Release Date:  January 29, 2001

RFA:  RFA-DA-01-007

National Institute on Drug Abuse

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



The purpose of this RFA is to support drug-use/abuse focused HIV/AIDS studies 
that address the particular challenges and needs of HIV-infected and at-risk 
adolescents.  Specifically, research applications are sought on:  (a) 
prevention of HIV infection and related infectious diseases among 
adolescents; (b) transmission by HIV-positive youth; (c) accessibility, 
integration, and management of adolescent-specific medical, mental health, 
and drug treatment services and interventions relative to HIV infection; (d) 
outreach strategies for high-risk adolescent sub-populations; and (e) 
analysis of infectious comorbidities and their influences on HIV progression.  
This RFA is also meant to encourage appropriate research with pre-
adolescents, such as strategies for early HIV prevention efforts in various 
settings (e.g., primary health care, community-based clinics, schools).


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), "HIV/AIDS and Drug Use Among Adolescents," 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 


This RFA will use the National Institutes of Health (NIH) research project 
(R01) and exploratory/developmental (R21) 
( award mechanisms.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  This RFA is a one-time 
solicitation.  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.


The National Institute on Drug Abuse (NIDA) intends to commit approximately 
$1,500,000 in FY 2001 to fund three to six new and/or competitive 
continuation grants in response to this RFA.  The total project period for an 
application submitted in response to this RFA may not exceed five years for 
the R01 and three years for the R21.  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 NIDA provide support for 
this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 



In contrast to attenuation of the infant AIDS epidemic in the United States, 
there is evidence that HIV infection rates are increasing in the adolescent 
population.  This expanding adolescent HIV epidemic is increasingly female, 
minority, and related to sexual transmission (i.e., heterosexual activity in 
females and homosexual activity in males).  Use of alcohol and illicit drugs 
by youth is related to early sexual experience.  These risky behaviors may 
lead to unprotected sexual intercourse and are related to the acquisition and 
transmission of HIV among adolescents.  Certain sub-populations of 
adolescents, in addition to females and minorities, are particularly at high 
risk for HIV infection.  Examples are homeless, runaway, and street youth who 
engage in unsafe sex as a means of obtaining drugs or money, especially in 
urban areas with high HIV rates, adolescents in juvenile detention centers 
where there is frequent HIV-associated risk-taking behavior, and drug-using 
adolescents in rural communities with increasing HIV seroprevalence.  Within 
the broad areas of HIV prevention, transmission, disease progression, 
consequences, and treatment, studies are greatly needed on specific concerns 
arising from the intersection of adolescence, drug abuse, and HIV/AIDS.  

Clinical care of HIV-infected adolescents involves unique challenges and 
management demands.  The presence of drug use/abuse provides additional 
unique challenges.  Information on the manifestations and progression of HIV 
disease in drug-using adolescents is critical to the further development and 
evaluation of an adolescent-specific therapeutic agenda.  Recent data provide 
evidence that there are differences in the immune systems of male and female 
adolescents and that adolescents’ immune systems differ from those of 
children and adults.  The long-term implications of these disparities, the 
immunologic potential of adolescents, the development of methods for 
enhancing adolescents HIV–specific immune responses, and complications of 
these processes related to drug abuse need further study. 

HIV-infected adolescents must face the common challenges associated with 
normal pubertal development, as well as the acceptance of chronic illness, 
complex drug regimens, and disclosure of condition to peers.  Adolescents 
often have difficulty with chronic, complicated therapeutic regimens 
initiated during this period.  There is need for adolescent-specific studies 
aimed at improving treatment adherence and preventing or minimizing the 
negative physical, psychological, cognitive, and social consequences of HIV 
infection during adolescence, for youth in general, and for drug-
using/abusing youth in particular.
Areas of Interest

To advance the current knowledge base about HIV/AIDS and drug abuse in 
adolescent populations, this RFA solicits applications covering a broad range 
of specific research topics.  To the extent possible and appropriate, 
investigators are encouraged to incorporate consideration of gender 
differences in their research designs and analyses.  The following are 
illustrative examples of research that would be responsive to this RFA.  They 
are intended as a guide and not meant to limit the themes or approaches that 
could be proposed.

