Full Text PA-95-057

HIV RISK BEHAVIORS, DETERMINANTS AND CONSEQUENCES

NIH GUIDE, Volume 24, Number 16, May 5, 1995

PA NUMBER:  PA-95-057

P.T.


Keywords: 


National Institute on Drug Abuse

PURPOSE

The purpose of this program announcement is to stimulate research on
the social and other environmental factors that influence the drug
injecting and sexual HIV risk behaviors of drug users and their
sexual partners.  Behaviors do not occur independent of, but are
shaped by, the social and physical environment, as well as the
individual's psychological and physiological status.  By
understanding how characteristics of the environment act and interact
with each other, and with other characteristics of the individual,
more effective HIV prevention strategies can be developed.  Important
aspects of this concept involve improving knowledge of factors that
determine the temporal variability in risk behaviors, i.e., why risk
behaviors occur at some times and not at others, and of factors
underlying behaviors that protect against HIV transmission.
Populations of interest include injecting drug users (IDUs), sexual
partners of IDUs, and non-injecting drug users whose HIV risk
behaviors may be related to their drug use.

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 program
announcement, HIV Risk Behaviors, Determinants, and Consequences, is
related to the priority area of reducing HIV transmission.  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) from 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 institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.

MECHANISM OF SUPPORT

Research support mechanisms include traditional research project
grants (R01), small grants (R03), and FIRST (R29) awards.
Submissions as Investigator-Initiated Interactive Research Project
Grants (IRPG) may be made.  For information on the IRPG mechanism,
see NIH Guide for Grants and Contracts, Vol. 23, No. 28, July 29,
1994.  Because the nature and scope of the research proposed in
response to this program announcement may vary, it is anticipated
that the size of an award will also vary.

Traditional research project grants (R01) provide support for up to
five years.  Small grants (R03) provide research support of up to
$50,000 per year in direct costs plus appropriate indirect costs for
up to two years.  FIRST (R29) awards provide support for five years
and up to $350,000 in direct costs over the entire project period.

RESEARCH OBJECTIVES

Background and Significance

Injection drug use and sexual activity with injecting drug users are
increasingly important modes of HIV transmission in the United
States.  Of 396,015 adult cases of AIDS reported to the CDC through
June 1994, 31 percent were injecting drug users and 3.5 percent were
sexual contacts of IDUs.  Of reported cases of AIDS among women in
the U.S., 48 percent were attributable to injection drug use and 20
percent were attributable to heterosexual contact with a male IDU,
making these the first and second highest exposure categories,
respectively, in women. Thirty eight percent of the 5,734 pediatric
AIDS cases were in children of mothers who injected drugs; 17 percent
were in children of mothers who were sex partners of IDUs.
Non-injecting drug use has also been associated with increased HIV
risk, (e.g., in homosexual and bisexual men, in sexual exchanges for
"crack" cocaine).  Of particular concern is that the proportion of
cases related to drug abuse has steadily increased over the last
decade.

Among drug users and their sexual partners, considerable variability
exists in the extent of HIV risk behaviors, not only among different
individuals, but also for each person over time and from one
situation to another.  Factors that influence involvement in risky
behaviors are not well understood.  Research has focused primarily on
specific risk behaviors and on the individual "at risk."  Relatively
little attention has been given to the contextual, situational, or
temporal variability in these behaviors.  Of special interest is the
episodic nature of HIV risk-taking behaviors and the factors that
account for change and/or stability of such behaviors.  Research on
situational and other environmental factors that influence decisions
to engage in behaviors known to transmit HIV are needed to enhance
the development of effective strategies to prevent infection with
HIV.

Program Objectives

The primary goal of this program announcement is to improve the
knowledge base on social and other environmental factors influencing
drug-related HIV risk behaviors.  Studies should be focused on
hypothesis generation and testing in order to discover and clarify
determinants of HIV-related risk behaviors.  Study designs should
result in data on antecedents and consequences of behavior that
initiate, increase, maintain, or diminish risk behaviors.  Variables
may be selected from one or several domains of social, cultural,
economic, psychological, environmental, or physiological factors.
Applications using the dyad or social network within which risk
behaviors occur as the unit of study are encouraged.  Studies are
also encouraged that will enhance understanding of why some
individuals engage in certain types of risk behaviors that others
encountering many of the same influences do not.  While intervention
studies are not the focus of this program announcement, it is
intended that the knowledge gained from studies supported will
identify factors amenable to intervention.  Thus, research under this
program announcement should be applicable to public health
interventions and intervention research.

