Release Date:  September 20, 2001

RFA:  RFA-HD-01-017 

National Institute of Child Health and Human Development
National Institute of Mental Health
National Institute of Nursing Research

Letter of Intent Receipt Date:  December 17, 2001
Application Receipt Date:       January 18, 2002



Scientists concerned with HIV prevention are increasingly recognizing the 
influence of the social environment on individual risk behaviors.  However, 
the design of prevention strategies that effectively harness environmental 
influences has lagged behind this important insight.  This RFA seeks to 
expand our understanding of a major feature of the community environment - 
local community institutions such as churches, voluntary organizations, 
workplaces, and commercial establishments - and to explore the roles that 
such community institutions play in contributing to or impeding HIV 
prevention.  The RFA seeks research to examine the potential mechanisms 
through which local institutions can enhance prevention efforts, beyond 
providing the venue for individual-level interventions.  This announcement is 
the first phase of a larger initiative to develop innovative intervention 
approaches that effectively involve local community institutions in HIV 
prevention.  This initial RFA solicits Exploratory/Development Grant (R21) 
applications for formative research designed to create a body of data that 
will inform the design and evaluation of such innovative approaches. 


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) is related to one or more of the priority areas.  
Potential applicants may obtain "Healthy People 2010" at 


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. Faith-based organizations are eligible to apply for 
these grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators. 

This RFA will use the National Institutes of Health (NIH) 
Exploratory/Developmental Grant (R21) award mechanism.  Responsibility for 
the planning, direction, and execution of the proposed project will be solely 
that of the applicant.  This RFA is a one-time solicitation. The objective of 
the Exploratory/Developmental Grant (R21) mechanism is to encourage 
applications from individuals who are interested in testing innovative or 
conceptually creative ideas that are scientifically sound and may advance our 
understanding of how community-level institutions such as faith based 
organizations, commercial organizations and work sites influence HIV risk and 
prevention among their constituencies.  The exploratory/developmental 
mechanism of grant support is intended to enable an investigator to explore 
the feasibility of an innovative research question or approach.  Thus, 
preliminary data specific to the proposed project are not expected, but 
evidence supporting feasibility is desirable.  

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


NICHD intends to commit approximately $2 million in total costs [Direct plus 
Facilities and Administrative (F&A) costs] in FY 2002 to fund six to ten new 
grants in response to this RFA. NINR intends to commit approximately $750,000 
in total costs to fund one or two new grants to Principal Investigators who 
are nurses or scientists from schools of nursing.  NIMH intends to commit 
approximately $250,000 to fund one new grant.  An applicant may request a 
project period of up to three years and a budget for direct costs of up to 
$200,000 per year.  Because the nature and scope of the research proposed may 
vary, it is anticipated that the size of each award will also vary.  Although 
the financial plans of NICHD, NIMH, and NINR 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 meritorious applications.  
The award is not renewable.



When community institutions are involved in HIV prevention, they may engage 
in activities such as providing educational interventions, distributing 
condoms, sponsoring community outreach activities such as street ministries 
or public awareness campaigns, or coordinating with other community 
organizations in service-delivery or fund-raising activities.  These 
community-level activities are critically important components of national 
AIDS prevention strategies, and have been supported by government and private 
funding agencies such as the Centers for Disease Control and Prevention, NIH, 
SAMSHA, as well as by foundations and other civic and religious 

Despite the impressive involvement of many community institutions in 
prevention activities, little research exists that systematically examines 
the diverse ways in which these organizations can contribute to HIV 
prevention and the factors that make them effective or ineffective in doing 
so.  This initiative seeks to build a body of basic social science knowledge 
that will lead to innovative and effective approaches to HIV prevention by 
expanding thinking on how community institutions affect HIV risk and 

For purposes of this initiative, an institution is defined as a formal 
organization that is located in a community, engaged with community 
residents, and focused around a mission or activity. Examples of community 
institutions include churches, grocery stores, schools, and voluntary 
associations.  Institutions have formal structures, usually involving a 
hierarchy headed by a leader who directs what the institution does and acts 
as a gatekeeper.  Institutions also have procedures, rules, and rituals that 
are part of their culture.  Institutions embody norms and values, both in 
their mission and in their structure and operation.  Institutions have 
constituent groups they serve, benefit from, and depend upon.  Institutions 
depend on in-kind or financial resources for survival, and obtain these 
resources from a variety of sources including individual members, customers, 
clients, other organizations, and government or private agencies.  
Institutions, as structures, have a certain amount of inertia, but because 
they are fundamentally social creations, they must constantly respond to the 
changing nature and needs of their constituent groups in order to survive.  
Thus, they may evolve and re-create themselves over time.  Also, institutions 
have relationships with other institutions, relationships that may reflect 
shared norms and interests or conflicting values and goals.  Institutions at 
the local or community level may be embedded in an institutional hierarchy, 
for example, a church that belongs to a larger denomination.  Institutions 
are influenced by many aspects of their context - the institutional hierarchy 
in which they are embedded (and the norms and expectations that hierarchy 
sets for them) - and by the community context as well.  These must be 
reconciled in some way in the institution’s norms, operation, and activities.

