RESEARCH ON ALCOHOL-RELATED HIV/AIDS IN WOMEN

RELEASE DATE:  October 30, 2002
 
RFA:  AA-03-004

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

LETTER OF INTENT RECEIPT DATE: December 13, 2002

APPLICATION RECEIPT DATE: January 13, 2003  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
applications to support research to identify and characterize the role 
of alcohol, drinking behaviors, and drinking environments in the 
epidemiology and natural history, pathogenesis, prevention, treatment 
and control of HIV/AIDS among women. The number of women with HIV 
infection and AIDS has been increasing steadily worldwide.  According 
to the World Health Organization (WHO), approximately 16 million women 
are living with HIV/AIDS worldwide, accounting for 46 percent of the 
32.4 million adults living with HIV/AIDS. As HIV/AIDS research becomes 
more focused, there is growing evidence that alcohol consumption may 
play an important role in sexual transmission, susceptibility to 
infection, and progression of HIV disease among women. In addition, 
alcohol use, abuse, and dependence among women may have a significant 
impact on the occurrence and course of comorbid conditions such as HCV, 
oral and esophageal candidiasis and TB, pregnancy and birth outcomes, 
adherence to medications and provider advice, provider and patient 
attitudes towards treatment, and survival. 

The goal of this Program Announcement is to encourage 
multidisciplinary, interdisciplinary, and collaborative studies that 
focus on a range of epidemiologic and intervention issues within HIV 
and alcohol among women.  It advances research goals set forth in the 
NIH Fiscal Year 2003 Plan for HIV-Related Research.  Relevant 
objectives identified in the plan include:

- Characterize the relative importance of alcohol use in the 
acquisition and subsequent transmission of HIV in order to identify and 
apply appropriate alcohol use interventions as public health measures.

- Investigate the social and environmental factors that contribute to 
HIV infection, behaviors after infection, and co-occurring conditions 
(e.g., substance use, mental illness, homelessness, hepatitis, STDs, 
tuberculosis), including the causes and implications of stigma.

Special emphasis will be given to research which examines the 
effectiveness of interventions that extend beyond the level of the 
individual woman, with the aim of bringing all of the resources of a 
given community to bear on the twin epidemics of alcohol and other 
substance abuse and HIV/AIDS.  Such research will encompass secondary 
analysis of existing data sets from studies of HIV/AIDS among women. 
The community-level focus of this RFA is, in turn, consistent with 
goals articulated by the international AIDS research community in its 
attempt to stem the spread of HIV/AIDS in resource poor areas of the 
world.  With increasing knowledge of the dimensions of the HIV epidemic 
in parts of Asia and Africa has come heightened awareness of the 
critical importance of involving community members as equal partners in 
every aspect of the research process.

This Request for Applications is intended to appeal to a broad audience 
of alcohol and HIV/AIDS researchers, including alcohol researchers with 
no prior experience in HIV/AIDS research, but with a keen appreciation 
for the relationship between problem drinking and HIV/AIDS and a strong 
interest in acquiring such experience; HIV/AIDS researchers with no 
prior alcohol research experience who realize the importance of more 
intensive alcohol interventions to improving clinical outcomes among 
HIV+ women; and those with prior research experience in the area of co-
occurring HIV/AIDS and alcohol and other substance abuse. Given the 
breadth of research objectives included in this announcement, potential 
applicants are encouraged to carefully review all sections of the 
announcement for research opportunities.

RESEARCH OBJECTIVES

Background Information

In the United States, the proportion of reported U.S. AIDS cases 
occurring among women increased from 7 percent to 23 percent from 1985 
to 1998.  The proportion remained at 23 percent in 1999, possibly 
reflecting the success of antiretroviral therapies in preventing the 
development of AIDS.  Nonetheless, in 1999 more than 8,000 new cases of 
AIDS were reported among adolescent and adult women between 13 and 24 
years of age and nearly 7,000 new cases were reported in women between 
the ages of 24 and 29.  According the U.S. Surgeon General, "The 
epidemic has evolved from one centered on white gay men to one 
increasingly impacting people of color, women and the young."  Women 
aged 45-64 and 65 and older are also increasingly being diagnosed with 
HIV infection.  As of December 1999, women in these age groups 
accounted for 10 percent of the female cases. 

