National Institute of Nursing Research (NINR)
HIV/AIDS Testing and Follow-up Among the Underserved in the United States (R21)
R21 Exploratory/Developmental Research Grant Award
May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Companion FOA
PA-11-118, R01 Research Project Grant
FOA Purpose
The purpose of this initiative is to encourage research which will increase rates of HIV screening/testing and increase the number of persons who follow-up on a positive HIV screening test and receive treatment, particularly in underserved and at-risk populations within the United States. With this initiative, the ultimate goal is to decrease the rate of HIV transmission and increase the quality of life for people living with HIV/AIDS (PLWHA) by initiating diagnosis and treatment earlier.
Letter of Intent Due Date
Earliest Start Date(s)
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Over twenty percent of the 1.1 million HIV infected people in the U.S. are unaware of their infection (CDC Morbidity and Mortality Weekly Report-November 30, 2010- NHIS data 2001-2009). Late diagnosis of HIV results in increased transmission of HIV and missed opportunities for early treatment which extends life expectancy. The National HIV/AIDS Strategy has established a goal of increasing the awareness of HIV status in the U.S. population from 79% to 90% by 2015. This goal is of utmost importance in populations where the incidence is highest.
In order to realize a significant impact on the HIV/AIDS epidemic, not only testing, but linkage to care is a necessary part of a multi-pronged prevention approach. In recent years there have been a number of policy changes, recommendations, and outreach efforts to increase the number of persons who are aware of their HIV+ status. Nevertheless, screening rates have remained sub-optimal and confirmatory re-testing and treatment follow-up, even more problematic. Some do not seek care until they develop an opportunistic infection or are in a state of advanced AIDS, when the treatments available are no longer effective. Underserved populations, which are impacted disproportionately by HIV/AIDS, are more likely to succumb to this fate because of poor access to health care. The low screening rates in underserved populations are followed by even lower rates of receiving results and all subsequent steps between screening and treatment. In order to reduce the incidence of new HIV infections, it is necessary to increase the number of persons screened for HIV and, for those HIV+, complete the required follow-up and entry into treatment. Optimal frequency of testing at different levels of risk and the optimal level of intervention to help those individuals who test HIV negative to remain HIV negative are important areas. The barriers and facilitators to testing and then follow-up must be identified and effective interventions which can increase the number of HIV+ persons completing follow-up are needed.
Unique barriers or facilitators to testing and linkage to care may exist within certain groups or communities and thus, research focus could include individual, community, social, economic and policy level investigations. Populations of primary focus would include, but are not limited to, populations with high prevalence, those incarcerated or in the penal system, homeless/runaways, or those with substance abuse or mental illness. Also of particular importance is enhancing outreach and HIV testing availability for adolescents at risk of HIV infection, particularly minority adolescents and young men who have sex with men. For adolescent populations, interventions that utilize a developmental approach to reach youth, as well as innovative models utilizing technology, media and social networks to increase testing among youth are encouraged. Further, minority women, especially those pregnant and at risk for mother to child HIV transmission, would be critically important to test and link to care in order to prevent new HIV infections among children. Barriers to testing and linkage to care may be, but are not necessarily limited to issues such as psychological barriers (such as stigma), health literacy, spiritual issues, health care seeking behaviors, access to health care and cost effectiveness. Innovative approaches that utilize technology to address barriers, in particular HIV stigma, are needed. As well, the facilitators of HIV testing and follow up should be identified and could also include individual, community, social, economic and policy level research projects.
Finally, dissemination and implementation research identifying the optimal models for HIV testing and linkage to care is important. This is especially important in non-medical settings or non-traditional testing centers where certain populations (such as severely mentally ill) may seek service. Therefore, community based participatory research (CBPR) and research projects including strategies for implementation/dissemination are particularly encouraged, as are those projects which draw on existing infrastructures or resources.
Examples of suitable research topics for this FOA include, but are not limited to, the following:
Studies seeking to identify effective models for HIV testing and linkage to care in populations with highest prevalence for HIV.
Studies exploring the relationship between levels of risk for HIV and frequency of HIV testing.
Identification of effective testing strategies which link those individuals who test HIV negative to necessary HIV prevention programs, enhancing the likelihood they remain HIV negative.
Studies utilizing existing databases to provide information for policies/recommendations impacting HIV testing and linkage to care.
Qualitative studies informing development of outreach strategies for vulnerable/underserved/hard to reach populations for HIV testing and follow-up care, such as homeless, runaways, or those with substance abuse, mental illness, cognitive impairment or disabilities.
Studies exploring barriers to and/or factors enhancing testing and follow up care.
Intervention studies evaluating strategies to increase testing and follow up care for those populations with poor access to health care.
Identification of effective strategies for implementation/dissemination of testing and linkage to care into community clinics/settings.
Studies utilizing age-appropriate approaches optimizing outreach to youth, as well older adults, in order to increase testing and follow up care.
Interventions that utilize innovative models leveraging information technology, electronic media, social networks and/or Health tools to increase testing and follow up treatment/care.
Individual, community, social, economic and/or policy level investigations exploring outreach and testing/follow up care for minority women, especially those pregnant and at risk for mother to child HIV transmission.
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.
Higher Education Institutions:
For profit Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Eligible Individuals (Project Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Required and Optional Components
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate "optional" components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed..
PHS 398 Research Plan Component
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the Center for Scientific Review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Jeanette M. Hosseini, Ph.D.
Email: jeanetteh@mail.nih.gov
Bill G. Kapogiannis, M.D.
Email: kapogiannisb@mail.nih.gov
Kelli Oster
Email: Osterk@mail.nih.gov
Bryan Clark
Email: clarkb1@mail.nih.gov