Release Date:  January 29, 2001

RFA:  RFA-DA-01-006

National Institute on Drug Abuse

Letter of Intent Receipt Date:  February 28, 2001
Applicaton Receipt Date:        March 28, 2001



The National Institute on Drug Abuse (NIDA) invites applications for 
international, cross-disciplinary research on HIV/AIDS, other blood-borne 
infections [i.e., hepatitis B virus (HBV), and hepatitis C virus (HCV)], 
tuberculosis (TB), and comorbid conditions and consequences in injecting and 
noninjecting drug users, their sexual partners, and their children.  This RFA 
is intended to build on lessons learned in developed countries in response to 
the intertwined epidemics of drug abuse and the spread of HIV/AIDS and other 
infectious diseases.  It seeks to foster cross-national and international 
research collaborations that, through both independent research and the 
recruitment, training, and mentoring of new, multi-disciplinary researchers, 
lead to the development, adaptation, replication, and evaluation of effective 
interventions and approaches to slow or reverse the spread of HIV and other 
infections in vulnerable drug-using populations.

Epidemiologic studies on the dynamics of drug abuse and HIV demonstrate a 
continual need to reach new and emerging risk groups in diverse geographic 
settings with effective prevention interventions.  Recent data indicate that 
injecting drug use is now a major mode of HIV transmission in many parts of the 
world.  As many as 134 countries and territiories had documented cases of 
injecting drug use in 1999, compared with only 80 in 1992.  Of this same group, 
114 had reported HIV infection associated with drug injecting in 1999, compared 
with only 52 in 1992.  In 1999, about two-thirds (23.3 million) of the 33.6 
million people in the world living with HIV/AIDS live in sub-Saharan Africa.  
Historically,  the epidemic in sub-Saharan Africa has been driven by heterosexual 
transmission, but there, as elsewhere, injecting and noninjecting drug use are 
becoming increasingly important - and in some areas, predominant - as rates of 
drug use continue to rise.

Injecting and noninjecting drug use have synergistic effects on the spread of HIV 
and other infections to the general population, particularly when drug use is 
combined with high-risk, unprotected sex.  Challenges for cross-national and 
international HIV research efforts lie in the diversity of risk groups and 
communities of drug users; the rapidly changing drug- and sex-related risk 
profiles of susceptible populations; the variability in global injecting and 
noninjecting drug use patterns; the complex interactions among behavioral, 
ethnic/racial, sociocultural, environmental, and biomedical factors that influence 
the initiation and progression of drug abuse and the spread of HIV and other 
infections; and the differences among developing and developed countries as to 
their understanding of the intertwined epidemics of drug abuse and HIV, their 
public health knowledge and experience, and their capacities to respond with 
durable, effective measures to contain the epidemics.

This RFA will support cross-national and international research across the 
multiple disciplines of  virology, etiology, therapeutics and vaccines, 
ethnography and epidemiology, and the behavioral and social sciences on: the 
acquisition, transmission, and prevention of HIV and other blood-borne 
infections in sexually active populations of injecting and noninjecting drug 
users; the clinical course and consequences of HIV and other health 
conditions in diverse communities of drug users, their sexual partners, and 
their children; the causes and consequences of differences in HIV-associated 
risks, morbidity, and mortality between men and women, adolescents and 
adults, and in majority and minority populations; and the design, 
development, adaptation, and evaluation of behavioral and biomedical 
prevention interventions to reduce the global scope and burden from drug use- 
and sex-related risk behaviors on the spread of  HIV and other infectious 
diseases.  Researchers are encouraged to utilize, adapt, and integrate 
complementary and multimethod approaches in their study designs, including 
those of epidemiology and ethnography, prevention science, virology, and 
clinical medicine.  Established researchers are also urged to recruit new, 
domestic and foreign researchers to work on their projects, to provide 
training and mentoring to help achieve their project’s specific aims, and to 
nurture the career development and independence of new researchers with 
potential to enrich the multiple disciplines involved in preventing HIV and 
other infections in high-risk drug-using populations.


