COMMUNITY IMPLEMENTATION OF HIV PREVENTION INTERVENTIONS

Release Date:  February 28, 2001

RFA:  RFA-MH-01-006

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute of Nursing Research
 (http://www.ninr.nih.gov)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)

Letter of Intent Receipt Date:  April 13, 2001
Application Receipt Date:       May 11, 2001

THIS REQUEST FOR APPLICATIONS (RFA) USES "MODULAR GRANT" AND "JUST-IN-TIME" 
CONCEPTS.  THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION 
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO 
THIS RFA.

PURPOSE

The National Institute of Mental Health (NIMH), the National Institute of 
Nursing Research (NINR) and the National Institute on Drug Abuse (NIDA) invite 
research grant applications that target research on the translation and 
adoption of empirically tested and proven Human Immunodeficiency Virus (HIV) 
research-based prevention interventions into community-based public health 
settings.  This initiative is intended to foster partnerships among 
researchers and community-based organizations in the process of adapting and 
adopting proven interventions.  Areas of research appropriate to this RFA 
include:  studies of implementation approaches and organizational and 
environmental characteristics that impede or foster implementation; cost-
effectiveness of efficacious strategies; identification of characteristics of 
community organizations most prepared to implement research-based 
interventions; and studies of the impact of efficacious interventions in 
community settings.  Research on characteristics of interventions and of 
community settings that contribute to the likelihood of sustaining an 
intervention over time are also of interest.  Multidisciplinary teams and 
collaborative alliances are strongly encouraged.  This effort is being 
initiated in consultation with the Centers for Disease Control and Prevention.  

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 RFA, “Community Implementation of 
HIV Prevention Interventions,” 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 and foreign, 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. 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 collaborative R01 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 five years.  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 
September 30, 2001.

For all competing 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 being undertaken at NIH.  More 
detailed information about modular grant applications, including a sample 
budget narrative justification pages and a sample biographical sketch, is 
available via the Internet at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Applications that 
request more than $250,000 in any year must use the standard PHS 398 (rev. 
4/98) application instructions.

For the purposes of this RFA, the guidelines provided in PAR-98-017 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html) are to be 
followed for applications using the collaborative R01 mechanism.

FUNDS AVAILABLE

NIMH intends to commit approximately $2,000,000 in FY 2001 to fund five to 
seven grants in response to this RFA.  NINR intends to commit approximately 
$500,000 or the equivalent of two R01s in response to this RFA. NIDA also 
intends to commit approximately $500,000 or the equivalent of two grants in 
response to this RFA.  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 award.  
Although the financial plans of the Institute 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 past decade has witnessed numerous advances in preventing HIV infection.  
Many of these advances have occurred as the result of the efforts of HIV 
prevention researchers as well as those of many community-based HIV prevention 
programs.  Despite advances in our knowledge, it is clear that information, 
strategies and models for HIV prevention have not always reached community 
program coordinators.  Likewise, information developed by community programs 
has frequently not reached or influenced HIV prevention researchers.  The 
future effectiveness of HIV prevention efforts will be greatly affected by the 
degree to which we are successful in increasing cross-fertilization among 
researchers and community programs. 

It is extremely important that working relationships be established between 
the research community and the community of public agencies and organizations 
actually delivering prevention programs to high-risk populations.  Models of 
technology transfer need to be developed and validated in large-scale 
community settings.  These models must include effective training for 
community providers as well as ongoing assessment of what happens to research-
based interventions when they are put into practice.  Methodologies that 
include measurable outcomes must be developed to assess the impact of various 
interventions in the community.  Critical to the success of these efforts will 
be an awareness of the cultures in which the interventions were undertaken and 
ways in which existing interventions may have to be modified to be successful.  
Interventions that leave in place infrastructures capable of complex problem 
solving, program evaluation, and ongoing two-way communication with the 
research community, should ease the path for future technology transfer. 

