Full Text AA-97-003
 
DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS
 
NIH GUIDE, Volume 25, Number 41, November 29, 1996
 
RFA:  AA-97-003
 
P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  AIDS 
  Disease Prevention+ 

 
National Institute on Alcohol Abuse and Alcoholism
 
Letter of Intent Receipt Date:  March 21, 1997
Application Receipt Date:  April 24, 1997
 
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. Alcohol consumption has been identified as an important
behavioral cofactor for HIV infection and has been consistently
associated with HIV-risk behaviors over time.  Alcohol use has been
shown to predict time to seroconversion among gay men. Significantly
higher rates of HIV infection are found among clinical samples of
alcoholics and nonclinical samples of individuals who meet criteria
for alcohol dependence than in the general public.
 
In addition, reduction in alcohol use is associated with reduced
sexual risk taking.  Alcohol-related HIV interventions are currently
being tested among gay and bisexual men, Native American youth, and
persons in alcoholism treatment. Initial results suggest that a wide
range of HIV-risk behaviors can be reduced after intervention and at
follow-up, particularly among gay men. 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.
 
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. 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 alcohol users.  In addition, this RFA
addresses secondary prevention among HIV infected 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.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) Awards (R29).  Research project grant
applications (R01) from foreign institutions are limited to three
years.
 
MECHANISM OF SUPPORT
 
Research support may be obtained through an application for a regular
research project grant (R01) or FIRST (R29) award.  Applications are
also encouraged for exploratory/developmental Grants (R21), which are
limited to two 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.
 
Applicants may submit applications for Investigator-Initiated
Interactive Research Project Grants (IRPGs).  Interactive Research
Project Grants require the coordinated submission of related research
project grant (R01) and, to a limited extent FIRST Award (R29)
applications 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 and
R29 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 FIRST Awards or 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, Maryland 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 $2.0 million will be available to fund
approximately ten grants under this RFA.  This level of support is
dependent on the receipt of sufficient number of applications of high
scientific merit. Although this program is provided for in the
financial plan of the NIAAA, the award of grants pursuant to this RFA
is also contingent upon the availability of funds for this purpose.
The earliest possible award date is September 30, 1997.
 
RESEARCH OBJECTIVES
 
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
gay or bisexual men, alcoholics in treatment, alcohol abusing women
and minorities, and adolescents initiating sexual behavior in the
context of drinking.  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 naturally-occurring preventive programs, timely and
cost-effective approaches may include:
 
a)  developing "augmenting" HIV interventions within the context of
clinical or epidemiological studies to address alcohol-related
problems (e.g., improving adherence of alcohol abusers to therapeutic
regimes involving protease inhibitors).
 
b)  supplementing 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.)
 
A wide range of contexts may be appropriate for 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 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.
Interventions need to be developed that take into account these
recent findings concerning high-risk behavior under conditions of
intoxication.
 
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
youth, 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 family members to reduce the risk for HIV
infection.
 
o  College and School-Based Studies:  Interventions are needed in
school and college environments to alter drinking practices that
contribute to unprotected sex, sexual assaults, and spread of
sexually transmitted diseases. Late adolescence and the transition
from high-school to college is when many young people are initially
freed from parental controls, increase their levels of alcohol
consumption, and increase sexual activity.  Often high rates of
drinking and binge drinking are encountered on college campuses.
Studies of alcohol-focused interventions that are currently being
carried out in school or college contexts could be usefully expanded
to evaluate effects of these interventions on high-risk sexual
behavior.
 
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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
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 20, 1994 (FR 59 14508-14513) and reprinted
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 21, 1997, 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-97-003
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 409
6000 Executive Boulevard 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.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office 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@odrockm1.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.  Applications for support mechanisms other than R01 (i.e.,
an R29) must cite the relevant program announcement on line 2 in
addition to listing the current RFA.  Applications for FIRST awards
(R29) must include at least three sealed letters of reference
attached to the face page of the original application.  FIRST award
(R29) applications submitted without the required number of reference
letters will be considered incomplete and will be returned without
review.  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 photocopies in one package to:
 
DIVISION OF RESEARCH GRANTS
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-97-003
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 409
6000 Executive Boulevard, 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 1997 funding consideration.
 
Applications must be received by April 24, 1997.  If an application
is received after that date, it will be returned to the applicant
without review. The Division of Research Grants (DRG) 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 DRG 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
DRG 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 DRG 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:
 
1. The scientific, technical, or medical significance and originality
of the proposed research and its relevance to the goals of this RFA:
 
2. The appropriateness and adequacy of the experimental approach and
methodology, including adequacy of quality control methods, proposed
to carry out the research such as adequacy of plans to measure
biological markers relevant to AIDS behavioral research e.g.,
seroconversion.
 
3. The adequacy of the qualifications (including level of education
and training) and relevant research experience of the principal
investigator and key research personnel.
 
4. The availability of adequate facilities, general environment for
the conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research.
 
5. The reasonableness of budget estimates and duration for the
proposed research.
 
6. When applicable, adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
these subjects will also be evaluated.
 
When applicable, the initial review group will also examine the
provisions for the protection of human and animal subjects and the
safety of the research environment.
 
The review criteria for Exploratory/Developmental Grants (R21) and
FIRST Awards (R29) are contained in their program announcements.
 
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
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues 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:
 
Linda Hilley
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4703
FAX:  (301) 443-3891
Email:  lhilley@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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