The Public Health Services (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, "International 
Studies on Drug Abuse and HIV/AIDS," is related to one or more of the 
priority areas.  Potential applicants may obtain a copy of "Healthy People 
2010" at


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 


The mechanism of support for this RFA will include the investigator-initiated 
research project (R01), small grant (R03), and exploratory/developmental 
(R21) award mechanisms.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant. 
Applicants are also advised to contact NIDA program staff listed under 
INQUIRIES for additional information. Modular budgeting procedures apply for 
grants up to $250,000.  See for further 
information about modular budgets.

The total project period for an application submitted in response to this RFA 
may not exceed five years for the R01, two years for the R03, and three years 
for the R21.  Specific information and preparation guidelines for individual 
research mechanisms can be obtained under "Funding" from the NIDA home page 


NIDA intends to commit approximately $1,500,000 in FY 2001 to fund five to 
six new awards 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.  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 has shown that major modes of transmission of HIV and other blood-
borne infections in drug-using populations are through multiperson reuse or 
sharing of contaminated syringes and other injection equipment and through 
unprotected sexual contact with infected individuals (often in conjunction 
with drug use, including the noninjecting - smoking or inhaling – use of 
heroin and crack cocaine).  Since the AIDS epidemic first emerged in the 
1980s, researchers have designed and assessed a range of  prevention 
intervention strategies to reduce transmission risks for HIV and other 
infections in drug users, their sexual partners, and their children.  Single 
and combined components of different HIV prevention interventions and 
services have been found to be effective in reaching at-risk populations of 
drug users to help them reduce their risks of acquiring or transmitting HIV 
and other infections.  Over time, these strategies and/or their components 
have been implemented among diverse risk groups (e.g., men and women, 
adolescents and adults, and in majority and minority populations) in multiple 
sites, in different regions of the United States, and in different countries.  
In some instances, HIV prevention interventions that originated in other 
countries have been adapted and implemented in the U.S.  Cumulative research 
findings have shown that decreases in the prevalence of risk behaviors, and 
conversely, increases in protective behaviors, are associated with declining 
incidence in HIV and other blood-borne infections in at-risk populations. 

Despite the significant advances that have been made, however, HIV and other 
infectious diseases continue to spread among drug-using populations in the 
U.S. and worldwide.  The cumulative evidence shows that no single approach is 
sufficient to avert new HIV and other infections in all drug users and their 
sexual partners.  Research gaps remain in a number of key areas, including 
but not limited to our understanding of the epidemiology of risks for 
HIV/AIDS in drug-using populations and others at risk; the clinical course 
and consequences of HIV and co-occurring infections associated with continual 
risky drug use and sexual practices; the individual (e.g., age, gender, 
race/ethnicity) and environmental (e.g., social, economic, cultural) factors 
that influence attitudes, beliefs, and behaviors related to drug use and 
risky sex; and the impact of drug abuse, HIV/AIDS, and related infectious 
diseases on diverse community populations throughout the world.  Cross-
national and international studies are needed to address these research gaps 
and to develop and implement comprehensive, cost-effective interventions to 
prevent the spread of HIV and other infections among drug-using populations.

Areas of Research Focus
This initiative will support cross-national and international research that 
includes but is not limited to the following interrelated areas: 

1)  Risk-factor epidemiology of HIV and co-occurring blood-borne infections 
in drug-using men and women, in their sexual partners, and in their children.  

2)  Behavioral dynamics and drug use-related processes associated with the 
acquisition and transmission of HIV and other infections, including 
individual, social, environmental, cultural, economic, gender-based, and 
other factors which influence transitions between noninjecting and injecting 
drug use. 

3)  Adaptation, replication, and evaluation of outreach-based prevention 
interventions to reduce risk behaviors and avert incident HIV and other 
infections in high-risk populations. 

4)  Development and testing of innovative, durable, and cost-effective 
behavioral and biomedical approaches to prevent disease transmission and 
enhance adherence with risk reduction interventions and available drug and 
medical treatment regimens. 

5)  Comparative studies of the single and combined components of various 
prevention/ intervention strategies and services among drug-using men and 
women and their sexual partners in diverse international settings, including 
studies of their differential impacts on the incidence, prevalence, and 
transmission of HIV and other blood-borne infections, their cost-
effectiveness, and the nature and extent of their linkages to other social, 
health, and medical services.

