LONG-TERM MAINTENANCE OF HIV/STD BEHAVIOR CHANGE

Release Date:  January 11, 2000

RFA:  MH-00-004

National Institute of Mental Health
National Institute on Alcohol Abuse and Alcoholism

Letter of Intent Receipt Date:  February 17, 2000
Application Receipt Date:  March 17, 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 (NIMH) and National Institute on Alcohol 
Abuse and Alcoholism (NIAAA) are encouraging research applications that address 
the issue of relapse to high-risk behaviors after effective interventions that 
have resulted in significant behavior change.  In addition, investigators are 
encouraged to develop and test interventions to prevent return to unsafe 
behaviors as a result of mental distress, recurring alcohol or substance abuse.  
This Request for Applications (RFA) is critical because prevention efforts must 
be developed in order to sustain the changed behaviors over time and prevent 
return to unsafe sexual or drug using behaviors that may result in re-exposure 
to HIV.

The urgency of the AIDS crisis demands that top priority be given to research 
with implications for preventive interventions that reduce the incidence of 
relapse to high-risk behaviors and maintenance of long-term healthy behaviors.  
Research is needed to develop methods and techniques to understand, prevent, 
and/or change high-risk sexual and related alcohol/substance-abusing behaviors 
and to maintain behavior change in the long-term.  In addition, research is 
encouraged to identify psychological, social, and cultural factors that 
contribute to relapse in general, and to understand the specific role of alcohol 
and substance abuse in precipitating relapse situations.  Research is needed to 
determine the role of alcohol consumption in the initiation and maintenance of 
high-risk behaviors.  Even if an AIDS vaccine were to be identified in the next 
few years, prevention efforts would continue to be the primary way to stop the 
further spread of HIV infection.  Because long-term maintenance of low-risk, 
HIV-related behaviors is a critical issue in the primary prevention of the 
spread of HIV, this program announcement solicits theoretically grounded 
research applications focusing on behavioral strategies for relapse prevention.

While there are effective HIV/STD prevention programs that contribute to 
behavior change during the intervention, there are a paucity of studies about 
how to maintain that behavior change beyond one year.  This is a major issue in 
having these effective interventions adopted in public health agencies and 
managed care facilities because the length of time that the low risk behaviors 
are maintained determines the cost effectiveness of implementing these 
preventive interventions.

The major objective of research supported under this RFA would be to identify 
effective ways to prevent relapse to behaviors that place persons at high risk 
for infection by the AIDS virus.  Studies would examine the psychological, 
physiological, social, and cultural determinants of relapse to high-risk 
behaviors.  Findings from these studies will contribute to a better 
understanding of different factors may contribute to relapse to high risk 
behaviors so that these issues can be addressed in the original intervention and 
booster sessions.  For example, the effect of mental distress, alcohol and other 
substance use on judgment, decision making, and perception of risk associated 
with relapse to high-risk behaviors would be identified and effective 
interventions developed using this information.  Because social pressure, 
especially among youth, may be associated with relapse, interventions to change 
social norms to ensure maintenance of safer sexual behaviors may be tested.  In 
addition to examining issues of maintenance of behavior change in primary 
prevention, this RFA will also address these issues in secondary prevention.

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), Long-
Term Maintenance of HIV/STD Behavior Change, is related to the priority areas of 
Mental Health and Mental Disorders, STD, and HIV/AIDS prevention.  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.  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) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA may 
not exceed five years for an R01 application.  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.

For all competing R01 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 $250,0000 in any year must use the standard 
PHS 398 (rev. 4/98) application instructions.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.2 million in total support in FY 
2000 to fund three to four new awards in response to this RFA.  The NIAAA 
intends to commit up to $600,000 to fund two new awards. 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 the 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 
competing renewal applications will be accepted and/or if this RFA will be 
reissued.

RESEARCH OBJECTIVES

Background

While there are effective HIV/STD prevention programs that contribute to 
behavior change during the intervention, there is a paucity of studies about how 
to maintain that behavior change beyond one year.  The major objective of 
research supported under this RFA would be to identify effective ways to prevent 
relapse to behaviors that place persons at high risk for HIV/STD infection.

Relevant research is encouraged to improve knowledge and understanding of 
determinants of relapse behaviors and strategies to increase long-term 
maintenance of initially successful behavior change.

Areas of Interest

The following section suggests areas of research to meet the health promotion 
and disease prevention objectives of this RFA.  However, researchers do not need 
to limit their research proposals to the following topics:

o  factors that differentiate persons who relapse from those who maintain low-
risk behaviors;

o  psychological, physiological, social, and cultural determinants of relapse to 
high-risk behaviors;

o  understanding how use and abuse of alcohol, may precipitate a return to HIV 
risk behavior;

o  developing and testing interventions to control alcohol use or abuse and 
relapse to unsafe HIV-related behaviors;

o  understanding how the psychological, physiological, social, and cultural 
determinants of relapse to high risk behaviors vary by alcohol problem severity 
and treatment status;

o  relationship of knowledge and attitudes associated with maintenance of low-
risk behaviors;

o  dose response from intervention and role of mediators in behavior change and 
long-term maintenance;

o  role of self-efficacy in relapse to high risk behaviors;

o  effect of alcohol and substance use on judgment, decision making, and 
perception of risk associated with relapse to high-risk behaviors;

o  effects of affective states on the maintenance of low-risk behaviors;

o  role of social pressure, social norms and culture associated with relapse and 
ensuring long-term maintenance of safer HIV/STD related behaviors;

o  role of media and other forms of communication in changing social norms and 
contributing to the maintenance of low-risk HIV/STD behaviors;

o  effective coping strategies to handle relapse episodes to stimulate recovery 
to low-risk behaviors;

o  testing of relapse models from other health areas (e.g., alcohol, smoking 
cessation, weight control, etc.) in maintaining low-risk HIV/STD behaviors;

o  role of the quality of the couple relationship in maintaining safer HIV/STD 
risk behaviors; and

o  relapse preventive interventions targeted to specific at-risk populations.

SPECIAL REQUIREMENTS

In order to assess maintenance of behavior change, the assessments should be 
conducted at least 24 months after the initial intervention is completed.  The 
Institute will convene an annual meeting of successful grantees in order to 
share strategies that are being implemented.  Provisions for this meeting, to be 
held in the Washington, D. C. area, should be included in the budget.

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:
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. Willo Pequegnat, at the address listed 
under INQUIRIES, by February 17, 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.  (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

FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments) 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.

DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 4 of 
the PHS 398 (rev 4/98).  It is not required nor will it be accepted at the time 
of application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form.  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-00-004.  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, LONG-TERM MAINTENANCE OF HIV/STD 
BEHAVIOR CHANGE (MH-00-004), 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:

Dr. Willo Pequegnat
Center for Mental Health Research on AIDS
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 March 17, 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.  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 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:  February 17, 2000
Application Receipt Date:  March 17, 2000
Peer Review Date:  June 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:

Willo Pequegnat, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email:  Wpequegn@nih.gov

Kendall J. Bryant, Ph.D
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505, 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:

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

Judy Simons
Grants Management Branch
National Institute of Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504, MSC-7003
Bethesda, MD  20892-7003
Telephone: (301) 443-2434
FAX:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH) and 93.273 (NIAAA).  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.

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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