COMORBID MENTAL DISORDERS AND HIV/STD PREVENTION

Release Date:  January 29, 1999

RFA:  MH-99-008

P.T.

National Institute of Mental Health

Letter of Intent Receipt Date:  April 7, 1999
Application Receipt Date:  May 7, 1999

PURPOSE

Prevention programs must be based on the actual needs of the relevant
populations.  There is evidence of an interaction of comorbid mental health
factors, such as alcohol/drug use and abuse with high risk sexual behaviors. 
Alcohol and drugs may provide a disinhibiting effect as an impetus to engage
in unsafe behaviors, but a more complex conceptualization which includes
mental health factors may be required to design effective prevention programs. 
The purpose of this RFA is to design interventions that address these multiple
factors associated with high-risk behavior in order to prevent the spread of
HIV/STDs.

As the third decade of HIV/STD prevention research is being initiated, it is
necessary to build prevention programs based on actual needs and motivations
of at-risk populations in order to facilitate and stimulate their
participation.  Prevention programs that focus on only one aspect of risk
behaviors may not be as effective as multimodal, multifocused programs.  There
is evidence that there is an interaction of comorbid mental health factors,
such as alcohol/drug use and abuse with high-risk sexual behaviors in some
populations.  For example, in a sample of homosexual men, the consistent use
of non-injection drugs (e.g., amyl nitrite or amphetamines) rather than
episodic use, does affect seroconversion.  Mental disorders and mental health
factors (sensation seeking, poor impulse control) have also been associated
with high-risk behaviors.  Alcohol and drugs may provide a disinhibiting
effect as an impetus to engage in unsafe behaviors, but a more complex
conceptualization which includes mental health factors may be required to
design effective prevention programs.

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 Request for Applications (RFA),
"Comorbid Mental Disorders and HIV/STD Prevention," is related to the priority
areas of mental health, mental disorders, STDs and HIV/AIDS.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Foreign institutions are not eligible for
small research grant (R03) or program project grant (P01) awards. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project
grant (R01), small research grant (R03) and program project grant (P01) award
mechanisms.  Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  This RFA is a one-time
solicitation.  Future unsolicited competing continuation applications will
compete with all investigator-initiated applications and be reviewed according
to the customary peer review procedures.  The anticipated award date is
September 30, 1999.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.7 million in FY 1999 to fund three
to five new grants in response to this RFA.  An applicant may request a
project period of up to five years and a budget for direct costs of up to
$500,000 per year, excluding indirect costs on consortium arrangements. 
Because the nature and scope of the research proposed may vary, it is
anticipated that the size of each award will also vary.  Although the
financial plans of the Institute provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of applications of outstanding scientific and
technical merit.  At this time, it is not known if competing renewal
applications will be accepted and/or if this RFA will be reissued.

RESEARCH OBJECTIVES

The following five broad areas of research address HIV/STD-disease prevention
in individuals with comorbid mental health factors.  Researchers need not
limit themselves to these topics.

Basic Behavioral and Social Science Research

o  Cultural differences and their impact on substance abuse (e.g., heavy
drinking on weekends may be an expected and acceptable behavior in some social
networks)

o  Role of substance use and abuse in counteracting sexual dysfunction and its
impact on high-risk behaviors

o  Contextual issues (location, partnership type) as they relate to comorbid
factor/high risk sexual behavior

o  Impact of sensation-seeking/adventurism characteristics on high-risk 
sexual and drug using behavior.

o  Longitudinal studies, especially with youth (ages 12-21), focused on the
developing interaction of alcohol/drugs with sex

o  Studies of high-risk sex among high-risk youth, i.e., runaways, and
homeless or incarcerated youth

o  Integrative studies that take into account personal, situational, social,
geographical, and/or cultural variables

o  Impact of Stages of Change factors on HIV/STD prevention in populations
with mental disorders and comorbid alcohol/drug abuse

o  Studies of state dependence (e.g., depression, anxiety, drug intoxication)
issues on practice of HIV/STD prevention skills.

Epidemiology

Networks: social, sexual, drug-using, commercial/distribution

o  Comportment (social structuring of behavior under the influence of
substances, attribution of drugs and their effects)

o  Migration patterns -- effects of different geographical environments on
social norms/behaviors (e.g., studies of Puerto Ricans in New York and in
Puerto Rico, studies of migrant workers)

o  Interaction of psychopathology and stigmatization in regard to high risk
behavior

o  Life course perspective -- substance use and high risk may be
associated with age cohorts (e.g., young homosexual men in the process
of coming out may rebel against safer sex norms)

o  Role of conformity to current body image standards in high risk drug
use (including steroids) and sex

o  Role of marketing and advertising on social acceptability of drugs
and sexuality

o  Impact of childhood psychopathology on development of high-risk
substance abuse and sexual behaviors

Methodology

o  Development and improvement of methodology for mapping social
networks

o  Development of better data-analysis procedures (e.g., development of
procedures to deal with episodic co-occurrence of high-risk behavior)

o  Development and improvement of assessments and descriptions of drug
use and sexual behavior patterns

o  Development of non-intrusive ways to monitor continuously the sexual
and substance-use behaviors that address problems with self-report
methods

