Full Text HS-94-003

HIV COST AND SERVICES UTILIZATION STUDY

NIH GUIDE, Volume 22, Number 31, August 27, 1993

RFA:  HS-94-003

P.T. 34

Keywords: 
  Health Services Delivery 
  Health Care Economics 
  AIDS 


Agency for Health Care Policy and Research

Letter of Intent Receipt Date:  December 22, 1993
Application Receipt Date:  February 22, 1994

PURPOSE

The Agency for Health Care Policy and Research (AHCPR) supports and
conducts health services research, including evaluations of health
care systems.  The purpose of this Request for Applications (RFA) is
to invite applications for cooperative agreements with the AHCPR to
conduct a study of utilization, cost, financing, access to, and
quality of health care services for persons infected with the Human
Immunodeficiency Virus (HIV).  This HIV Cost and Services Utilization
Study (HCSUS) is intended to provide up-to-date, policy-relevant
information on the delivery of health care and associated social
services to people with HIV infection.

This study will develop and analyze information on the delivery of
health care to persons with HIV infection in a variety of health care
settings and geographic areas.  In addition to the conduct of
research and report of findings in the scientific literature, this
project will provide analyses that have utility for meeting
short-term needs for policy-relevant information.

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 RFA,
HIV Cost and Services Utilization Study, is related to the priority
areas of HIV infection, sexually transmitted diseases, immunization
and infectious diseases, and clinical preventive services.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, non-profit organizations,
public and private, including universities, clinics, units of State
and local governments, non-profit firms and foundations; or consortia
of organizations, if the application is submitted by a domestic,
non-profit, public or private organization.  A consortium may include
other types of organizations, such as for-profits.  Applications from
minority and women investigators are encouraged.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be the cooperative agreement (U01), an assistance mechanism
(rather than an acquisition mechanism), in which substantial AHCPR
scientific and programmatic involvement with the awardee(s) is
anticipated during the performance of the activity.  Under this
cooperative agreement, the AHCPR seeks to support and stimulate the
awardee's activity by collaborating and otherwise facilitating the
activity in a partner role, while avoiding a dominant role,
direction, or prime responsibility.  Details of the responsibilities,
relationships, and governance of the project to be funded under this
cooperative agreement are listed under Terms and Conditions of Award.

The total project period for applications submitted in response to
this RFA may not exceed four years.  The anticipated award date is
July 1, 1994.  Although this project is provided for in the financial
plans of the AHCPR, any award(s) pursuant to this RFA is contingent
upon the availability of funds for this purpose.  Award of
continuation funding beyond the initial budget period will depend
upon availability of funds, satisfactory progress, and annual
progress reviews according to customary AHCPR administrative
procedures.

FUNDS AVAILABLE

The AHCPR expects to award a total of $15 million over four years
under this RFA to one or more applicants.  Up to $3 million will be
available in Fiscal Year (FY) 1994 and an average of $4 million for
each of the next three fiscal years.

RESEARCH OBJECTIVES

Background

Over the preceding decade, rapid changes have occurred in the
availability of services for, and the treatment of, persons with HIV
infection, and in the characteristics of the population of persons
newly infected with HIV.  The swift pace of change means that
existing data on health care services to people with HIV infection
quickly become dated.  Policy-makers involved in funding,
establishing, developing, and managing health care programs for
persons with HIV infection, as well as health care providers, their
patients, and the patients' families, have a need for current
information about patterns of service delivery.

The ability of health care policy-makers to stay well-informed about
HIV-related services delivery is limited by the rapidity with which
the epidemic has evolved and complicated by wide variations in
patterns of treatment across regions of the country, socioeconomic
groups, and systems of health care.  Most studies of health care
delivery to persons with HIV infection have gathered data from a
homogeneous patient group, in a single community, receiving services
from a single provider; and thus do not reflect the spectrum of
health care delivery systems that provide services to persons with
HIV infection.  Because of differences in methodology, aggregating
these narrowly focused studies is rarely feasible.