HIV infection disproportionately affects African American and Hispanic 
women.  Together they represent less than 25 percent of all U.S. women, 
yet they account for more than 77 percent of AIDS cases in women.  
HIV/AIDS is now the third leading cause of death among women ages 25 to 
44 and the leading cause of death among African American women in this 
age group.

There is a strong association between the abuse of alcohol and other 
substances and the acquisition and progression of HIV/AIDS among women.  
National Institute on Allergy and Infectious Disease-sponsored cohort 
studies in the U. S. have found that factors associated with an 
increased risk of heterosexual HIV transmission include alcohol use, 
history of childhood sexual abuse, current domestic abuse, and use of 
crack/cocaine.  As HIV/AIDS research becomes more focused, there is 
growing evidence that alcohol consumption may play an important role 
not only in sexual transmission and susceptibility to infection among 
women, but in the occurrence and course of comorbid conditions such as 
HCV, and TB, adherence to medications and provider advice, provider and 
patient attitudes towards treatment, and survival.  Recent evidence has 
indicated that there are interactive effects of alcohol use and HIV 
infection on brain functioning and cognitive processes in both men and 
women which may affect judgment regarding high risk behaviors, as well 
as adherence to complex HIV medication regimens and to physician 
advice.  Increased levels of alcohol consumption have also been 
associated with diminished immune function, as evidenced by reduced 
levels of CD4 and CD8 activity.  However, many questions about the 
relationship between alcohol consumption and increased susceptibility 
to HIV infection, accelerated progression to AIDS, and accelerated 
course of the disease among women remain unanswered.  For example, 
there is a need for more information about the extent to which these 
alcohol-related effects vary between women and men, and on the role of 
confounding factors such as HIV strain variations, varying patterns of 
adherence to HIV medications, and comorbid mental and somatic illnesses 
and environmental stresses.  Of particular interest with regard to the 
unique physiology of women is the impact of alcohol on the course of 
HIV infection in pregnancy, and possible gender-based differences in 
the occurrence and course of liver disease, among other topics.  It is 
therefore of continuing importance to conduct research which seeks to 
clarify the role of alcohol in HIV transmission and disease progression 
among women, and to develop and test preventive interventions which 
both reduce the risk of alcohol-related HIV transmission among women 
and improve the treatment of HIV-infected women with co-occurring 
alcohol abuse/dependence.

The complex and global nature of unresolved questions surrounding 
alcohol and HIV/AIDS relationships among women indicates the need for a 
multidisciplinary approach to research. Investigators representing a 
broad array of academic disciplines and engaged in cross-cutting fields 
of science are encouraged to consider designing hypotheses-driven 
studies that utilize rigorous methodologies from epidemiological, 
basic, clinical, and behavioral research.  Special emphasis areas 
include:

1. Epidemiology and Natural History of Alcohol Use and HIV/AIDS:  
Improved understanding of the epidemiology of alcohol use, abuse, and 
dependence in relationship to HIV/AIDS among women will help to 
identify high-risk groups and promote development of effective HIV 
prevention and treatment efforts, including medical management of 
HIV/AIDS disease among women.  There is a need for basic epidemiologic 
research to strengthen understanding of the determinants, processes, 
and cultural and contextual issues influencing HIV-related risk and 
protective behaviors.  For example, studies are needed to:

- Gain insight into the alcohol – HIV/AIDS relationship among women 
through population-based research on alcohol consumption patterns of 
groups of women at risk for HIV infection, including women 65 and 
older.

- Identify and model the impact of alcohol consumption patterns on the 
spread of HIV infection and associated opportunistic infections among 
women of all ages over time.

- Develop and test models analyzing the complex interrelationships 
between women's sexual/physical victimization and subsequent alcohol 
consumption and involvement in HIV-risky sexual behaviors.

