INTERNATIONAL INITIATIVES TO PREVENT HIV/STD INFECTION

Release Date:  October 31, 2000  (Revised November 16, 2000 - See NOT-MH-00-017)

RFA:  MH-01-004

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

Letter of Intent Receipt Date:  January 15, 2001
Application Receipt Date:       March 13, 2001

THIS 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

Although some developing countries have implemented successful HIV/STD 
prevention programs and policies, there is an urgent need to scale up these 
efforts and to find low-resource, cost-effective prevention programs.  According 
to the World Bank, AIDS has eradicated a half-century of development in most 
affected countries.  The impact on life expectancy among adults between the ages 
of 25 to 44 is staggering, and one child in ten is orphaned in Africa.  AIDS is 
now considered a national security issue by the United States (U.S.).	

Under this initiative, the National Institute of mental Health (NIMH) and the 
National Institute of Nursing Research (NINR) will encourage new and expanded 
collaborative efforts between U.S.-supported researchers and researchers in 
other nations to test behavioral interventions to stop the spread of HIV 
infection and its consequences.  This initiative will support co-operative 
relationships between U.S. and foreign research groups to:  1) identify 
successful interventions for targeted populations, 2)facilitate the conduct of 
scientifically valid and ethically sound HIV/AIDS prevention research, and, 3) 
develop methods to implement prevention programs for large-scale use.

Although not participating in this RFA, the National Institute of Child 
Health and Human Development (NICHD) also maintains an interest in domestic 
and international HIV-related intervention research.  For specifics, see 
http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm.

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), 
International Initiatives to Prevent HIV/STD Infection, MH-01-004, is related to 
the priority areas of Mental Health and Mental Disorders, STDs, and HIV.  
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. Foreign institutions are not eligible 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 Grants (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.  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 R03 applications and applications for R01s 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 examined by the NIH.  Complete and detailed instructions and information 
on Modular Grant applications can be found 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.

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-99-140.html.  R03s are limited to 
$50,000 direct cost for each of the two years and are not renewable.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.8 million in FY 2001 to fund 3 new 
and/or competitive continuation grants and 6 competitive supplements in response 
to this RFA.  NINR intends to commit approximately $500,000 in FY 2001 to fund 
one or 2 new grants or 2 competitive supplements.  An applicant may request a 
project period of up to 5 years and a budget for direct costs of up to $350,000 
per year for new grants and $200,000 for supplements.  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 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.  A request for a 
competitive supplement may not exceed the length of the current project period 
ending date of the parent grant to which the supplement applies, and will 
request direct costs in $25,000 modules, up to the total maximum direct cost 
request of $200,000.

RESEARCH OBJECTIVES

Background

A major area of research under this initiative will be the adoption and 
adaptation of prevention programs that are appropriate for international 
studies.  Potential applicants will be encouraged to use a behavioral prevention 
tool developed by NIMH, called the  NIMH AIDS Strategic Intervention Simulation 
Tool,  which was demonstrated at the XIIIth International AIDS Conference in 
Durban, South Africa.  This program permits users to select prevention programs 
likely to have the greatest impact on HIV/STD incidence.  This initiative will 
also encourage the further development and evaluation of theoretical models that 
explore the relationships among interventions, risk behaviors, and 
characteristics of the HIV epidemic.  This methodology will also be used to 
evaluate the impact of theoretical research in policy development and strategic 
HIV/STD prevention plans.

This research initiative will support but is not limited to the following 
research areas:

o  Identification of the social, economic, and cultural dynamics that contribute 
to the rapid spread of HIV/STDs in developing countries,

o  Testing of interventions based on psychological, social, economic, and 
cultural dynamics of gender and sexual identity that operate in HIV risk,

o  Development and testing of interventions targeted at HIV-infected persons to 
reduce their HIV/STD risky behaviors,

o  Description of effective HIV/STD prevention efforts in countries with 
different HIV prevalence and high-risk population (nascent = < 5 percent, 
concentrated = 5 percent in one or more at-risk population, generalized = spread 
beyond original at-risk groups) by using mathematical modeling procedures, 