While the principal audience for the findings from the HCSUS will be
policy-makers at the Federal, State, and local levels, HCSUS also
should furnish information of interest to health care providers,
health services researchers, and consumers of HIV-related health care
and support services.  The needs of the principal audience for
timely, policy-relevant information require that the HCSUS focus on
services utilization and financing, and the factors affecting them.
The HCSUS is not intended to include program evaluation, community
intervention, laboratory experiments, controlled trials, clinical
research or efficacy studies, epidemiology, or prevention research.

This project will provide information relevant to the formulation of
legislation, regulation, and program administration.  Mechanisms to
ensure timely analyses of relevant health care policy issues are
considered critical for success of the project developed under this
RFA, and are discussed below in the section, SPECIAL REQUIREMENTS.

The HCSUS is conceived as extending and refining the base of
knowledge developed by prior studies of health care delivery to
people with HIV infection.  The HCSUS builds upon, but does not
replicate the "AIDS Costs and Services Utilization Survey (ACSUS)"
supported by the AHCPR.  The ACSUS collected data about the use of
health care services by HIV-infected persons during an eighteen month
period.  Under AHCPR auspices, Westat, Inc., the ACSUS contractor,
recruited a diverse cohort of 2,090 persons with HIV infection at 26
participating sites in 10 selected cities; surveyed their quarterly
use of services on six occasions between April 1991 and December
1992; and obtained supplementary data from billing, medical, and
Medicaid records.  Analysis of the ACSUS interview data has begun.
The National Technical Information Service (NTIS) has received a
public use data set containing information from the screener
questionnaire administered to over 5,000 patients; persons wishing to
obtain these data can call the NTIS at (703) 487-4650 and ask for
"AIDS Cost and Services Utilization Survey I" (Order Number:
PB93-505899GEI).  An AHCPR publication describing the ACSUS study
design in greater detail, (ACSUS Report 1:  "Research Design and
Analysis Objectives"), is available from the AHCPR Clearinghouse,
(see INQUIRIES).  Additional public use data sets and reports will
become available in the future.

Prior to the development of this RFA, the AHCPR conducted a series of
discussions with public and private organizations and individuals
concerned with the delivery of health care and support services to
people with HIV infection.  Comments and information concerning the
focus and technical aspects of the proposed project were solicited.
In collaboration with the Health Resources and Services
Administration (HRSA), PHS, and the National Community AIDS
Partnership, the AHCPR sponsored a conference in November 1992, to
discuss a national agenda for HIV service delivery research and
evaluation.  Copies of the report of this conference, "Creating an
Agenda for Research and Evaluation:  HIV Service Delivery, the Ryan
White CARE Act, and Beyond," are available from the AHCPR.  On June
24-25, 1993, the AHCPR conducted a public meeting to solicit further
advice on technical aspects of the research design of this RFA.  The
report of the meeting, entitled "HIV Cost and Services Utilization
Study:  Technical Issues," will be available to applicants.
Information on obtaining the written materials noted above is
provided under the section INQUIRIES.

Objectives and Scope

Questions concerning differences among various systems of health care
delivery continue to arise and will grow in salience as proposals for
health care reform are advanced.  Throughout the course of the HIV
epidemic, questions have been posed concerning the utilization,
costs, and outcomes of care provided by different types of providers.
Answers to these questions will provide decision-makers at Federal,
State, and local levels with important information for the planning,
development, and implementation of health care services and programs.
The goals of the HCSUS are directed toward providing answers to these
policy-relevant questions.

The first goal of the HCSUS will be to compare the experiences of
people receiving health care from different care delivery settings or
systems.  The HCSUS will address the question:  how do health care
delivery settings vary in terms of patterns of utilization, costs of
care, quality of care, access to care, meeting service needs, quality
of life, and patient satisfaction?  The HCSUS will provide comparable
data on patients receiving services from different types of care
providers.