- Examine the impact of alcohol use on sexual risk behaviors among 
women.

- Examine patterns of HIV infection and variability in strains of HIV 
in heavy drinking women both in the U.S. and abroad to guide vaccine 
development.

- Characterize alcohol use and alcohol use disorders in high-risk women 
with HIV/AIDS, including those with co-occurring medical and 
psychiatric conditions and those who are medically underserved and 
difficult to reach.

- Describe more fully the role of gender in the intersection of alcohol 
and HIV/AIDS epidemics.

- Examine the impact of alcohol-related public policies, including 
those affecting legal and illegal (particularly in foreign settings) 
alcohol production, access, taxation, etc., on the spread of HIV and 
other STDS among women.

2. Prevention of HIV Risk Behaviors Related to Alcohol: Behavioral, 
affective, and cognitive factors affect the risk for HIV infection and 
the efficacy of HIV prevention and treatment among women who use and 
abuse alcohol. Models should be developed for interrelating these 
individual factors with contextual and social factors that influence 
alcohol misuse, sexual risk-taking, and other HIV risk behaviors. 
Development and testing of new interventions are needed at various 
levels, including: individual, dyadic, social network, organizational, 
and community.  The following areas are suggested and not 
exclusive:

- Target and retain the highest risk women drinkers (including those 
from difficult-to-reach, underserved populations) in HIV/STD prevention 
and treatment interventions — including trials for prophylactic 
vaccines. 

- Develop community-based interventions, e.g., bar-based server 
training, to alter alcohol availability among women and to improve 
linkage of alcohol and HIV preventive services.

- Develop school-based interventions targeting young women, including 
middle school, high school, and college curricula focusing on the 
relationship between alcohol-related sexual risk behaviors and 
HIV/AIDS.

- Assess ways in which membership in social organizations or less 
formal networks may reduce women's HIV/STD vulnerability, and develop 
and test interventions that build upon these insights.

- Develop and test prevention programs that reduce young women's 
vulnerability to alcohol-related sexual assault and HIV/STD infection.

- Motivate women drinkers—including those who perceive themselves to be 
at low risk for HIV infection—to decrease risky sexual and substance 
use behaviors.

- Assess the relationship of alcohol consumption, alcohol-related 
sexual expectancies, social norms, and decision-making on HIV risk 
behaviors among women of all ages.

- Develop and test preventive interventions for women based on social 
dynamics and environmental characteristics of high-risk alcohol-related 
settings and situations (e.g., bars, parties, neighborhoods with a high 
density of drinking outlets, etc.).

- Develop and test family and peer group interventions to reduce 
alcohol use, unsafe behavior and exposure to co-occurring risks such as 
violence, poor health care and disease among women.

- Improve methods for assessing and analyzing complex relationships 
between alcohol use and abuse, psychological, and environmental 
factors, including alcohol regulations and policies, and HIV-related 
risk behaviors among women. 

3. Medical Aspects of Treatment Among HIV-Positive Individuals with 
Alcohol Use Disorders:  Alcohol use may be a key determinant in disease 
transmission and progression, adherence and response to therapeutic 
regimens, among other effects on women. Still many questions remain 
unanswered with regard to how the co-occurrence of HIV/AIDS and alcohol 
abuse/dependence currently influences clinical decision making, and how 
provider practices could be modified to improve clinical outcomes among 
women. Research is needed to determine whether and how alcohol affects 
disease progression in various organ systems in HIV+ women; to develop 
and evaluate pharmacological interventions for the treatment of alcohol 
dependence in HIV+ women; to guide the development of HIV treatment 
regimens tailored to the needs of women with coexisting alcohol 
abuse/dependence; and to improve motivation for treatment and adherence 
to treatment among women.  Specifically research efforts are needed to:

- Develop and test therapeutic regimens for women which are based on 
a)drug-drug interactions between alcohol and antiretroviral 
medications; b)changes in drug metabolism in women with alcohol-related 
liver dysfunction and other physiologic impairments; c)results of 
testing for drug resistance; and d)lifestyle factors in heavy drinking 
women (e.g., structured treatment interruptions, salvage therapies, 
etc.).  Examine effects of drug sequence on occurrence and course of 
liver and other organ dysfunction.

- Compare the efficacy of various pharmacological interventions for the 
treatment of alcohol dependence (e.g. Naltrexone) in HIV+ women.

- Advance understanding of the dynamics between alcohol use and abuse 
and adherence to HIV therapeutic regimens among women, and test 
strategies to improve compliance.

- Investigate mechanisms by which alcohol consumption affects liver 
disease progression in women with HIV, including those coinfected with 
hepatitis C (HCV), to improve clinical outcomes in heavy drinking 
women.

- Improve guidelines for prophylaxis and treatment of opportunistic 
infections among women by examining the relationship between alcohol-
related host defense impairment and the emergence and course of disease 
caused by pathogens such as M. tuberculosis, S. pneumoniae, P. carinii, 
HCV, and candida.

- Investigate impact of alcohol on HIV-specific complications among 
women, including neuropathogenesis and pathogenic processes involved in 
AIDS dementia and peripheral neuropathy; cardiomyopathy; enteropathy 
and wasting; oral, gastrointestinal, and genital candidiasis, among 
other conditions. Determine whether and how hormonal status of women 
affects the occurrence and course of HIV-specific complications.

- Study the impact of alcohol on fat redistribution and other aspects 
of fat, protein, and carbohydrate metabolism and nutrition in women 
with HIV/AIDS.  Examine influence of hormonal status on fat 
distribution, metabolism and nutrition in heavy drinking women with 
HIV/AIDS.

- Enhance linkage of primary medical care and reproductive health care 
with alcohol prevention and treatment services for HIV-infected women 
with co-occurring alcohol misuse.

- Improve medical technology for rapid diagnosis and determination of 
HIV genetic subtypes and drug resistance patterns in heavy drinking 
women.

4. Strategies to Interrupt Mother-to-Child transmission applicable to 
resource-rich and –poor countries:   Although rates of vertical 
transmission of HIV in the U.S. and other resource rich areas of the 
world  have declined dramatically since the introduction of 
antiretroviral regimens which prevent mother-to-child transmission, 
vertical transmission remains a very serious problem in resource-poor 
nations and among poor populations in resource-rich nations.  Much 
remains to be learned about the role of alcohol in vertical 
transmission of HIV and about the role of interventions targeting women 
who misuse alcohol in preventing vertical transmission.  Such 
interventions, given their relative affordability, would have 
particular relevance in resource-poor areas where access to effective 
medications may be extremely limited.  Areas which require further 
investigation include:

- Effect of alcohol on the mechanisms and timing of mother-to-child HIV 
transmission (in utero, intrapartum, and postpartum via breast milk), 
including impact of alcohol on mechanisms of protective immunity to HIV 
in newborns and infants. 

- Impact of alcohol use among pregnant women on adherence to 
antiretroviral regimens to prevent mother-to-child transmission.

- Interactions between HIV therapeutics, alcohol, and medications used 
for the treatment of alcohol dependence in pregnant women.   Impact of 
these interactions on the efficacy of antiretroviral regimens to 
prevent vertical transmission and implications of these interactions 
for the maintenance of alcohol pharmacotherapy or antiretroviral 
therapy.

- Role of integrated alcohol prevention and treatment services, 
reproductive health, family planning, social services, mental health 
services, and pediatric health services in improving health outcomes in 
HIV-infected mothers and their children.

5. Multi-level Behavioral and Psychosocial Approaches to the Prevention 
of HIV Transmission Among Individuals Who Misuse Alcohol and to the 
Treatment of Individuals with Co-occurring HIV/AIDS and Alcohol 
Abuse/Dependence: The implementation of research-based 
behavioral/psychosocial interventions which will complement state-of-
the-art pharmacologic interventions for the treatment of alcohol 
dependence in HIV+ women will be critically important to the 
achievement of improved clinical outcomes.  Research is needed to 
better characterize and address the impact of behavioral and 
psychosocial factors on access to treatment and on drinking and 
HIV/AIDS outcomes among women, and to ameliorate negative behavioral, 
affective, physical, cognitive and social consequences of HIV infection 
in alcohol-using and -abusing women through multilevel interventions.  
Such interventions may target, separately or in combination, individual 
women, couples, families, treatment programs and networks of programs, 
and communities.   Specifically, research efforts are needed to:

- Integrate alcohol risk reduction goals into HIV/AIDS treatment 
programs which serve women, including behavioral, psychosocial, and 
pharmacological interventions.  Evaluate effectiveness of 
behavioral/psychosocial interventions to help women stop drinking and 
avoid relapse. Develop tailored treatments as needed for special 
populations such as underserved minority women, pregnant women, and 
women with comorbid psychiatric diagnoses.

- Integrate HIV risk reduction goals into alcohol abuse treatment 
programs which serve women, including behavioral, psychosocial, and 
educational interventions.  Evaluate the effectiveness of HIV risk 
reduction strategies for women in alcohol treatment settings. Develop 
tailored treatments as needed for special populations such as 
underserved minority women, pregnant women, and women with comorbid 
psychiatric diagnoses.

- Develop and test interventions to improve the quality of life of 
women with coexisting HIV/AIDS and alcohol use disorders (e.g., 
strategies to reduce the impact of alcohol-related consequences on 
social, family, vocational functioning and well-being, and on the 
course of AIDS-related illnesses.)

- Increase knowledge of effective collaborative approaches to the 
organization and management of services for HIV-positive women, 
including adolescents, with alcohol use disorders, including analyses 
of barriers to access and utilization of services, and strategies to 
overcome them (e.g., mobile vans as a means for improving health care 
access by women who abuse alcohol).

- Improve understanding of the relationship between alcohol use and 
abuse, access to care, and delivery and cost of services for infected 
women. 

6. Biological Research on Alcohol and HIV/AIDS: Lack of knowledge on 
the influence of alcohol on HIV infectivity and viral replication among 
women is a major impediment to understanding HIV-related morbidity and 
mortality.  Therefore, research that provides detailed knowledge of 
possible gender-based differences in how alcohol and HIV, each in its 
own way or acting in concert, usurp host defense mechanisms and enhance 
viral replication is urgently needed.  Biological research that 
delineates the multiple effects of alcohol and HIV on host defense 
mechanisms and disease progression among women will provide a rational 
basis for the development of new methods of therapeutic intervention. 
The following topics serve to illustrate the types of research that 
would be responsive to this RFA:

- Effects of alcohol on viral burden, immune function, and organ system 
dysfunction in HIV-infected women of all ages or in appropriate animal 
models. 

- Organ system changes (e.g., changes in endothelial cell permeability 
to HIV proteins, etc.) at the tissue, cellular, and molecular levels 
that may influence infectivity, viral load, disease progression and/or 
therapeutic response among women.

- Animal models of alcohol consumption and AIDS to explore effects on 
HIV infectivity, cellular metabolism and immune state dynamics among 
women and to explore the influence of age/hormonal status on these 
effects. How may these effects vary pre- and post-puberty; pre- and 
post-menopause?

- New in vitro models to characterize the effects of alcohol on the 
response of cellular systems to HIV among women (e.g., blood brain 
interface, placental interface, vaginal mucosa, etc.) 

- Drug-drug interactions between alcohol and antiretroviral drugs among 
women, including altered pharmacokinetics, metabolism and toxicity due 
to chronic or acute alcohol consumption.

7. Community-Based Participatory Research:  Community-based 
participatory research in public health is a partnership approach to 
research that equitably involves, for example, community members, 
organizational representatives, and researchers in all aspects of the 
research process.  The partners contribute their expertise and share 
responsibilities and ownership to enhance understanding of a given 
phenomenon, and to integrate the knowledge gained with action to 
improve the health and well-being of community members.  Such research 
recognizes the community as a social and cultural entity with the 
active engagement and influence of community members in all aspects of 
the research process.  Within the area of community-based participatory 
research, suggested special emphasis areas include:

- Research on the characteristics of community-based organizations and 
coalitions most likely to be successful in implementing effective 
science-based interventions targeting high-risk women drinkers.

