Release Date:  December 31, 2001

RFA:  RFA-DA-02-009

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 18, 2002
Application Receipt Date:       April 16, 2002



The National Institute on Drug Abuse (NIDA) invites domestic and 
international research applications on the development and testing of new 
intervention approaches to prevent HIV and other blood-borne and sexually 
transmitted diseases (STDs) in drug users and their sexual partners. NIDA-
sponsored research has demonstrated that, in the absence of an AIDS vaccine 
and no cure, comprehensive HIV prevention remains the most effective, 
sustainable, and cost-effective approach to avert new HIV infections in drug-
using populations. This RFA seeks to build on lessons learned since the 
epidemics of drug abuse and HIV/AIDS emerged in the early 1980s by addressing 
research gaps in HIV prevention and drug use. Over the past two decades, 
considerable scientific progress has been made in understanding, preventing, 
and treating HIV/AIDS and other infections among drug users. Yet much remains 
unknown or poorly understood today. Emerging drugs of abuse, such as the club 
drugs ecstasy, GHB, ketamine, and methamphetamine, as well as more potent 
supplies of heroin, cocaine, marijuana, and other drugs, are rapidly changing 
the profiles of populations at risk for drug use and its health and medical 
consequences, including the transmission of HIV and other infections. Racial 
and ethnic minority populations, women, and adolescents have been deeply 
impacted by drug abuse, HIV/AIDS, and related infectious diseases in recent 
years, and new HIV infections have continued in both the U.S. and in other 
nations. Risk behaviors associated with HIV/AIDS are similar to those for 
viral hepatitis (i.e., hepatitis B [HBV] and hepatitis C [HCV]) and other 
STDs. HBV and HCV viral infections have become increasingly prevalent in 
injecting and non-injecting drug-using populations, as have drug-resistant 
strains of gonorrhea and tuberculosis.  New and improved approaches to 
prevent the acquisition and ongoing transmission of these infections are 
urgently needed, as are strategies to improve access to diagnostic screening 
and care.  

The purpose of this RFA is to stimulate research on the development of new, 
improved, and innovative intervention approaches to prevent HIV and other 
blood-borne and sexually transmitted infections in drug users and their 
sexual partners. Well-designed, targeted prevention interventions are readily 
adaptable and responsive to changing patterns of drug use and HIV risk 
behaviors, to a variety of local settings, and to the diverse characteristics 
and needs of drug users and their sex partners. It is important to assess the 
effectiveness, sustainability, and durability of existing HIV prevention 
interventions and, as appropriate, to modify them to meet changing population 
characteristics, needs, and circumstances.  It is equally important to 
consider newly developed, tested, and implemented intervention approaches 
that take evolving scientific findings on drug use and related risk behaviors 
into account. 

Moreover, as epidemiological data on HIV and other infections suggest, many 
injecting and non-injecting drug users who could potentially benefit the most 
from HIV prevention efforts remain underrepresented in public health 
interventions and/or inaccessible or resistant to outreach efforts aimed at 
behavioral risk reduction. Clearly, new intervention approaches to prevent 
HIV and other infections in drug users must reach the most vulnerable 
populations and their communities.


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, "New Approaches 
to Prevent HIV/Other Infections in Drug Users," 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.  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) investigator-
initiated research project (R01), small grant (R03), and 
exploratory/developmental (R21) award mechanisms.  The 
exploratory/developmental (R21) grants are limited to 3 years and small 
grants (R03) are limited to 2 years.  Both are non-renewable and limited in 
direct cost amount per year (R03, $50,000; R21, $100,000).  The R03 mechanism 
is intended for newer, less experienced investigators, for investigators at 
institutions without well-developed research traditions and resources, or for 
experienced investigators wishing to change research directions or test new 
methods or techniques.  The R21 mechanism is intended to encourage 
exploratory research projects with sound methodology and strong rationales in 
underdeveloped research areas of HIV prevention interventions for drug users, 
such as the areas covered in this RFA.  Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of the 

Applicants are advised to contact NIDA program staff listed under INQUIRIES 
for additional information.  Refer to the announcement for the specific 
eligibility requirements for the small grant (R03) at and the 
developmental/exploratory grant (R21) at:  Because the 
nature and scope of the research proposed in response to this RFA may vary, 
it is anticipated the size of an award will also vary.  Awards under the R01 
mechanism may not exceed 5 years.  Awards under the R03 mechanism are limited 
to 2 years, and R21 awards are limited to 3 years.  

The anticipated award date is September 30, 2002.  This RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  Applications judged to be 
nonresponsive to the RFA will be returned to the applicant.

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


NIDA intends to commit approximately $2,000,000 in FY 2002 to fund about six 
new awards in response to this RFA.  Because the nature and scope of the 
research proposed may vary, it is anticipated that the number of awards and 
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.  



