Full Text PAS-97-093
NIH GUIDE, Volume 26, Number 27, August 15, 1997


National Institute of Child Health and Human Development
National Institute of Dental Research
National Institute of Mental Health
Application Receipt dates: May 1, September 1,  January 1
NICHD,  NIDR and NIMH  invite qualified researchers to
submit applications to study the social and behavioral
aspects of the transmission of HIV through sexual
intercourse, including oral sexual practices.  NICHD has
a longstanding commitment to research focusing on sexual
behavior, behavior change and HIV prevention, especially
among men and women of reproductive age (including
adolescents), and among vulnerable populations. NIDR
supports biomedical and behavioral research on the oral
transmission of HIV, including research on sexual
behavior relevant to oral routes of transmission. NIMH
supports an extensive program of HIV prevention research
related to various aspects of mental health.
This program announcement describes NICHD's,  NIDR's and
NIMH's  programs of behavioral research in the sexual
transmission of HIV, which includes four general areas:
(1)demographic studies of sexual behaviors related to HIV
transmission; (2) studies of the interrelationships among
social, institutional, economic and cultural contexts and
sexual behavior; (3) studies of the interrelationships
between pregnancy, pregnancy prevention and HIV
prevention; and (4) theoretically grounded intervention
studies within these areas.
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 is related to the
priority areas of family planning and the prevention of
HIV infection and STDs. Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report: Stock No.
017-001-0047400) or "Healthy People 2000" (Summary
Report: Stock No. 017-001-0047301) through the
Superintendent of Documents, Government Printing Office,
Washington, D.C. 20402-9325 (telephone 202-512-1800).
Applications may be submitted by domestic for-profit and
nonprofit 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.
This PA will use the National Institutes of Health (NIH)
research project grant (R01) and FIRST award
(R29) mechanisms. 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 PA may
not exceed five years.
This  program announcement  has $2.7 million dollars in
total costs set aside for the first year of awards. The
NICHD set aside will total $1.7 million. The NIDR set
aside will be total of $1.0 million. Additional funding
or co-funding will also be available from NIMH.  The
number of awards and level of support will depend on
receipt of  applications of high scientific merit.  The
usual policies governing grants administration and
management, including facilities and administrative
costs, will apply.  Although this program is provided for
in the financial plans of the NICHD and NIDR, awards
pursuant to this program announcement are contingent upon
availability of funds for this purpose.  Funding beyond
the first and subsequent years of the grant will be
contingent upon satisfactory progress during the
preceding years and availability of funds.
New applications submitted for the September 1, 1997,
January 2 and May 1, 1998 receipt dates will be eligible
for funding under this announcement.  Competing
continuation applications for already funded projects
will NOT be eligible.  Although the NICHD, NIDR and NIMH
have continuing interest in the research area of this PA,
the latest anticipated date for new awards to be made
with set-aside funds from NICHD and NIDR is February,
Until such time as vaccines and cures for infection with
the HIV virus are a practical  reality, prevention of
infection must rely upon individuals' practicing
protective behavior. Specific sexual behaviors that
prevent infection - such as avoiding sexual intercourse
with infected individuals and using condoms - are
influenced both by personal factors such as attitudes,
knowledge, and abilities and by more distal factors
characterizing the contexts in which individuals'
behaviors are carried out. While most behaviors that are
protective have been well-defined, new information may
require altered messages regarding risk and protective
behaviors. For example, recent reports have suggested
that oral sexual practices (e.g. oral-genital receptive
sex) previously considered to be relatively risk-free may
actually pose significant risks for HIV transmission.
Social and cultural environments may predispose people to
act  in certain ways, and may also influence how easy it
is for them to change their behaviors or to maintain
protective behaviors.  Competing motivations for
establishing and maintaining sexual relationships and for
pregnancy or pregnancy prevention  may interact with HIV
prevention motives and with the social environment to
influence behavioral outcomes.  Such motives are in turn
likely to be shaped in important ways by life course
experience: health and development;  educational and
economic achievement, migration,  marriage and marital
dissolution, and fertility.  These personal and
contextual factors can interact in powerful and complex
ways to determine behavioral risks for HIV infection and
the most promising pathways to reducing risk.