- Studies which identify and evaluate outcome measures and data 
collection systems appropriate to the evaluation of research-based HIV 
prevention interventions for women in community settings.

- Research on models for facilitating cooperation among research and 
service professionals.

- Studies of the mechanisms by which institutions which serve women 
network with other community agents and other community institutions.  
When and how do such connections and collaborations improve HIV and AOD 
prevention efforts?  When and how do they fail to do so?

- Multi-level collaborative research to study patterns of communication 
between various sectors of society (e.g., Federal, state, and local 
governments, community-based service organizations, and the business 
community, etc.) and their impact on the delivery of prevention, 
intervention, and treatment services to women with coexisting HIV/AIDS 
and alcohol use disorders.
 
- Programs of community-based participatory research involving U.S.-
supported researchers and researchers in other nations to evaluate 
community-level strategies to arrest the global spread of HIV infection 
and its consequences among women. 

8. Dissemination and Diffusion of Research Findings:  Despite advances 
in our knowledge of effective approaches to preventing HIV infection, 
it is clear that information, strategies, and models for HIV prevention 
have not always reached community program levels.  Likewise, 
information developed by community programs has frequently not reached 
or influenced HIV prevention researchers.  It is extremely important 
that more effective collaborative relationships between the research 
community and the community of public organizations delivering 
prevention programs to high-risk women be developed in such a way that 
a sustainable research infrastructure is established and/or enhanced at 
the level of local communities.  Models of technology transfer need to 
be developed and validated in large-scale community settings.  These 
models must include effective training for community providers as well 
as ongoing assessment of what happens to research-based interventions 
when they are put into practice.  Critical to the success of these 
efforts will be an awareness of the cultures in which the interventions 
were undertaken and ways in which existing interventions may have to be 
modified to be successful.  Interventions which leave in place 
infrastructures capable of complex problem solving, program evaluation, 
and ongoing two-way communication with the research community should 
facilitate future technology transfer.  

Suggested areas of research include but are not limited to:

- Studies that develop and test different models for transferring 
effective research-based HIV prevention interventions for women into 
relatively resource poor communities.

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

- Collaborative programs to train minority investigators to conduct 
clinical, biomedical, and prevention research which explores the impact 
of alcohol abuse on HIV transmission, disease progression, and clinical 
outcomes among women.

MECHANISMS OF SUPPORT 

This RFA will use the following NIH award mechanisms:
- Research projects (R 01);
- Small grants (R03); 
- Exploratory/developmental grants (R 21); 
- Education projects (R 25); 

Applications for R01s may request support for up to 5 years.  
Facilities and Administrative (F&A) costs will be awarded based on the 
negotiated rate at the time of the award.

Under the NIAAA Small Grant mechanism (R03) applicants may request 
either $25,000 or $50,000 in direct costs per year for up to two years. 
These awards are not renewable; however, a no-cost extension of up to 
one year may be granted to the grantee institution prior to expiration 
of the project period. Before completion of the R03, investigators are 
encouraged to seek continuing support for research through a research 
project grant (R01). (See Program Announcement PA-99-098, "NIAAA Small 
Grant Program," http://grants.nih.gov/grants/guide/pa-files/PAR-
99-098.html, for a complete description of the R03 mechanism.) 

NIAAA Exploratory/developmental grants (R21) are limited to 3 years for 
up to $100,000/year for direct costs. (See Program Announcement PA-99-131, 
"NIAAA Exploratory/Developmental Grant Program," 
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a 
complete description of the R21 mechanism.)

Exploratory/Developmental Grants and Small Grants cannot be renewed: 
however, a no-cost extension of up to one year may be granted prior to 
expiration of the project period.  Investigators are encouraged to seek 
continued support after completing an Exploratory/Developmental Grant 
project or a Small Grant project through a Research Project Grant 
(R01).

