Elevating community voices by developing a user-centered approach to enable self-testing and remote data collection among under-represented populations (project elevate)
Active Cooperative Agreement Awarded Last action
- Award ID
- U01FD007976
- Recipient
-
Florida State University UEI JF2BLNN4PJC3
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $2,900,000
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date 68% complete
- Originally
- Funding agency
- Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Florida, USA
Award details come from USAspending.gov.
Description
- Abstract
- The advent of remote technologies such as video conferencing and secure web-portals have revolutionized approaches to health data collection and access to healthcare. For example, these technologies can be deployed in fully remote and hybrid approaches for clinical trials which could help promoting more participation among under-represented groups as well as by bridging geographic distance and reducing participant burden (e.g., less travel time, more flexibility and confidentiality). Remote or online approaches can also increase access to critical services (e.g., mental health counseling, sexually transmitted testing [STI] prevention) that are scarce or geographically dispersed. However, these approaches have yet to be optimized for all possible beneficiaries of technological advances in clinical trials and healthcare, especially targeting under-represented populations that are disproportionately experiencing social and geographic isolation. Groups like asian american and pacific islander (aapi - including native hawaiian), american indian (AI) and hispanic/latino populations are often under-represented in clinical trials, so much so that they often occupy the racial/ethnic category of "other" in research studies. Notably, their under-representation not only leads to this literal "othering," but also prevents scientists from identifying their unique concerns which in turn diminishing the relevance and effectiveness of technologies and distribution campaigns among them. Sexual and gender minorities (SGM) such as GAY, lesbian, bisexual, and transgender populations are also often not strategically sampled for clinical trials, and SGM identities are often not even measured in clinical trials. But many health concerns addressed in clinical trials are over-represented in SGM populations compared to general populations (e.g., HIV, stis, mental health concerns), thus, making many novel health technologies (vaccines, antibiotics, hormonal therapies) disproportionately relevant to these populations. SGM populations may experience social isolation at increased rates relative to the general population, which can be further exacerbated by medical mistrust and stigmatizing experiences in healthcare and research contexts. To address these concerns, the current proposal seeks to leverage the team's existing community connections in states across 4 different regions of the U.S. Among the aforementioned groups to: (1) (a) CO- create and maintain 4 virtual and hybrid advisory groups to address health issues and (b) develop materials for the conduct of remote advisory groups; (2) CO-develop and administer a national needs assessment survey for the referenced 4 groups (n = 800) addressing the use of home self-testing technology (up to 3 types) and remote data collection for healthcare research and healthcare provision; and (3) pilot a community driven approach to introducing home self-testing technology and remote data collection to potential participants from these groups to assess feasibility and acceptability.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $100,000 | |
| Amendment | $100,000 | |
| Amendment | $100,000 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $300,000 | |
| Amendment | $300,000 | |
| Amendment | $300,000 | |
| Amendment | $50,000 | |
| Amendment | $50,000 | |
| Amendment | $50,000 | |
| Amendment | $50,000 | |
| Amendment | $500,000 | |
| Amendment | $500,000 | |
| Original award | $500,000 |
Show all 17
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Compass Inc. | $60,651 |
Quick answers
Who received award U01FD007976?
U01FD007976 was awarded to Florida State University by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on June 1, 2023.
How much is award U01FD007976 worth?
$2,900,000 has been obligated on U01FD007976.
Which agency awarded U01FD007976?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD007976, with funding from Office of the Commissioner (Food and Drug Administration).
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