HEALTH CARE SERVICES FOR PERSONS WITH HIV INFECTION

NIH GUIDE, Volume 22, Number 33, September 17, 1993



PA NUMBER:  PA-93-110



P.T. 34



Keywords:

  AIDS 

  Health Services Delivery 



Agency for Health Care Policy and Research

National Institute on Alcohol Abuse and Alcoholism

National Institute on Drug Abuse

National Institute of Mental Health



PURPOSE



The Agency for Health Care Policy and Research (AHCPR), National

Institute on Alcohol Abuse and Alcoholism (NIAAA), the National

Institute on Drug Abuse (NIDA), and the National Institute of Mental

Health (NIMH) support and conduct extramural research and evaluations

of health care services and health care systems.  This program

announcement (PA) focuses on research related to care for persons

with Acquired Immune Deficiency Syndrome (AIDS) and other Human

Immunodeficiency Virus (HIV)-related diseases.



The continued growth of the HIV epidemic has created an urgent need

to better understand the public policy implications of providing care

for persons with HIV infection.  Critical issues include:  the

epidemic's expansion into new populations, the availability of new

treatment modalities, the recognition of HIV-related illness as a

chronic disease, the interaction of HIV infection with substance

abuse and with the resurgence of tuberculosis, the passage and

implementation of the Ryan White Comprehensive AIDS Resources

Emergency (CARE) Act, and health care reform.  This PA emphasizes a

need for short-term research to better inform decision-makers

developing public policy concerning the delivery of health care

services to people with HIV-related diseases.



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 program

announcement, Health Care Services for Persons with HIV Infection, is

related to the services and protection objectives of several priority

areas including HIV infection, sexually transmitted diseases, and

immunization and infectious diseases.  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 and foreign organizations,

public and private, including universities, clinics, units of State

and local governments, and foundations.  The AHCPR by law can support

only non-profit organizations; the NIAAA, NIDA, and NIMH can support

for-profit as well.  Applications from minority and women

investigators are encouraged.



MECHANISM OF SUPPORT



This program announcement will use the research project grants (R01)

mechanism.  Responsibility for the planning, direction, and execution

of the proposed project will be solely that of the applicant.

Projects should be accomplished in one to three years.



RESEARCH OBJECTIVES



Background.  The AIDS epidemic has spread to previously unaffected

populations and has placed an increased burden on individuals with

HIV infection and their families, providers of health care,

communities, and governments.  Although HIV infection is spreading to

new populations, the difficulties in obtaining health care and

supportive services faced by people with HIV infection continue to

focus attention on gaps and inequities in the health care system.



New treatments have caused HIV-related illnesses to shift from acute,

fatal ailments to chronic illnesses with which individuals may live

asymptomatically for long periods.  However, the response of the

health care delivery system remains oriented to acute care, rather

than preventive and primary care; and continues to be based on

hospital and medical services that often do not complement community

outreach, social support services, and long-term care.  The

divergence between the acute-care based health care system and the

chronic care paradigm of HIV infection is generating new health care

policy questions.



The frequent association of HIV infection with homelessness, mental

illness, poverty, and substance abuse requires that the study of the

HIV epidemic occur in conjunction with analyses of socioeconomic and

other conditions.  The resurgence of tuberculosis (TB), often in

persons with HIV infection, creates new challenges for those seeking

to improve care of the dually infected population.  Public policy

concerning HIV infection also must address the distinct needs of

special populations such as minorities; women; adolescents; children,

including abandoned and orphaned children; residents of rural

communities; and prisoners.



Research Issues.  Research is needed to build the scientific

foundation necessary for development of informed HIV-related health

care policy recommendations.  Some research questions require

long-term study; however, the intent of this PA is to encourage

research designs and methods that produce results quickly.  The

AHCPR, NIAAA, NIDA, and NIMH have identified five service research

areas as priorities:  (1) cost and financing of HIV/AIDS treatments

and services; (2) organization and delivery of services; (3)

characteristics and interactions of providers and patients; (4)

co-morbidity; and (5) special populations.  The questions raised

within these research areas often are interdependent and may be

applicable to topics in other areas.  Applicants need not limit

themselves to these questions.



1.  Cost and Financing of HIV/AIDS Treatments and Services



To focus the debate on future financing and organization of

HIV-related care, information is needed about costs of care, the

variation of costs within different health care settings, the

relation of costs to health needs and outcomes, and the relative

roles of private and public sectors in financing care.  Efforts are

required to discern how changes in health care systems, such as those

being implemented in several States, will address the needs of

persons with HIV infection, and affect reimbursement, financing, and

expenditures for HIV-related care.  Examples of research questions

are:



o  What are the current and projected unmet needs and service

demands, utilization patterns, and costs of providing health and

mental health care, substance abuse treatment, and support services

for individuals with HIV disease and their families over the duration

of the illness?



o  How do different levels and mechanisms of State and Federal

financing such as enhanced Medicaid reimbursement for AIDS care,

funding of HIV treatment centers, use of Medicaid waivers, and

Medicaid payment of private insurance premiums affect availability,

accessibility, and outcomes of HIV-related care?



o  What are the relationships among community-based services,

including home health care and other forms of supportive and

long-term care, and the utilization and costs of ambulatory,

inpatient, emergency room, and nursing home services?