Interventions

o  Encouragement of substance abusers to have safer sex (even if the
causal paths are not fully understood and proven)

o  Intervention approaches with comorbid individuals (e.g., simultaneous
vs. sequential interventions to address comorbid drug use and risky sex)

o  Studies of whether or not lowering rates of substance abuse within a
community lowers rates of high-risk sex

o  Determining whether or not establishment of alternative social
settings (e.g., social environments that are free of substance abuse)
lowers rates of high-risk sex within a community

o  Impact on HIV/STD prevention of behavioral and pharmacological
treatment of mental disorders in persons who have varying patterns of
substance abuse and who refuse substance abuse treatment

o  Impact on HIV/STD prevention of behavioral and pharmacological
treatment of substance abuse in persons who have comorbid mental
disorders and who refuse mental health treatment

o  Development of interventions to minimize/prevent HIV/STD infection/
transmission in persons who exhibit comorbid mental health factors,
engage in substance abuse, and drop out of treatment or show varying
degrees of non-adherence to treatment

Policy

o  Natural experiments of the impact of taxation policies, closing of
venues, etc., on drug and alcohol abuse, high-risk sex, and HIV/STDs;
use of historical data sets (e.g., data on increases in alcohol taxes in
a region and the impact of such increases on the incidence of HIV/STDs
in that same region, especially as compared to a control region; data on
the long-term impact of closing public sex environments)

o  Rapid response to naturally occurring events (e.g., change in
partner-notification law, access to methadone maintenance treatment, or
fads in drug use) on high-risk sexual and drug-abuse behavior

o  Impact of Drug Wars between Cartels on use patterns in different
settings, including international settings

o  Impact of policies related to law enforcement (e.g., community
policing, local priorities, drug courts, access to services/benefits) on
HIV/STD prevention in comorbid populations

o  Impact of changes in the health-care system (e.g., managed care,
carve-ins and -outs, criteria for medical necessity, limitations on
length of treatment, restrictions on evaluation methods, and limited
formularies) on HIV/STD prevention efforts in the health-care system

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).  It
is also NIH 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 Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which was published in the Federal
Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for
Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the
web at: https://grants.nih.gov/grants/guide/notice-files/not94-105.html

INCLUSION OF CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS

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

All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects" that was published in
the NIH Guide for Grants and Contracts, March 6, 1998, and is available
at the following URL:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

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 a letter of intent that
includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the
identities of other key personnel and participating institutions, and
the number and title of the RFA in response to which the application may
be submitted.  Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application,
the information that it contains allows Institute staff to estimate the
potential review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to the program staff listed under
INQUIRIES by the letter of intent receipt date listed in the heading of
this RFA.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 710-0267, Email: GrantsInfo@nih.gov.  The application is
also available at https://grants.nih.gov/grants/forms.htm.

The RFA label available in the PHS 398 (rev. 4/98) application form must
be affixed to the bottom of the face page of the application.  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, Comorbid Mental Disorders and
HIV/STD Prevention (MH-99-008), must be typed on line 2 of the face page
of the application form and the YES box must be marked.

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:

Willo Pequegnat, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209 MSC 9619
Bethesda, MD  20892-9619

Applications must be received by May 7, 1999.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIMH staff.  Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIMH in accordance with the review criteria
stated below.  As part of the initial merit review, all applications
will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
National Advisory Mental Health 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 the application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals.  Each of these criteria will be addressed and considered in
assigning the overall score, weighting them as appropriate for each
application.  Note that the application does not need to be strong in
all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may
propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the
aims of the application are achieved, how will scientific knowledge be
advanced?  What will be the effect of these studies on the concepts or
methods that drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project?  Does the applicant acknowledge potential problem
areas and consider alternative tactics?

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

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

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

The initial review group will also examine: the appropriateness of
proposed project budget and duration; the adequacy of plans to include
both genders, minorities and their subgroups, and children as
appropriate for the scientific goals of the research and plans for the
recruitment and retention of subjects; the provisions for the protection
of human and animal subjects; and the safety of the research
environment.

Schedule

Letter of Intent Receipt Date:    April 7, 1999
Application Receipt Date:         May 7, 1999
Peer Review Date:                 June/July 1999
Council Review:                   September 1999
Earliest Anticipated Start Date:  September 30, 1999

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

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:

Willo Pequegnat, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209 MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email: wpequegn@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Rockville, MD  20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

NIAAA is not co-sponsoring this RFA but is committed to understanding
the complex interaction among psychological/psychiatric processes, drug,
and alcohol abuse among populations at risk for or infected with
HIV/AIDS.  Please contact Kendall Bryant, Ph.D., Health Scientist
Administrator, National Institute on Alcohol Abuse and Alcoholism,
Willco Building, Room 505, 6000 Executive Boulevard, Rockville, MD
20892-7003; telephone: (301) 443-8820; fax: (301) 443-8774; Email:
KBRYANT@WILLCO.NIAAA.NIH.GOV.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.242.  Awards are made under authorization of the Public Health
Service 5600 Fishers Lane Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered under
PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part
74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. 
Awards will be administered under PHS policy as stated in the NIH Grants
Policy Statement (October 1, 1998).

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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