ECONOMIC EVALUATION IN HIV AND MENTAL DISORDERS PREVENTION

Release Date:  October 2, 1998

PA NUMBER:  PA-99-001

P.T.

National Institute of Mental Health
Agency for Health Care Policy and Research

PURPOSE

The National Institute of Mental Health (NIMH) and the Agency for Health Care
Policy and Research (AHCPR) are encouraging applications for the support of
research on the economic evaluation of either planned or completed studies of
preventive interventions aimed at HIV/STDs, Mental Disorders or Dual Diagnoses. 
Included are studies to prevent the spread of HIV/STD, help people cope with
disease, or obtain health care or treatment of HIV/STD-related problems.  The
purpose of this Program Announcement (PA) is to encourage investigator-initiated
research on cost-benefit, cost-effectiveness, and cost-utility analyses of both
primary and secondary preventive interventions that are universal (targeted to
the general public), selective (targeted to a subgroup whose risk is higher than
average), or indicative (targeted to those who already have signs or symptoms
[e.g., STDs]).  This PA is critical because in this era of diminishing AIDS and
other prevention programs, and of health care programs for persons with AIDS,
determining the cost-effectiveness of programs can be critical in establishing
national priorities in health care research and in the adoption of successful
prevention programs by local and state health agencies.

The urgency of the crisis demands that top priority be given to research with
implications for developing cost-effective preventive interventions that access
hard-to-reach populations which are at high risk for HIV infection.  Even if an
effective AIDS vaccine were to be identified in the next few years, prevention
efforts would continue to be the primary way to stop further spread of HIV
infection.  The development of cost effective intervention programs, including
those that combine psychosocial and pharmacological interventions for HIV, is a
priority for public health.  Research is needed to develop methods and techniques
to assess the cost and utility of prevention programs.

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 establishing priority areas.  This PA, Economic Evaluation in HIV
and Mental Disorders Prevention is related to the priority areas of mental health
and mental disorders and HIV infection.  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 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

AHCPR cannot, by law, make grants to for-profit organizations.  However, for-
profit organizations may participate as subcontractors or members of consortia.
Organizations described in section 501(c)4 of the Internal Revenue Code that
engage in lobbying are not eligible.

MECHANISM OF SUPPORT

This PA will use the individual research project (R01) mechanism.  Responsibility
for the planning, direction, and execution of the proposed project will be solely
that of the applicant.

RESEARCH OBJECTIVES

Background

As many as one-third of American adults will suffer a diagnosable mental disorder
or substance abuse disorder sometime in their lives, and 20 percent have a mental
disorder at any given time.  Although treatment of mental and substance abuse
disorders remains vitally important, much greater effort than ever before needs
to be directed to prevention.  Prevention offers the hope that millions will
avoid the emotional suffering caused by mental and substance abuse disorders. 
Furthermore, the costs to the Nation related to treatment for these disorders and
lost productivity associated with them are staggering, ranging into billions of
dollars annually.

Over 640,000 AIDS cases have been diagnosed and over 390,000 people have already
died; over 40,000 new HIV infections are estimated to occur each year.  An
increasing percentage of the Nation's health and mental health care expenditures
are being spent on the treatment of HIV infection and AIDS.  The cost of treating
HIV disease in 1993 has been estimated to have been $11.8 billion.  NIMH has over
a decade of prevention research findings which demonstrate that behavioral
interventions can prevent the further transmission of the virus.  More recent
research on interventions for seropositive persons provides evidence of fewer
hospital visits and enhanced quality of life after coping and stress reduction
interventions.

Policy makers, community planning groups, and other key health and mental health
decision makers need to balance the costs and effectiveness of interventions when
planning their prevention programs aimed at HIV, mental disorders, or dual
diagnoses.  Well-designed economic evaluation studies can provide a data base on
the cost-effectiveness of prevention programs to inform these health policy
decisions.

Approximately 1.3 percent of the Nation's health care expenditures was spent on
the treatment of HIV disease in 1993.  Many persons with HIV infection, however,
find that access to care is inadequate or unavailable to them because of lack of
insurance or its cost.  Current health care system changes provide a unique
opportunity to demonstrate whether or not primary and secondary prevention
efforts effectively contribute to major savings in health care costs.  There is
an urgent need to increase the data base concerning the cost-effectiveness of
prevention programs aimed at HIV, mental disorders, or dual diagnoses.

