Need Addressed

The United Nations’ Program on HIV and AIDS (UNAIDS) set the ambitious 90-90-90 goals to achieve detection of 90% of HIV cases, get 90% of those cases on treatment, and 90% of those treated to have viral suppression by 2020 toward ending AIDS. In 2019, global progress toward achieving these goals included 84% knew their status, 87% of people aware of their status were accessing treatment, and of those accessing treatment 90% were virally suppressed. While some nations were successful in achieving these goals, progress in other nations appeared to be stalled. UNAIDS took lessons from nations that were successful in addressing the 90-90-90 targets and created new 2025 targets emphasizing rights-based and people-centered HIV responses focused on three interlinked areas – the enabling environment (the 10s), service access (the 95s), and service integration.

  • ‘The 10s’ call for the removal of societal and legal barriers to HIV services so that less than 10% of countries should have punitive laws and policies in place that target people living with HIV, or marginalized populations; less than 10% of people experience stigma and discrimination, and less than 10% of people experience gender inequality or violence.
  • ‘The 95s’ call for 95% testing, treatment, and viral suppression targets. As well as 95% access to combination prevention services; 95% access to sexual reproductive health services; and 95% coverage of prevention of mother-to-child transmission services.
  • The integration target calls for 90% of people living with HIV, and people at heightened risk of HIV, being linked to services important for their overall health. These include mental health, preventing and addressing gender-based violence, sexual reproductive health and rights, communicable and non-communicable disease services.

C-THAN aims to address the 95% testing, treatment, and viral suppression goals via the development of the most powerful, robust, and cost-effective tools available including highly sensitive and specific field-ready diagnostics to dramatically improve care, retention, and clinical outcomes for PLWHA in LMICs. Adding services for HIV-related co-morbidities addresses the integration target with technologies such as POC tests for tuberculosis, viral hepatitis, and HIV-associated diseases such as cancer and cardiovascular disease through the same clinic network could improve outcomes and potentially reduce costs (see research priorities below).

Patient Persona(s)

Our prototypical patient is a person in an LMIC who is living with HIV/AIDS (PLWHA) or someone who is at high risk of acquiring HIV.  The patient may be self-testing or seeking care at an HIV/STD screening facility, a primary health care facility, or an HIV/antiretroviral therapy (ART) specialty clinic.

Scope

The proposed project must focus on a specific need related to HIV prevention, treatment, and/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. Qualified projects should be:

  • Based upon a working prototype (for new technologies) or an existing device (which will serve as the base for adaptation)
  • Demonstrate test characteristics such as clinical sensitivity and specificity, feasibility, or implementation science 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).

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)

Application Instructions FAQs