This Program Announcement expires on January 3, 2004 unless reissued.


Release Date:  April 26, 2001

PA NUMBER:  PA-01-084

National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Neurological Disorders and Stroke
Office of Research on Women's Health
National Center for Complementary and Alternative Medicine

Application Receipt Dates:  May 1, 2001, September 1, 2001, January 2, 2002


The National Institute of Allergy and Infectious Diseases NIAID), the 
National Institute of Child Health and Human Development (NICHD), the 
National Institute on Drug Abuse (NIDA), the National Institute of 
Dental and Craniofacial Research (NIDCR), the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK), the National 
Institute of Neurological Disorders and Stroke (NINDS), the Office of 
Research on Women's Health (ORWH), and the National Center for 
Complementary and Alternative Medicine NCCAM), National Institutes of 
Health (NIH), invite applications for highly focused basic research 
integrated with the Women's Interagency HIV Study (WIHS) scope and 
structure.  This PA is a renewal of PA-97-105, which was published in 
the NIH Guide on 09/05/1997.

Applications are expected to utilize the WIHS study population, a large 
cohort of HIV-infected women in the U.S., to formulate specific 
hypotheses concerning HIV/AIDS pathogenesis in women. The WIHS cohort 
is followed in five large metropolitan areas (New York, Washington DC, 
Chicago, Los Angeles and San Francisco).


The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas. This Program 
(WIHS), is related to the “HIV” focus area. Potential applicants may 
obtain a copy of "Healthy People 2010" at
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.

This PA 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 PA may not exceed four years.

Applications submitted in response to Program Announcements are 
assigned according to established PHS referral guidelines.  When the 
subject of an application is of interest to more than one component of 
NIH, dual assignments are made.

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by the NIH. Complete and detailed instructions and information on 
Modular Grant applications can be found at

A notice of modification and update (OD-00-046) regarding modular 
grants was released on 7/24/00 and can be found at


A.  Background
HIV in women is increasing globally. Women constitute over 45% of the 
approximately 36 million people estimated to be living with AIDS 
worldwide in 2000 and 47% of the nearly 5 million adults who were newly 
infected with HIV during the year 2000.

In the United States (U.S.), the epidemic began expanding among women 
in the late 1980s.  As of June 2000, the Centers for Disease Control 
and Prevention (CDC) estimated that the cumulative number of AIDS cases 
in adults and adolescents women in the U.S. was 124,911 (approximately 
17% of all AIDS cases)-— with 10,469 AIDS cases reported in the 12-
month period July 1999-June 2000. In the same 12-month period, 6,984 
HIV infections were reported among adult and adolescent women. In this 
group, self-identified exposure categories included heterosexual 
contact with HIV-infected men (41%), injection drug use (20%), 
other/risk not reported (38%) and receipt of blood transfusions or 
blood components (1%).  

In addition, the impact of HIV/AIDS in the U.S. has been particularly 
severe in minority populations and, recently, among young people. In 
the 36 geographic areas with name-based HIV reporting, 78% of new HIV 
infections in women between July 1999 and June 2000 occurred among 
African American and Hispanic women. Among men, these minorities 
represented 59% of new HIV infections. In the same 12-month period, 
young people aged 13 to 24 accounted for 16% of newly reported AIDS 
cases, evenly divided between women and men. 

Since the widespread introduction of highly active antiretroviral 
therapy, the death rate in persons with AIDS has decreased dramatically 
nationwide. As a result, among women 25 to 44 years old, AIDS has 
dropped from the third leading cause of death in 1995 to the fifth 
leading cause of death in 1998. However, the reduction in AIDS deaths 
among women has not been as marked as the death reduction among men.  