Areas of Interest

The following section suggests areas of research to meet the economic evaluation
of health promotion and disease prevention objectives of this PA.  Researchers
are encouraged to develop rigorous research designs to provide data on the cost-
benefit, cost-effectiveness, and cost-utility analyses of existing or proposed
AIDS preventive interventions.  This list is not intended to be restrictive.

Cost-effectiveness

In order for effective HIV/AIDS and mental disorders preventive interventions to
become the standard for care in public health agencies and community-based
organizations, cost-effectiveness must be demonstrated.  Studies are needed that
evaluate:

o  the cost-effectiveness of existing or planned interventions to prevent the
further spread of HIV infection, or new cases of mental disorders and dual
diagnoses;

o  the cost-effectiveness of existing or planned preventive interventions to
enhance coping, improve quality of life, and minimize physical disability and
hospitalizations associated with seropositive persons, or those at risk for
mental disorders and dual diagnoses;

o  the cost-effectiveness of the relative contributions of prevention strategies
for drug users, both singly and in combination with HIV interventions (e.g.,
outreach, HIV testing and pre- and post-test counseling, drug abuse treatment,
or needle exchange), in different geographic areas and for different groups;

o  the cost-effectiveness of interventions to promote maintenance of safer
behaviors and adherence to health and intervention care and intervention
regimens; and

o  the utility of economic analyses and findings for prevention planning groups
and other programmatic decision makers.

Financing of Health and Mental Health Services

Financing is an integral part of the delivery of services.  Studies are needed
to assess:

o  the effect of alternative ways of financing health and mental health services
on the accessibility, delivery, utilization, cost, and quality of preventive
interventions aimed at HIV, mental disorders, and dual diagnoses; and

o  the costs and benefits of alternative public and private systems to finance
mental health services to persons with HIV disease.

Health Insurance

Studies of the impact of health insurance benefits which provide important data
on meeting the needs of persons at risk for, and with, HIV infection, mental
disorders, and dual diagnoses are needed.  Studies are needed that evaluate the:

o  effects of specific insurance coverage policies on access to and delivery of
preventive interventions aimed at HIV, mental disorders, and dual diagnoses;

o  simulated effects of provider and consumer behavior under various health
insurance options and estimates of the cost of different health insurance
coverage; and

o  long-term effects of preventive interventions aimed at HIV, mental disorders,
and dual diagnoses on the demand for health insurance.

Methodological Research

Research is encouraged that will develop and test the application of new methods
of cost-effectiveness analysis of HIV/AIDS prevention programs.  Studies are
needed that:

o  generate simulation models that advance understanding of the financing of
prevention;

o  assess the utility of evaluation methods and findings for prevention planning
groups and other programmatic decision makers;

o  develop and define econometric models which link HIV-related behaviors to HIV
health outcomes (e.g., models to translate behavioral effects of interventions
to predictions of numbers of HIV infections averted);

o  refine methodologies of cost-benefit, cost-effectiveness, and cost-utility
analyses related to prevention aimed at HIV, mental disorders, and dual
diagnoses;

o  improve methods for assessing quality of life that involves less reliance on
the health delivery system among persons living with AIDS;

o  improve methods for assessing quality of life among persons living with
HIV/AIDS relative to changes in the chronicity of the disease, advances in
therapeutics, and variations in the  availability of resources in the health
delivery system;

o  determine the marginal costs and costs/benefits of adding prevention programs
in different targeted population groups, with varying levels of HIV prevalence
and projected prevalence;

o  assess the best measures of quality of clinical preventive services;

o  determine the effects of the type of health care organization on provider and
patient behavior relative to preventive services;

o  assess the advantages and disadvantages of different approaches to HIV/AIDS
prevention within the primary health care setting;

o  evaluate the cost/benefit considerations among alternative ways to prevent HIV
infection in newborns and infants; and

o  establish the cost/benefit advantages and disadvantages of targeted culturally
sensitive programs versus broadly-aimed general preventive programs.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH and AHCPR that women and members of minority groups
and their subpopulations must be included in all supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).  AHCPR follows the revised NIH guidelines as
applicable.

