Expired PA-14-132: Accelerating Improvements in the HIV Care Continuum (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH) National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	Accelerating Improvements in the HIV Care Continuum (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	February 28, 2017 - This PA has been reissued as PA-17-182. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PA-14-132
Companion Funding Opportunity	PA-14-130, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.279, 93.856
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages innovative studies to address gaps in HIV care continuum research. The HIV care continuum has provided a useful framework for tracking progress towards the National HIV/AIDS Strategy (NHAS) HIV-testing and HIV-treatment goals, and helped to guide a growing body of research to better understand and intervene at one or more steps in the continuum. Yet, there are some aspects of entering and remaining in HIV care that are relatively less studied than other areas, and merit urgent attention.

Key Dates

Posted Date	February 28, 2014
Open Date (Earliest Submission Date)	April 7, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard AIDS dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	January 8, 2017
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Since the HIV care continuum framework was first used to synthesize estimates of national (USA) prevalence of persons testing positive for HIV, linkage to care, and viral suppression, it has been frequently used to evaluate national, state, and local performance with respect to these steps of HIV care. This "treatment cascade" has been a useful tool to assist communication about National HIV/AIDS Strategy (NHAS) goals, has prompted efforts to enhance harmonization and utilization of data capture techniques and datasets to better track progress, has helped to guide community planning and service provision, and has stimulated work on novel research directions.

In July 2013, the White House issued an Executive Order focused on the HIV Care Continuum, to bring further attention to the imperative to improve to increase HIV testing, services, and HIV treatment, and to strengthen the capacity of federal agencies to work together to enhance services and optimally target research. This initiative is responsive to this directive, in the identification of key areas in continuum research that merit urgent attention.

One of the limitations in HIV care continuum research to date is that most current understanding of patients' success and challenges in navigating the care continuum is derived from cross-sectional data. However, initiating treatment and engagement in care is not always a linear process; a substantial portion of patients are intermittently engaged in care. Also, some patients disengage from care for a significant period of time, and are thus defined as "lost to care." Finally, with greater frequency, patients may be entering the testing and care system through less conventional means (e.g., via home-based HIV-testing or other non-traditional testing venues). Collectively, this set of issues suggests a need for studies that examine progress through the continuum of care in pathways that are less step-wise.

Population-based data used to summarize HIV continuum outcomes in various catchment areas may also mask important differences between subgroups, and these differences may also vary by context. If the overall goal is to improve patient outcomes and potentially reduce new infections, then it is critical to better understand and intervene with those at highest risk for HIV infection (e.g., young men who have sex with men (MSM), and those most likely to have difficulties entering and navigating the continuum of HIV care (e.g., people living with co-morbidities and life circumstances that may be barriers to consistent engagement in care). Therefore, to the extent possible, more fine-grained data, analyses, and study are needed regarding subgroups within the treatment cascade, and to better identify targets for tailored interventions.

Regarding co-morbidities, many people navigating the HIV care continuum also have co-occurring medical conditions and other health care and service provision needs, including mental illness and substance abuse. The global HIV epidemic is also closely braided with other infectious diseases such as tuberculosis, hepatitis, and sexually transmitted infections. Moreover, many women at risk for or living with HIV can benefit from routine gynecologic care and reproductive health services. There are questions about what kind of care integration approaches and models could help to drive effective care integration across multiple conditions, and whether such approaches result in demonstrated improvement in HIV care access, satisfaction, quality, clinical outcomes, and retention.

As operationalized, the HIV care continuum also favors better tracking, understanding and intervention delivery towards those who test HIV-positive and need linkage to HIV care. However, the vast majority of persons who receive an HIV test are seronegative, and there is no systematic follow-up and limited understanding of if, when, and how they will present for any subsequent HIV-testing. A comprehensive HIV prevention research agenda could benefit from additional work to better understand and intervene with individuals who receive an HIV test but would conventionally have no further contact with HIV-related services until a future HIV test or diagnosis.

