Full Text PA-95-083


NIH GUIDE, Volume 24, Number 30, August 18, 1995

PA NUMBER:  PA-95-083

P.T. 34

  Risk Factors/Analysis 
  Behavioral/Social Studies/Service 
  Disease Prevention+ 

National Institute on Drug Abuse
National Institute of Mental Health


The purpose of this program announcement (PA) is to support basic
social and behavioral research on women's HIV risk and/or protective
behaviors combined with community-level intervention strategies aimed
at understanding and preventing HIV/AIDS in women whose drug and sex
practices put them at high risk of HIV infection, i.e., not-in-
treatment injection drug users (IDUs), crack users, injecting and
noninjecting sexual partners of male and/or female IDUs, and women
who trade sex for drugs, money, or subsistence.  Historically, these
women have been omitted from research or have been difficult to reach
and retain in research; as a result, the knowledge base is often
limited to the male experience.  Because of the increasing and
disproportionate numbers of women acquiring HIV disease, this PA
seeks to widen the research base on HIV risk behaviors and risk-
taking contexts by focusing on women and including protective
behaviors and contexts in addition to risks.

The NIH Office of AIDS Research has approved monies to support
research in several areas related to this announcement, including HIV
in women and children and behavioral research in drug-abusing


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,
Women's HIV Risk and Protective Behaviors, is related to the priority
areas of alcohol and other drugs and mental health and mental
disorders.  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


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.


Awards made under this PA will use the investigator-initiated
research project grant (R01) mechanism.  Because the type and scope
of proposed research responsive to this PA may vary, it is
anticipated that the size and period of the award will vary also.



By year end 1994, more than 58,000 U.S. women were reported with
AIDS.  In 1994, 41 percent of these cases resulted from injection
drug use, and 15 percent resulted from heterosexual contact with an
IDU (Centers for Disease Control (CDC) 1995).  Indeed, women's drug-
and sex-risks for HIV frequently co-occur.  Women's drug use often
involves membership in a network with HIV-infected individuals where
direct and indirect sharing of injection equipment and/or sexual
liaisons are transacted and where the social context (e.g., shooting
gallery) affects the likelihood of transmitting HIV.  Women's drug
use may also lead to trading sex for drugs or money, especially when
they smoke crack cocaine.  Studies show that drug-dependent women are
more likely than men to engage in high-risk sex and that women IDUs
are more likely to acquire HIV sexually than men.  Violence may be an
additional risk factor, because women with abusive partners practice
more HIV risk behaviors and are less likely to seek drug treatment,
otherwise reduce risky behavior, or disclose their HIV status to
their partners than nonabused women.

Data on women's drug use and HIV serostatus are available from
National Institute on Drug Abuse's (NIDA) Cooperative Agreement
Research Program, which tested 2,975 women for HIV between July 1,
1992 and December 31, 1993.  Of these, 10.6 percent were
seropositive.  By drug use category of the last 30 days,
seropositivity occurred in 8.5 percent of women who injected drugs,
in 13.4 percent of women who injected drugs and used crack cocaine,
and in 9.9 percent of women who used crack but did not inject.  While
the last category -- crack only -- does not consider injection
history, a connection between crack use and sexual transmission is
emerging.  A recent three-city study of young adults in the inner
city found that crack smokers had significantly higher rates of HIV
seropositivity (15.7 percent) than nonsmokers (5.2 percent), and
seroprevalence was highest among women (Edlin et al., 1994).  In
addition, CDC data indicate that the fastest growing exposure
categories of AIDS involve heterosexual contact.  Heterosexual
contact cases in women increased by 108 percent between 1989 and
1992, compared with increases of 43 percent among IDUs and 21 percent
in homosexual/bisexual men (Haverkos, 1993).

Women's unique HIV transmission contexts and behaviors, including the
link between drug dependence and risky sex as well as the potential
for vertical transmission to infants, have implications for the
development of targeted, gender-specific risk reduction
interventions, including programs for pregnant women.  It is also
important to note that HIV in this country has disproportionately
affected African Americans and Hispanics.  These groups constitute
approximately 18 percent of the U.S. population, but 77 percent of
AIDS cases in women in 1994 (rates for African American and Hispanic
women were 16 and 7 times higher, respectively, than for white
women).  Similarly, a majority of perinatally-acquired pediatric AIDS
cases were in African Americans and Hispanics (again, mothers'
exposure categories were chiefly drug-related).

