Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH) National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Promoting Engagement in Care and Timely Antiretroviral Initiation Following HIV Diagnosis (R34)
Activity Code	R34 Clinical Trial Planning Grant Program
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-MH-12-061
Companion FOA	RFA-MH-12-060, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.279
FOA Purpose	This Funding Opportunity Announcement (FOA) seeks research to improve medical care engagement and treatment adherence among HIV infected individuals in the first twelve months following HIV diagnosis, enrollment in HIV primary care, or initiation of antiretroviral treatment (ART). In targeting these periods, this FOA invites applications to address the need for efficacious interventions to promote rapid linkage to medical care following HIV diagnosis, enhance retention in early HIV primary care, and improve readiness to voluntarily initiate and adhere to antiretroviral medications. The overarching aims of this initiative are to develop and test interventions to reduce the time between HIV diagnosis and achievement of first undetectable viral load among patients for whom ART is indicated, as well as to reduce racial/ethnic disparities in HIV treatment outcomes. The initiative invites interventions targeting patients in care or those recently diagnosed but not yet in care, as well as interventions that target care providers and/or care systems. Researchers responding to this FOA are expected to advance the development and testing of interventions that would be implemented within the context of settings providing HIV prevention, care, and related services, which include but are not limited to HIV testing sites, primary care clinics, substance abuse treatment sites, community-based organizations, AIDS Drug Assistance Programs, and services funded by the Ryan White HIV/AIDS Program or the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Intervention approaches that are readily feasible within existing HIV testing and care settings are strongly emphasized.

Posted Date	June 2, 2011
Open Date (Earliest Submission Date)	August 9, 2011
Letter of Intent Due Date	August 9, 2011
Application Due Date(s)	September 9, 2011 by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	November 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April1, 2012
Expiration Date	September 10, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites research to improve medical care engagement and treatment adherence among HIV infected individuals in the first twelve months following HIV diagnosis, enrollment in HIV primary care, or initiation of antiretroviral treatment (ART). In targeting these periods, this FOA invites applications to address the need for efficacious interventions to promote rapid linkage to medical care following HIV diagnosis, enhance retention in early HIV primary care, and improve readiness to voluntarily initiate and adhere to antiretroviral medications. The overarching aims of this initiative are to develop and test interventions to reduce the time between HIV diagnosis and achievement of first undetectable viral load among patients for whom ART is indicated, as well as to reduce racial/ethnic disparities in HIV treatment outcomes. This initiative invites interventions targeting patients in care or those recently diagnosed but not yet in care, as well as interventions that target care providers and/or care systems. Research teams responding to this announcement are expected to advance the development and testing of interventions that would be implemented within the context of settings providing HIV prevention, care, and related services, which include but are not limited to HIV testing sites, primary care clinics, substance abuse treatment sites, community-based organizations, AIDS Drug Assistance Programs, and services funded by the Ryan White HIV/AIDS Program or the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Intervention approaches that are readily feasible within existing HIV testing and care settings are strongly emphasized.

The purpose of this R34 funding opportunity is to support early stage research regarding the development and pilot testing of interventions that address the goals of this FOA, with a focus on evaluating their feasibility/acceptability and obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study. This may include: 1) the development, manualization, standardization, pilot testing, and preliminary impact assessment of novel or adapted treatments and/or interventions, 2) the refinement, modification, adaptation and/or pilot testing of interventions with demonstrated efficacy for use in broader scale efficacy or effectiveness trials, or 3) other novel research that requires preliminary testing or development. The collection of data regarding feasibility, acceptability, safety, tolerability, and the preliminary impact of an intervention on target outcomes is appropriate in an R34 study. Although pilot studies of novel and adapted interventions are expected, the limited sample sizes typically supportable under the R34 mechanism mean that efforts to obtain precise estimates of intervention effect size through studies with adequate statistical power are often not possible or justified.

The efficacy of combination ART for the treatment of HIV disease is firmly established. Sustained suppression of HIV replication through ART and attendant increases in CD4 T-cell count are strongly associated with improved patient outcomes. In treatment settings such as the U.S. where ART is broadly available, dramatic declines in HIV/AIDS-related mortality have been observed since the introduction of ART.