The methods by which institutions influence individuals’ health and other 
behaviors have been described by a number of theoretical approaches, 
including but not limited to social capital theories, social network 
theories, diffusion theories, and systems theories.  They are thought to 
operate by attaching people to services, bringing meaning to lives, 
empowering, and strengthening families and communities.  They can also act as 
controls on behavior, supporting and shaping social norms.  They can affect 
the resources that individuals are able to bring to bear on preventing 
illness, protecting health, and responding to illness.  In addition, 
institutions can provide direct health services and resources, sponsor 
disease screening, or provide health insurance of various sorts to all or 
selected members of groups connected to the institution.  Or, institutions - 
intentionally or unintentionally - can provide the opportunity for risk 

To be effective, HIV prevention efforts must reach people at high risk for 
infection and those who are already infected. To the extent that such 
individuals are disconnected from mainstream institutions (e.g., faith-based 
organizations, schools or voluntary organizations), community institutions 
may be challenged to effectively engage in HIV prevention efforts.  This 
initiative seeks research to explore such challenges by examining:  (1) the 
ways in which individuals who are potentially at high risk for HIV connect 
with community institutions; (2) how the norms and practices of community 
institutions may affect HIV risk and prevention, either negatively or 
positively; (3) how institutions initiate and/or maintain connections with 
potentially at-risk individuals and help to strengthen their ability to avoid 
risk; (4) how community institutions can effectively reach HIV-positive and 
at-risk individuals and engage them in effective prevention interventions; 
and (5) what characterizes institutions that are able to contribute 
effectively to HIV prevention, either individually or in cooperation with 
other organizations.    

Research Scope

The RFA solicits exploratory, collaborative, multidisciplinary research to 
better understand the ways in which the structure and dynamics of community 
institutions influence HIV prevention and the ways in which individuals at 
high risk of HIV infection or infected with HIV are linked to community 
institutions. These exploratory studies are intended to lay the groundwork 
for (a) interventions at the institutional level, and (b) expanded, 
theoretically driven studies of the role of institutions in HIV prevention.  
The RFA focuses on minority communities in the U.S. because of their 
disproportionate risk of HIV. 

The objective of this RFA is to create a body of data to guide the design, 
implementation, and evaluation of future interventions and prevention 
strategies.  Funded research will help to explore the potential for novel 
approaches to involving various types of community institutions or 
strengthening their impact on HIV risk behaviors, both within their own 
constituents as well as more broadly in the community.  This announcement 
seeks applications for formative or exploratory research.     

An important goal of these exploratory grants will be to develop and refine 
specific causal models (sometimes called “logic models”), based in theory and 
observation, that describe the mechanisms through which interventions and 
strategies at the institutional level or involving community institutions are 
expected to contribute to HIV prevention.   Subsequent stages of this 
initiative, if implemented, would provide support for testing these models 
through experimental designs and/or fully developed observational studies.

This RFA calls for a focus on institutions at the community level, 
institutions that have ongoing, quantifiable, and direct interaction with at 
least some proportion of community members. Applicants who propose research 
involving specific community institutions must provide information on the 
history, mission, constituency, funding, and structure of the institution, as 
well as evidence of the institution’s commitment to engaging actively with 
the research project.  Investigators are encouraged to focus on types of 
community institutions that have not regularly been involved in HIV 
prevention efforts.  However, an application may also address:  (1) 
cooperative arrangements involving institutions that are and are not 
experienced in HIV prevention; and/or (2) institutional or contextual factors 
and approaches that enhance the effectiveness with which experienced 
community institutions address HIV risk and prevention.

The research proposed must be informed by clearly articulated theory 
regarding both HIV prevention and institutional development, change, and 
influence.  This RFA does not point to any particular theory or theories.  
Potentially applicable theories relating to institutions include, but are not 
limited to, the following:  theories of social stratification, organizational 
theories, feminist theory, functionalist theories, new institutionalist 
theories, ecological theories, political economic theories.  It is hoped that 
research carried out under this initiative will contribute to the further 
development of theory regarding the role of community institutions in HIV 

Researchers are encouraged to consider a full range of appropriate 
qualitative and quantitative methods in designing their research.  
Multidisciplinary approaches are encouraged.  Applicants may consider the 
involvement of a wide range of scientists, including but not limited to those 
who study religion, institutional organization, service delivery, behavior 
change, persuasive communication, and community organization and dynamics.  
Anthropologists, geographers, economists, political scientists, 
psychologists, and sociologists all might have skills of use in developing 
these studies. Each research team must include significant, substantive 
involvement of individuals from the institution or institutions to be the 
focus of the study.