6)  Virologic, immunologic, genetic, and drug use factors and the mechanisms 
by which they may influence susceptibility, recovery and persistence, and 
progression of HIV and other diseases in drug-using men and women, in their 
sexual partners, and in their children. 

7)  Socioeconomic and demographic characteristics, sexual and drug-using 
behaviors, HIV virologic and immunologic status, and the health and medical 
consequences of HIV and other blood-borne infections in drug-using 
populations and others at risk. 

8)  Development of innovative, comprehensive interventions to improve access 
to and delivery of vaccines (e.g., hepatitis A and B vaccines), 
antiretroviral and other therapeutic agents, routine screening services for 
sexually transmitted diseases (STDs), and HIV testing and counseling services 
to drug-using populations and others at risk. 

9)  Comparative effectiveness and sustainability of prevention and treatment 
interventions in diverse international settings, including studies of access 
and adherence to multiple types of behavioral and therapeutic interventions, 
and the development of improved, accessible clinical management approaches. 

10)  Bioethical considerations in research methodologies, and in the design 
and implementation of culturally appropriate, available, and affordable 
prevention interventions, including counseling and testing services, medical 
care, and drug treatment to drug-using men and women, their sexual partners, 
and their children infected with HIV and other infectious diseases. 


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 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 are 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 differences.  Inasmuch 
as laboratory, field, and clinical research findings on HIV/AIDS suggest that 
there are gender differences in a number of important areas, investigators 
are encouraged to examine sex differences in their study designs.


It is the policy of NIH that children (i.e., individuals under the age 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 Contract, March 6, 1998, and is available at the following URL 

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


The National Advisory Council on Drug Abuse recognizes the importance of 
research involving the administration of drugs to human subjects and has 
developed guidelines relevant to such research.  Potential applicants are 
encouraged to obtain and review the recommendations before submitting an 
application that will administer compounds to human subjects.  The guidelines 
are available on NIDA’s home page at or 
may be obtained by calling (301) 443-2755.


Researchers funded by NIDA who are conducting research in community outreach 
settings, clinics, hospital settings, or clinical laboratories and have 
ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling. HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
include injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see


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.


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 all personnel 
and participating institutions; and the number and title of the RFA in 
response to which the application is being 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 NIDA staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538


The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  Application kits are available at most 
institutional offices of sponsored research and may be obtained 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,  E-mail:  


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 


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

FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) 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.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page (see for sample 
pages).  At the top of the page, enter the total Direct Costs requested for 
each year.  This is not a Form page.

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 F&A) 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 their 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.

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:

- 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; and
- List selected peer-reviewed publications with full citations.

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.

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 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 title and number of this RFA must be 
typed in Item 2 on the face page of the application form, and the YES box 
must be marked.

The sample RFA label available at: 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 three signed photocopies in one package to:

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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

Applications must be received by the 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 Research (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 
responsiveness by NIDA.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.

Applications that are complete will be evaluated for scientific and technical 
merit by a peer review group convened in accordance with the standard NIH 
peer review procedures.  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 on Drug Abuse.


The goals of NIH-supported research are to advance the 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.

(1)  Significance:   Are the goals and objectives of this application 
relevant to this RFA?  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 
method?  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 to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

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

- The adequacy of plans to make data available to other investigators in a 
timely fashion.

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

- 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.

- The adequacy of plans for including children as appropriate for the 
scientific goals of the research.

Letter of Intent:          February 28, 2001
Application Receipt Date:  March 28, 2001
Peer Review Date:          June/July 2001
Council Review:            September 2001				
Earliest Start Date:       September 30, 2001			


Award criteria that will be used to make award decisions include scientific 
merit as determined by peer review, availability of funds, and programmatic 


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

Direct inquiries regarding programmatic issues to:

Helen Cesari, M.Sc.
Center on AIDS and Other Medical Consequences of Drug Abuse 
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone :  (301) 402-1918
FAX :  (301) 443-4100

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX :  (301) 594-6847

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538


This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  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 are 
administered under PHS 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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