At the current stage of the HIV/AIDS epidemic, new paradigms have 
emerged that are likely to influence the direction of future research 
on HIV/AIDS.  Marked gender differences may exist in HIV disease 
progression, response to antiretroviral therapy and complications of 
therapy. Differences in HIV pathogenesis may be the basis for gender 
specific differences in health outcomes. Women with HIV/AIDS suffer 
from a variety of conditions unique to women such as human papilloma 
virus abnormalities, vulvar and vaginal carcinomas and pelvic 
inflammatory disease.  In addition, HIV-infected women have a higher 
prevalence of recurrent yeast infections, genital ulcer disease, and 
severe herpes infections than their male counterparts. Studies have 
demonstrated a wide variety of adverse conditions associated with 
antiretroviral therapy and these conditions affect many organ systems. 
Women infected with HIV may develop complications that are different 
from those in men. Since highly active antiretroviral therapy may 
extend HIV seropositive women’s lives, in depth studies are necessary 
to investigate the factors and mechanisms underlying the pathogenesis 
of HIV disease and the pathogenesis of such chronic toxicities. 

Studies of HIV/AIDS in women can play a unique role in testing new 
biological or socio-behavioral hypotheses at the population level and 
in linking basic science findings and laboratory methods to 
epidemiologically well-defined populations and communities.
The Women's Interagency HIV Study (WIHS), a multicenter, prospective 
study, was established in 1993 to carry out comprehensive 
investigations of the impact of HIV infection in women.  A total of 
2,641 women (2066 HIV positive and 575 negative), 80% of minority 
background, were enrolled. In addition to NIAID, other NIH institutes 
currently fund different components of the WIHS. These Institutes 
include: the National Institute of Child Health and Human Development 
(NICHD), the National Institute on Drug Abuse (NIDA), the National 
Institute of Dental and Craniofacial Research (NIDCR), and the National 
Cancer Institute (NCI).  The WIHS has interacted with the community 
from the outset, by soliciting the community's input to better identify 
problems and to pursue research opportunities. Community involvement 
through the individual WIHS sites and the Community Advisory Board 
(CAB) continues to be encouraged to foster women's participation and 
understanding of research scope and results.
The WIHS was established to investigate the clinical, laboratory and 
psychosocial aspects of HIV infection in women, in a multi-site, 
prospective fashion.  The WIHS is well positioned to contribute key 
information on many aspects of HIV infection and disease in women 
particularly in the era of combination antiretroviral therapy. Such 
aspects include the history of HIV treatment and its virologic and 
immunologic characteristics, gender differences in biologic markers of 
HIV, gynecologic manifestations, and socio-behavioral patterns.  During 
the course of the study, progress in HIV/AIDS research will require 
flexibility in modifying goals and adjusting the infrastructure to 
reflect new knowledge and state-of-the-art methodology.  Research in 
the WIHS is able to correspond to changes in HIV/AIDS research partly 
because clinical care and research activities for WIHS participants are 
carried out at the same health facilities. This allows for real-time 
clinical observation and laboratory testing of participants. The rapid 
implementation of new research protocols will be facilitated by close 
coordination between investigators proposing studies under this Program 
Announcement and the WIHS Executive Committee and Working Groups. 
B.  Research Objective and Scope
Applicants are invited to propose studies focused on basic mechanisms 
of HIV infection and disease in women. Applications in response to this 
Program Announcement may include expansion of ongoing studies and new 
studies. In addition, studies may involve all WIHS sites or may be 
limited to defined subsets of the WIHS population, when special 
requirements exist, such as the need for more frequent participant 
visits.  Studies may address, in detail, biological aspects of HIV 
infection and how such aspects affect women's health. Proposed studies 
should emphasize investigations predicated upon specific hypotheses.  
Applications may focus on investigations in the specific areas of 
interest of the collaborating NIH Institutes, as outlined below.  
Important areas of investigation include, but are not limited to, the 
following subjects:
NIAID: grant applications in the areas of molecular basis of HIV 
infection and disease progression in women in the antiretroviral era, 
including the interplay of host and viral characteristics; 
characterization of HIV in cervico-vaginal mucosa and its relationship 
with HIV in blood; HIV virologic and immunologic factors and their 
relationship with endocrinologic factors in HIV infected women; 
characterization of viral reservoirs and their role in HIV-infected, 
antiretroviral-treated women.  

NICHD: grant applications in the areas of endocrinologic factors 
(including both endogenous and common exogenous hormonal exposures), 
HIV expression, and disease progression; interactions between pregnancy 
and HIV infection; and fertility-related behaviors among HIV-
seropositive women.