Information about NIAAA Alcohol Education Project Grants may be found 
at http://grants.nih.gov/grants/guide/pa-files/PAS-99-165.html

As an applicant you will be solely responsible for planning, directing, 
and executing the proposed project.  This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation applications 
based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer 
review procedures.

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats.  (See 
http://grants.nih.gov/grants/funding/modular/modular.htm.)
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.

FUNDS AVAILABLE  

NIAAA intends to commit up to 3 million dollars in FY 2003 to fund 
eight to twelve new and/or competitive continuation grants in response 
to this RFA.

An applicant may request a project period of up to 5 years and, if 
applying for an R01 award, a budget for direct costs of up to $500,000 
per year.  If applying for a small grant (R03) or developmental 
exploratory grant (R21), please see the budget limitations described 
under the "Mechanisms of Support" section, above.  Applications for 
exploratory/developmental research (R21) involving innovative concepts 
and methodologies are also strongly encouraged.

Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and 
duration of each award will also vary. Although the financial plans of 
the NIAAA 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 applications. At this time, it is not 
known if this RFA will be reissued. 

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the 
following characteristics:
 
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges,             
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES 

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas: scientific/research, peer review, and financial or grants 
management issues.

Direct your questions about behavioral and social science research 
issues to: 

Kendall Bryant, Ph.D.
Scientific Director Alcohol and HIV/AIDS Research
Chief, Collaborative and Special Health Programs
Office of Collaborative Research 
Suite 302
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 402-9389
FAX: (301) 480-2358
Email: kbryant@niaaa.nih.gov

Direct your questions about epidemological research issues to:

Vivian Faden, Ph.D.
Chief, Division of Biometry and Epidemiology 
Suite 514 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard
Bethesda, MD  20892-7003.  
Telephone:  (301) 594-6232

Direct your questions about clinical and prevention research issues to:

Robert C. Freeman, Ph.D.
Health Scientist Administrator
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505
Bethesda, MD 20892-7003
e-mail:  rfreeman@mail.nih.gov
phone:  301-443-8820
fax:  301-443-8774

Direct your questions about basic research issues to:

Denise Russo, Ph.D.
Chief, Division of Basic Research
Suite 402
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Bethesda, MD  20892-7003
Telephone:  (301) 402-9403
Fax:  (301) 594-0673
E mail:  drusso@niaaa.nih.gov

Direct your questions about review matters to:

Eugene G. Hayunga, Ph.D.
Chief, Extramural Project Review Branch
Office of Scientific Affairs 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD 20892-7003 
Rockville, MD 20852 (for express/courier service) 
Telephone: (301) 443-4375  FAX: (301) 443-6077

Direct your questions about financial or grants management matters to: 

Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
email:  jsimons@willco.niaaa.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 date listed at the beginning 
of this document.  The letter of intent should be sent to:

RFA-AA-03-004
Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Suite 409, MSC 7003
Bethesda, MD 20892-7003 (use Rockville, MD 20852 for express/courier 
service)
Telephone:  (301) 443-4375
FAX:  (301) 443-6077

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: 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: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application 
must be sent to:

RFA-AA-03-004
Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Suite 409, MSC 7003
Bethesda, MD 20892-7003 (use Rockville, MD 20852 for express/courier 
service)
Telephone:  (301) 443-4375
FAX:  (301) 443-6077

APPLICATION PROCESSING: 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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIAAA.  Incomplete applications will be returned 
to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

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 NIAAA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the National Institute on Alcohol 
Abuse and Alcoholism 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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you 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 your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  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?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  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 INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, 
below.)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: December 13, 2002 
Application Receipt Date: January 13, 2003
Peer Review Date:  March-April 2003
Council Review:  June 4, 2003
Earliest Anticipated Start Date:  July 1, 2003

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.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  


INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for research 
involving human subjects.  You will find this policy announcement in the 
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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.

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.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.273 and 93.279, and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  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 described 
at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the 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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