Methodological advances in data collection and data
analytic techniques are beginning to make it possible to
examine in detail the contextual factors in which
individuals and couples exist, and to understand more
clearly the structural factors influencing their sexual
decisions. NICHD,  NIDR and NIMH seek research
applications that draw on both innovative theory and
innovative methodologies to address four general areas of
study, as described below.  The goal of this program
announcement is improved knowledge applicable to
behavioral strategies for the prevention of sexual
transmission of HIV infection.  Other sexually
transmitted diseases and other sequelae of sexual
behavior as well as relevant aspects of sexual behavior
itself also may be used as endpoints of proposed research
as long as the relationship of the specific research
question to HIV prevention is adequately justified.
Research Sought
(A) Demographic studies
Population-based studies of sexual behaviors related to
the risk of HIV infection contribute to HIV prevention in
many ways.  They provide essential information for
identifying population groups whose sexual behaviors
increase vulnerability to HIV infection as well as groups
in which the potential for increasing infection rates may
exist; they provide a means of monitoring trends in the
prevalence of risky sexual behavior as well as protective
behaviors within population groups  and they permit the
testing of models of the determinants of such behavior
over the life course within population samples (that is,
not samples recruited from clinics or on the basis of
some particular personal behavior or characteristic).
Population-based data provide perspectives on the
prevalence of such behaviors.  For example, they can
elucidate changes in  behaviors, norms, and status that
permeate a larger population and contribute to the
characteristics, resources, and behaviors of those most
vulnerable to HIV.  They can be used to examine processes
that influence sexual behavior regardless of HIV risk and
to examine how, whether and when heightened risk of, or
the perception of heightened risk of HIV affects those
Specific topics include but are not limited to:
Trends in HIV-related sexual behaviors and the
determinants of those trends.  (Note: new data collection
for the purpose of studying trends in sexual behavior
will not be supported unless it makes a substantial
scientific contribution beyond that made by ongoing data
collection activities conducted by CDC, NIH and other
federal and private groups).
Studies characterizing trends in the content of
information provided to students in the health
professions, health care professionals, the public or
members of high risk groups about sexual practices (e.g.
oral sex) as related to risks for HIV transmission.
Group differences in the determinants of HIV risk
Changes in family structure, organization, marriage and
cohabitation, and patterns of partner selection in
relation to HIV infection and the risk of such infection.
The relationship of  HIV-risk sexual behavior to life
course transitions such as cohabitation, marriage,
separation and divorce, parenthood, and changes in school
enrollment, labor force, and economic status.
Factors that predispose individuals to initiate sexual
behaviors that place them at risk of HIV at an early age.
Studies evaluating changes in sexual behaviors in
individuals and populations associated with new
information on risk and protective behaviors (e.g.
concerns regarding oral routes of HIV transmission).
Studies of norms and values related to sexual behavior,
sexual partnerships, and disease prevention,  their
variation among population groups and over time, and
their relationship to behavioral patterns.
Cross-cutting studies that link data collected in large
population samples with samples selected based on high
risk behaviors.
Methodological studies that extend and improve techniques
for data collection and analysis in studies of HIV-related
sexual behavior.
Development of methodologies for identifying populations
in which the potential for widespread HIV infection is
increasing, and for studying the spread of infection in
relation to population characteristics, dynamics, and
behaviors (e.g., network studies).
Demographic studies must be grounded in an appropriate
theoretical framework.  Although new data collection may
be justifiable under some circumstances, potential
applicants are encouraged to consider secondary analysis
of existing data.  A number of population-based sample
studies have been conducted in recent years, some  with
NICHD funding, and the data are available to researchers
(see "Research Designs and Data Sources," below).
Several of these have extended traditional survey
approaches in ways that improve and enrich data, such as
methodological improvements in the quality of self
reports, utilization of biospecimens, e.g. salivary or
oral measures, and integrating contextual or social
network data.
B) Contextual Determinants of Sexual Behavior
A significant body of evidence suggests that sexual and
prophylactic behaviors are influenced in important ways
by the contexts in which they occur.  Relevant dimensions
of context include the social (relationships with
partners, family, friends and co-workers), institutional
(legal, educational, religious, health infrastructure);
cultural (norms, values, and beliefs shared within and
across social groups), and physical (community
composition, prevalence of disease risk, poverty and
housing).  The specification of the ways in which these
aspects of context can influence behavior is far from
complete, yet there is reason to believe that improved
understanding of contextual influence could provide a
powerful tool for prevention of HIV. Research designs
which capture contextual influences as well as individual
determinants of behavior are called for.  For example,
studies might address the following questions:
How do individuals' social networks influence their
sexual behavior; how does sexual behavior influence
change and stability in social networks?