Research Goals and Issues

Given gender differences in life experiences, perceptions, social
statuses, and HIV risk behaviors, there is reason to believe that HIV
interventions and prevention messages must be tailored for women.
The principal goals of this PA are to develop and implement gender-
specific research strategies that address HIV prevention in groups of
women whose behaviors and relationships place them at high risk of
HIV infection.  NIDA and the National Institute of Mental Health
(NIMH) will support basic behavioral/social science research projects
and/or evaluations of behavioral change strategies.  These projects
should build on and extend existing knowledge about HIV risks,
prevention, and protective factors in women.

For each proposed project, it is suggested that applicants review the
relevant theoretical, empirical, and methodological literature;
identify unresolved questions related to the determinants and
contexts of drug use and HIV risk and protective behaviors in women
who are not in treatment; develop and implement gender-related
intervention strategies and measurement procedures; and present a
plan for rigorous community-based research to address the outstanding
questions.  Because behavioral change is often multidimensional, it
would be useful for applicants to propose measures covering a range
of structural, social, and psychological factors and rely on
qualitative as well as quantitative research strategies.  Most
importantly, applicants are encouraged to describe the unique
contributions and/or integrative value of their proposed studies to
understanding HIV prevention in women and to consider race/ethnicity
factors in these studies.

At least four themes are of interest.  Basic research in field
settings is needed on (1) the social and structural contexts of
women's HIV risk behavior transactions and (2) determinants,
mediators, and reinforcers of women's HIV risk and/or protective
behaviors related to drug use, injection equipment, and sex.
Community-based intervention research is needed to (3) develop
gender-specific methodologies and instrumentation to recruit and
retain women in research and measure their behaviors, and (4) develop
and evaluate behavior change strategies aimed specifically at women.
Overlap and integration of these themes are encouraged.  Thematic
issues can include but are not limited to:

1.  The Social and Structural Contexts of Women's HIV-Related
Behaviors and Transactions.

Studies are encouraged that focus on social structures and social
contexts of women's HIV-related behavior transactions as well as
barriers and opportunities for change.  Suggested themes include:

o  Gender-specific interpersonal contexts of HIV risk behaviors.
Issues include gender-specific barriers in relationships (e.g., power
differentials) with violent or nonviolent sexual partners and/or drug
partners that affect women's HIV risk behaviors and the ability to
decrease their risks.

o  Gender-specific economic contexts of HIV risks and barriers to
change.  Issues include trading sex for drugs, money, or subsistence,
as well as economic pressure on sex trade workers to have unsafe sex.
The economic context of living "on the streets" by runaway and
homeless young women may also affect their risk of infection via drug
or sex practices.

o  Structural contexts affecting access to prevention aids and
behavior change.  Macro contexts include community policy/programs
affecting access to needles and condoms and/or law enforcement
practices against drug use, sex trade, or illegal immigration, which
may lead women to avoid contact with HIV prevention programs for fear
of being identified, prosecuted, and/or losing custody of their
children.  Also important are medical care and drug abuse services
system factors that may influence the delivery and effectiveness of
HIV interventions (e.g., linkage of primary medical care, HIV
prevention, drug abuse treatment, and treatment of comorbid mental

o  Membership/roles in social networks.  Using qualitative and
quantitative approaches to map linkages between individuals, issues
involve nonrandom properties of networks, norms, and group dynamics
that socially isolate and/or affect behavioral transactions across
cultural, age, and gender groups.  Suggested themes include:

o  Composition and stability of drug and sex networks
o  Nonrandom injection sequencing within networks of IDUs o  Gender
roles and the organization of drug procurement o  Lesbian/gay IDU
networks and bridges to other networks o  Norms about needle hygiene
and exchange of sex for drugs o  Gangs/cliques/street youth and the
initiation and extension of sexual activity and drug use

2.  Determinants, Mediators, and Reinforcers of Women's HIV-Related

NIDA and NIMH are interested in behavioral influences especially as
they vary demographically and/or culturally. Suggested themes are:

o  Physical, sexual, and/or emotional abuse.  Research is needed to
address physical and/or sexual violence against women and the
relationship of violence and abuse to high- risk behaviors and
women's ability to adopt HIV risk- reduction practices.  Young women
in abusive home settings may be a critical group.

o  The effect of serostatus on women's HIV risk behaviors and
behavior change.  Issues include the role of HIV antibody testing
and/or serostatus on behavior, motivation to change, and prevention
efforts; also how fertility/motherhood issues interact with
serostatus to affect behavior change.

o  The effect of pregnancy, childbearing, and childrearing on women's
HIV risk behaviors and behavior change.  Research is needed on
whether these conditions affect the social isolation of women and
their access/receptivity to HIV risk-reduction measures.

o  Women's reasoning/relational styles.  Issues include women's
unique psychosocial development and gender socialization and the
resulting effect on the ability to implement risk reduction or
interpret prevention messages.

