HIV/AIDS AND THE SEVERELY MENTALLY ILL

Release Date: June 16, 1998

PA NUMBER: PA-98-080 (see replacement PA-04-024)

P.T.

National Institute of Mental Health

PURPOSE

Research is urgently needed to adequately respond to the AIDS epidemic among
people with persistent and recurrent psychiatric disorders such as schizophrenia,
depression or bipolar disorder.  This program announcement (PA) is sponsored by
the NIMH to stimulate investigator-initiated research that targets persons with
severe mental illness (SMI) either before or after HIV infection.  It solicits
studies on the SMI population that address the epidemiology of HIV infection,
epidemiology of sexual and drug-use risk behaviors and other relevant risk
behavior patterns, risk reduction and transmission prevention interventions,
treatment of mental illness and the neuropsychiatric sequelae due to HIV
infection, service provision research or other issues relevant to persons with
SMI.  An important objective of this PA is to encourage integration both across
and within these different areas and the translation of these research findings
to applied mental health and public care systems.  Multidisciplinary research
teams and collaborative alliances are encouraged.

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 PA, HIV/AIDS and the Severely Mentally
Ill, is related to the priority areas of mental health and mental disorders and
HIV infection.  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 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 R03, P01, or K-
Series awards.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

K-Series Awards

Applications may be submitted on behalf of candidates by domestic, non-Federal
organizations, public or private, such as medical, dental, or nursing schools or
other institutions of higher education. Minorities and women are encouraged to
apply. Candidates must be U.S. citizens or noncitizen nationals, or must have
been lawfully admitted for permanent residence and possess an Alien Registration
Receipt Card (I-151 or I-551) or some other verification of legal admission as
a permanent resident.  Noncitizen nationals, although not U.S. citizens, owe
permanent allegiance to the U.S.  They are usually born in lands that are not
states but are under U.S. sovereignty, jurisdiction, or administration. 
Individuals on temporary or student visas are not eligible.

Other eligibility requirements for research career awards are as follows:

K01 (Mentored Research Scientist Development Awards):  The candidate must have
a research or a health-professional doctorate or its equivalent, and must have
demonstrated the capacity or potential for highly productive independent research
in the period after the doctorate.  The candidate must identify a mentor with
extensive research experience.

K02 (Independent Scientist Award): The candidate must have a doctoral degree and
peer-reviewed independent, research support at the time the award is made.  In
addition, the candidate must demonstrate that the requested period of research
focus will foster his/her career as a highly productive scientist in the
indicated field of research.

K05 (Senior Scientist Award):  The candidate must be a senior scientist and a
recognized leader in the field with a distinguished record or original
contributions, must have long-term support from a funding instate or center; and
must have peer-reviewed grant support at the time of the award.

Each of these Research Career Awards is fully described in its own specific
Program Announcement, which is available from program staff listed under
INQUIRIES and on the NIH Guide homepage at:
http://www.nih.gov/grants/guide/index.html

MECHANISM OF SUPPORT

The mechanisms available for support are research project grants (R01), small
research grants (R03), program project grants (P01), Mentored Research Scientist
Development Awards (K01), Independent Scientist Awards (K02), and Senior
Scientist Awards (K05).

Because certain grants have special eligibility requirements, application
formats, and review criteria (i.e., small grants, K-Series grants), applicants
are strongly encouraged to consult with the NIMH program staff listed under
INQUIRIES and obtain the appropriate additional announcements for those grant
mechanisms.

An applicant planning to submit a new investigator-initiated grant application
requesting $500,000 or more in direct costs for any year is advised that he or
she must contact Institute program staff (see INQUIRIES, below) before submitting
the application, i.e, as plans for the study are being developed.  Furthermore,
the applicant must obtain agreement from Institute staff that the Institute will
accept the application for consideration for award.  Finally, the applicant must
identify, in the cover letter that is sent with the application, the staff member
and Institute who agreed to accept assignment of the application.