NIDA: grant applications investigating direct and indirect effects of 
drug use and associated infectious co- morbidities, such as chronic 
hepatitis C; metabolic complications such as wasting, lipid and glucose 
disorders; the impact of drug use, HIV and HIV therapies on peri- and 
post- menopausal co-morbidities and biological markers; drug-drug 
interactions and hepatotoxic effects of pharmacotherapies; viral strain 
variation in association with ongoing drug injection and development of 
viral resistance to anti-retroviral therapy.

NIDCR: grant applications investigating the in vivo role and mechanism 
of action of oral antiviral factors (salivary and mucosal); the 
influence of oral co-infections on HIV infection and disease 
pathogenesis; the role of the oral pharyngeal region as a reservoir of 
HIV infection; oral diagnostics and therapeutics; the role of host 
response in candida infections; and characterization of salivary 
molecules exhibiting anti-candida activities. 
NIDDK: grant applications to elucidate the pathogenesis of 
lipodystrophy (lipoatrophy and lipohypertrophy) in HIV patients; 
studies of abnormalities of insulin sensitivity, glucose homeostasis, 
lipoproteins, and other components of the "Metabolic Syndrome" or 
"Syndrome X" in patients with HIV; studies of the AIDS wasting syndrome 
(AWS), including the effects of HIV on endocrine and gastrointestinal 
function, metabolism, appetite and diet, physical activity, and body 
composition; studies of the pathogenesis and natural history of 
endocrine, gastrointestinal and renal dysfunction in HIV-positive 
women, including mechanisms of  hepatic and renal toxicity. 
NINDS: grant applications investigating the pathogenesis of central and 
peripheral nervous system abnormalities caused directly or indirectly 
by HIV infection in HIV-positive women. Such research could include the 
role of genetic factors, immune status, and hormonal function in women 
at risk for AIDS-related neurological disorders.
NCCAM:  grant applications to investigate the use of complementary and 
alternative medicine (CAM) therapies among women in the cohort, with 
attention to comparisons between women using and not using a specific 
CAM modality.  Applications to evaluate the effect of CAM on disease 
markers, symptoms, progression, and sequelae; the influence of CAM on 
medication side effects; and clinical outcomes will be considered.

ORWH: ORWH will be providing partial funding to selected grants awarded 
by the Institutes identified above, contingent upon the availability of 
funds.  Grant applications investigating the racial/ethnic differences 
during early HIV infection and HIV disease progression.  Two areas of 
particular interest are differences in high-risk behaviors (sexual or 
drug-related) and racial/ethnic differences during early HIV infection 
and HIV disease progression across a woman’s life span.

In addition to addressing the aspects described above in the main study 
population (approximately 2000 HIV seropositive women), focused studies 
may be conducted in the approximately 500 HIV seronegative women who 
are currently under active follow-up.  These HIV negative women 
represent a critical control population for research in areas such 
metabolic changes under highly active antiretroviral therapy and aging.

C.  Research Structure
Scientific questions addressed by studies submitted under this Program 
Announcement may utilize biological specimens already collected and 
banked or specimens to be collected prospectively. Stringent monitoring 
of specimen utilization will occur throughout the study duration to 
permit specimen use by a broad number of investigators. Use of WIHS 
specimens will be restricted to the use stated in the grant. To address 
any peer-review concerns regarding specimen access, applicants are 
advised to provide a letter of support with their application from the 
WIHS Executive Committee demonstrating the establishment of a 
collaboration with the WIHS investigators.

Inquiries on this matter should be directed to the Program staff of the 
participating NIH Institutes.

It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear, compelling rationale, and justification are 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 UPDATED "NIH Guidelines For Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(; a 
complete copy of the updated Guidelines are available at:  
The revisions relate to NIH-defined Phase III clinical trials and 
require:  a) all applications or proposals and/or protocols to provide 
a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.


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 which is 
available at the following URL address:    
Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES. Program staff may provide additional 
relevant information concerning the policy.


All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.


Applications are to be submitted on the grant application form PHS 398 
(rev. 4/98) and will be accepted at the standard application deadlines 
as indicated in the application kit. Application kits are available at 
most institutional offices of sponsored research and may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone 301/710-0267, email: In addition, the application kits can be found on 
the following URL:

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any 
amended/revised version of the preceding grant application types 
requesting $500,000 or more in direct costs for any year are advised 
that he or she must contact the Institute or Center (IC) program staff 
before submitting the application, i.e., as plans for the study are 
being developed. Furthermore, the application must obtain agreement 
from the IC staff that the IC will accept the application for 
consideration for award. Finally, the applicant must identify, in a 
cover letter sent with the application, the staff member and Institute 
or Center who agreed to accept assignment of the application. 

This policy requires an applicant to obtain agreement for acceptance of 
both any such application and any such subsequent amendment. Refer to 
the NIH Guide for Grants and Contracts, March 20, 1998 at


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

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) 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.

Page 4 of the PHS 398. It is not required and will not be accepted with 
the application.

the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o  BUDGET NARRATIVE JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
for sample pages.) At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page.

Under Personnel, provide budget narrative for ALL personnel by 
position, role and level of effort.  This includes consultants and any 
“to be appointed” positions.  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 all 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 a Letter of Commitment 
or Intent if there is or is to be a subcontract/ 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, including consultants, following the 
instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at:

-  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 
-  List selected peer-reviewed publications, with full citations

o  CHECKLIST - This page should be completed and submitted with the 
application.  Applicant institutions should calculate the Facilities 
and Administration (F&A) costs using the current negotiated F&A rate, 
less exclusions, for the initial budget period and all future budget 
periods.  It is not necessary to list the exclusions on the Checklist 
nor anywhere in 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 title and number of the program announcement must be typed on line 
2 of the face page of the application form and the YES box must be 

Applications not received as a single package on the receipt date or 
not conforming to the instructions, including page limitations and font 
size, contained in PHS 398 Application Kit (rev. 4/98) (as modified in, 
and superseded by, the special instructions below, for the purposes of 
this PA), will be judged non-responsive and will be returned to the 

Effective for the receipt dates beginning September 1, 2000, 
applications not in compliance with the modular application 
instructions will be returned to the applicant institution by the 
Center for Scientific Review (CSR).  Applications revised and 
resubmitted to NIH in a timely manner may remain in the intended review 
cycle. (See

The title and number of the program announcement must be typed on line 
2 of the face page of the application form and the YES box must be 

Submit a signed, typewritten original of the application, including the 
checklist, and five signed photocopies in one package to:

BETHESDA, MD 20892-7710
(Use BETHESDA, MD 20817 for express/courier delivery)


Applications will be assigned on the basis of established NIH referral 
guidelines. Applications will be evaluated for scientific and technical 
merit by an appropriate scientific 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 

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 meritorious 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 

(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 

(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 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 be 
evaluated as well.

o The reasonableness of the proposed budget and duration in relation to 
the proposed research

o The adequacy of the proposed protection for humans or the 
environment, to the extent they may be adversely affected by the 
project proposed in the application.


Applications will compete for available funds with all other 
recommended 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:

Paolo Miotti, M.D., M.P.H.
Telephone:  (301) 496-9176
FAX:  (301) 402-3211
Heather Watts, M.D.
Telephone:  (301) 496-7339
FAX:  (301) 496-8678

Henry Francis, M.D.
Telephone:  (301) 443-2146
FAX:  (301) 443-4100

Maryann Redford, D.D.S., M.P.H.
Telephone:  (301) 544-5588
FAX:  (301) 480-8254
Barbara Linder, M.D., Ph.D.
Telephone:  (301) 594-0021
FAX:  (301) 480-3503
A.P. Kerza-Kwiatecki, PhD.
Telephone:  (301) 496-1431
FAX:  (301) 402-2060
Morgan N. Jackson, M.D., M.P.H.
Telephone:  (301) 402-1278
FAX:  (301) 480-3621

Lisa Begg, Dr.P.H.
Telephone:  (301) 402-1770
FAX:  (301) 402-1798

Direct inquiries regarding fiscal matters to:
Ms. Theresa Mercogliano
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 2261
Bethesda, MD  20892 (use Bethesda, MD 20817 for express/courier delivery)
Telephone:  (301) 402-5512
FAX:  (301) 480-3780

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.856. Awards are made under authorization of Sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92. 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 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, and 
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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