HIV PREVENTIVE INTERVENTIONS FOR THE SEVERELY MENTALLY ILL

Release Date:  February 1, 2000

RFA:  MH-00-012

National Institute of Mental Health

Letter of Intent Receipt Date:  April 24, 2000
Application Receipt Date:  May 23, 2000

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS RFA 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS 
RFA.

PURPOSE

The National Institute of Mental Health requests applications to be 
supported under this RFA with the major objective of developing HIV 
preventive interventions for persons with severe mental illnesses 
(SMI).  A small body of outcome studies shows that relatively 
intensive, theoretically-based, and culturally-tailored behavior change 
programs, relying heavily on cognitive behavioral skills training, have 
been successful as risk-reduction strategies for persons with SMI.  
However, a number of important HIV prevention issues have not been 
adequately studied, there are methodological limitations in the few 
promising HIV intervention models, and psychiatric aspects related to 
HIV infection require more attention.  Some of the more prominent 
issues that need to be studied include (i) interventions tailored to 
risk situations encountered by persons with SMI, (ii) gender and age-
tailored interventions, (iii) long-term maintenance of behavior change, 
(iv) community level and population-focused interventions, (v) 
secondary prevention interventions for HIV-seropositive individuals, 
(vi) adherence to therapeutic regimens and psychological coping.  This 
RFA emphasizes the need to disseminate empirically validated HIV 
preventive interventions for persons with SMI to practicing clinicians 
and community-based 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), HIV Preventive Interventions for the Severely 
Mentally Ill, is related to the priority area of Mental Health and 
Mental Disorders.  Potential applicants may obtain a copy of "Healthy 
People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/

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 grants.  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 (RO1) and small research grant (RO3) award mechanisms.  
Collaborative R01s will also be accepted.  The total project period for 
an RO1 application submitted in response to this RFA may not exceed 
five years.  RO3 grants are limited to two years and are not renewable.  
The RO3 is limited to $50,000 direct costs for each of these two years.  
This RFA is one-time solicitation.

Because the small grants have special eligibility requirements, 
application formats, and review criteria, applicants are strongly 
encouraged to consult with program staff (listed under INQUIRIES) and 
to obtain the appropriate additional announcements for those grant 
mechanisms.  Special instructions and information for the RO3 grant 
program is found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html  Special 
requirements and instructions for Collaborative R01s may be found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html

Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  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 29, 2000.

For all R03 applications and all competing RO1 applications requesting 
up to $250,000 direct costs per year, specific application instructions 
have been modified to reflect “MODULAR GRANT” and “JUST-IN-TIME” 
streamlining efforts being undertaken at NIH.  More detailed 
information about modular grant applications, including a sample budget 
narrative justification pages and a sample biographical sketch, is 
available via the Internet at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Applications 
that request more than $250,000 in any year must use the standard PHS 
398 (rev. 4/98) application instructions.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1,500,000 to fund five to 
seven new and/or competitive continuation grants in response to this 
RFA.  An applicant may request a project period of up to five years for 
an RO1 application.  Because the nature and scope of the research 
proposed may vary, it is anticipated that the size of each award will 
also vary.  It is expected that direct costs will be awarded in modules 
of $25,000, however program and grants management adjustments may be 
necessary prior to award.  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 this RFA will be 
reissued.

RESEARCH OBJECTIVES

Background

“SMI” refers to a wide range of psychiatric diagnoses, but they have in 
common psychiatric symptoms that persist over time and are functionally 
disabling in daily living skills including family relations, 
educational attainment, occupational productivity and social role 
functioning.  SMI includes schizophrenia, schizoaffective disorder, 
bipolar disorder, major depression, autism and obsessive compulsive 
disorder.  These disorders affect at least 2.8 percent of the U.S. 
population or 5 million people (National Advisory Mental Health 
Council, 1995).  Recent epidemiological trends of the AIDS epidemic 
indicate that some segments of the US population have been more 
vulnerable to HIV infection than others, and persons with SMI are 
perhaps the most vulnerable disenfranchised subpopulation.  This 
emerging association between HIV disease and socially marginalized 
communities has been revealed for persons with SMI in several studies 
of an alarmingly high prevalence of HIV infection among men and women 
with SMI in large urban areas (from 4 to 23 percent).  If only 10 
percent of persons with SMI were HIV positive, the medical costs 
associated with such a public health problem would be exorbitant:  
about $28.6 billion.

Some behavioral assessment and behavioral epidemiology studies confirm 
that adolescents, men and women with SMI are indeed populations at high 
risk for contracting HIV infection.  Published studies of HIV-related 
risk taking by adults with SMI vary widely in terms of recruitment 
sites and strategies, sample composition, risk assessment, definition 
of SMI and other methodological features.  In addition, certain factors 
specific to this population that contribute to HIV risk have rarely 
been taken into account, including symptoms of mental illness, co-
occurring substance abuse and alcohol use, or the sequelae of having a 
profound mental illness.  Therefore, future HIV prevention efforts must 
be understood within a broader context of mental illness.  
Additionally, better efforts are needed to link the risk situations and 
relationships encountered by persons with SMI to the content of HIV 
preventive interventions.  This can best be accomplished by 
concurrently studying HIV risk and preventive interventions with risk 
linked to and in the context of specific intervention programs.  
Because HIV has disproportionately affected persons with SMI as well as 
other disenfranchised subpopulations (e.g., the urban poor, ethnic 
minorities), interventions that improve social support and empower 
individuals who have often faced structural impediments to health and 
success in our society may more readily lead to long-term behavior 
change.  In general, it will be necessary for investigators to develop 
and test a broader repertoire of intervention models—assessed at 
multiple levels: individual, system, network, care provider and 
community.  It will be important to establish the sustained integration 
of HIV prevention programs across the multiple care and social service 
systems for persons with SMI.

