DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS

Release Date:  January 9, 1998

RFA:  AA-98-001

P.T.

National Institute on Alcohol Abuse and Alcoholism

Letter of Intent Receipt Date:  March 20, 1998
Application Receipt Date:  April 21, 1998

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate
the design, development, and testing of alcohol-related HIV preventive
interventions that have the potential for reducing the risk of transmission of
HIV in alcohol using, abusing, and dependent populations.  This Request for
Applications (RFA) reflects "Findings and Recommendations" suggested by the "NIH
AIDS Research Program Evaluation: Behavioral, Social Science, and Prevention
Research Area Review Panel."  The review panel recommended a substantial increase
in support for preventive intervention research in a diverse range of alcohol-
related settings, drinking populations, and HIV-risk populations. In addition,
this RFA is responsive to a proposed HIV Prevention Science Initiative by the
Office of AIDS Research that seeks to stimulate further research on the impact
of "... early identification (of HIV infection), counseling, and other behavioral
interventions, and HIV treatment on risk behaviors, the utilization of HIV
prevention services, and the transmission of HIV."  The focus of this primary
priority area is the behavior of HIV-infected individuals as it relates to
further transmission of HIV and the prevention thereof (among alcohol and
substance abusing populations). A commitment to multidisciplinary research and
to research that focuses on a range of population groups is implicit in this
priority.

Investigators are encouraged to move beyond basic behavioral studies to measure
the efficacy and effectiveness of substance use risk-reduction interventions in
populations at risk for both alcohol problems and HIV infection. The emphasis of
this RFA on prevention research in the alcohol/AIDS area continues the previous
focus of the NIAAA Prevention Research Branch on primary prevention of HIV and
alcohol abuse among male and female alcohol users.  In addition, this RFA
addresses secondary prevention issues among HIV infected male and female
alcoholics who may be more likely than other HIV infected individuals to engage
in high-risk sexual behavior, to use unclean needles, and to have problems
adhering to therapeutic treatments for HIV and AIDS.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA is related to the priority area
of AIDS prevention.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report:  Stock
No.017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (Telephone: 202-512-1800).

ELIGIBILITY

Applications may be submitted by domestic and foreign, for-profit and non-profit,
public and private organizations, 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 Investigators.

MECHANISM OF SUPPORT

Research support may be obtained through an application for a regular research
project grant (R01). Applications are also encouraged for
Exploratory/Developmental Grants (R21), which are limited to 2 years for up to
$70,000 per year for direct costs.  Exploratory/Developmental Grants are also
available for the secondary analysis of existing alcohol abuse prevention
research data that examine intervention effects related to alcohol use.  These
grants are limited to 2 years for up to $100,000 per year for direct costs.

Applicants may submit applications for Investigator-Initiated Interactive
Research Project Grants (IRPGs).  Interactive Research Project Grants require the
coordinated submission of related research project grants(R01)from investigators
who wish to collaborate on research, but do not require extensive shared physical
resources.  These applications must share a common theme and describe the
objectives and scientific importance of the interchange of, for example, ideas,
data, and materials among the collaborating investigators.  A minimum of two
independent investigators with related research objectives may submit concurrent,
collaborative, cross-referenced individual R01 applications.  Applicants may be
from one or several institutions.  Further information on these and other grant
mechanisms may be obtained from the program staff listed under INQUIRIES. 
Further information on the IRPG mechanism is available in program announcement
PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995.

Potential applicants for Exploratory/Developmental Grants may obtain copies of
the specific announcements for these programs from the NIAAA Home Page at
HTTP://WWW.NIAAA.NIH.GOV or from the Office of Scientific Affairs, NIAAA, Willco
Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, MD 20892-7003.
Telephone: 301-443-4375 or FAX 301-443-6077.  Further information on these and
other grant mechanisms may be obtained from the program staff listed under
INQUIRIES.

FUNDS AVAILABLE

It is estimated that up to $4.0 million will be available to fund approximately
15 grants under this RFA.  This level of support is dependent on the receipt of
a sufficient number of applications of high scientific merit.  The award of
grants pursuant to this RFA is contingent upon the availability of funds for this
purpose.  The earliest possible award date is September 30, 1998.