Despite these advancements, many people living with HIV do not benefit from treatment because they are poorly engaged in medical care (1-4). For example, it is estimated that up to 50% of persons in the U.S. with known HIV infection are not fully engaged in regular medical care (2, 5). The depth of the problem is illustrated by a recent South Carolina study, which determined that only about half of HIV patients attended a medical care appointment in 2006, and just one-third were continuously in care over a three year period (6). Incomplete engagement in care significantly contributes to an estimate that only 19% of U.S. HIV-infected individuals maintain an undetectable viral load (2). Poor engagement in care has been associated with increased mortality and reduced life expectancy among HIV-infected individuals (7-9) and helps to explain gender and racial/ethnic disparities in HIV treatment outcomes (4, 8, 10).

HIV care represents a treatment cascade, where each step is contingent upon the achievement and maintenance of the prior one (11). Persons diagnosed with HIV infection must first link to primary care in order to receive treatment. Regular medical appointment attendance is essential for clinical monitoring to determine when ART may be indicated. Those who initiate ART must subsequently maintain strong adherence and persistence to these regimens to optimize treatment outcomes. Challenges and disparities are evident at each of these steps in the treatment cascade, and few evidence-based interventions exist to address these concerns.

Linkage to care. A recent meta-analysis reported that approximately 36% of U.S. individuals newly diagnosed with HIV infection do not link to primary medical care within twelve months (12). Disparities by race/ethnicity, gender, and age have been evident in HIV care engagement. The limited research available suggests that a number of psychosocial and structural barriers to HIV health care initiation could be addressed to expedite and improve linkage to care, and these include emotional concerns, mental illness, substance use, HIV stigma, unstable housing, lack of insurance coverage, and poorly integrated testing and care services.

Early retention in HIV care. Retention early in the course of HIV care is critical because many patients present with advanced HIV disease. In one Alabama clinic setting, 60% of HIV patients missed a medical appointment in the first year after initiating care, and disparities were evident in that missed visits were more common among patients who were younger, female, black, and who had substance abuse disorders and lacked private health insurance (9). Patients who miss a medical appointment in the first year of HIV care show over twice the mortality rate of patients who attend all visits, even when controlling for CD4 cell count at presentation and ART initiation (9). Patient attendance at all HIV medical appointments during the first two years of care also strongly predicts earlier ART initiation (13), and differential rates of medical appointment attendance over time help explain racial disparities in the achievement of viral suppression (10). Proven interventions to promote and sustain patient retention in early HIV care are lacking.

ART Readiness, Initiation, and Early Adherence. Increasing evidence indicates that patients benefit from initiation of ART earlier in the course of HIV disease, and recently revised treatment guidelines recommend initiation of ART at higher CD4 cell counts. As a result, ART is indicated for more patients overall, as well as earlier in the course of their HIV care. It has been estimated that 21% of HIV infected U.S. individuals who are receiving care and for whom ART is indicated are not receiving ART (5). In a nationally representative cohort, 29% of women with HIV infection who met criteria to initiate ART reported not using treatment, and African American women were approximately twice as likely as White women to report non-use even after controlling for confounding factors (14). Delayed ART initiation and early treatment discontinuation have been associated with factors including inconsistent clinic attendance, active substance use, lack of trust in medical providers, and provider misperceptions about who is likely to be non-adherent to ART. Although the decision to initiate ART remains a personal one that must be made voluntarily by the patient in consultation with a provider, there is a lack of tools and evidence-based interventions to help patients make informed choices about voluntary ART initiation, and for promoting treatment readiness among those interested in receiving ART (15). Furthermore, interventions that help patients achieve high adherence and sustained persistence to ART regimens early in the course of care may provide a constructive foundation for their optimal long-term use of these medications. The importance of strong and sustained early ART adherence is underscored by research indicating that the duration of sustained viral suppression after initial achievement of suppression can reduce the long-term risk of viral failure, irrespective of adherence (16). Adherence interventions should therefore target both behavioral adherence and biological outcomes such as viral suppression.