Since HIV/AIDS first emerged in the 1980s, researchers have designed and 
assessed a range of prevention intervention strategies to reduce transmission 
risks for HIV and related co-infections in injecting and non-injecting drug 
users, their sexual partners, and their children. Single, combined, and 
multiple components of different HIV prevention interventions have been shown 
to be effective in reaching drug users to help them reduce their behavioral 
risks for HIV and other infections. While these strategies and/or their 
components have been implemented among a variety of risk groups and settings, 
the cumulative evidence has shown that no single approach is sufficient to 
avert new HIV and other infections in all drug users and their sexual 
partners. Epidemiological patterns of drug abuse and risk behaviors 
constantly change and new infections of HIV and other blood-borne and 
sexually transmitted infections continue to emerge and spread. The emphasis 
of this RFA is on research gaps in current intervention approaches to prevent 
HIV and other infections in drug users and their sex partners. It invites 
researchers to apply new findings on changing patterns of drug use, at-risk 
populations, and emerging infectious diseases in the development of novel 
approaches -- and in the strengthening and improvement of existing 
interventions -- to prevent HIV and other blood-borne and sexually 
transmitted infections.  Researchers are encouraged to utilize and integrate 
complementary methodological approaches in their study designs, including 
epidemiology, ethnography, behavioral and prevention science, virology, and 
clinical medicine.  

Areas of Research Focus
This RFA will support research on topics that include but are not limited to 
the following: 

o  The development and testing of innovative prevention intervention 
approaches to address new or changing patterns and contexts of drug use and 
sexual risk behaviors and their implications for transmission of HIV and 
other blood-borne and sexually transmitted infections.

o  Research to develop and improve methods to access and recruit not-in-
treatment drug users, including new initiates to drug use and non-injecting 
drug users at risk of transitioning to injecting drug use, to participate in 
targeted prevention interventions to reduce drug use and sex-related risk 
behaviors, HIV disease transmission, co-morbidity, and mortality. 

o  Identification of individual and community-level factors that impact the 
initiation and sustainability of HIV prevention interventions and their 
outcomes over time, and how they can be adapted, extended, or replicated 
across demographically, ethnically, and culturally diverse drug-using groups 
and community settings.  

o  Development of new strategies to link community-based outreach/risk 
reduction to hard-to-reach drug users and their sex partners and to referrals 
and access to prevention interventions and services for HIV counseling and 
testing, diagnostic screening for related co-infections, drug treatment, and 
medical care.

o  Studies of underlying mechanisms that contribute to the effectiveness of 
existing HIV prevention interventions to extend, strengthen, develop, or re-
direct interventions to meet the changing needs and characteristics of drug 
users, their sex partners, and their communities.

o  Research to understand why even the most effective HIV prevention 
interventions may not appreciably benefit all drug users who participate in 
them, to better characterize drug-using subgroups and individuals at risk who 
are refractory to existing behavioral interventions, and to develop and test 
new approaches that engage drug users who are marginalized, resistant, 
fearful of being stigmatized, or hard-to-reach.

o  Studies to improve outreach, recruitment, adherence, and retention of HIV-
infected drug users and their sex partners in clinical trials of new 
approaches to prevent HIV/AIDS and other blood-borne and sexually transmitted 

o  Studies to enhance understanding of the social, cultural, and 
environmental factors and contexts associated with the co-occurrence of 
HIV/AIDS and other infectious diseases in drug users and their sex partners, 
and to design new intervention approaches to address such co-occurring 
conditions. Such factors and contexts may include, e.g., relationships among 
peer groups, beliefs about gender roles, and social mixing patterns of risk 
cohorts and their social networks relative to transitions from non-injecting 
to injecting drug use or from unsafe drug use and unsafe sex.

o  Development and testing of new prevention intervention strategies that are 
linked to a variety of ancillary services (e.g., rapid diagnostic assays, HIV 
counseling and testing, and medical and drug treatment) or that are adapted 
and tailored to underserved and stigmatized populations, such as drug 
injecting women, the sex partners of drug injectors, adolescents, new 
initiates to drug use and new injecting drug users, and men who use drugs and 
have sex with men.

o  Evaluation studies to determine the relative effectiveness, cost-
effectiveness, and sustainability of new HIV prevention interventions (and/or 
their single or multiple components) in demographically, ethnically, and 
culturally diverse populations and their communities. 


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 clinical research 
projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
a complete copy of the updated Guidelines are available at  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.


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 

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 of the Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA's Home Page at 
under Funding 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


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 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 IC staff to 
estimate the potential review workload and plan the review.

The letter of intent is to be sent by the letter of intent receipt date 
listed to:  

Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier or express delivery)
Telephone:  (301) 443-2755


The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at must be used in 
applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable format.  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.

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 must be 
sent to:

Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier or express delivery)

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.


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 and responsive to the RFA will be evaluated for scientific 
and technical merit by an appropriate peer review group convened by NIDA 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 on Drug Abuse.

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 
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, all applications will 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 (including data safety 
monitoring plans), animals or the environment, to the extent they may be 
adversely affected by the project proposed in the application.

o  The relevance of the proposed work to the purpose of the RFA.


Letter of Intent Receipt Date:    March 18, 2002
Application Receipt Date:         April 16, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002


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.


Potential applicants are strongly encouraged to contact the appropriate staff 
for additional information and specific application procedures or to clarify 
any issues.

Direct inquiries regarding programmatic issues to:

Elizabeth Lambert, M.Sc., or Helen Cesari, M.Sc.
Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse 
6001 Executive Boulevard
Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 402-1933 or 402-1918
FAX:  (301) 480-4544
Email: or 

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

Direct inquiries regarding fiscal matters to:

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


This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  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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