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 in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

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" published in the NIH Guide for Grants and
Contracts, March 6, 1998, and is available at the following URL address: 
http://www.nih.gov/grants/guide/notice-files/not98-024.html

AHCPR also encourages investigators to consider including children in study
populations, as appropriate.  AHCPR announced in the NIH Guide, Volume 26, Number
15, May 9, 1997, that it is developing a policy and implementation plan on the
inclusion of children in health services research.  This notice is available at:
http://www.ahcpr.gov

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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard AIDS 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; fax: (301) 480-0525 Email: GrantsInfo@NIH.GOV.  State and local government
applicants may use form PHS-5161-1, Application for Federal Assistance (rev.
5/96), and follow those requirements for copy submission.  Applicants may also
obtain application materials from: Equals Three Communications, Inc., 7910
Woodmont Avenue, Suite 200, Bethesda, MD 20814-3015, telephone (301) 656-3100,
FAX (301) 652-5264.

An applicant planning to submit a grant application that requests $500,000 or
more in direct costs for any one year is required to contact, in writing or by
telephone, NIMH or AHCPR program staff when the application development process
begins.  Furthermore, the application must obtain agreement from the IC staff
that the IC will accept the application for consideration for award.  The
applicant Principal Investigator must identify, in the cover letter sent with the
application, the program staff member of NIMH or AHCPR who has agreed to accept
assignment of the application.  If the NIMH or AHCPR is willing to accept
assignment of the application for consideration of funding, the staff will notify
the Center for Scientific Review before the application is submitted.

An application requesting $500,000 or more in any one year received without
indication of prior staff concurrence and identification of that contact will be
returned to the applicant without review.  Refer to the NIH Guide for Grants and
Contracts, March 29, 1998 (http://222.nih.gov/grants/guide/notice-files/not98-
030.html)

The title, "Economic Evaluation In HIV and Mental Disorders Prevention," and
number of the program announcement must be typed in Section 2 on the face page
of the application of the PHS 398.

The completed original application and five legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate peer review group convened in accordance with the standard NIH
or AHCPR peer review procedures.

As part of the initial merit review, all applications will receive a written
critique and may 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 may receive a second-
level review by an appropriate national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance the 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 high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(1) Significance:  Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive this
field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level of
the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

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 also be evaluated.

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

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

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

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications; The following will be considered in making funding decisions:

o scientific merit as determined by peer review

o availability of funds

o balance among target populations, with priority given to understudied
populations, and among program areas

o balance among geographic areas

o balance among all program areas

INQUIRIES

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

Direct inquiries regarding programmatic issues, to:

Willo Pequegnat, Ph.D.
Office of AIDS Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-101
Rockville, MD  20857
Telephone: (301) 443-6100
FAX: (301) 443-9719
Email: Wpequegn@nih.gov

Doreen S. Koretz, Ph.D.
Prevention, Early Intervention, and Epidemiology Research Branch
National Institute of Mental Health
5600 Fishers Lane, Room 18C-14
Rockville, MD  20857
Telephone:  (301) 443-1636
FAX:  (301) 443-4611
Email:  Dkoretz@nih.gov

David Lanier, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
6010 Executive Boulevard, Room 224
Rockville, MD  20852-4908
Telephone: (301) 594-1357
FAX: (301) 594-3721
Email: dlanier@ahcpr.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
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: Diana_Trunnell@nih.gov

Mable L. Lam
Grants Management Staff
Agency for Health Care Policy and Research
2101 Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  (301) 594-1447
FAX:  (301) 594-3210
Email:  mlam@ahcpr.gov

Although not a formal sponsor of this program announcement, the National
Institute of Child Health and Human Development (NICHD) welcomes applications for
the economic evaluation of programs that integrate prevention of AIDS and other
sexually transmitted diseases with prevention of unintended pregnancy.  NICHD
also provides support for research applying economic concepts and frameworks to
the study of AIDS-related sexual and protective behaviors.  For further
information potential applicants may contact Susan Newcomer at (301) 496-1174,
Email: newcomes@hd01.nichd.nih.gov.

Several other Institutes have an interest in research in this area, including the
National Institute of Nursing Research, the National Institute on Alcohol Abuse
and Alcoholism, the National Institute on Aging, and the National Institute on
Drug Abuse.  Applications submitted in response to this Program Announcement will
be referred to initial review groups in accordance with PHS referral guidelines.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.242 (NIMH) and 93.226 (AHCPR).  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241 and 285) and Title IX (42 U.S.C. 299-299c-6) and
administered under PHS grants policies and Federal Regulations 42 CFR 52, 42 CFR
67, Subpart A 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.  Awards will be administered under PHS grants policy as stated in
the Public Health Service Grants Policy Statement (April 1, 1994).

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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