Applicants should provide their own conceptualization or typology of
health care settings or systems.  One approach is to consider
locations of care.  Important settings include, but are not limited
to:  ambulatory HIV clinics affiliated with hospitals; health
maintenance organizations (HMOs), especially Medicaid HMOs;
free-standing clinics, including specialized HIV clinics, as well as
community or neighborhood health centers; and community-based health
care providers, including private practices.  Other types of
settings, such as community-based AIDS service organizations,
substance abuse treatment centers, sexually transmitted disease (STD)
clinics, or providers of mental health care, also may be included.
Other conceptualizations of service delivery systems are possible and
justifiable.

Various other factors are correlated with provider type and may
directly affect service utilization.  These include case-mix factors:
gender; race/ethnicity; HIV exposure group, such as gay and bisexual
men, injecting drug users; age; and insurance status.  Data on these
characteristics are necessary when developing statistical models to
estimate differences by type of care setting.  The relationships of
such characteristics to service utilization, costs, access, and
quality of care also are of interest.

In addition, the major or usual source of care for a given person may
change over time as a result of changes in employment, insurance, or
severity of illness.  A second goal of the HCSUS is to investigate
factors related to transitions between provider types and examine
changes in utilization over time and by disease severity at the level
of the individual patient.  This goal includes more specific issues,
such as the extent to which loss of private insurance leads to a
shift from the private to the public sector, and the extent to which
(and the point at which) people with symptomatic HIV infection seek
and/or are referred to care provided by a specialist, rather than a
generalist.

People with HIV infection may use several providers of different
types concurrently.  Public policy has focused on expanding
community-based services with the goal of reducing institutional and
emergency room care.  The third goal of the HCSUS is to provide
information on factors that affect utilization and costs of the full
array of services related to care for HIV infection and examine the
degree to which the use of one service type affects use of other
types.  Relevant services include, but are not limited to: inpatient,
emergency room, and ambulatory clinical care and health-related
support services; home health care; long-term care; psychosocial
support; housing; and other community-based services.

A related question that the HCSUS will address is the degree to which
some services act as substitutes for others.  In particular, the
study should be designed so as to examine the degree to which, and
the conditions under which, community-based services, including home
health care and other forms of supportive care, affect the
utilization and costs of institutional care, such as inpatient
hospital use, nursing home use, and "inappropriate" emergency room
use.

Study Design

The choice of study design is intimately connected to the nature of
the research questions to be studied and the intended audience(s) for
the findings.  A large-scale project such as HCSUS must accommodate
several goals and audiences.  In discussions with various
organizations and individuals prior to the development of this RFA,
it became apparent that there is no clearly optimum study design that
will achieve all objectives.  In particular, choice of study design
will depend upon how one chooses to balance (1) a descriptive versus
analytic emphasis, and (2) investigating focused hypotheses versus
developing a multi-purpose data set for answering questions that may
arise in the future.  Applicants are encouraged to propose a position
on these continua and to justify the suitability of their study
design to that balance.

As noted in the report of the public meeting, "HIV Cost and Services
Utilization Study:  Technical Issues," there is debate concerning the
advantages of longitudinal versus cross-sectional designs.
Applicants have the latitude to propose either type of design, or
some combination of both; applicants should justify their design
choice in terms of its suitability for providing credible information
on the three major issues outlined above.  Accordingly, applicants
have significant freedom in developing their study design.  They are
encouraged to design new research strategies, use new combinations of
methods, or tailor existing methods to their research questions.

Attendees of the public meeting on technical aspects of research
design for this RFA noted that it would be useful to organize
presentation of the study design in terms of two components:  core
and special studies.

Study Design:  Core Study

The methodology and data collection activities proposed by the
applicant to address the goals noted above will establish the central
core of the project's design.  The project core should be capable of
addressing a broad range of health care policy issues using uniform
data collection procedures across all sites.

