Expired PA-14-133: Advancing Structural Level Interventions Through Enhanced Understanding of Social Determinants in HIV Prevention and Care (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	Advancing Structural Level Interventions Through Enhanced Understanding of Social Determinants in HIV Prevention and Care (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	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-14-133
Companion Funding Opportunity	PA-14-134, R21 Exploratory/Developmental Research Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.855, 93.856
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages applications that propose to understand and address social determinants associated with the prevention and treatment of HIV. This FOA describes two research endeavors that are unique and overlapping. The first is to characterize those social determinants that are most relevant to HIV prevention and treatment outcomes, particularly in their association with inequities in HIV risk or disease outcomes. The second is to develop and test structural interventions aimed at reducing the negative impact or maximizing positive aspects of social determinants.

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 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

This Funding Opportunity Announcement (FOA) encourages applications that propose to understand and address social determinants associated with the prevention and treatment of HIV. This FOA describes two research endeavors that are unique and overlapping. The first is to characterize those social determinants that are most relevant to HIV prevention and treatment outcomes, particularly in their association with inequities in HIV risk or disease outcomes. The second is to develop and test structural interventions aimed at reducing the negative impact or maximizing positive aspects of social determinants.

Background

Social determinants are an important, but under investigated contributing factor to risk and resilience for health. Social determinants can be defined as overlapping social and economic factors that influence health. Several agencies and entities, including the World Health Organization and the U.S. Centers for Disease Control and Prevention launched initiatives that emphasize the importance of addressing social determinants in order to reduce health disparities and achieve health equity (http://www.who.int/social_determinants/en/, http://www.cdc.gov/socialdeterminants/). The difference between addressing those social determinants that impact population health (e.g., lack of clean water in a village) and those that impact certain groups within a population (e.g., lack of housing) is an important distinction as the latter is connected to disparities in health outcomes. This FOA is focused on the latter as it focuses on those social determinants most strongly associated with disparities in HIV prevention and treatment outcomes.

Significant disparities in rates of HIV exist in and outside of the United States and there is mounting evidence of the disparities in HIV disease outcomes within certain subpopulations (e.g., men who have sex with men (MSM), women living in Africa). Addressing the psychosocial factors and individual risk behaviors associated with HIV transmission has been a significant focus of behavioral interventions for HIV prevention, and more recently, these approaches have been applied to HIV treatment related behaviors such as medication adherence. However, the focus on individual-level psychosocial factors alone fails to adequately account for the intersection of those factors with broad social factors (e.g., housing, neighborhood). The complex relationship between psychosocial factors and social conditions may explain why effective options to prevent and treat HIV have not yet been maximally effective in eliminating disparities in HIV rates and disease outcomes.

Linking factors together at different levels may also facilitate the development of multi-level structural interventions, more so than examining them independently. For example, several factors have been associated with risk for HIV acquisition among African women, including age, co-habitation status, history of violence, depression, employment status, and degree of education. There remains a gap in the knowledge as to the risk attributable to a factor or set of factors, the effectiveness of interventions to modify those factors and the cost required to bring those interventions to scale. Importantly, in order to devise effective interventions to address these various factors, the framework of the intervention must target those factors that are amenable to change.

The current gaps to fill can be characterized as: 1) a lack of broad understanding of the way in which social determinants interrelate and operate synergistically, and whether they can accrue to have a multiplicative effect on HIV prevention or treatment success, 2) a lack of understanding regarding the degree of attributable risk ascribed to different social factors in determining HIV infection, medication adherence, viral suppression or mortality, 3) a lack of understanding as to why some individuals, despite being exposed to some social conditions that are associated with HIV acquisition or negative care and treatment outcomes are not significantly negatively impacted.

Objectives

This FOA distinguishes the two broad areas of research, social determinants and structural interventions. Research on the factors that interrelate and underlie social determinants could include those at the individual (e.g., self-efficacy, coping), interpersonal (e.g., social capital, culture), or systems/community (e.g., institutionalized racism, policies) levels. Research related to those factors that underlie social determinants would seek to understand how these multi-level factors operate individually and in combination to increase the vulnerability of certain groups with regard to HIV acquisition or care and treatment outcomes. The relationship between social determinants and syndemics observed in populations is particularly important given the evidence of the multiplicative impact of factors such as mental health and substance use on risk for HIV acquisition.

