STRUCTURAL INTERVENTIONS TO PREVENT HIV/STD INFECTION

Release Date:  August 31, 2001

RFA:  RFA-MH-02-006

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)

Letter of Intent Receipt Date:  December 15, 2001
Application Receipt Date:       January 15, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED 
IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The social and physical environment can support or constrain behaviors 
related to HIV/STD risks in communities.  Increasingly, specific 
characteristics of the social environment (e.g., social norms held by peers) 
and the physical environment (e.g., number and types of places for 
congregating) are being identified as factors associated with HIV risk 
behaviors (Cohen, Scribner, & Farley, 2000).  For example, collective 
efficacy (the extent to which adults in a neighborhood share and enforce a 
common but implicit standard of neighborhood conduct) is a powerful predictor 
of neighborhood violence as well as other behaviors that may be relevant to 
HIV risk (Sampson, Raudenbush, & Earls, 1997).  The code of the streets 
(where informal social norms are enforced in some contexts using subtle non-
verbal and verbal cues) is another dimension that may be relevant to HIV-
relevant risk behavior (Anderson, 1999).  Similarly, the existence of public 
spaces (such as parks, abandoned properties) where behavior can occur 
unobserved by others or where alcohol is available can encourage risky 
behaviors including those relevant to HIV transmission and prevention  
(Peirce, Frone, Russell, Cooper, & Mudar, 2000; Skjaeveland & Garling, 1997).

Although the causal role of social and physical factors has been extensively 
studied in relation to violence and physical safety, it has received 
inadequate attention to date in relation to HIV risk behavior and its 
prevention (Brown & Altman, 1983).  Therefore, research applications will be 
encouraged that: (1) examine the settings in which HIV/STD risk behaviors 
take place and the extent to which their physical and social characteristics 
contribute to HIV risk behaviors; (2) identify through observational and 
descriptive studies potential ways in which physical and social contexts can 
be modified to reduce HIV/STD risk behaviors; (3) examine the social ecology 
of communities to understand the social and physical dynamics of social 
control affecting individual HIV-related risk behaviors and the processes 
leading to a change in societal norms; (4) develop preventive interventions 
to minimize adverse physical and social environmental effects on HIV 
transmission and strengthen positive effects of such settings on HIV/STD-
relevant risk behaviors; and (5) identify factors in the physical and social 
environment that promote or impede the effectiveness of existing HIV/STD 
behavioral preventive interventions.

The NIH AIDS Strategic Plan has identified structural interventions to 
prevent HIV transmission as a high-priority area.  The HIV/STD prevention 
program developed under this research initiative would have the potential to 
affect the AIDS epidemic nationally and internationally by preventing risk 
behaviors in large groups of at-risk people.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA), Structural Interventions to Prevent HIV/STD Infection, is 
related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government.  Foreign institutions are eligible for the R01 but 
not for small grants (R03).  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Research Project 
grant (R01) and the Small Research Grant (R03) award mechanisms.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for 
an application submitted in response to this RFA may not exceed 5 years for 
an R01 award and 2 years for an R03 award.  R03 grants are not renewable.  
This RFA is a one-time solicitation.  Future unsolicited competing 
continuation applications will compete with all investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 1, 2002.

For all R03 and R01 applications requesting up to $250,000 direct costs per 
year, specific application instructions have been modified to reflect 
“MODULAR GRANT” and “JUST-IN-TIME” streamlining efforts that have been 
adopted by the NIH.  Complete and detailed instructions and information on 
Modular Grant applications have been incorporated into the PHS 398 (rev. 
5/2001).  Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

Because the small grants have special eligibility requirements, application 
formats, and review criteria, applicants are strongly encouraged to consult 
with program staff listed under INQUIRIES and to obtain the appropriate 
additional announcements for those grant mechanisms.  Special instructions 
and information for the small grant program is found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html (applicable for 
both NIMH and NICHD for the purposes of this RFA only).  

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.2 million in FY 2002 to fund 
three to five new grants under this RFA.  NICHD intends to commit 
approximately $500,000 in FY 2002 to fund one new grant.  Because the nature 
and scope of the research proposed may vary, it is anticipated that the size 
of each award will also vary.  It is expected that direct costs will be 
awarded in modules of $25,000; however, program and grants management 
adjustments may be necessary prior to an award.  Although the financial plans 
of the Institutes provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of applications of outstanding scientific and technical 
merit.  