o  Testing of comprehensive school-based education programs that include 
components of life skills and modes of preventing HIV infection in pre-
adolescent, adolescent, and young adult populations,

o  Testing the efficacy of voluntary counseling and testing programs in reducing 
high-risk behaviors and in reducing HIV/STDs, especially in couples,

o  Studying the impact of different social marketing and condom-availability 
strategies on reduction of risk behaviors and HIV/STDs,

o  Adapting and testing of prevention programs for at-risk populations (e.g., 
wives of men who are at risk, widows, unskilled women, commercial sex workers, 
orphans, school dropouts, street children, truck drivers, migrants, bisexual 
men, rural and tribal populations, slum dwellers, persons with mental illness or 
cognitive deficiencies),

o  Testing of combined disease prevention (HIV/STDs) and reproductive health 
programs in reducing HIV/STD risk behaviors,

o  Examining the role of HIV medical treatment on risky behaviors of HIV+ 
persons and designing interventions to increase disclosure and reduce high risk 
behaviors,

o  Designing and testing of programs to address the effects of social stigma and 
disclosure on adoption of risk-reducing behaviors (e.g., use of condoms, seeking 
testing, telling partners about serostatus, etc.),

o  Identification of gender roles in acquisition and transmission of HIV/STDs 
and designing of preventive interventions that address these factors,

o Development and testing of mathematical models aimed at examining the 
relationships among disease epidemiology, patterns of sexual behavior, and 
intervention strategies,

o  Evaluation of 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,

o  Testing of HIV/STD interventions to overcome a history of childhood sexual 
abuse and to prevent revictimization,

o  Studying the impact of child-headed households and parental loss on childhood 
development and early initiation of risky HIV/STD behaviors,

o  Testing of interventions that teach parents how to instruct their children 
about sexual behavior and AIDS stigma and the impact of these programs on the 
behavior of children, 

o  Designing of interventions to enhance healthy sexual development and 
responsible protective behaviors (including access to and use of barrier 
methods, avoidance of too-early or nonconsensual sex, and abstinence from unsafe 
sexual behavior),

o  Development and testing of interventions combining prevention programs at 
different levels of social organizations (e.g., individual, couple, family, 
community, and society [media or policy])and examine how these levels interact 
to impact on HIV risk and protective behaviors and HIV transmission in different 
countries.

SPECIAL REQUIREMENTS

A meeting of principal investigators conducting international 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 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 the program staff 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) 710-0267, Email: 
[email protected].  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.  The 
research grant application form PHS 398 (rev. 4/98) is to be used in applying 
for these grants, with the modifications noted below.

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.

F&A costs will not be paid (either directly, under a consortium agreement, or 
through a contract under a grant) to an organization located outside the 
territorial limits of the U.S. or an international organization regardless of 
location.  There are two exceptions to this:  The American University, Beirut 
and the World Health Organization. (Page III-69 of the NIH Grants Policy 
Statement).

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.  Type the RFA number 
(MH-01-004) 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, International 
Initiatives to Prevent HIV/STD Infection, RFA MH-01-004, must be typed on line 2 
of the face page of the application form and the YES box must be marked.

The sample RFA label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.   

Submit a signed, typewritten original of the application, including the 
Checklist, and 3 signed photocopies, in a 1 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, 2 additional copies of the application must be sent 
to:  

Willo Pequegnat, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619 (Express mail: Rockville, MD 20852)

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 NINR 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 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 NIMH or NINR 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:    January 15, 2001
Application Receipt Date:         March 13, 2001
Peer Review Date:                 May/June 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:

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:  [email protected]

Dr. Hilary Sigmon
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone: (301) 594-5970
FAX: (301) 480-8260
E-mail: [email protected]

Direct inquiries regarding review issues to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6206, MSC 9609
Bethesda, MD 20892-9609
Telephone:  (301) 443-3367
Email: [email protected]

Direct inquiries regarding fiscal matters to:

William F. Caputo
Grants Management Branch, DEA
Division of Extramural Activities
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:  [email protected]

Mr. Robert Tarwater
Office of Grants and Contract Management
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone: (301) 594-2807
FAX: (301) 480-8260
E-mail: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242   NIMH 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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