RESEARCH OBJECTIVES

Alcohol consumption has been identified as an important behavioral cofactor for
HIV infection and has been consistently associated with HIV-risk behaviors over
time. Significantly higher rates of HIV infection are found among clinical
samples of male and female alcoholics and nonclinical samples of individuals who
meet criteria for alcohol dependence than in the general public. In addition,
reduction in alcohol use in treatment samples is associated with reduced sexual
risk taking. Higher levels of alcohol use has also been shown to predict higher
incidence of infection and reduced time to seroconversion among gay men, and non-
adherence to medical regimens among  infected individuals. Although, there is
limited research among minority and impoverished women who are at increasing risk
for HIV infection, alcohol use by women and their partners has been linked to
increased sexual violence and susceptibility to HIV infection.
Alcohol-related HIV interventions are being tested among gay and bisexual men,
Native American youth, incarcerated young adults, and persons in alcoholism
treatment. Initial results after intervention and at follow-up suggest that a
wide range of HIV-risk behaviors can be reduced, particularly among gay men and
in alcohol treatment contexts. This research suggests that substance abuse
prevention and treatment programs that include HIV components are more effective
in reducing alcohol consumption and risky sexual practice than programs those
that do not contain these components.  Similarly, it appears that HIV prevention
programs that include an alcohol risk-reduction component may be more effective
in reducing HIV risk behaviors than those that do not.

Preventive interventions may be initiated and implemented by the investigators
themselves for the specific purpose of testing effects of the strategies; or the
interventions may occur naturally through the actions of public and private
organizations (e.g., reduction in availability and accessibility of alcohol,
increased distribution of condoms at bars, health promotion campaigns that
highlight linkages between alcohol use and AIDS).  Investigator-initiated
alcohol-focused interventions may also be nested within the context of naturally
occurring HIV interventions, such as vaccine trials, permitting the effects of
both types of interventions to be studied simultaneously.  These alcohol-focused
interventions can be aimed at individuals, social networks, institutions, and
specific alcohol settings such as bars and clubs, to change alcohol-related
sexual expectancies, behavioral norms, and HIV risk-taking behaviors. 
Populations at risk for HIV who also abuse or are dependent on alcohol are most
in need of study.  These special subgroups include alcohol abusing women and
minorities, gay or bisexual men, male and female alcoholics in treatment, and
adolescents initiating sexual behavior in the context of drinking in which HIV
is prevalent.  Other groups of interest that may be indirectly affected by
alcohol use include partners and families of HIV-infected alcoholics.

In addition to developing and testing new investigator-initiated interventions
or measuring effects of naturally-occurring preventive policies or programs,
timely and cost-effective approaches may include:

a) developing additional HIV interventions within the context of clinical studies
to address alcohol-related problems (e.g., improving adherence of alcohol abusers
to therapeutic regimens involving protease inhibitors).

b) augmenting ongoing alcohol-problem intervention studies to include HIV
infected or at-risk populations and adapting the intervention to address HIV
issues in this subgroup (e.g., including HIV-risk populations in comparisons of
brief motivational counseling and cognitive-behavioral interventions).

Several areas of emphasis for particular high-risk groups or innovative
approaches to multidisciplinary research may be appropriate for proposed
intervention studies.  These include, but are not limited to:

o  Hard-to-reach populations:  Alcohol abusers often delay entering medical
settings where they could be identified as needing appropriate interventions and
are often difficult to retain in controlled clinical trials. Such difficulties
in attracting and retaining alcohol-abusing individuals may have particular
significance for the testing and evaluation of HIV vaccines and therapeutics. 
New interventions need to be developed to attract and retain individuals at
extremely high-risk for alcohol abuse and HIV infection, and new research designs
and analytic strategies need to be developed to adequately evaluate these
interventions in settings in which high rates of attrition may occur. 
Intervention strategies might, for example, include more informal and culturally
relevant drop-in clinics, and different analytic procedures, such as case-control
or case-based designs may be necessary to test the effects of these interventions
on such variables as HIV exposure, alcohol abuse, and retention in vaccine or
therapeutics trials.

o  Health-Care Systems: Increasing attention is being paid to the role of health-
care systems and professionals in preventing alcohol-related problems before they
occur, in facilitating early detection of alcohol-related high-risk behaviors,
and in providing appropriate treatment.  Experimental and quasi-experimental
designs may be used within health-care settings to test the efficacy of
preventive strategies.  These strategies may include risk assessment, brief and
more extensive advice, case monitoring, and improved linkage to services for
alcoholics in treatment or for HIV-infected individuals with alcohol problems.

o  Application of Basic Behavioral Research to Interventions:  A wide range of
preintervention studies have addressed the relationship of cognitive and
physiological effects of alcohol use on high-risk sexual behavior.  These studies
have measured the effects of alcohol-related sexual expectancies, physiological
disinhibition, decision making while intoxicated, and affect regulation.  Theory
driven interventions need to be developed that take into account these recent
findings concerning high-risk behavior under conditions of intoxication.
Components of interventions can be designed to rigorously test the mediating
effects of key theoretical constructs.