The successful applicant will be expected to provide information
about the delivery of health care services to persons with HIV
infection as a function of:

o  Provider Setting:  Information should encompass the major types of
providers of HIV-related health care, including (but not limited to)
public hospitals, health maintenance organizations, community health
centers, community-based physicians, and other health care and
support services providers;

o  Geographic Region of the United States:  Service delivery patterns
vary in different areas of the country.  A major virtue of a
large-scale study such as the HCSUS is its ability to gather data in
a uniform manner from several geographical areas.  HCSUS should
provide information from several geographically diverse areas.
Applicants may wish to consider including, and provide justification
for, areas with moderate, as well as high, levels of HIV
seroprevalence;

o  Sociodemographic Characteristics:  Information should include a
sample that represents different populations, defined by gender, race
or ethnicity, and exposure group.  Ideally, the sample would be large
enough to permit separate analyses to be conducted within these
different groups; and

o  Stages of HIV infection:  This would include persons at different
stages of HIV infection, such as asymptomatic, symptomatic non-AIDS,
and AIDS.

The HCSUS will obtain information about the characteristics of the
care setting in order to describe characteristics of different
provider types, and address questions about the organizational
context in which services are delivered to persons with HIV
infection.  Applicants should explicitly discuss the particular
organizational characteristics to be measured and the procedures for
measuring them.

The HCSUS will provide information on factors that affect service
delivery.  Important aspects of service delivery include:  rates of
service utilization, financing and costs of care, access barriers and
unmet service needs, and quality of care.  Other factors of interest
are patient satisfaction, quality of life, and survival.  In
addition, measures of continuity and coordination of care, especially
as people move between different care systems such as clinical health
care and substance abuse treatment systems, are of interest.

The core component of the HCSUS will sample people receiving services
related to their HIV infection.  Although such a sample cannot
provide definitive information on access barriers, since those
outside the care system are not included, it is appropriate to obtain
information concerning current barriers or obstacles to care and,
retrospectively, factors that may have impeded access to services at
earlier stages of the disease.

As noted above, the HCSUS sample will be heterogeneous in terms of
usual source of care, gender, race/ethnicity, geographical location,
and exposure group.  Applications that present a detailed and
feasible probability sampling procedure of these populations are of
special interest.  The AHCPR, however, does not mandate probability
sampling procedures for the HCSUS.  If probability sampling is not
used in the core study, the applicant may propose to develop a
special study (see section "Study Design:  Special Studies"), to
supplement the core study for the purpose of estimating the extent of
bias in the core sample.

Certain information, such as a comprehensive enumeration of all
providers of different services, financing, or measures of quality of
life, may have to be obtained from patients themselves.  Measures of
quality of care and of disease stage may require review of medical
records.  Measures of provider characteristics may be obtained from
organization personnel and documents.  The applicant, however, may
propose other sources of data.  The AHCPR is interested in
applications that present creative and innovative methods for data
collection.

The applicant will be expected to impose relevant uniform data
collection procedures at each data collection site.  Methods for
assuring data quality and uniformity should be described.  The
applicant also should describe procedures for minimizing nonresponse
bias and for reducing loss to follow-up.

As reflected in the report of the public meeting, "HIV Cost and
Services Utilization Study:  Technical Issues," there is no consensus
on the proper method for measuring costs.  One approach is to obtain
detailed information on charges from billing data and then to adjust
those charges in some manner.  An alternate approach would focus on
units of service received and impute a cost per unit of service.
This approach would not necessarily require that resources be
expended to obtain billing data.  Each approach has its benefits and
drawbacks, and other approaches are possible.  The applicant should
describe and justify procedures for cost estimation in detail.
Moreover, the applicant should assure that the HCSUS data can be used
for relevant cost-effectiveness analyses.

At a minimum, the core data set should include:  measures of service
utilization; health-related quality of life, including well-being and
functional status; satisfaction with care; perceived barriers to
accessing care; unmet service needs; health insurance; employment
status; income both personal and household; type of residence and
household composition; and other sociodemographic characteristics.
In addition, sufficient clinical data should be collected to stage
study participants in terms of disease progression at periodic points
in time; such clinical data might include CD4 cell data, HIV-related
symptoms, comorbid conditions, and current use of alcohol or illicit
drugs.  In addition, the data set developed by the core study should
be sufficiently comprehensive to address future policy issues that
may arise.  The applicant should describe and justify the specific
measures to be included in the core data set.