Relevant research questions include, but are not limited to:

o How are individuals who are HIV-positive or potentially at high risk for 
HIV connected with community institutions of various types?  What potential 
but unexplored mechanisms exist for effectively reaching such individuals?  
What are the spatial and social relations of HIV risk groups and how might 
these guide institution-based prevention efforts? 

o How can community institutions effectively reach HIV-positive and at-risk 
individuals and engage them in effective prevention interventions?  How can 
institutions effectively link provision of care with prevention?  Is this an 
effective strategy for reaching vulnerable populations?

o What are the mechanisms through which community institutions influence 
health and well being, generally, and health behaviors and HIV risk and 
protection specifically?

o How do institutions maintain connections with potentially at-risk 
individuals and help to strengthen their ability to avoid risk?

o How do institutions shape and enforce community norms relevant to HIV risk?  
How does this differ by type, structure of institution, relationships among 
institutions, or community context?

o In what ways do community institutions impede effective HIV prevention?  
What factors are responsible for such barriers and how can they be addressed?

o What characteristics of institutional norms, structure, operation, and 
activities are associated with effective HIV prevention in particular 
communities and settings?

o What is the role of institutional leaders and gatekeepers in creating and 
sustaining effective prevention efforts?  How does institutional involvement 
in HIV prevention that is initiated by an individual leader at a given 
institution become “institutionalized?”

o How do institutions network with other community actors and other 
institutions?  When and how do such connections and collaborations improve 
HIV prevention efforts?  When and how do they fail to do so?

o What effects do various forms of instability that affect community 
institutions, their constituencies, and their relations with other 
organizations have on HIV prevention efforts? Examples of instability include 
storefront churches that move to new locations, urban renewal that displaces 
the populations served by institutions, and coalitions that form and dissolve 
in response to specific funding opportunities.  

o How does conflict within and between community institutions over norms and 
intervention strategies, e.g., zero tolerance of certain behaviors VS so-
called harm reduction approaches, affect prevention efforts?


o  Funding under this RFA is intended to support work that will lead to 
innovative interventions and prevention strategies. Research supported must 
either lay the groundwork for further in-depth and basic research to inform 
or guide the development of practical and effective HIV prevention strategies 
at the community level, or develop a specific intervention strategy. 

o  Applications that propose to conduct research leading to the development 
and testing of interventions must provide a plan for addressing issues 
relating to ongoing sustainability of such interventions at the end of the 
research period.

o  Applications must present detailed descriptions of past, current and 
planned collaborations with the community institutions named as participants 
in the study.  This is to include descriptions of the mechanisms planned to 
ensure successful cooperation.

o  Applications must include funds in the budget for an annual two-day 
meeting of grantees in the Washington DC area.


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 (; 
a complete copy of the updated Guidelines is available at  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 


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,” published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available on the Internet at: 

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


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:


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.


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: 

Applicants may wish to place data collected under this RFA 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.


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 this  RFA. 
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 NICHD staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent to Dr. Susan Newcomer at the address 
listed under INQUIRIES, below, by December 17, 2001.


The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at are to be used in 
applying for these grants.  Beginning January 10, 2002, the NIH will return 
applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301-710-0267, Email: 


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 is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions. 

Submission 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:

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

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

Applications must be received by January 18, 2002.  If an application is 
received after that date, it will be returned to the applicant without 

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.


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

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 NICHD Division of Scientific Review in accordance with the 
review criteria stated below.  As part of the initial merit review, all 
applications will receive a written critique and may 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 National 
Advisory Child Health and Human Development Council, the National Advisory 
Mental Health Council or the National Advisory Nursing 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 
their 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 deserve 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 (if any)?

(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 

In addition, applications will be evaluated with respect to:

o The nature and adequacy of cooperative arrangements involving community 
level institutions.

o The adequacy of the proposed plan for addressing issues relating to ongoing 
sustainability of proposed interventions. 

o The adequacy of the proposed plan to share data, if appropriate.

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 

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

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


Letter of Intent Receipt Date:    December 17, 2001
Application Receipt Date:         January 18, 2002
Peer Review Date:                 March/April 2002
Council Review:                   June 2002
Earliest Anticipated Start Date:  August 2002


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 concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.  A complete 
listing of contacts for both programmatic and fiscal/administrative inquiries 
may be found at:


This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.864 (NICHD, Population Research), 93.361 (NINR), and 93.242 (NIMH).  
Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
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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