Expired PA-14-128: Targeted Basic Behavioral and Social Science and Intervention Development for HIV Prevention and Care (R21)

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	Targeted Basic Behavioral and Social Science and Intervention Development for HIV Prevention and Care (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	Reissue of PA-11-277
Related Notices	January 9, 2017 - This PA has been reissued as PA-17-105. 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-14-128
Companion Funding Opportunity	PA-14-127, 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, 93.855, 93.856
Funding Opportunity Purpose	The goal of this funding opportunity announcement (FOA) is to provide a global outline of areas for innovative, targeted basic behavioral and social science research and intervention development research to reduce the number of new HIV infections and improve the overall health of those living with HIV and encourage research grant applications in these areas. This FOA encourages research designed to (a) conduct basic behavioral and social science research that is needed to advance the development of HIV prevention and care interventions, (b) translate and operationalize the findings from these basic studies to develop interventions and assess their feasibility and (c) conduct tests of the efficacy of HIV prevention and care interventions. The R21 mechanism is specifically intended to encourage new exploratory and developmental research projects. These studies should break new ground or extend previous discoveries toward new directions or applications. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel methodologies, tools, technologies, or interventions that could have a major impact on health research and practice. Unlike applications under the R01 mechanism, preliminary data are not required for R21 applications. Preliminary data may nonetheless be included if available.

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

Purpose

This Funding Opportunity Announcement (FOA) provides a global outline of areas for innovative, targeted basic behavioral and social science research and intervention development research to reduce the number of new HIV infections and improve the overall health of those living with HIV that we intend to fund. This FOA encourages research designed to (a) conduct basic behavioral and social science research that is needed to advance the development of HIV prevention and care interventions, (b) translate and operationalize the findings from these basic studies to develop interventions and assess their feasibility and (c) conduct tests of the efficacy of HIV prevention and care interventions. This FOA is informed by priority areas from the National HIV/AIDS Strategy for the United States and the NIH Office of AIDS Research (OAR) Strategic Plan for HIV/AIDS Related Research.

This FOA encourages novel, high impact behavioral and social science research that will contribute to the creation of empirically-based HIV-risk reduction approaches that could be used to pave the way for prevention, reduction of clinical impact, and cure. High impact can be achieved either by large effect size or very broad reach. This FOA outlines the following aims to achieve these goals: (1) conduct targeted basic behavioral and social science research to identify and quantify both micro- and macro-level social and behavioral determinates that mediate or moderate HIV acquisition, transmission and care, (2) advance combination behavioral-biomedical approaches to HIV-related interventions, (3) increase intervention potency and durability, (4) enhance targeting on those most highly impacted by the pandemic, (5) identify novel intervention approaches and methodologies and (6) target multiple levels of influence on HIV acquisition, transmission, and care, thereby advancing the development and testing of interventions delivered beyond the individual level (structural, community, social/sexual networks, etc).

This FOA focuses on basic behavioral and social science research only. Applicants with a focus on NeuroAIDS are referred to HIV Infection of the Central Nervous System (PA-14-094) and Eradication of HIV from central nervous system reservoirs (PA-14-095).

Background

In 2011 more than 1.1 million people were living with HIV in the U.S. and it is estimated that about 50,000 adults and adolescents become infected annually. Globally, 2.3 million new infections were estimated to occur in 2012 bringing the total number of people living with HIV to 35.3 million. Of those living with HIV in the US, an estimated 15.8% are unaware of their diagnosis and account for a disproportionate share of new infections. The expanding pandemic worldwide continues to bring immense suffering, causes needless loss of life, and exacts an enormous economic burden.

Globally, HIV rates differ by age, race, ethnicity, geographic location and risk behavior category. Thus, novel, high impact approaches are needed to ensure that there are efficacious interventions that address the myriad of needs that exist. Similarly, the needs of those individuals who are at risk for HIV may be unique from the needs of those individuals who are known to be HIV positive. For those individuals living with HIV, interventions are needed that focus on safer sexual behavior, remaining adherent to their HIV medication, receiving consistent HIV medical care, and maintaining a high quality of life free of suffering from mental illness, substance abuse, stigma and discrimination. For individuals that are HIV negative, interventions are needed to ensure that they remain uninfected and engage in regular HIV testing.

