Full Text PA-95-030

PREVENTION OF RELAPSE TO HIGH-RISK BEHAVIORS

NIH GUIDE, Volume 24, Number 5, February 10, 1995

PA NUMBER:  PA-95-030

P.T. 34

Keywords: 
  Behavioral/Experimental Psychology 
  Mental Disorders 
  Disease Prevention+ 


National Institute of Mental Health
National Institute on Drug Abuse

PURPOSE

The National Institute of Mental Health (NIMH) and National Institute
on Drug Abuse (NIDA) are encouraging research applications that
address the issue of relapse to high-risk behaviors after behavior
change.  This program announcement (PA) is critical because
prevention efforts must be developed to sustain the changed behaviors
over time and prevent relapse.

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.  Research is needed
to develop methods and techniques to understand, prevent, and/or
change high-risk sexual and drug-abusing behaviors and to maintain
long-term behavior change.  In addition, research is encouraged to
identify psychological, social, and cultural factors that contribute
to relapse.  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.

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,
Prevention of Relapse to High-Risk Behaviors, 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
202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, 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.
Foreign organizations and institutions are not eligible for First
Independent Research Support and Transition (FIRST) (R29) awards or
program project grants (P01).

MECHANISMS OF SUPPORT

Support for applications submitted in response to this program
announcement will be through individual research projects (R01s),
FIRST awards (R29), and program project grants (P01).

RESEARCH OBJECTIVES

Background

The major objective of research supported under this PA is to
identify effective ways to prevent relapse to behaviors that place
persons at high risk for infection by the AIDS virus.  The behaviors
involved in such risk are sexual behaviors (e.g., having unprotected
sexual contact with an infected individual) and contamination of drug
injection equipment.  Current research indicates that the acquisition
of knowledge through educational materials is not sufficient to
produce sustained behavior change in many individuals who participate
in high-risk behaviors.  Relevant research is encouraged to improve
knowledge and understanding of relapse behaviors.

Study Populations/Target Groups

Study populations or target groups should include those most likely
to relapse to high-risk behaviors.  These would include predefined
groups such as gay and bisexual men, particularly young men, and drug
users who inject.

Areas of Interest

The following section suggests areas of research to meet the health
promotion and disease prevention objectives outlined above.
Researchers responding to this PA, however, need not limit themselves
to these topics.

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

o  Research on the psychological, physiological, social, and cultural
determinants of relapse to high-risk behaviors

o  Research on the relationship of knowledge and attitudes associated
with maintenance of low-risk behaviors

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

o  Studies on how low self-efficacy and a sense of helplessness may
contribute to relapse

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

o  Studies on the social pressures associated with relapse, and
changing social norms that can ensure maintenance of safer sexual
behaviors

o  Studies on coping with relapse episodes to stimulate recovery to
low-risk behaviors

o  Studies testing relapse models from other health areas (e.g.,
smoking cessation, weight control) to HIV/AIDS

o  Research testing relapse preventive interventions targeted to
specific at-risk populations

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted under the receipt deadlines for
AIDS applications.  Application kits are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, Westwood Building, Room 449, Bethesda,
MD 20892, telephone 301/435-0714.  The title, Prevention of Relapse
to High-Risk HIV Behaviors, and number of the program announcement
must be typed in Section 2a on the face page of the application.

Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resources for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator could be included
with the application.

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

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room
Bethesda, MD  20892
Bethesda, MD  20817 (express mail)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit by an appropriate initial review group in
accordance with the standard NIH peer review procedures.  Following
scientific-technical review, the applications will receive a
second-level review by the appropriate national advisory council.

Applications that are complete and responsive to the program
announcement 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 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.

Review Criteria

Criteria for scientific/technical merit review of applications are:

o  Significance and originality from a scientific or technical
standpoint of the goals of the proposed research

o  Qualifications and experience of the principal investigator and
demonstrated staff expertise in family processes, prevention
research, statistics, cultural competence, AIDS, and other areas
specific to the questions under investigation

o  Adequacy of the conceptual and theoretical framework for the
research, including cultural relevance to the target populations and
evidence of familiarity with relevant research literature

o  Scientific merit of the research design, approaches, intervention,
and methodology

o  Access to target population(s)

o  Sample selection and retention methods and efforts to determine
factors that influence refusal rate

o  Adequacy of the data analysis plan

o  Adequacy of the existing and proposed facilities and resources

o  Appropriateness of the budget, staffing plan, and time frame to
complete the project

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

The initial review group will also examine the provisions for the
protection of human subjects and the safety of the research
environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to that Institute.  The following will be
considered in making funding decision:

o  Scientific merit as determined during the peer review process

o  Availability of funds

o  Balance among target populations with priority given to
understudied populations

For applications assigned to the NIMH or NIDA, additional criteria
concern:

o  Balance among theoretical and multicultural approaches, and

o  Balance among geographic areas

INQUIRIES

Inquiries 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.
Office on AIDS
National Institute of Mental Health
Parklawn Building, Room 10-75
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email:  WPEQUEGN@AOAMH2.SSW.DHHS.GOV

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3065
FAX:  (301) 443-6885
Email:  DT21a@NIH.GOV

Direct inquiries regarding projects with a focus on drug abuse
aspects of HIV/AIDS to:

Steven W. Gust, Ph.D.
Deputy Director, Office on AIDS
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-05
Rockville, MD  20857
Telephone:  (301) 443-6697
FAX:  (301) 443-2317
Email:  SGUST@AOADA2.SSW.DHHS.GOV

Direct inquiries regarding projects with a focus on issues relevant
to nursing practice to:

June R. Lunney, Ph.D., R.N.
Health Promotion/Disease Prevention Branch
National Institute of Nursing Research
Building 45, Room 3AN-12
45 Center Drive MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  JLUNNEY@EP.NINR.NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.242, Mental Health Research Grants, and 93.279,
Drug Abuse 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.

The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.
This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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