One definition of structural interventions refers to public health interventions that promote health and improve the risk environment by altering the structural context in which health is produced and reproduced. Thus, the second aspect of this FOA encourages applications that utilize a framework for understanding social determinants in the development of structural interventions to improve access to and uptake of effective HIV prevention and treatment tools (e.g., HIV testing, condoms, linkage to HIV care, ART). To accomplish this, a strong theoretical basis or operationalized framework is encouraged as part of the justification for the particular intervention being developed and/or tested.

Broadly, this FOA calls for basic social science and intervention research that aims to:

1) Identify multi-level factors (individual, familial, societal, economic and legislative) which underlie those social determinants that are associated with risk for HIV acquisition or negative HIV care and treatment outcomes at the individual or population levels. Research that focuses on modifiable factors beyond the individual-level is encouraged.

2) Identify individual and/or community-level mechanisms (e.g., coping, social networks) associated with desired HIV prevention or HIV disease outcomes despite exposure to negative social, economic and/or legal conditions. Research that operationalizes resilience as distinct from risk factors is particularly encouraged.

3) Design multi-level, structural interventions to intervene upon specified social determinants or sets of social determinants to minimize the negative effects of those social determinants; attempt to reduce the social and structural barriers that negatively impact HIV risk, care and treatment and go beyond influencing individual knowledge, attitudes, and beliefs. Evidence-based justification (e.g., modeling data) for the design of the structural intervention is encouraged prior to proposing to test its impact on HIV prevention, care and/or treatment outcomes.

There are several factors that have been identified in the literature that, if addressed, could improve the HIV outcomes in prevention and treatment. These include, but are not limited to:

1) Stigma and Discrimination:

Stigma and Discrimination have been associated with poor uptake of prevention and treatment services, delayed entry into HIV care and negative economic consequences in the form of employment and housing discrimination. In addition, HIV-associated stigma occurs concurrent to stigma associated with sexual behavior, gender identity, drug use, and as well as race and gender-based discrimination.

Potential Research Questions:

What enables some individuals to accept an HIV test, enter into care, and/or adhere to medications, despite stigma and discrimination? How do stigma and discrimination associated with HIV interact with stigma and discrimination associated with race, gender and/or sexual orientation? What is the impact of reduction of stigma and discrimination on HIV prevention, care and treatment outcomes?

2) Economic Factors:

Lack of employment, living in poverty, lack of health insurance coverage, food insecurity and other financial constraints have been associated with HIV risk behaviors, delayed entry into medical care, malnutrition, non-adherence to HIV medication and poor mental health.

Potential Research Questions: What factors mediate and/or moderate the association between economic factors and negative health outcomes? What economic strengthening approaches are effective to mitigate negative HIV associated health outcomes and what, if any, are the positive downstream effects?

3) Social Violence:

Social violence, physical and verbal abuse, childhood sexual abuse, domestic and/or intimate partner violence, neighborhood violence have all been associated with fears of negotiation during sex, delays in uptake of prevention and treatment, and unwillingness to disclose one's HIV status.

Potential Research Questions: What interventions are effective that target factors beyond individual knowledge, attitudes and beliefs to address the negative influence of social violence on HIV prevention, care and treatment outcomes? What factors are associated with resilience, at the individual and/or community level, in the context of violence and abuse and are those factors also associated with HIV prevention, care and treatment outcomes?

4) Legal Factors:

Incarceration, engagement in illegal activity, HIV-related criminalization, immigration status and deportation fears have been associated with lack of uptake and engagement in HIV prevention and care, increased HIV risk behavior in the form of needle sharing and transactional sex, and are related to social factors such as neighborhood violence and social network instability.

Potential Research Questions: What impact do legal or policy-level factors have on positive and negative HIV prevention, care and treatment outcomes? What are the relevant mediators and moderators of the potential relationships?

As a result of the broad scope of science called for in this FOA, it is expected that multi-disciplinary teams, including expertise outside of health and public health, would be assembled. Research teams could include expertise in legal studies, policy, urban planning, economics, statistical modeling, marketing, cultural, race and gender studies or other areas, as relevant to the set of social determinants of interest.

Within this FOA, research is encouraged to take a developmental perspective that addresses the substantial changes that occur across the lifespan (from infancy through older adulthood) that are associated with HIV prevention and care challenges. Factors can include individual-level factors, but with the goal of understanding their relationship to community and/or societal-level factors.

In addition, this FOA encourages modeling research that attempts to understand the interplay of social, economic, and legal factors to determine the individual and collective influence on HIV prevention, care and treatment outcomes. For understanding legal and policy-level factors, research that proposes to rigorously evaluate the impact of the initiation of laws or policies on individuals and communities through naturalistic, observational research paradigms is encouraged.

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 scope of the proposed project should determine the project period. The maximum project period is 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