There has been great progress in the development of efficacious HIV-related interventions, including male circumcision, HIV testing, HIV treatment adherence, and pre-exposure prophylaxis (PrEP). Interventions that target individual-level behavior change are available and have likely impacted the pandemic by curbing HIV incidence in the face of growing HIV prevalence. However, incident infections remain unacceptably high in many US and global populations. Interventions are needed that increase at an individual and community level the uptake of regular HIV testing and identify those with undiagnosed HIV infections and link them to care. Interventions are also needed for individuals living with HIV to optimize their HIV care and management of co-morbidities. Therefore, the development of innovative behavioral, social, and integrated behavioral/biomedical approaches remains critical in order to address the HIV pandemic.

This FOA encourages researchers 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 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. Additionally, given the complexity of advancing HIV prevention and care research, multidisciplinary approaches are encouraged that draw appropriately from multiple disciplines to reach solutions based on new understandings of these complex problems. Teams could include researchers from the fields of public health, public policy, behavioral and social science, systems science, economics, health disparities, organizational behavior, demography, choice architecture, neuroscience, epidemiology, and behavioral economics.

Research Scope

To meet the aims outlined in this FOA, research is needed in the following areas. The listed areas of research are considered high priority, but this is not an exclusive list of potentially important research directions nor is it listed in order of priority.

1. Conduct targeted basic behavioral and social science research to identify and quantify both micro- and macro-level social and behavioral determinants associated with HIV acquisition, transmission and care

Studies to identify the societal, environmental, genetic, developmental, and personality factors associated with the risk of acquiring or transmitting HIV;
Research to further develop complex theories and models that incorporate biological-behavioral-social-environmental interactions as they relate to HIV-associated risk, vulnerability, disease progression, and resilience.

2. Studies to advance combination behavioral-biomedical intervention approaches:

Studies to build on findings and approaches within cognitive neuroscience and behavioral economics to develop interventions to improve decision making, especially in situations of heightened emotions or stress as well as understand decision making around the uptake and use of interventions that have partial efficacy. This would also include research into preventive and therapeutic misconceptions about the efficacy of experimental products or the benefits of participation in clinical trials;
Studies to assess and mitigate risk compensation/behavioral disinhibition (i.e., the extent to which biomedical prevention strategies may alter the real or perceived risk of HIV transmission risk behaviors, and subsequent engagement in those risk behaviors);
Studies to optimize the provision of brief, evidence-based counseling that results in durable adherence to product (i.e., PrEP, microbicide) and risk reduction guidelines.

3. Studies to increase intervention potency and durability:

Studies to improve intervention efficacy and effectiveness;
Studies to identify modifiable factors that affect the durability of effective prevention interventions and develop strategies to enhance long term maintenance;
Studies to develop novel approaches for augmenting the impact of interventions to promote HIV treatment adherence and persistence;
Studies that take advantage of the ubiquitous nature of mobile technologies to enhance the reach and impact of HIV prevention and care interventions;
Studies to understand and promote adherence to biomedical HIV prevention strategies for the purpose of maximizing their effectiveness and impact.

4. Studies to enhance prevention efforts targeting populations highly impacted by HIV:

Studies to better understand and increase adoption of and adherence to biomedical prevention methods among those most highly impacted by HIV;
Studies to understand and decrease the differential effects of biomedical HIV prevention strategies in different populations;
Studies to develop and evaluate innovative prevention interventions for men who have sex with men (MSM) from diverse backgrounds which address the elevated community risks for MSM, such as late diagnosis and elevated prevalence in partner populations;
Studies to develop and test innovative prevention and care interventions for transgender individuals that address their unique HIV prevention and care needs;
Studies that consider an integrated approach to prevention and care for subjects with co-morbidities that may affect HIV risk and treatment, with a special emphasis on subjects with neuropsychiatric diagnoses, youth, and/or the aging population and those that have or are experiencing violence and abuse;
Studies to develop and evaluate prevention interventions which make use of new technologies to identify recent infection, assess community-level risk for transmission, or identify co-factors for HIV transmission;
Studies designed to develop and test interventions to reduce racial/ethnic, gender, and age-related disparities in HIV care and prevention utilization, adherence, and treatment/prevention outcomes.