RESEARCH OBJECTIVES

Background

Systematic investigation of the magnitude of the AIDS epidemic in persons with
SMI did not begin until the early 1990s, in part due to false assumptions about
the sexuality and drug use of this population.  Thus, there is a paucity of
research on HIV infection in persons with SMI.  Recognizing the scarcity of
empirical information to guide HIV prevention and treatment decisions for persons
with SMI, the NIH Office on AIDS identified research on this understudied
population as one of its highest priority research initiatives for FY 99. 
Research on the epidemiology of HIV infection in national samples of persons with
SMI has been limited to certain geographic areas and to certain subpopulations
and must therefore be broadened in a number of ways.  Research on the behavioral
epidemiology of HIV and AIDS in persons with SMI has been more abundant but our
knowledge in this area is still limited.  Assessment and data collection methods
for documenting risk-taking must be improved.  New research studies need to be
devoted to basic measurement concerns, including the reliability and validity of
self-reported sexual and drug use behavior.  Both quantitative and qualitative
studies are needed to understand patterns of risk behavior over time in larger
and more varied samples.  Also, research efforts on HIV-related risk behavior
must be broadened to examine contextual determinants of risk behavior and the
social organization of sexual and drug-use behavior.  Controlled prevention
trials are only just beginning and in some cases the results are promising but
beneficial effects are short-lived. Intervention trials need to be tailored to
the population of SMI.  Most importantly, there is limited data to ascertain
whether the few promising intervention models are generalizable to the natural
setting.  The complexity and multiplicity of effects of HIV infection in persons
with SMI demand a comprehensive approach for its study.

Areas of Research

Research studies should be focused primarily on populations of the severely
mentally ill although other mentally ill populations may sometimes be relevant. 
Examples of research that would be an appropriate response to this Program
Announcement include, but are not limited to:

Methodology:

o  Research on the phenomenology and classification of HIV-related mental
disorders and symptoms

o  Studies on methodological features of HIV-related risk taking

o  Studies on the development of new instruments or adaptation of existing
measures to assess HIV-related changes in mental and psychological status or to
improve methods for measuring behavior change

Epidemiology and Risk Factors:

o  Research on the incidence and prevalence and other aspects of the epidemiology
of HIV infection

o  Studies that identify the behaviors and contexts that place persons with
severe mental illness and their communities at risk for HIV

o  Research on the correlates, determinants and distribution of HIV-related risk
behaviors

o  Studies of vulnerable high-risk populations (e.g., adolescents at risk for
mental disorders; homeless individuals multiply diagnosed with HIV, substance
abuse and mental illness)

o  Studies of comorbid influences (e.g., substance abuse) that increase risk
behavior

Treatment, Prevention and Services:

o  Research on management and treatment approaches to HIV infection

o  Studies of theory-driven behavioral interventions (at the individual, group
or community levels) to reduce high risk behaviors and prevent HIV infection

o  Research on the development and testing of behavior change strategies to
reduce HIV-related risk behaviors

o  Studies of medical or neuropsychiatric manifestations of HIV infection that
may result in onset of severe mental illness (e.g., HIV-related dementia,
psychotic disorders, delirium, CNS opportunistic infections and tumors, systemic
abnormalities, psychoactive agents, adverse effects of certain medical
treatments)

o  Studies on the implementation and fidelity of successful research
interventions

o  Research on mental health service needs and assessment of the most effective
methods for providing and financing services to HIV-infected individuals

o  Studies of barriers to HIV-related care for psychiatric patients (e.g.,
stigma, denial of illness, and adherence to treatment regimens)

o  Research on the effects of antiretroviral treatments on neuropsychological and
psychological conditions as well as effects of psychoactive medications on
psychopathological conditions associated with HIV infection

o  Policy relevant research which helps to reduce the gap between HIV behavioral
science and the legislative process

o  Research on community participation and information dissemination activities
and strategies

o  Studies on the impact of HIV counseling and testing on risk behaviors

o  Studies that assess the effectiveness of behavioral interventions in natural
settings

o  Research on the dissemination of effective intervention strategies with
different subpopulations of severely mentally ill infected with HIV

o  Studies that translate research results into community programs, moving from
research interventions to ongoing public health programs and cost effectiveness

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.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS 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 address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard AIDS-related application deadlines as
indicated in the application kit.  Application kits are available at most
institutional offices of sponsored research and may be obtained 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; fax: (301) 480-0525; Email: [email protected].  The title and number of
the program announcement must be typed in Section 2 on the face page of the
application.