3.  Gender-Specific Methodological and Measurement Studies.

NIDA and NIMH encourage the development of methodologies and measures
sensitive to women, especially multidimensional outcome measures of
behavior change.  Suggested themes include:

o  Innovative strategies, sampling, and tracking plans to identify,
access, recruit, engage, intervene with, retain, and follow up women
at highest risk for HIV.  These women, particularly when in abusive
relationships, are often hard to reach, tend to drop out, and are
lost to followup.

o  Development of instruments and scales with proven validity and
reliability among women.  Design specificity to different
racial/ethnic populations is especially desired.

o  New techniques or technologies for accruing data efficiently and
economically.  Investigators are encouraged to develop innovative
strategies to deliver research findings to the field in a timely

4.  Gender-Specific Behavior Change Interventions.

NIDA and NIMH wish to support theoretically based interventions as
well as interventions based on what is learned in basic research:

o  Studies are needed to evaluate what works, for whom it works,
under what circumstances it works, and how long it works, taking into
account the levels of risk engaged in as well as the episodic nature
of HIV risk behaviors/behavior change and need for intermittent

o  Prevention messages.  Studies are sought that address how women's
behavior change is related to the structure, context, duration, and
content of education and prevention messages, specifically, which
media and messages have the most impact or cumulative impact (e.g.,
news reports, talk shows, movies, personal experiences, community
messages in churches, clinics, or social agencies).

o  Studies of strategies to link HIV behavior change interventions
for women to health care services and to drug abuse treatment, and
vice versa (i.e., linkage of health care and drug treatment services
to HIV behavior change interventions).

o  Woman-controlled technologies, such as the female condom or
microbicides.  Issues include whether these technologies are viable
options for women at high risk of HIV; perceptions surrounding the
technologies; reasons for and barriers facing their use; and optimal
approaches to educate women (and men).

o  Other studies are encouraged that focus on individual gender-
related attributes and/or the interaction of gender with
race/ethnicity and the impact of these attributes and statuses on HIV
risk behaviors and behavior change.

NIDA Policy on HIV Counseling and Testing

Researchers funded by NIDA, who are conducting research in community
outreach settings, clinics, hospital settings, or clinical
laboratories, and have ongoing contact with clients at risk for HIV
infection, are strongly encouraged to provide HIV risk-reduction
education and counseling.  HIV counseling should include offering HIV
testing available on-site or by referral to other HIV testing
services.  Persons at risk for HIV infection include injection drug
users, crack cocaine users, and sexually active drug users and their
sexual partners.

Health Services Research Priorities

Historically, NIDA's research agenda has included a health services
research component; more recently, NIDA has placed increased
importance on health services research, especially related to cost
and financing as well as organizational aspects of drug abuse
treatment/prevention.  Therefore, applicants are encouraged to
address one or more issues on: costs, cost effectiveness, access and
utilization of services, financing, characteristics and matching, and
organization and management.

Only 25 percent of the NIDA grant budget may be used for services.
These services must be directly related to the research study.
Therefore, applicants who choose to address health services issues
are strongly encouraged to form linkages and agreements with
community service agencies.


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

Confidentiality.  The Public Health Service (PHS) has a formal policy
concerning Certificates of Confidentiality and communicable disease
reporting.  In brief, the policy reflects the expectation that
research projects will cooperate with State and local health
departments to assure that the purposes of reporting are
accomplished, and the expectation that health departments will
develop relationships with research projects that assist their
mission without thwarting the research goals. A description of the
policy as well as Instructions for Applicants can be obtained after


Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) 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 Grants Information, Division of
Research Grants, National Institutes of Health, 6701 Rockledge Drive,
Room 3032 - MSC 7762, Bethesda, MD 20892-7762, telephone
301-710-0267.  The title and number of this PA must be typed in Item
2 on the face page of the application.

The completed original 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 courier/overnight service)


Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in
accordance with 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 the 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

o  scientific or technical significance and originality of the
proposed research;

o  appropriateness and adequacy of the research approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the principal
investigator and staff;

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 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

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


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


Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Susan Coyle, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-42
Rockville, MD  20857
Telephone:  (301) 443-6720
FAX:  (301) 443-2636

Willo Pequegnat, Ph.D.
Office on AIDS
National Institute of Mental Health
5600 Fishers Lane, Room 10-75
Rockville, MD  20857
Telephone:  (301) 443-6100
FAX:  (301) 443-9719

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8-A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847

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


This program is described in the Catalog of Federal Domestic
Assistance No. 93.279 and 93.242.  Awards are authorized under the
Public Health Service Act, Section 301 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.  Grants will be administered under PHS grants policy as
stated in 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 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 of 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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