RESEARCH OBJECTIVES

Background

The NIMH AIDS program has adopted the following four phases in AIDS 
prevention research:  Phase I: Discovery Studies; Phase II: Exploratory 
Studies; Phase III: Efficacy Studies; and Phase IV: Effectiveness Studies.  
This research initiative will support, but is not limited to, the following 
research areas:

Phase I:  Discovery Studies

These studies are designed to:

o  Clarify how social norms are formed and determine individual HIV-related 
behavior in a variety of social contexts at multiple levels;

o  Assess how well various social-marketing and AIDS prevention campaigns 
reduce risk behaviors and HIV/STDs in different environmental settings; 

o  Identify the environmental, social, economic, and cultural dynamics that 
contribute to the rapid spread of HIV/STDs in high-risk communities;

o  Determine how neighborhood density affects environmental factors 
associated with increasing or reducing HIV risk behaviors (e.g., alcohol 
outlets, pharmacies, health clinics, counseling and testing sites, STD 
clinics, hotels, recreation sites); and

o  Elucidate how and how well characteristics of social networks can overcome 
environmental barriers to practicing safer HIV-related behaviors.

Phase II:  Exploratory Studies

These studies are designed to:

o  Describe settings (public and private) where HIV/STD risk behaviors occur 
and the extent to which their physical and social characteristics influence 
risk behaviors;

o  Assess the preventive impact of community- and family-oriented social 
control actions and communications that focus on influencing their members’ 
HIV/STD risk behaviors;

o  Identify through descriptive studies of how the physical environment in 
high-risk areas might be modified to minimize HIV/STD risk behaviors;

o  Examine the social ecology of communities and development of collective 
efficacy, with the goal of enhancing the ability of communities to prevent 
HIV/STD transmission;

o  Evaluate the formal and informal communication patterns, including the 
mass media and the web, through which HIV/STD prevention information can be 
diffused to at-risk communities; and

o  Explain how physical environments, community efficacy, and social control 
interact to affect health behaviors related to HIV and STDs.

Phase III:  Efficacy Studies

These studies are designed to:

o  Demonstrate the impact of comprehensive structural HIV preventive 
interventions in different settings (e.g., school, work, church, hotels, 
recreational sites, testing and counseling sites, primary health care 
clinics); 

o  Test interventions based on psychological, social, economic, and cultural 
dynamics of gender and social identity that operate in communities to prevent 
HIV/STD risk;

o  Evaluate structural interventions (e.g., health policy implemented by 
public health agencies, laws passed related to health care access or public 
housing relocation programs) aimed at reducing the HIV/STD risky behaviors of 
HIV-infected persons; 

o  Test the impact of combined disease-prevention (aimed at HIV/STDs) and 
reproductive-health programs, as well as HIV medical treatment on reducing 
HIV/STD risk behaviors;

o  Test interventions that combine prevention programs at different levels of 
social organization (e.g., individual, couple, family, community, and society 
[media or policy]), and examine how these levels of intervention interact to 
affect HIV risk and protective behaviors as well as HIV transmission in 
different at-risk communities.

Phase IV:  Effectiveness Studies

These studies are designed to:

o  Demonstrate effectiveness of structural interventions that have already 
been tested under controlled conditions when implemented by public health 
agencies and community-based organizations (CBOs); and

o  Evaluate the cost-effectiveness of structural interventions that are 
demonstrated to be efficacious.

Ethical and Methodological Studies

These studies are designed to:

o  Identify the ethical and legal issues associated with conducting 
structural intervention research in communities (e.g., achieving informed 
consent, confidentiality, privacy, equity for control group, duty to warn, 
etc.); and

o  Develop innovative methodology to study the impact of structural 
interventions on communities.

SPECIAL REQUIREMENTS

A meeting of principal investigators conducting structural HIV/STD prevention 
research under this initiative will be held in Washington, DC, annually.  
Funds for these meetings should be included in the budget.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).  A 
complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) 
all applications or proposals and/or protocols to provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and, b) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm 

Applicants may wish to place data collected under this RFA (PA) in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows Institute 
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to the program staff listed under 
INQUIRIES by the letter of intent receipt date listed in the heading of this 
RFA.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable PDF format. For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions beginning on page 
13 of the application instructions. 

The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9609
Telephone:  (301) 443-3367
Email:  jnoronha@mail.nih.gov

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIMH or NICHD staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the participating Institutes in accordance with the review 
criteria stated below.  As part of the initial merit review, all applications 
will receive a written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the top 
half of the applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the NIMH or NICHD National 
Advisory Council.

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserves a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers?  Are there 
appropriate investigators from the country in which the research will be 
conducted?  Is there a history of collaboration among members of the 
investigative team?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

Schedule

Letter of Intent Receipt Date:    December 15, 2001
Application Receipt Date:         January 15, 2002
Peer Review Date:                 March 2002
Council Review:                   May/June 2002
Earliest Anticipated Start Date:  July 1, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Willo Pequegnat, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-1187
FAX:  (301) 443-9719
Email:  wpequegn@nih.gov

Susan Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6981
FAX:  (301) 496-0962 
Email:  Snewcomer@nih.gov 

Direct inquiries regarding fiscal matters to:

William F. Caputo
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  wcaputo@nih.gov 

Kathy Hancock     
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  hancockk@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH) and 93.864 (NICHD).  Awards are made under authorization of the 
Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by 
Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants 
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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