The completed original application and five legible copies must be sent or
delivered 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in accordance with
the standard NIH peer review procedures.  As part of the initial merit review,
all applications will receive a written critique and may 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 appropriate national
advisory council or board, when applicable.

Review Criteria for Research Project Grant Applications

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 review, comments on the following aspects of the application will be made
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 the assignment of the overall score:

(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?

(6) Appropriateness of the proposed budget and duration in relation to the
proposed research;

(7) Adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

The initial review group will also examine the provisions for the protection of
human and animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of Women, Minorities, and
Children as Subjects in Clinical Research.

Review Criteria for Program Project Grant Applications

Individual projects will be evaluated using the above review criteria for
research projects.  In addition, the relationship and contributions of each
research component and core (excluding those removed through recommendations by
the IRG) to the overall theme of the program project are discussed and evaluated. 
This should be a separate consideration that is not influenced by the merit
ratings of the individual projects.  Although projects not recommended for
inclusion in the program automatically are removed from consideration as part of
the overall program project, such projects will reflect on the leadership
capabilities of the principal investigator and will be considered in the overall
merit.

The overall program project application is evaluated considering the remaining
projects, supporting cores, and the administrative structure.  For the program
project to receive a priority score, it must consist of at least three projects
(each found to have significant and substantial merit) for the duration of the
project period.  Each core must provide essential functions or services for at
least two of these projects.

Specific factors to be evaluated in the consideration of the overall program
project are as follows:

(1) Scientific Considerations - the following criteria must be evaluated:

o  Scientific merit of the program as a whole, as well as that of individual
projects;

o  Significance of the overall program goals;

o  Scientific gain of combining the component parts into a program project
(beyond that achievable if each project were to be pursued separately);

o  Cohesiveness and multidisciplinary scope of the program and the coordination
and interrelationship of all individual research projects and cores to the common
theme;

o  Leadership and scientific ability of the principal investigator/program
director and his or her commitment and ability to develop a well-defined central
research focus and to devote adequate time and effort to the program; and

o  Past accomplishments of the program or a demonstrated ability in mounting
similar programs.

(2) Administrative Considerations - For all program project applications, in
addition to evaluating the scientific components, review also will assess:

o  Academic environment and resources in which the research will be conducted,
including availability of space, equipment, human subjects, animals, or other
resources as required, and the potential for interaction with scientists from
other departments;

o  Institutional commitment to the requirements of the program, including fiscal
responsibility and management capability of the institution to assist the
principal investigator/program director and his or her staff in following HHS,
PHS, and NIH policy;

o  Administrative planning and leadership capability to provide for internal
quality control of ongoing research, allocation of funds, enhancement of internal
communication and cooperation among the investigators involved in the program,
and replacement of the principal investigator/program director if required on an
interim or permanent basis;

o  Appropriateness of the budget in relation to the proposed program; and

o  Human subjects protection, animal welfare, and biohazard issues.

Review Criteria for Research Career Awards will include items concerning:

(1) The Candidate

(2) Career Development and Research Plan

(3) Institutional Environment and Commitment to the Candidate

Specific criteria within each of these items will vary from mechanism to
mechanism.  Specific information is available from program staff listed under
INQUIRIES and on the NIH Guide homepage at:
http://www.nih.gov/grants/guide/index.html

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

David M. Stoff, Ph.D.
Office on AIDS Research
National Institute of Mental Health
Parklawn Building, Room 18-101
Rockville, MD  20857
Telephone:  (301) 443-4625
FAX:  (301) 443-9719
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.242, Mental Health Research Grants.  Awards are made under authorization of
the Public Health Service 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 grants
policy as stated in the Public Health Service Grants Policy Statement (April 1,
1994).

PHS strongly encourages all grant and contract recipients to provide a smoke-free
workplace and promote the nonuse 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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