In summary, the clinical significance of linkage to care, early retention, timely ART initiation, and early ART adherence make the periods immediately following HIV diagnosis, HIV care entry, and antiretroviral initiation important intervals where early and effective interventions might improve patient outcomes and address disparities. The development of optimal behaviors early in HIV care provides a constructive foundation on which patients can build a lifetime of engagement with HIV treatment. In addition, the importance of these early behaviors are critical to a "test and treat" approach to HIV prevention (17-18), which proposes that enhancing factors such as engagement in care, treatment initiation, and treatment adherence will not only benefit patient outcomes, but may also serve as a foundation for a comprehensive, community-wide approach to HIV prevention. Findings from the HPTN 052 trial confirm that antiretroviral treatment can indeed confer substantial prevention benefits. This FOA therefore seeks to simultaneously address HIV treatment and prevention goals by advancing strategies that could help reduce the time period between HIV diagnosis and achievement of first undetectable viral load among patients for whom ART is indicated.

This initiative corresponds to the priorities of the NIH Office of AIDS Research (NIH OAR) Trans-NIH Plan for HIV Research, which calls for research for "Improving Disease Outcomes for HIV-Infected Individuals" and "Reducing HIV-Related Disparities." These priorities are further represented within the National HIV/AIDS Strategy for the United States, which establishes "increasing access to care and improving health outcomes for people living with HIV" and "reducing HIV-related disparities and health inequities" as central priorities.

Research topics that are appropriate to this FOA include, but are not limited to:

• Conduct formative research to develop and test interventions for rapidly and effectively linking individuals diagnosed with HIV to primary medical care, including but not limited to interventions that can be directly integrated within post-test HIV counseling, outreach efforts, peer-navigation programs, treatment for mental illness and substance abuse, and contingency management approaches.
• Evaluate policies and test interventions that seek to enhance enrollment in primary HIV medical care and reduce the time between HIV diagnosis and initial medical evaluation for recently diagnosed individuals, and/or time to achievement of first undetectable viral load among those for whom ART is indicated.
• Develop and test novel interventions focused on enhancing and maintaining patient retention in primary medical care, particularly within the first year following initiation of HIV care.
• Develop, refine, and validate systematic approaches toward assessing and improving patient readiness to initiate antiretroviral treatment that could be implemented in clinical practice in accordance with treatment guidelines and recommendations, such as measurement tools, placebo practice trials, or other approaches.
• Develop and test the impact of interventions designed to help patients make informed choices about voluntary ART initiation of antiretroviral medications, when clinically indicated.
• Develop and test highly feasible and low-cost clinic- or community-based interventions to improve patient adherence and persistence to antiretroviral medications in the period following ART initiation. Adherence intervention trials should assess impact on both behavioral adherence and biological outcomes such as viral suppression.
• Develop and test interventions to improve provider communication skills and messaging to patients (and patient-provider communication more generally) regarding ART initiation and early ART adherence and persistence.
• Assess organizational and systems-level factors or approaches that may impact linkage to HIV care, patient retention, antiretroviral initiation, or antiretroviral adherence to inform policy and clinic practice.
• Develop and test targeted interventions designed to reduce documented racial/ethnic, gender, and age-related disparities in HIV care engagement and treatment outcomes.

1. Cheever LW. Engaging HIV-infected patients in Care: Their lives depend on it. Clin Infect Dis. 2007; 44:150-152.

2. Gardner EM, McLees MP, Steiner JF, et al. The Spectrum of Engagement in HIV Care and its Relevance to Test-and-Treat Strategies for Prevention of HIV Infection. Clin Infect Dis. 2011; 52(6):793-800.

3. Mayer KH. Linkage, engagement, and retention in HIV care: Essential for optimal individual- and community-level outcomes in the era of highly active antiretroviral therapy. Clinical Infectious Diseases. 2010; 52:S205-S207.

4. Smith KY. Paying the price for late starts and early stops: racial and sex disparities in HIV-related mortality. Clin Infect Dis. 2009; 49(10):1579-81

5. Teshale E, Kamimoto L, Harris N, et al. Estimated number of HIV-infected persons eligible for and receiving HIV antiretroviral therapy, 2003 -- United States [abstract 167]. Paper presented at the 12th Conference on Retroviruses and Opportunistic Infections (CROI), Feb 2005; Boston, MA.

6. Olatosi BA, Probst JC, Stoskopf CH, et al. Patterns of engagement in care by HIV-infected adults: South Carolina, 2004-2006. AIDS. 2009;23(6):725-30.