As part of the core study, applicants may wish to consider the
inclusion of supplementary approaches to the study of health services
for persons with HIV infection such as use of secondary data,
provider studies, case-control methods, cross-sectional analyses,
supplementation of and integration with existing data sources, and
case studies.  Links to and comparability with other data sources may
enhance the ability to respond effectively to policy issues using the
HCSUS data.

Study Design:  Special Studies

In addition to the project core, the response to this RFA may include
proposals for one or more special, focused studies that examine key
research questions in greater depth than is possible in the project
core.  The design and methodology of these special studies may differ
from that of the project core and from each other, but should be
coordinated with the core study.  Research issues that may be more
appropriately considered within the context of a special study
include:

o  Care of HIV-infected Patients in Rural Areas:  Obtaining a sample
of rural residents infected with HIV infection may be difficult to
integrate with the general sampling scheme for the core study.  This
special study would obtain information on relevant problems in HIV
service delivery for residents of several different rural areas;

o  Early Intervention and Linkage:  One special study could obtain a
supplemental sample of individuals who are at an early point in the
disease course, and who may or may not be in care.  This study could
address issues of access to care, early intervention and management,
and factors that facilitate linking people between HIV counseling and
testing sites, and other service providers; and

o  Probability Sample:  If a probability sample is not proposed for
the core study, applicants may consider obtaining a probability
sample of people with HIV infection receiving treatment in order to
assess the extent of bias within the core sample.

The "HIV Cost and Services Utilization Study:  Technical Issues"
Report, noted earlier, provides additional examples of research
issues that may be appropriate for inclusion as special studies.  It
also discusses research questions that may be considered for
inclusion in the core design and suggests technical considerations
for the project's research design.

Timetable

Allowing for start-up and close-out, the HCSUS should, at a minimum,
describe health care utilization experiences during 1995 and 1996.
Applicants should allow time for inter-site coordination in any
proposed schedules.

SPECIAL REQUIREMENTS

To promote the development of this multi-site collaborative project,
a number of additional issues should be addressed in applications
responding to this RFA, as discussed below.

Site Selection and Project Organization

In describing the selection of sites and the organization of the
project, applicants should:

o  discuss the reasons for their choice of study locations/sites;

o  describe and document their ability to recruit and retain a
sufficient number of study participants;

o  describe potential biases in the sample and discuss the degree to
which findings will be generalizable;

o  justify their selection of collaborating institutions and
investigators, and describe the complementary capacities each
site/collaborator would bring to the HCSUS;

o  describe, in detail, a mechanism to ensure that effective
collaboration will occur among sites, and, if the applicant(s)
proposes a consortium, among institutions and investigators, on
issues such as use of common protocols, facilitating the conduct and
monitoring of the study, uniform data collection and access to data,
reporting of results, and development of publications; and

o  demonstrate their ability to interact effectively with
collaborators and representatives of study sites, including Persons
Living with AIDS (PLWA) groups, community-based organizations, and
other service providers.

The AHCPR recommends that the applicant establish a Steering
Committee to provide advice and guidance, and to assist in governance
of the study and in conflict resolution.  The membership of the
Steering Committee may include, in addition to the Principal and
Co-Investigators, experts in HIV-related service delivery, research,
and policy development; HIV-infected persons and their
representatives; community-based organizations; and local and
national health service providers and institutions.

If a consortium of institutions responds to this RFA, the application
should describe a practical structure for consortium decision-making
and governance.  Unanticipated disagreements about methods, resource
allocation, standardization, authorship, etc., may arise during the
course of any project.  The consortium must be able to make unified
decisions on the issues' merits, without dissolving or routinely
relying upon outside arbitration.

Confidentiality of Data

Data from persons with HIV infection must be treated as highly
sensitive information.  The applicant must describe procedures for
ensuring confidentiality of data.  This should include a discussion
of who will be permitted access to the data, both the raw data and
machine-readable files, and how personal identifiers will be
safeguarded.