Once a person does test positive for HIV within the continuum of HIV care there are some junctures that need more research to fill important gaps. For example, the evidence base is weak for interventions to link people to care in a timely and effective manner. Earlier initiation of HIV antiretroviral therapy (ART) is also being encouraged. Yet, a significant proportion of those who are eligible to start ART do not initiate treatment - and this percentage could be increasing, since updated guidelines recommend ART initiation at earlier stage of disease progression, and in some places, upon HIV diagnosis. Work is needed to better understand and increase the proportion of patients who initiate treatment earlier in disease progression. Finally, as scientific progress towards long-term retention in HIV care is still relatively nascent, studies are needed to better understand this process, and to develop and test interventions to retain patients in care. Such trials are encouraged to target interventions to those most at risk for poor retention in care, and should consider an optimal definition for successful retention in care that accommodates barriers to clinic visits and current health status. Also, interventions to enhance retention in care need not occur in clinic settings, but rather could have innovative delivery methods.

Within this FOA, research is also encouraged that utilizes a developmental perspective that addresses the substantial changes that occur across the lifespan that are associated with HIV treatment challenges. Factors can include those at the individual, community, or societal level. These factors may significantly affect who is targeted by an intervention, how and where interventions are delivered, and what outcomes are assessed. For example, the recent CDC National HIV Prevention Progress report indicated that adolescents and young adults living with HIV had the lowest rates of successful linkage to HIV care.

An important component of this initiative will be collaborations between the scientific and service entities in communities. Research teams are required to have academic and Department of Health (DOH) partnerships for the research proposal, in order to optimize the match of the research directions with local needs, and to optimize the public health impact of the research implementation and findings.

Research Objectives and Scope

This initiative therefore seeks innovative, interdisciplinary HIV care continuum research in a range of domains that include, but are not limited to, the following topics:

Studies of longitudinal pathways into, through, and/or out of care, to better understand the multi-level factors (including systemic and structural) that influence this process, and to identify critical junctures for intervention that may increase the proportion of patients with consistent engagement in care, including studies that examine less conventional pathways into care.
Studies of basic behavioral and social science factors related to HIV self-testing, which could include individual, relationship, and contextual understanding of HIV self-testing, as well as subsequent behavior, such as linkage to care after an HIV-positive test, or subsequent risk behavior and future HIV testing decision-making.
Studies of innovative interventions designed to optimize re-engagement and retention in care for those who have not presented for an HIV care visit in a specified period of time. Improvements to this process could also take the form of better decision-making tools that first confirm that an individual is not in care elsewhere. Innovative tools could also be tested (e.g., via health information technologies) to better identify persons who are not in care.
Studies of the multi-level factors that may either impede (e.g., limited access to HIV testing, transitions in/out of correctional facilities) or facilitate (e.g., resilience-related strengths) engagement in care among specific at-risk subpopulations (e.g., young MSM, recent immigrant men and women, minority women), and, where appropriate, develop and pilot-test interventions designed to optimize cascade outcomes for these groups.
Studies of care integration and service co-location to advance better outcomes in the treatment cascade, such as the development and testing of novel approaches to coordinate care with more comprehensive responses to co-morbid medical and social service needs. Responsive studies could also include models to integrate prevention and care services.
Studies of the multi-level factors that influence behaviors after a negative HIV test, including repeat HIV-testing, and, where appropriate, development and testing of interventions designed to optimize repeat HIV testing, including interventions that reach individuals using technology (e.g., social media, messaging, applications on hand-held devices).
Studies of interventions for rapid and effective linkage of 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.
Studies of patient- and provider-level determinants/predictors of ART initiation, to inform the development and testing of strategies to counsel/educate newly diagnosed persons about when they should voluntarily initiate ART.
Studies of innovative interventions to improve patients' long-term retention in medical care.
Studies of provider, clinic and/or systems-level interventions, using implementation science methodologies, for HIV care continuum interventions, to promote the adoption, uptake and sustainability of evidence-based interventions in community and clinical settings.

Section II. Award Information

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 Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period	The maximum period of 5 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover