Expired PA-13-191: Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title	Structural Interventions, Alcohol Use, and Risk of HIV/AIDS (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-10-242
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. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-13-191
Companion Funding Opportunity	PA-13-192, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.273
Funding Opportunity Purpose	This FOA encourages R01 research grant applications from institutions/organizations that propose to investigate the effectiveness of structural interventions aimed at reducing the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, similar research extending into the realm of HIV/AIDS risk reduction is still in its developing stages.

Key Dates

Posted Date	April 11, 2013
Open Date (Earliest Submission Date)	August 7, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard 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.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	May 8, 2016
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 FOA encourages research on the effectiveness of structural interventions that reduce the risk of HIV/AIDS transmission by changing the environment of alcohol use. Although a variety of structural and environmental interventions have been employed successfully to reduce other drinking-related problems, there has been relatively little research that extends such efforts into the realm of HIV/AIDS risk reduction. Applicants are especially encouraged to examine the ramifications for HIV/AIDS risk particularly among high-risk populations for HIV of naturally occurring or already-announced changes in alcohol-related laws, regulations, programs or policies.

The role played by alcohol consumption as a facilitator of HIV/AIDS infection risk has been the subject of much research. A relationship between alcohol use and HIV/AIDS risk has been documented among men who have sex with men, adolescents, HIV-seropositive individuals, seriously mentally ill persons, and others.

Nevertheless, the putative link between alcohol use and involvement in HIV-risky behaviors has not been without challenge. A substantial body of evidence suggests that the relationship between drinking and risky behavior is likely to be the result of a complex interaction among personality, situational, and behavioral factors, as well as the sexual experience of the partners.

In the course of this debate, it has become increasingly apparent that individual-level behavior change approaches are, by themselves, unlikely to be sufficient in halting HIV spread. As a result, a number of investigators have started to look closely at the ways in which HIV spread may be curbed as a result of structural alterations. Structural (sometimes termed "environmental") interventions for HIV have been defined: as "programs or policies that change the environments in which risk behavior occurs, without attempting to change knowledge, attitudes or social interaction patterns of the persons at risk" and as "interventions that work by altering the context within which health is produced or reproduced".

Such interventions may take a number of forms. Blankenship and colleagues (2000) have identified two dimensions along which structural interventions can vary. For one thing, such interventions may locate the source of health problems in factors related to availability, acceptability, or accessibility. Availability interventions are rooted in the notion that health problems result from a lack of tools, behaviors, materials, or settings necessary to promote healthy outcomes (or, conversely, the excessive availability or these items). Acceptability interventions, based in the notion that public health is partly determined by that society’s cultural values and beliefs, alter social norms as a way of promoting public health. Accessibility interventions manipulate resources to promote public health and reduce disparities in health care allocation. The target for the intervention constitutes the second dimension along which structural interventions can vary: that is, each of these intervention types may target the individual, the organizational/ institutional level, or the environmental (social, legal, and physical) level. In sum, then, this framework suggests no less than nine kinds of structural interventions.

A variety of structural interventions have been studied with regard to their effectiveness at reducing either alcohol consumption or various problems associated with drinking. Many of these are based on the substantial evidence that reducing alcohol availability can reduce alcohol consumption. For instance, increasing the monetary price of alcoholic beverages, usually achieved through increasing taxes on alcoholic beverages, can reduce consumption and alcohol-related problems. Media-focused interventions can be regarded as structural-level approaches insofar as media affect the environment in which people live. Evidence from a community trial suggests that training in media advocacy can increase electronic and print media coverage of news events generated by local individuals, resulting in greater public and leader attention paid to specific issues as well as to local policies aimed at reducing alcohol-involved injury. Some structural approaches have sought to change community policies by directly approaching those community-level policy makers who set local priorities for allocating resources and enforcing laws related to, for example, underage alcohol sales and bar/restaurant alcohol serving practices. As some researchers have concluded that alcohol outlet density may be related to violent assaults in nearby areas when certain conditions prevail, some research has examined the effects of local land use and zoning practices in reducing alcohol availability, consumption and related problems. Moreover, some studies have found that alcohol server intervention programs can significantly reduce hazardous alcohol use among bar/restaurant patrons. Particularly germane to this FOA are analyses that indicate that more restrictive alcohol availability policies and stricter underage drunk driving laws are associated with lower rates of gonorrhea among certain age groups.

Thus, previous studies have studied the effects on alcohol consumption and related problems of structural changes in alcohol access/availability. However, few of these structural alterations have been examined for their potential in reducing the alcohol-related behavioral risks that lead to HIV/AIDS infection. Furthermore, while recognizing that HIV/AIDS prevention approaches long have reported some success in altering community behavioral norms through the dissemination of relevant HIV/AIDS information and risk reduction techniques through high-risk social networks, this Announcement seeks to stimulate research that assesses the effectiveness of truly structural changes that can be expected to impact alcohol-related HIV/AIDS risk. These alterations in programs, regulations, policies, systems, and environmental factors that influence the consumption of alcohol -specifically, how, who, when, where, how often, and how much alcohol is consumed -may also be examined for their effects in changing individual attitudes and perceptions related to alcohol-related HIV/AIDS risk. Potential applicants are especially encouraged to examine the ramifications for HIV/AIDS risk of naturally occurring or already-announced changes in alcohol-related laws, regulations, programs or policies, specifically by evaluating the impacts of such changes against those observed in appropriate comparison sites/communities. In sum, this FOA attempts to move prevention science toward the investigation of the effects of structural or environmental interventions in altering drinking environments as a way of stemming alcohol-related HIV/AIDS risk behaviors and infection rates.

Areas of Research Interest

This FOA focuses on intermediate-level factors that directly affect the drinking environment. Hence, applications appropriate for this announcement will assess the impacts on HIV/AIDS risk of changes in one or more features of the alcohol consumption environment, including but not limited to changes in:

the form of alcohol availability (e.g., the sale of distilled spirits by the individual drink; ban on beer keg sales to individuals).
alcohol server training programs
access of underage persons to alcohol
establishment/enforcement of curfews to limit hours of alcohol sales to young people, including restrictions on happy hours at alcohol-serving establishments
alcohol counter-advertising campaigns
retail prices of alcoholic beverages
restrictions placed on alcohol advertisements
enforcement of restrictions on public drinking
establishment of Employee Assistance Programs implemented at work settings to aid workers in curbing their alcohol use and related problems
local zoning of alcohol outlets
screening, assessment, and referral for intervention/treatment for mental disorders, problem drinking, and HIV risk behavior
physicians communication approaches with new HIV-positive patients concerning their alcohol use
policies and procedures in drinking establishments that affect intoxication levels and/or the likelihood of engaging in subsequent hi-risk sex
salience of warning labels on antiretroviral medications concerning drinking-associated risks
The above list is not intended to be exhaustive. Prospective applicants might well consider evaluating a combination of such strategies in their project.

In addition to primary prevention, structural interventions may focus on secondary prevention among individuals already infected with HIV. Such interventions may focus on increasing: the screening and identification of HIV+ alcoholics (often a hard-to-reach population), their engagement and retention in AIDS treatment protocols, or the development of new technologies to improve alcohol and HIV/AIDS treatment among multiply-diagnosed persons to address medically significant end points, such as liver failure. Importantly, structural alterations may address the stigma endured by HIV-positive persons with drinking problems, particularly the manifold ways in which stigma may hinder the retention of such persons in alcohol and HIV/AIDS treatment programs.

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

SF424(R&R) Cover