Community Involvement

The cooperation and participation of HIV-infected persons and their
representatives, community-based organizations, and local and
national health service providers and institutions will be critical
to the success of the HCSUS.  Accordingly, applications should
describe in detail the level of involvement in this project of the
community of people with HIV infection.  Involvement can occur both
at particular data collection sites and/or at the level of overall
project administration.  Participation may entail research
partnership, approval, advice, information, or other degrees of
involvement.

Rapid Response Capability

A principal purpose of the HCSUS is to conduct analyses and provide
rapid responses to expressed needs for health policy-relevant
information.  Applicants should describe procedures for producing
focused analyses in an expeditious manner, on demand.  A rapid
response capability will require cleaning and processing small
batches of data as soon as they are received from the field, updating
data files on a continuous basis, and maintaining sufficient staff to
conduct analyses of data on a short timetable.  Rapid response
mechanisms also are related to plans for uniform data collection and
may be facilitated by establishment of a data coordination center.

Applicants are encouraged to describe their proposed mechanisms for
ensuring such timely responses, including plans for:

o  collecting and maintaining at a central location a wide range of
updated and "cleaned" data in such a way that numerous
policy-relevant analyses may be conducted rapidly;

o  assuring flexibility, throughout the course of the study, in
collection of additional data necessary to inform emerging policy
issues;

o  identifying evolving policy issues and disseminating relevant
findings thorough periodic and continuing collaboration with
decision-makers and other data users representing, at a minimum, the
public policy sector, including Federal, State, and local officials.
Applicants should include plans and budgets for meetings at which
exchange with such groups may occur.  (At least one meeting should
take place annually in the Washington, DC, area.);

o  maintaining project staff capable of producing a rapid response to
unanticipated requests for analyses of policy issues, or for analyses
identified through collaboration with public sector decision-makers
and the AHCPR; and

o  describing plans for timely dissemination of research findings
through a rapid response mechanism, as well as publication in the
scientific literature.

Terms and Conditions of Award

This cooperative agreement anticipates substantial AHCPR scientific
and programmatic involvement with the awardee(s) throughout the
planning, implementation, termination, and close out of the HCSUS.

1.  Awardee Responsibilities

The awardee(s) will have primary and lead responsibility for all
tasks and activities including:  sampling, stratification, protocol
development, study organization, participant recruitment and
follow-up, data collection, quality control, data analysis and
interpretation, preparation of publications, community involvement,
collaboration among participating organizations, and liaison with
information users and policy-makers and other programs of related
research.  The awardee(s) also will have responsibility for providing
rapid response to requests for policy analyses, but may request the
AHCPR to assist in establishing priority in responding to requests
for such analyses.

The AHCPR is committed to disseminating the products of the HCSUS as
rapidly as possible.  In this context, products include both written
reports of findings and the data themselves.  The AHCPR will have
access to data from the HCSUS upon request.  All rights of access to
the data will be consistent with current Public Health Service
policies and Federal Regulations 42 CFR 67, as well as with section
903(c) of the PHS Act and other statutes listed under AUTHORITY AND
REGULATIONS.

2.  AHCPR Staff Responsibilities

The AHCPR Project Officer and other AHCPR staff will have substantial
scientific and programmatic involvement during the conduct of this
activity, through technical assistance, advice, and coordination
beyond the normal program stewardship for grants.  Collaboration on
study design and protocol development will occur after the award(s)
is made.  Specifically, AHCPR's role in the cooperative agreement
will include providing technical assistance, advice, and support to
the Principal Investigator in:

o  developing the program and setting priorities, including sampling,
design and protocol development, recruitment methods, data analysis
and interpretation, prioritization of policy issues requiring rapid
response, and preparation of research publications;

o  gaining access to related data bases;

o  establishing collaboration with other Federal agencies and
programs; and

o  disseminating research findings through the AHCPR's publication
program.

In addition, the AHCPR Project Officer will participate in or
coordinate strategy sessions with the awardee(s) on three occasions
in the first year and up to every six months thereafter to review
progress, discuss data collection and analysis, and assess
collaboration across sites.  The AHCPR will require prior written
approval for the addition or deletion of a participating or
collaborating institution, site, or other organizational component.