How do the economic, social, and institutional
characteristics of communities in which social and sexual
networks are embedded influence sexual behavior?  Do
individuals whose lives involve frequent changes of
residence change their social and sexual networks? How do
social and sexual networks overlap and what are the
implications of this for HIV-risk behavior?
What principles and processes govern the selection of
sexual partners and participation in sexual networks that
place individuals at risk of infection with HIV?  How
does the process of partnership formation vary by age or
maturational status, gender, sexual orientation,
socioeconomic status, and the prevalence of HIV in the
individual's community?
How do the circumstances under which sexual partnerships
are formed affect the perceptions of HIV risk within the
partnership and the behaviors that occur within it?  What
factors influence the stability and exclusiveness of
sexual partnerships, and how do HIV-risk behaviors vary
with the duration and other characteristics of
How does earlier experience of  involuntary sex or
violence or the fear of violence within a current
partnership influence risk behavior in that and
subsequent partnerships?
How do norms and values -- about morality, marriage,
monogamy, childbearing, or appropriate sexual behavior --
develop and change within and across social groups?  How
do such norms and values interact with other contextual
and individual factors to influence individuals' and
couples' sexual behavior?
How can research methods for studying contextual
influences on sexual behavior be improved?  How can
non-biased but cost-effective methodologies for network
studies be developed? How can contextual studies account
for the processes by which individuals self-select into
social networks, communities, and other contexts?  How
can studies of sexual partnerships account for
partnership formation processes and other sources of
sample bias?
How can non-biased samples  of couples at elevated risk
of HIV infection be obtained? There may be challenges in
obtaining samples  in which one partner is HIV+, or in
following samples in which partners are  in various
stages of relationship formation, change and dissolution.
What are appropriate models and analytic methods for
examining sexual behavior in the context of a couple, and
in relation to networks and the larger social context?
C) Integrating pregnancy and HIV prevention
Most heterosexual individuals who have sexual intercourse
desire to protect themselves from unwanted pregnancy most
of the time. At the same time, almost all individuals all
of the time wish to avoid infection with HIV.  However,
many of the medical methods available for pregnancy
protection do not provide protection from disease, and
condoms, male and female, which are most effective at
disease prevention, may not protect as well against
unwanted pregnancy.  Research is sought which examines
the inter-relationships among individuals' and couples'
desires for pregnancy, pregnancy prevention and avoidance
of the risk of infection with HIV.
How do individuals at risk of HIV infection balance
pregnancy prevention and disease prevention in making
decisions about sexual behavior and the introduction and
use of methods to prevent pregnancy and/or disease?
How do concerns regarding pregnancy or perceived health
risks or attitudes concerning contraception influence
oral sexual behaviors?
How does the duration and intimacy of the partnership
influence the partners' decisions concerning issues of
pregnancy, pregnancy prevention and the avoidance of
disease?  Does this vary over the life course?
How do individuals' estimations and abilities to
accurately estimate risk -- their own and their partner's
for pregnancy and HIV -- influence their use of
protection?  How do knowledge  and beliefs concerning
their own or their partner's serostatus affect use of
How does actual, objective, epidemiological risk of
exposure to disease and to pregnancy affect individuals'
use of  protection from unwanted pregnancy and from
D) Intervention Studies
Intervention studies are needed to build on the basic
science findings concerning behavior change.  Designing,
implementing and evaluating  interventions which utilize
mediating variables such as, for example, communication
skills concerning condoms, or sensitivity to peer or
media pressure, to enable individuals to acknowledge and
modify  risky behavior are appropriate research proposals
for this program announcement.  Understanding of local
issues is critical to the successful implementation of
targeted interventions.  Accordingly, interventions are
encouraged which involve community organizations in
design, implementation and replication of the project.