7. Giordano TP, Gifford AL, White AC, et al. Retention in care: A challenge to survival with HIV infection. Clin Infect Dis. 2007; 44: 1493-99.

8. Losina E, Schackman BR, Sadownik SN, et al. Racial and sex disparities in life expectancy losses among HIV-infected persons in the United States: Impact of risk behavior, late initiation, and early discontinuation of antiretroviral therapy. Clin Infect Dis. 2009; 49(10):1570-8.

9. Mugavero MJ, Lin HY, Willig JH, et al. Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis. 2009; 48(2):248-56.

10. Mugavero MJ, Lin HY, Allison JJ, et al. Racial disparities in HIV virologic failure: do missed visits matter? Acquir Immune Defic Syndr. 2009; 50(1):100-8.

11. Giordano TP, Suarez-Almazor ME, Grimes RM. The population effectiveness of highly active antiretroviral therapy: Are good drugs good enough? Curr HIV/AIDS Rep. 2005; 2:177-183.

12. Marks G, Gardner LI, Craw J, et al. Entry and retention in medical care among HIV-diagnosed persons: A meta-analysis. AIDS. 2010; 24(17):2665-78.

13. Ulett KB, Willig JH, Lin HY, et al. The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS. 2009; 23(1):41-9.

14. Lillie-Blanton M, Stone VE, Snow Jones A, et al. Association of race, substance abuse, and health insurance coverage with use of highly active antiretroviral therapy among HIV-infected women, 2005. Am J Public Health. 2010; 100(8):1493-9.

15. Grimes RM, Grimes DE. Readiness: The states of the science (or the lack thereof). Curr HIV/AIDS Rep, 2010; 7(4):245-52.

16. Lima VD, Bangsberg DR, Harrigan PR, et al. Risk of viral failure declines with duration of suppression on highly active antiretroviral therapy irrespective of adherence level. J AIDS. 2010; 55(4):460-465.

17. Dieffenbach CW, Fauci AS. Universal voluntary testing and treatment for prevention of HIV transmission. JAMA. 2009; 301(22):2380-2382.

18. Granich RM, Gilks CF, Dye C, et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009; 373(9657):48-57.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The participating ICs intend to commit the following amounts in FY 2012 for this FOA and the companion R01 FOA: NIMH intends to commit up to $2,000,000 to fund up to 4 awards NIDA intends to commit up to $500,000 to fund up to 2 awards An award issued under this FOA is contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Award Budget	Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any single year.
Award Project Period	The total project period may not exceed 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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
• Grants.gov
• 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Michael Stirratt, Ph.D.
Division of AIDS Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6199, MSC 9619
Bethesda, MD 20892
Telephone: 301-443-6802
Email: [email protected]

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 submission of applications for this FOA. 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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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 modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan..

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
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.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project hold the potential to inform or advance strategies that could reduce the time period between HIV diagnosis and achievement of first undetectable viral load among patients for whom ART is indicated, and/or reduce disparities in HIV treatment engagement and outcomes?

Investigator(s)

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? Does the investigative team have a track record of working together? Are appropriate expertise and collaboration present from clinicians or providers in the settings where the research will be conducted?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project propose novel approaches to promote rapid linkage to medical care following HIV diagnosis, enhance retention early in the course of primary care, or to assess and improve readiness to initiate antiretroviral medications, timely antiretroviral initiation when indicated, or antiretroviral adherence following ART initiation?

Approach

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? Is the proposed approach toward research participant recruitment and enrollment likely to be feasible and successful? For intervention studies, does the project propose to develop or test intervention approach which is likely to be feasible within existing HIV testing, care, and treatment settings?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the setting in which the research will be implemented appropriate to the scientific aims of the study?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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 from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the participating ICs , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Councils of the participating ICs. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource sharing policies.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Michael Stirratt, Ph.D.
National Institute of Mental Health
Telephone: (301) 443-6802
Email: [email protected]

Jacques Normand, Ph.D.
National Institute on Drug Abuse
Telephone: (301) 443-1919
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health
Telephone: (301) 443-3534
Email: [email protected].

Rita Sisco
National Institute of Mental Health
Telephone: (301) 443-2805
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse
Telephone: (301) 253-8729
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.