The AHCPR reserves the right to terminate or curtail the study in the
event of:

o  substantial shortfall in participant recruitment, follow- up, data
reporting, quality control, or other major breech of the protocol; or

o  substantive changes in the agreed-upon protocol with which the
AHCPR does not agree.

These special Terms of Award apply in addition to and not in lieu of
otherwise applicable PHS grants policies and Federal regulations.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND
MINORITIES IN RESEARCH STUDY POPULATIONS

The AHCPR requires all applicants for research grants to include
minorities and women in study populations so that research findings
can be of benefit to all persons at risk of the disease, disorder, or
condition under study.  Special emphasis must be placed on including
minorities and women in studies of diseases, disorders, and
conditions which disproportionately affect them.  This policy applies
to males and females of all ages.  If women or minorities are
excluded or inadequately represented in research, a clear and
compelling rationale should be provided.  The AHCPR will not award
grants for applications which do not comply.  If the application does
not contain the required information, it will be returned without
review.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study. This information should be included in the form PHS 398 in
Sections 1 to 4 of the Research Plan and summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
AHCPR recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., American
Indians/Alaskan Natives, Asian/Pacific Islanders, African Americans,
Hispanics).  Where appropriate, the applicant must provide the
rationale for studies on single minority population groups.

Peer reviewers will address specifically whether the applicant's
research plan conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific questions(s) addressed and the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 22, 1993, a
letter of intent that includes the name, address, and telephone
number of the Principal Investigator; identifies co-investigators and
other key personnel and member institutions, community-based
organizations, and any other participating organizations or
institutions; and states the number and title of the RFA in response
to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the consideration of any subsequent applications, the
information allows AHCPR staff to estimate the potential review
workload and avoid conflict of interest in the review.

The letter of intent is to be sent to the HCSUS Project Officer at
the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  State and local government applicants may use form
PHS 5161.  These forms are available at most institutional offices of
sponsored research; the Office of Grants Information, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone (301) 435-0714; and from the
Scientific Review Branch, Agency for Health Care Policy and Research,
2101 East Jefferson Street, Suite 602, Rockville, MD 20852, telephone
(301) 594-1449.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page of the application.  Failure
to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the title and number of the RFA must be
typed in Section 2a on the face page of the application form and the
YES box must be marked.

The page limitations described in the instructions for the PHS 398
have been modified for this RFA.  The application must not exceed 40
pages, (rather than the customary 25 pages), for Items 1-4 of the
Research Plan.

The completed original application, including the Checklist, and four
legible copies (two copies when using the PHS 5161) must be sent or
delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

Applications submitted under this RFA must be received by the
Division of Research Grants, NIH, by February 22, 1994.  If an
application is received after that date, it will be returned to the
applicant.

One copy, labeled "Advance Copy," must be submitted simultaneously
to:

HCSUS Project Officer
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852

Conference for Prospective Applicants

The AHCPR plans to convene a conference for prospective applicants in
Rockville, Maryland on October 1, 1993. Attendance is not a
prerequisite to applying.  Attendees must pay for their own travel
and accommodation costs.  For additional information, contact Ms.
Ruth Ann Celtnieks, telephone (301) 594-1354, extension 118, FAX
(301) 594-2155.

REVIEW CONSIDERATIONS

All applications will be judged on the basis of the scientific merit
of the proposed project and the documented ability of the
investigator to meet the RESEARCH OBJECTIVES of the RFA.  Upon
receipt, applications will be reviewed by the Referral Office,
Division of Research Grants, NIH, for completeness, and by AHCPR
staff for responsiveness to the RFA.  Incomplete and nonresponsive
applications will be returned to the applicant without further
consideration.  All accepted applications will undergo peer review
for scientific merit by a special study section.  Applications also
will be reviewed by AHCPR's National Advisory Council for Health Care
Policy, Research, and Evaluation.  Review criteria for AHCPR grant
applications are significance and originality from a scientific and
technical viewpoint; adequacy of the method; availability of data or
proposed plan to collect data required for the project;
qualifications and experience of the principal investigator and
proposed staff; adequacy of the plan for organizing and carrying out
the project; reasonableness of the proposed budget; and adequacy of
the facilities and resources available to the applicant.  Although
the technical merit of the proposed protocol is important, it is not
the sole criterion for selection of the awardee(s).  Other
considerations, such as the timeliness of the proposed data
collection and analyses, access to subjects, and potential for strong
collaboration, will be part of the evaluation criteria.