Such proposals may target any population vulnerable to
HIV and may include consideration of co-morbid conditions
such as other STDs and oral conditions. This  PA
particularly encourages studies of populations most
vulnerable to the sexual transmission of HIV -- minority
men and women, men who have sex with men, and
disadvantaged youth. Particular questions of interest
include but are not limited to:
How can the social context in which individuals live and
the changes in those contexts via migration or change of
residence -- their social networks, communities, schools,
homes, work environment -- be taken into consideration
when designing and implementing interventions?  How can
the influence exerted by elements of the social,
institutional and cultural contexts be harnessed in the
development of more effective interventions?
How can HIV-related behavior change interventions be
improved to take account of individuals' potentially
competing concerns about  pregnancy and disease
prevention?  Given the need to combine condom (or other
barrier) use with hormonal contraception or sterilization
to achieve the highest levels of protection against both
pregnancy and disease among at-risk sexually active
heterosexual  people, what interventions, delivered by
which agencies or individuals,  are effective?
How do local conditions, such as condom distribution
programs, or support for or opposition to behavior change
interventions from the community's civic, educational
and religious institutions impact individual behavior?
Research Designs and Data Sources
The utilization of existing data is strongly encouraged
for its cost-efficiency whenever scientific goals can be
met by its use.    There is a wide range of such data
collected in the U.S. and available for research
purposes.  Each data set has its particular strengths and
weaknesses, which the investigator must understand and
deal with.  Such resources  include, but are not limited
to, the various  rounds of the National Survey of Family
Growth, the National Survey of Adolescent Males, the
National Survey of Men, The National Longitudinal Study
of Adolescent Health,  the National Health and Social
Life Survey, the Chicago Sexual Health and Life Project,
and data made available through the Sociometrics STD/HIV
archive.  Researchers may be aware of, and have access
to, other data that are appropriate for answering the
HIV/AIDS behavior questions they wish to pose.   Data
collected in or from other countries can provide powerful
resources for addressing many of the research questions
in this announcement.
New data collection is justifiable if existing data are
not appropriate to the aim of the study.  In such cases,
scientific sampling procedures are highly desirable to
ensure that sample biases do not vitiate the research
objectives. Prior contact with the staff named below is
strongly encouraged for any applicant considering such an
effort, and is mandatory should the direct cost of the
project exceed $500,000 in any year.   Applicants
proposing new data collection are encouraged to make
their data available for use by other researchers and
should outline plans for accomplishing this in the
Applicants proposing research that draws on social
scientific approaches that have not been widely applied
to research on HIV-related sexual behavior are
particularly encouraged to apply.   As noted recently by
an Institute of Medicine workshop, "Assessing the Social
and Behavioral Science Base for HIV/AIDS Prevention and
Intervention", improved strategies for behavioral
intervention will require broader perspectives than have
been applied in the past.  Collaborations involving
anthropologists, historians, economics, sociologists,
political scientists, epidemiologists, and psychologists
may be needed to advance theoretical and methodological
approaches to HIV prevention.  Therefore applicants are
encouraged to consider research designs which are
innovative, integrative of multiple perspectives, and
which utilize,  as appropriate, a range of methods and
analytic techniques.  In addition, the recent Ad Hoc
Panel on NIDR AIDS Research (June, 1997) strongly
recommended pursuing collaborative research on behavioral
and/or biological factors influencing oral transmission
of HIV.
Research may focus on samples in the United States and
other nations, and on  individuals of either or both
sexes and of all ages as appropriate to the scientific
questions being examined.  Studies of  populations at
heightened vulnerability to the sexual transmission of
HIV -- e.g., minority men and women, men who have sex
with men, and disadvantaged youth-- are particularly
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 20, 1994 (FR 59 14508-14513) and in the NIH Guide
for Grants and Contracts, Volume 23, Number 11, March 18,
All applications for clinical research submitted to NIH
are required to address these policies.  NIH funding
components will not award grants or cooperative
agreements that do not comply with these policies.
The research grant application form PHS 398 (revised
5/95) is to be used in applying for these grants.  These
forms are available at most institutional business
offices and from the Office of Extramural Outreach and
Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda MD 20892,
telephone 301-710-0267 Email asknih@odrockml.od.nih.gov;
and from the program administrator listed under
In order for the application to be considered for set-aside
funds, the PA Title and number must be typed on
line 2A of the face page of the application form. Submit
a signed, typewritten original of the application
including the Checklist, and three signed photocopies, in
one package, to:
Division of Research Grants
National Institutes of Health
6701 Rockledge Dr. Room 1040,  MSC 7710
Bethesda Maryland 20892-7710
At the time of submission, one additional copy of the
application must be sent to:
Susan F. Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
Center for Population Research
National Institutes of Child Health and Human Development
6100 Executive Boulevard,  Room 8B13
Bethesda,  Maryland 20892-7510
EXPRESS MAIL: Rockville, Maryland 20852
Applications must be received by the regular deadlines
for AIDS-related applications, May 1, September 1 and
January 1.