5. Studies to identify new intervention approaches and methodologies:

Studies using new and expanding social media and communications technologies to recruit, enroll, and retain high risk groups (e.g., young men and women, MSM, transgendered individuals) who may be difficult to reach by other more traditional means, for HIV testing, prevention efforts, and linkage to care;
Studies to identify and integrate biological markers (biomarkers) and novel behavioral indicators associated with the acquisition or transmission of HIV;
Studies to develop and use modeling techniques and systems science approaches (e.g., network analyses and systems dynamics approaches) to identify the most effective core elements of interventions and estimate and test when and where and under which conditions they should be targeted to an individual, social group, family, community, health care or other system to achieve maximum benefit;
Studies to develop and use adaptive designs and pre-specified decision rules that are based on participant characteristics and responses to treatment in order to customize the intervention strategy;
Studies to further elucidate individual-level risk by using geospatial, neighborhood mapping or other techniques to determine and target community-level risk.

6. Studies to incorporate context into the development and testing of interventions beyond the individual level:

Studies to address social and structural determinants of HIV infection that may facilitate or impede the outcome of interventions;
Research to enhance our understanding of how social and sexual networks influence HIV risk and transmission and develop network based approaches (real world or virtual) to improve HIV prevention and care;
Research to define specific mechanisms by which cultural experience impacts neurobehavioral and HIV acquisition risk trajectories, and identify time-points and circumstances that would optimally allow a change in the trajectory to a more positive outcome;
Studies to develop and test innovative community, clinic and provider level strategies and combination behavioral-biomedical HIV approaches that reduce the risk of infection in high prevalence communities, improve engagement in primary HIV medical care, and improve treatment adherence and retention;
Studies to examine the impact of policies on the social environment that serve as facilitators or barriers to HIV susceptibility.

This FOA is not encouraging applications in the following areas:

International research in high resource countries or regions in countries that do not have a high or increasing prevalence rate of HIV;
Research to develop and test individual-level interventions and/or group-based interventions that have limited potential for widespread uptake or significant population-level reach;
Research that proposes adaptations of existing efficacious interventions. Such applications may be acceptable under PA-14-131 - Improving Delivery of HIV Prevention and Treatment through Implementation Science and Translational Research (R01).

The R21 mechanism is specifically intended to encourage new exploratory and developmental research projects. These studies should break new ground or extend previous discoveries toward new directions or applications. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel methodologies, tools, technologies, or interventions that could have a major impact on health research and practice. Unlike applications under the R01 mechanism, preliminary data are not required for R21 applications. Preliminary data may nonetheless be included if available.

NIMH has established clear decision rules for deciding whether to invest in adapting or extending an effective treatment or preventive intervention. These are outlined in the 2010 NIMH National Advisory Mental Health Council (NAMHC) Report, From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses . NIMH views research to adapt existing, effective treatments as a priority only when:

1. Through adaptation the treatment will be accessible to a subgroup (e.g., taking an adult treatment and making it developmentally appropriate for a young child).

2. The study tests the efficacy of an evidence-based treatment from one domain and adapts it for use in another (e.g., a successful prevention intervention is revised and tested to target treatment adherence, a smoking cessation intervention approach is adapted to a HIV-prevention intervention).

3. The study tests a revised intervention that is based on remediating documented mechanisms of non-response to the existing intervention. That is, there is theoretical and empirical support for the adaptation target (e.g., the adaptation changes a factor that has been associated with non-response, partial response, patient non-engagement, or relapse).

4. New research generates predictors of benefits or adverse events that require validation that cannot be accomplished using existing data.

5. Evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to the existing intervention.

6. Clear explication of the mechanism by which a moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/ or biological data that support the mechanism hypothesis).

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 Resubmission 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	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Award Project Period	The total project period may not exceed 2 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