Special Review Criteria

In addition to the review criteria noted above, the review committee
will independently evaluate each application in response to this RFA
against the following special scientific and technical review
criteria:

o  the degree to which the study focuses on assessing issues of
health policy relevance; and issues of service utilization,
financing, access barriers and unmet service needs, and costs and
quality of care;

o  inclusion of a variety of study sites representing diverse
organizational configurations and geography;

o  assurance of the demographic and socioeconomic diversity of the
sample, especially the representation of women and members of
communities of color, across the spectrum of HIV-related disease
stages;

o  the scientific and technical merit of the application, including
for example, the adequacy of the plan and the rationale for the core
study; the adequacy of the rationale for inclusion/exclusion of
special studies; sampling, including sampling site selection, sample
size, minimization of nonresponse bias; longitudinal versus other
designs; data collection, including type and quality of data to be
collected from patients and organizations; length of observation
period; and links with other data sources;

o  the appropriateness of the mechanism proposed for rapid response
to requests for provision of information and analyses of HIV-related
policy issues;

o  the quality of the organizational and institutional arrangements
to ensure adequate internal collaboration. Also, in the case of a
consortium, the degree of clarity in the specification of activities
and in the description of coordination efforts among organizational
participants. This description should include the role and extent of
any collateral or supplemental support provided to the applicant
organization by the other consortium members;

o  the prior demonstrated ability of the applicant to cooperate with
governmental and other groups such as consortium members,
subgrantees, subcontractors, community-based organizations, data
supplying organizations, respondents, and site representatives;

o  the degree of community involvement and the nature of the
involvement;

o  the composition of the research team, including evidence of
necessary experience and expertise, and appropriateness of relative
time commitments;

o  the appropriateness of the proposed budget and the extent to which
the fiscal plan provides assurance that effective use is likely to be
made of the funds awarded; and

o  adequacy of plans for protecting human subjects and for
maintaining data confidentiality.

AWARD CRITERIA

Applications will compete for available funds with all other
applications for this RFA.  The following will be considered in
making funding decisions:  quality of the proposed project as
determined by peer review, and availability of funds.  The earliest
anticipated date of award for applications will be July 1, 1994.

The AHCPR will determine funding based on recommendations from peer
review and AHCPR's Council, the likelihood of successful
collaboration based upon sufficient compatibility of features, and
availability of funds.

INQUIRIES

Those considering an application in response to this RFA are
encouraged strongly to discuss their project with AHCPR program
administrators before formal submission.  The AHCPR welcomes the
opportunity to clarify any issues or questions from potential
applicants.  Copies of this RFA and background documents, including
the "HIV Cost and Services Utilization Study:  Technical Issues"
Report, will be available from the AHCPR Publications Clearinghouse,
P.O. Box 8547, Silver Spring, MD 20907, (1-800-358-9295).

Direct inquiries regarding programmatic issues and address the letter
intent to:

HCSUS Project Officer
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
Telephone:  (301) 594-1354, ext. 131 or 118

Direct inquiries regarding fiscal matters to:

Mr. Ralph L. Sloat
Grants Management Officer, Office of Management
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  (301) 594-1447

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.226.  Awards are made under authorization of the
Public Health Service Act, Title IX, as amended by Public Laws
101-239 and 102-410 (42 U.S.C. 299-299c-6).  Awards are administered
under the PHS Grants Policy Statement and Federal Regulations 42 CFR
67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local
governments).  This program is not subject to the intergovernmental
review requirements of Executive Order 12372.

.

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