Applications will be received by the NIH Division of
Research Grants.  As part of the initial merit review, a
process may be used by the initial review group in which
applications will be determined to be competitive or
non-competitive based on their scientific merit relative to
other applications received.  Applications judged to be
competitive will be discussed and be assigned a priority
score. Applications determined to be non-competitive will
be withdrawn from further competition and the Principal
Investigator and the official signing for the applicant
organization will be notified. Following review by the
Initial Review Group, applications will be taken to the
NICHD, NIDR or NIMH  Advisory Council for a second level
of review and Institute program staff will make a final
funding decision based on scientific merit, program
relevance and the advice of Council.
GRANT APPLICATIONS (as per the NIH GUIDE, Volume 26,
Number 22, June 27, 1997)
Reviewers will be instructed to (a) address the five
review criteria below and (b) assign a single, global
score for each scored application.  The score should
reflect the overall impact that the project could have on
the field based on consideration of the five criteria,
with the emphasis on each criterion varying from one
application to another, depending on the nature of the
application and its relative strengths.
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 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?
In addition to the above criteria, in accordance with NIH
policy, all applications will also be reviewed with
respect to the following:
The adequacy of plans to include both genders,
minorities, and their subgroups as appropriate for the
scientific goals of the research.  Plans for the
recruitment and retention of subjects will also be
The reasonableness of the proposed budget and duration in
relation to the proposed research
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
The initial review group will also examine the provisions
for the protection of human subjects and the safety of
the research environment.
Awards will be made based on the scientific merit as
determined by peer review, on programmatic priorities and
on the availability of funds.
Written, email and telephone inquiries concerning this PA
are encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcomed. Direct
inquires regarding programmatic issues to:
Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute for Child Health and Human Development
6100 Executive Boulevard,  Room 8B13
Bethesda,  Maryland 20892
Telephone: 301/496-1174, FAX: 301/496-0962
Email: NewcomeS@hd01.nichd.nih.gov
Patricia Bryant, Ph.D.
Director, Behavior, Health Promotion and Environment
National Institute of Dental Research
Natcher Building, Room 4AN 18A
45 Center Drive MSC 6402
Bethesda,  Maryland 20892-6402
Telephone: 301/594-2095  FAX 301/480-8318
Email: BryantP@de45.nidr.nih.gov
Willo Pequegnat, Ph.D.
Office on AIDS
National Institute of Mental Health
Parklawn Building
5600 Fishers Lane, Room 10-75
Rockville, Maryland 20857
Telephone: 301 443-6100, FAX 301: 443-9719
Email: wpequegn@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Melinda Nelson
NICHD, Office of Grants and Contracts
Building 61E Room 8A
Bethesda, Maryland  20892
Telephone:  301/496-5481  FAX: 301/402-0915
Mr. Martin R. Rubinstein
Grants Management Office
National Institute of Dental Research
Natcher Building, Room 4AN 44A
45 Center Drive MSC 6402
Bethesda MD 20892-6402
Telephone: 301/594-4800
Email: Rubenstein@de45.nidr.nih.gov
Ms. Diana Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building
5600 Fishers Lane, Room 7C-08
Rockville, Maryland 20857
Telephone: 301 443-2805
The interests of the three co-sponsoring Institutes are
complemented by those of several other Institutes at NIH.
NIAID funds studies which focus on vaccine development,
biological endpoints of behavior and treatment of  HIV
infection;  NIAAA supports research which links HIV
prevention to  alcohol use and abuse; NIDA supports
studies which relate to drug use and abuse as a primary
focus of HIV infection, including the linkage of drug use
to risky sexual behaviors.
This program is described in the Catalog of Federal
Domestic Assistance No. 93.864 (Population Research)
NO.93.121  and No. 93.242 (NIMH).  Awards are 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 grant
policies and Federal Regulations, 42 CFR Part 52 and 45
CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order
12372, or to Health Systems Agency review.
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 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

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