Disparities in COVID-19 Therapeutics and Vaccinations Pilot Grant Program

Overview

The Coronavirus Disease (COVID-19) pandemic is a public health emergency that has been particularly severe in its effects on racial and ethnic minority populations in the United States. There is tremendous hope that vaccinations for SARS-CoV2 that are now being deployed in the United States under Emergency Use Authorizations will slow the spread of this virus and protect the general population. While there are recommendations about the highest priority groups to receive initial vaccinations (e.g. https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm), there are concerns that minority groups also will be disadvantaged in receiving vaccinations, may have differential acceptance of vaccines, and there might be disparities in deployment of other treatments (e.g. monoclonal antibodies).

The Clinical and Translational Science Institute (CTSI) wishes for University of Pittsburgh investigators to identify potential disparities and to develop solutions to reduce any disparities in delivery of COVID-19 vaccines and/or therapeutics. To help this effort, CTSI will award a small number of grants for up to $25,000 in funding to reduce disparities in COVID-19 vaccination and/or therapeutics.     

Aims and Requirements

To be eligible for funding, proposals must investigate a problem directly related to equitable distribution of COVID-19 vaccines and/or therapeutics. There are no restrictions on whether this work is basic science, clinical science, epidemiology, health services or psychosocial research. This program is designed to support research which will help understand the causes and magnitude of disparities in delivery of COVID-19 vaccines and/or therapeutics and that will help develop countermeasures to these disparities. These grants are designated for research that creates generalizable knowledge and are not to support rescue or operational efforts.

This program will favor projects with a well-described and direct implementation path to reducing the harmful effects of COVID-19 in populations. This program will have preference for projects that are novel as opposed to incremental efforts from already established and funded research.

Given the size of pilot awards, some investigators may propose to begin projects that lead into larger scale trials or studies. In those instances, applications should include a clear plan for how the work will obtain subsequent funding. Preference will be given for pilot projects that achieve a deliverable increment of knowledge within the funding period.

Examples of responsive proposals might include:

• Comparison of development and outcomes for different schemes for distribution and delivery.
• Does actual access to other medical care influence access to COVID-19 treatment?
• What individual or community experiences shape attitudes towards receiving treatments or vaccines?
• What knowledge or knowledge gaps are related to community receptiveness towards vaccination?
• Are there distribution deserts resulting from inequitable establishment of vaccine distribution sites or from community distrust of healthcare?
• Comparing effectiveness of different strategies to influence community acceptance of vaccines.
• Modeling the influence of social media, scams, influencers on community uptake of vaccination.
• Do social factors (e.g. zip code) affect a biological variable (e.g. gut microbiome) that influences response to vaccine?
• What are actionable targets for structural interventions to promote racial or social equity in COVID prevention and treatment?
• Modeling the impacts of vaccination on non-COVID outcomes, such as other medical problems, employment, or education.
  
  
  

 

 

Funding Information

Award funding of up to $25,000 is available to cover direct costs; no indirect support will be provided. The award period will last for 12 months, beginning when all regulatory and administrative approvals have been received. Pilot awards from CTSI do not have any mechanism for no-cost extensions; any funds that are not spent during the award period will be forfeited.

Before any funding can begin, awardees must provide documentation of all necessary regulatory approvals (IRB, IACUC, hSCRO, IBC, CORID, etc.).

Eligibility

The Principal Investigator (PI) must be a University of Pittsburgh faculty member. Postdoctoral trainees and trainees in clinical training programs are not eligible. Early career faculty members on training awards or clinical research scholars (for example, K-series grants or similar career development grants) would be eligible. 

New investigators are encouraged. Established investigators must demonstrate how the pilot project is a distinctly new effort relative to their prior funded work. 

Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-Investigators may include collaborators from any institution. We encourage cross-disciplinary teams, teams connecting community partners, or teams including other universities. Because the mission of CTSI includes promotion of research at the University of Pittsburgh, applicants should justify extensive off-campus collaborations.

Special Requirements:  
The National Center for Advancing Translational Sciences (NCATS) funds the CTSI Pilot Translational Core in order to promote research solutions that explore novel and new opportunities to move discoveries into humans. In contrast to the disease or organ-specific branches of NIH, the NCATS mission is to catalyze translation of discoveries rather than on basic discovery research. Therefore, these programs particularly encourage research that goes beyond a select disease category or specialty.

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu

Submission Format and Requirements

 

 

Round 1: Letter of Intent

Submit a letter of intent that summarizes the proposed research. Each submission must include the following sections:

1. Study Title: Include the title of the proposal at the top of the page, along with the PI name and contact email.
2. Abstract and Scope of Work (500 word limit): Provide a high-level overview of the study and the proposed work. Be sure to indicate how the proposed research is responsive to the geographical requirements of this funding program.
3. Study Team: Provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person).

Applications should be in the form of a single PDF document that uses Arial size 11 font with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Friday, March 12. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

See below for review criteria.

SUBMISSION PORTAL

Round 1: Review Criteria

The review of letters of intent will be conducted by the faculty and staff of CTSI. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round. Advancing projects will be notified by 5 p.m. on Tuesday, March 23.

Round 2: Full Packet Submission

Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Friday, April 9. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Include the following sections, beginning each section on a new page:

A. Scientific Abstract (250-word limit): Briefly summarize the proposed work.

B. Research Plan (three-page limit, including tables and figures): This section should include the following elements from a traditional NIH proposal to best allow reviewers to address the review criteria:

1. Specific Aims
2. Significance
3. Innovation
4. Approach

C. References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.

D. Budget with Budget Justification (no page limit): Use PHS 398 Form Page 4 and Page 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested. 

Grant funds may NOT be budgeted for:

• Salary support for the PI or faculty collaborators^*
• Effort for post-doctoral trainees or fellows
• Routine office supplies or communication costs, including printing
• Meals or travel, including to conferences, except as required to collect data
• Professional education or training
• Computers or audiovisual equipment (exceptions require clear justification)
• Manuscript preparation and submission
• Indirect costs​

^*Effort is required of the principal investigator and must be reflected on the budget page. This effort should be cost shared by the department or other entity that will support such effort. Reviewers understand that this may be a very small proportion of effort given the size of this award, but will be cautious if investigators do not appear to have sufficient time to complete a project.

Any salary support requested in a submitted budget should reflect federal fringe benefit rates. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, adjustments to the requested budget will be made at that meeting.

E. Proposal Timeline (up to half a page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program, because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.

F. Human and/or Animal Subjects (no page limit): NIH supported pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children.

Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before NCATS will approve project funding. Likewise, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval.

Applicants must describe any human and/or animal subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing HRPO / IACUC review is encouraged. Similarly, this section should discuss if other special regulatory approval is required prior to funding: Human Stem Cell Research Oversight (hSCRO), Institutional Biosafety Committee (IBC), Committee for Oversight of Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.

Round 2: Review Criteria

It is a requirement that review of CTSI Pilot proposals should address the NIH review criteria. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach, and Environment. Special emphasis will be given to a rating of the Overall Impact of the proposed project.

NIH Review Criteria:

1. Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field.
2. Significance: Does the project address an important problem or a critical barrier to progress in the field?
3. Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
4. Innovation: Does the project shift current research or does the clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
5. Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 
6. Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the time frame allotted?

Program-Specific Criteria:

1. Responsiveness to the RFA: Does the proposed project have relevance to understanding disparities related to COVID-19 vaccines and/or therapeutics.
2. Partnership: Does the proposal develop inter-institutional, inter-departmental, or inter-disciplinary partnerships? Does the project promote community engagement in the research enterprise?