Areas of Interest

The following section includes suggested areas for research.  The list is 
suggestive and not exhaustive, but it does place an emphasis on studies that 
require collaboration between researchers and community-based organizations 
and stresses issues that will enhance our knowledge and understanding of how 
best to implement research-based HIV prevention interventions in communities 
at high risk of HIV.

o  Studies that assess what happens to research-based interventions when they 
are implemented on a community level

o  Studies that develop and test different modes for transferring effective 
research-based HIV prevention interventions into the community
  
o  Studies that identify and evaluate outcome measures appropriate to the 
evaluation of research-based HIV prevention interventions implemented in 
community settings

o  Research on the characteristics of community-based organizations most 
likely to be successful in implementing research-based interventions
 
o  Research on the characteristics of research-based interventions that 
increase the likelihood that they will be successfully implemented in at-risk 
communities

o  Development and validation of effective models for the translation of 
research-based HIV prevention interventions into the community

o  Studies of the cost-effectiveness of research-based HIV prevention 
interventions when implemented in different settings

o  Research on models for facilitating cooperation among research and service 
professionals

o  Studies of the adoption of research-based HIV prevention interventions in 
ethnically diverse communities and the identification of strategies to adapt 
proven interventions to these communities 

o  Studies of the organizational environment and how it facilitates or impedes 
implementation of research-based HIV prevention interventions
  
o  Studies that test strategies to enhance facilitating factors and diminish 
impeding factors

o  Studies of the development of new technologies to inform, train and assist 
community-based organizations in implementing and sustaining efficacious HIV 
prevention interventions including use of the internet, CD-ROMS or other 
potentially cost-effective modalities

o  Studies of mechanisms that would enable community-based organizations to 
advise and communicate with the research community on needed research to 
improve responses to ongoing or emerging HIV-related public health issues

o  Studies of clients of community-based organizations to assess their 
reactions to research-based interventions

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 subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 are 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.

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.

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 Dr. Louis Steinberg, at the address 
listed under INQUIRIES, by the letter of intent receipt date listed in the 
heading of this RFA.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

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 
Institute staff.  Additional information about modular grant applications is 
available at: http://grants.nih.gov/grants/funding/modular/modular.htm.    

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) costs] for the initial budget period.  Items 8a and 8b 
should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 4 
of the PHS 398 (rev 4/98).  It is not required nor will it be accepted at the 
time of application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form.  It is 
not required nor will it be accepted at the time of application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested for 
each year.  This is not a Form page.

o  Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application and must display the 
RFA number [MH-01-006]. A sample modified mailing label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in pdf format.  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, Community Implementation of 
HIV Prevention Interventions, MH-01-006, must be typed on line 2 of the face 
page of the application form and the YES box must be marked. 

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:

Louis H. Steinberg, Ed.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room, 6201 MSC 9621
Bethesda, MD 20892-9621
 
Applications must be received by May 11, 2001.  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 NIMH 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 
NIMH 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 National Advisory Council of the participating institutes.

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 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 
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.

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

Schedule

Letter of Intent Receipt Date:    April 13, 2001
Application Receipt Date:         May 11, 2001
Peer Review Date:                 June/July 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 30, 2001

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:

Louis H. Steinberg, Ed.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6201, MSC 9621
Bethesda, MD 20892-9621
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
E-Mail: lsteinbe@nih.gov

Hilary D. Sigmon Ph.D., R.N.
Program Director
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Rm. 3 AN-12
45 Center Drive MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5970
FAX:  (301) 480-8260
E-Mail:  hilary_sigmon@nih.gov

Helen Cesari, M.Sc.
Associate Director for Research Management
Center on AIDS & Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Blvd
Room 5198  MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 402-1918
FAX:  (301) 480-4544
E-Mail: mhc30x@nih.gov 

Direct inquiries regarding fiscal matters to:

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

Robert Tarwater
Grants Management Specialist
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Rm. 3 AN-12
45 Center Drive MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-2807
FAX:  (301) 480-8260
E-Mail:  robert_tarwater@nih.gov 

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
E-Mail:  gf6@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.  
93.242 (NIMH), 93.279 (NIDA), and 93.361 (NINR).  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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