Areas of Interest

Research studies must target persons with SMI, before or after HIV 
infection, or the HIV-related neuropsychiatric aspects of mental 
illness.  Examples of research that would be an appropriate response to 
this RFA include, but are not limited to:

o  Epidemiological research to develop data bases in diverse geographic 
regions

o  Studies of theory-driven multi-modal interventions at the 
individual, system, network, care provider and community levels in HIV 
seronegative and seropositive youth and adults

o  Studies of the influences of substance abuse/alcohol, adverse 
medical health outcomes or other comorbid/co-occuring disorders on 
treatment readiness, long term recovery and adoption of safe behaviors

o  Studies of interventions for vulnerable subpopulations of persons 
with SMI at risk for, or infected with, HIV (e.g., homeless persons)

o  Development and evaluation of interacting behavioral and 
pharmacological interventions for mental health disorders, drug and 
alcohol addiction

o  Research to improve coordination and integration of interventions 
among mental health treatment, drug and alcohol treatment and primary 
medical care as well as other treatments (e.g., STD, social services, 
community-based HIV prevention)

o  Behavioral research on the feasibility and acceptability of female-
controlled barrier methods, in particular microbicides, as an 
alternative prevention strategy

o  Research on adherence to treatment regimens including communication 
techniques to improve shared decision making between health care 
providers and HIV-infected persons with SMI

o  Research on the impact of HIV therapeutic treatment regimens on 
adherence, psychological coping, behavioral strategies to manage 
symptoms secondary to treatment protocols and continued risky behavior

o  Development and evaluation of interventions to promote treatment 
adherence

o  Studies of the effects of HIV-related stigmatization and also of 
interventions to minimize the impact of stigmatization, to maintain 
positive behavior change, to enhance quality of life and to assist in 
psychological coping

o  Research on psychiatric aspects of HIV infection (e.g., psychiatric 
symptoms in symptomatic and asymptomatic HIV infection, psychiatric 
sequelae of notification of infection, violence or suicide and AIDS)

o  Treatment research on psychiatric disorders in HIV infection (e.g., 
pharmacologic or nonpharmacologic treatment of mood or psychotic 
symptoms)

o  Studies of interventions to address the psychiatric, 
neurobiological, behavioral and cognitive consequences of HIV disease

o  Research on distributions and determinants of other infectious 
diseases associated with HIV/AIDS (e.g., tuberculosis, hepatitis, STDs) 
among persons with SMI as well as preventive interventions

o  Research on the cost and financing of preventive intervention 
programs including cost-benefit, cost-effectiveness and cost-
utilization

o  Studies that disseminate empirically validated HIV prevention 
interventions into the outreach, transitional living, community 
services and other ongoing public health programs

o  Research on HIV-related mental health services and their 
effectiveness including organization and delivery of services, 
characteristics and interactions of providers and patients

o  Studies that translate efficacious interventions to effective 
interventions ready for adoption by service providers

This RFA also encourages the use of collaborative RO1 applications.  
For example, collaborative research might include:

o  Large scale treatment (psychosocial and/or psychopharmacologic) 
prevention trials focused on HIV and mental disorders, using common 
protocols across sites,

o  Studies of HIV infected persons with SMI which compare mental health 
service delivery and/or financing schemes in different regions,

o  Basic-clinical collaborations of HIV in persons with SMI involving 
multiple sites, some with access to well characterized clinical samples 
and others with state of the art laboratory methods (e.g., immunology, 
virology, STD outcomes),

o  Studies of low prevalence clinical populations infected with HIV or 
populations of minority subjects requiring several sites to assemble a 
sufficiently large sample size.

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 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:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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://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 Dr. David Stoff, listed under 
INQUIRIES, by April 24, 2000.

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) 435-0714, Email: GrantsInfo@nih.gov.  The application 
is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award.  It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers and Institute staff.  The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications  will request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year for RO1 
applications and $50,000 per year for RO3 applications  (Applications 
that request more than $250,000 direct costs in any year must follow 
the traditional PHS 398 application instructions.)  The total direct 
costs must be requested  in accordance with the  program guidelines and 
the modifications made to the standard PHS 398 application instructions 
described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative  (F&A) 
costs] for the initial budget period Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398.  It is not required and will not be accepted 
with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

o  Under Personnel, List key project personnel, including their names, 
percent of effort, and roles on the project.  No individual salary 
information should be provided.  However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000.  List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of key personnel, and the role on the project.  Indicate whether 
the collaborating institution is foreign or domestic.  The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount.  Include the Letter of Intent to 
establish a consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by  reviewers in the assessment of each individual's 
qualifications for a specific role in the proposed project, as well as 
to evaluate the overall qualifications of the research team.  A 
biographical sketch is required for all key personnel, following the 
instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm 

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate 
the type of agreement and the date.  All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o  The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

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 and 
must display the RFA number MH-00-012. A sample modified mailing label 
is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please 
note this is in pdf format.  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, HIV Preventive Interventions for the Severely 
Mentally Ill, MH-00-012, 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:

David M. Stoff, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619

Applications must be received by May 23, 2000.  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, a process will be 
used by the initial review group in which applications 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 
the applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the 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 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 
methods?  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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The 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.

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research

o  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.

Schedule

Letter of Intent Receipt Date:  April 24, 2000
Application Receipt Date: May 23, 2000
Peer Review Date: June/July 2000
Council Review:  September 2000
Earliest Anticipated Start Date:  September 29, 2000

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:

David M. Stoff, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-4625
FAX:  (301) 443-9719
Email:  dstoff@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
Bethesda, MD 20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@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 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 and 45 CFR Part 74.  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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