o  Media/Communications:  Ongoing research is needed to assess the efficacy of
media strategies, alone or combined with other strategies, to prevent alcohol-
related risky sexual behavior. Applicants are encouraged to develop and test
promising media messages, new communications technologies, and special media for
cultural subgroups to determine the most effective media/communications
approaches for varied target audiences.  Of particular interest are communication
strategies that reach audiences at highest risk for alcohol abuse and HIV-
infection, which include impoverished youth and women, selected ethnic
minorities, gay and bisexual men, and male and female partners of HIV-infected
individuals.

o  Family Studies:  Research suggests that family involvement, broadly defined,
can enhance the effectiveness of school-based and clinic-based alcohol prevention
programs among youth at-risk for alcohol problems.  Research on homeless and
runaway youth indicates a high rate of co-occurring alcohol abuse and unsafe
sexual behavior, often resulting in the spread of sexually transmitted diseases. 
Research needs to be expanded in this area to develop effective interventions
among group or family members to reduce the risk for HIV infection.

o  Collaborative Community-Based Research:  As behavioral researchers focus on
problems of substance abuse and AIDS they are increasingly involved in the
communities that are most affected. Urban ethnic and racial minority
neighborhoods are particularly affected and often hard to access. To overcome
barriers to access, behavioral scientists have formed productive collaborative
alliances with organizations within these community environments including non-
government organizations (NGOs). In the case of this RFA, researchers and NGOs
are encouraged to collaborate in developing and testing interventions for alcohol
abuse and HIV problems. Where appropriate, proposed community-based research
should provide support for researchers within the NGO, to promote joint
participation in a scientific knowledge-building process. Effective collaborative
relationships should facilitate rigorous scientific evaluation of intervention
outcomes.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by March 20, 1998, 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 of 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 NIAAA staff to
estimate the potential review workload and avoid conflict of interest in the
review.

The letter of intent is to be sent to:

RFA-AA-98-003
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 409, MSC 7003
Bethesda, MD  20892-7003
FAX:  (301) 443-6077

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) 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 301/435-0714, Email: asknih@od.nih.gov.

The RFA label available in the PHS 398 (rev. 5/95) application form must be
affixed to the bottom of the face page of the application.  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.  Page limits and limits on size of type are strictly
enforced.  Non-conforming applications will be returned without being reviewed.

Submit a signed, typewritten original of the application, including the checklist
and three signed photo copies 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 also be
sent to:

RFA AA-98-003
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)

Failure to forward the above two applications to NIAAA at the above address may
delay consideration of an application such that it may not be received in time
for FY 1998 funding consideration.

Applications must be received by April 21, 1998.  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 and must be prepared in the format of a revised application.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and for
responsiveness by the NIAAA.  Incomplete applications will be returned to the
applicant without further consideration.  If the application is not responsive
to the RFA, the 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 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
the Institute in accordance with the review criteria stated below. As part of the
initial merit review, a streamlined review process may be used by the initial
review group in which applications may or may not be discussed based on their
scientific merit relative to other applications received in response to the RFA. 
Applications which are fully discussed will be assigned a priority score. 
Applications which are not discussed will be withdrawn from further
considerations and the Principal Investigator and the official signing for the
applicant organization will be notified.  The second level of review will be
provided by the National Advisory Council on Alcohol Abuse and Alcoholism.

Review Criteria

Criteria to be used in the scientific and technical merit review of the research
grant applications will include the following:

Significance:  Does the study address an the goals of the RFA?  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?

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 designs?

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?

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

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

Budget:  Is the requested budget and estimation of time to completion of the
project appropriate for the proposed research?

In addition, plans for the recruitment and retention of subjects will be
evaluated as will the adequacy of plans to include both genders and minorities
and their subgroups as appropriate for the scientific goal of the research.

The initial review group will also examine the provisions for the protection of
human and animal subjects and the safety of the research environment.

AWARD CRITERIA

Applications recommended for approval by the National Advisory Council on Alcohol
Abuse and Alcoholism will be considered for funding on the basis of the overall
scientific and technical merit of the application as determined by peer review,
NIAAA programmatic needs and balance, and the availability of funds.

INQUIRIES

Potential applicants are strongly encouraged to seek preapplication consultation,
for which purpose they may contact the individuals listed below.

Direct inquiries regarding the proposed research to:

Kendall Bryant, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8820
FAX:  (301) 443-8774
Email:  kbryant@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Judy Simons
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2434
FAX:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance, No.
93.273.  Awards are made under the authorization of the Public Health Service
Act, Sections 301 and 464H, and administered under the PHS policies and Federal
Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR
Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of
Human Subjects."  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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