o  Measurement of incidence and prevalence of HIV infection and related 
infectious diseases among drug-abusing adolescents.
o  Development, evaluation, and dissemination of prevention strategies to 
reduce the incidence of drug-use related HIV infection, including:
- study of community-based behavioral and social intervention strategies 
to reduce needle-sharing and high-risk sexual behavior among injection 
drug users, crack cocaine users, and their sexual partners;
- approaches targeting youth at high risk for initiating injection drug 
use and/or initiating sexual risk behaviors associated with drug use;
- primary prevention programs that include both HIV and drug abuse 
prevention (especially the integration of HIV risk components with 
existing drug abuse prevention programs);
- joint drug abuse and HIV prevention programs for high-risk groups, such 
as gay/bisexual males, heterosexual females, minorities, street youth, 
and adolescents in continuation high schools and juvenile detention; 
- prevention programs for underserved populations (e.g., Native American, 
African American, rural, etc.).
o  Outreach strategies for high-risk adolescent sub-populations.
O  Development of methods and screening procedures for use by healthcare 
providers to identify youth at risk of future exposure to HIV infection, 
particularly those in elementary and middle schools.
o  Impact of public policy on prevention and treatment of HIV infection among 
o  Impact of use of illicit drugs on the effectiveness of HIV therapy.
o  Evaluation of the complications of HIV therapy during adolescent 
maturation, such as metabolic (including nutritional), endocrine, and 
cardiovascular disorders, drug-drug interactions, and hepatotoxicity, 
relative to substance abuse, other pharmacotherapies, and co-infections, such 
as hepatitis C.
o  Improvement of access to and utilization of health services by drug-using 
HIV-infected adolescents, including strategies to:
- improve adherence with HIV medications;
- recruit and retain participants in HIV/AIDS treatment; and
- deliver linked medical and drug abuse treatment services.
o  Organization and management of services for HIV-positive adolescent drug 
abusers, including analyses of barriers to services and access and 
utilization, and strategies to overcome them (e.g., mobile vans as a means 
for improving health care access by drug abusers).
o  Cost, cost-benefit, and cost-effectiveness of interventions to reduce HIV 
risk behaviors and prevent the transmission of HIV among adolescents.
o  Development of interventions to support transitions from pediatric to 
adolescent and from adolescent to adult health care settings.
o  Factors that may make adolescents more vulnerable to HIV infection (e.g., 
hormonal contraceptives, prevalence of STDs), and how use of illicit drugs 
may influence such vulnerability.
o  Adolescent-specific disease progression in drug-using youth, including:
-	effects of puberty-associated hormonal levels on HIV progression;
- gender differences in pathways to and progression of HIV-infection 
among adolescents; and
- adolescent-specific immune responses to HIV infection and drug abuse, 
including reproductive immaturity and hormonal changes.
o  Relationships between ongoing drug use, health, mental health, and 
development of HIV-positive youth.
o  Assessment of infectious comorbidities (e.g., viral hepatitis) and their 
influences on HIV progression.
o  Effects of HIV infection and disease progression on drug use patterns and 
the resulting influence of drug use on morbidity.
o  Behavioral and psychosocial consequences of HIV diagnosis during the 
critical developmental period of adolescence (e.g., drug use, risky sexual 
behavior, depression).
o  Special issues in rural and international settings.


It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of  
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
a complete copy of the updated Guidelines is available at  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) 
all applications or proposals and/or protocols to provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" 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.


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 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


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 all other 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 NIDA staff 
to estimate the potential review workload and plan the review.

Send the letter of intent (by receipt date listed in the heading of this RFA) 

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.  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:

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

o  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.

4 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.

o  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 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 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 

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 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.

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.

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 RFA title and number must be typed on 
line 2 of the face page of the application form, and the YES box must be 

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:

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
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

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 
for 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 the 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 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4)  Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5)  Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

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

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

o  The adequacy of the proposed protection for humans, 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.


Letter of Intent Receipt Date:    February 28, 2001
Application Receipt Date:         March 28, 2001
Peer Review Date:                 June/July 2001
Council Review:                   September 2001
Earliest Anticipated 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 encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jessica Campbell, Ph.D.
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) 402-0854
FAX:  (301) 443-4100

Direct inquiries regarding review issues 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
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


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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