The developmental phases of risk behaviors also need to be studied to
determine when transitions occur and when would be the best
opportunities for intervention and change.  For example, we need to
improve understanding of the impact of social and cultural factors on
the development of drug injection and drug-use related sexual
behaviors, identification of competing needs and choices that are
involved in situations in which risky behaviors occur, assessment of
the impact of factors such as perceptions of HIV prevalence and
community (social network) drug use patterns, and delineation of
relationships between developmental processes and risk, (e.g.,
adolescent's establishment of independence from family).

Other examples of areas of interest include, but are not limited to:

a.  Initiation of drug injection, including factors influencing the
transition from non-injecting to injecting use, e.g., assessment of
the roles of social networks, peer influence, and community
influences.

b.  Continuation of injecting drug use with particular examination of
injection patterns associated with use of specific drugs or drug
combinations, sharing of needles and other paraphernalia, sexual
risk, gender roles, and choice of location for drug use.

c.  Physiologic effects of drugs (e.g., withdrawal, impaired learning
or reasoning while abusing drugs) and their interaction with
psychological, social, and environmental factors in determining the
natural history of drug use and HIV risk behaviors.

d.  Factors affecting decisions to use risk reduction strategies,
such as bleach disinfection, refraining from sharing, discontinuing
injection, or participation in needle exchange programs; factors
related to relapse from these risk reduction strategies to behavior
with increased risk levels.

e.  Sexual risk behaviors associated with drug use, such as the
mechanisms by which "crack" cocaine use, methamphetamine use, or
specific aspects of drug use among homosexual or bisexual men,
adolescents, women, and other under-studied groups contribute to
risk.

f.  Aspects of the social dyad, social networks, peer influences,
peer group composition, and beliefs about gender roles that may
contribute to sexual risk taking in conjunction with or separate from
drug use.

g.  Environmental and community-level structural factors that may be
associated with level of HIV risk, including factors such as the
prevalence of drug use in a region or community, population trends,
economic resources available to a community, access to sterile
syringes, the presence of institutions that support family cohesion,
etc.  Regional or community-level interpersonal factors could also be
studied, e.g., neighborhood cohesion, overlap of various social
networks, communication styles, police-resident interactions,
attitudes towards drug and alcohol users in the community, etc.

h.  Specification of factors that influence drug using and sexual
behaviors in HIV seropositive drug abusers.

i.  Studies that specifically focus on understanding individuals who
have avoided or reduced risk, despite the influence of factors
normally associated with high levels of risk.  Such studies should
clarify protective factors, whether they be interpersonal,
environmental, or intrapersonal.

j.  Studies of the relationship between the natural history of HIV
infection and transmission risk and behaviors.

k.  Studies of the impact of cognitive and/or neurologic impairment
that results from drug use as well as HIV infection on the
decision-making processes involved in avoiding or engaging in risk
behaviors.

l.  Studies on the time course of the multilevel processes
(physiological, psychological, social, and environmental) that
determine particular risk behaviors on the part of individuals.  Such
studies may involve naturalistic methodologies such as case
histories, diary keeping, and the like.

m.  Studies to develop new or adapt existing methodologies to improve
validity and reliability of measures, and to strengthen research
designs and data analytic capabilities.

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 new
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 of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person 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 at the standard AIDS
receipt dates indicated in the application kit.  Application kits
are available at most institutional offices of sponsored research
and may be obtained from the Office of Grant Information,
Division of Research Grants, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, telephone  301/435-0714.  The
title and number of this program announcement must be typed in
Item 2a on the face page of the application.

FIRST award applicants must include at least three sealed letters
of reference attached to the face page of the original
application.  FIRST award applications submitted without the required
number of reference letters will be considered incomplete and
will be returned without review.

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 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

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.  Small grants do not receive a second-level review.

Review Criteria

o  Scientific, technical, or medical significance and originality of
the proposed research;

o  Appropriateness and adequacy of the research approach and
methodology proposed to carry our the research;

o  Qualifications and research experience of the principal
investigators;

o  Availability of resources necessary to the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  Adequacy of the plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research.

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

AWARD CRITERIA

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

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Richard H. Needle, Ph.D., M.P.H.
Community Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-30
Rockville, MD  20857
Telephone:  (301) 443-6720
Email:  rn28e@nih.gov

Direct inquiries regarding fiscal matters to:

Dr. Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gfleming@aoada2.ssw.dhhs.gov

AUTHORITIES AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279 and 93.242.  Awards are made under
authorization of the Public Health Service Act, Section 301, and
administered under PHS policies and Federal Regulations at 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.

Grants must be administered in accordance with the Public Health
Service Grants Policy Statement (DHHS Publication No. (OASH)
82-50-000 GPO 0017-020-0090-1 (rev. 4/94).

The PHS strongly encourages all grant and contract 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 routing 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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