2.  Organization and Delivery of Services



Research is required to ascertain how HIV service delivery systems

function in different communities to enhance the effectiveness,

reduce the cost of the services delivered, maximize the individual's

dignity and autonomy, and integrate HIV-related care into the

mainstream of health care services.  While case management has been a

key organizational component in the response of many communities to

the challenge of caring for individuals with HIV-related diseases,

many research issues remain.  Establishing effective health care

delivery systems requires an understanding of the availability of

different service providers and the extent to which they coordinate

their services.  Examples of questions of interest include:



o  What is the effect of HIV case management on clinical outcomes,

patient and caregiver satisfaction, access to and utilization of

services, costs of care, and quality of life?



o  What is the effect of different delivery settings such as public

vs. private, inpatient vs. outpatient, home care vs. various housing

and intermediate care options, and substance abuse treatment setting

options on cost, utilization, treatment effectiveness, patient and

provider satisfaction, perceived quality of care, and quality of

life?



o  How do multi-professional, one-stop shopping approaches, and other

organizational models affect the delivery of HIV-related clinical

services, mental health care, substance abuse treatment, early

intervention, and support services to HIV-infected persons?



3.  Characteristics and Interactions of Providers and Patients



To address the many different needs of persons with HIV infection, a

complex array of formal and informal care providers has evolved.

With HIV infection increasingly recognized as a chronic disease,

questions are raised about the linkage between the provision of acute

and long-term care services.  Analyses of the elements defining

appropriate and effective care and a better understanding of the

actions of the care provider and the consequences of those actions

for the patient are essential to the further improvement of HIV care

delivery systems.  Some questions are:



o  What are the attitudes and actual behaviors of providers regarding

the provision of services to patients with HIV?



o  What characteristics of providers and their provision of services

are associated with patient satisfaction and effective use of and

adherence to prescribed regimens?



o  How effective are various early interventions in preventing acute

phases of HIV-related disease, enhancing health outcomes and quality

of life, and reducing health care costs?



4.  Issues Related to Co-morbidity



Increasingly, persons with HIV infection have several conditions of

co-morbidity, such as TB, mental illness, alcoholism, and drug abuse

that affect individual health outcomes and disease transmission and

call attention to the need for coordination of care delivery.

Research is needed to clarify the relationship between these

conditions and HIV-related illness, morbidity, health care

utilization, organizational characteristics of delivery systems, and

costs and financing of care.  Some questions are:



o  What services are available to address health care and related

needs for the drug-using population with HIV infection?  How can

health services be integrated with substance abuse treatment, HIV

testing, and mental health and social support services?



o  What is the economic effect of TB and multi-drug resistant (MDR)

TB on the cost of HIV-related care?  What is the cost effectiveness

of various TB treatment strategies for persons with HIV infection.



o  To what extent do treatment practices of health care providers

lead to poor adherence and development of MDR-TB in HIV infected

patients?



5.  Special Populations



The AHCPR, NIAAA, NIDA, and NIMH are interested in studies of the

preceding four research areas that target the unique concerns of drug

abusers in and out of treatment, sex partners and families of drug

abusers, minorities, native Americans, homosexual populations, women,

adolescents, children including abandoned and orphaned children, the

indigent, the homeless, prisoners, and residents of rural

communities.  Examples of research needs are:



o  How can rural health care systems establish coordinated,

comprehensive, and quality patient care programs for patients with

HIV-related illness?



o  What are the additional services, such as day care for children,

psychosocial services, or drug treatment, required to enhance access

to HIV-related treatment for women and their families?  What are the

social and financial burdens of families caring for more than one HIV

infected family member?



o  How does utilization of HIV-related care vary among women,

children, adolescents, and others?  What is the role of socioeconomic

and cultural factors in the transmission of HIV, the disease process,

and early and continuous access to care among these populations?



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND

MINORITIES IN RESEARCH STUDY POPULATIONS



The AHCPR and the National Institutes of Health (NIH) require 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 and NIH 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, the AHCPR and NIH recognize 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.



For foreign awards, the policy on inclusion of women applies fully.

Since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



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.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 09/91), and will be accepted at the standard AIDS

application deadlines as indicated in the application kit.  (State

and local governments may use form PHS 5161 and follow those

requirements for copy submission.) Application kits are available at

most institutional offices of sponsored research; from 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 title and

number of the PA must be typed in Section 2a on the face page of the

application.



The completed original application of form PHS 398 and five legible

copies must be sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



The Division of Research Grants (DRG) will not accept any application

in response to this announcement that is essentially the same as one

pending initial review, unless the applicant withdraws the pending

application.  The DRG will not accept any application that is

essentially the same as one already reviewed.  This does not preclude

the submission of substantial revisions of applications already

reviewed, but such applications must include an introduction

addressing the previous critique.  Applications for R01 grants must

be received by the Division of Research Grants, NIH.  The first

application receipt date for this PA is January 2, 1994.  Thereafter,

the deadline dates for HIV applications are May 1, September 1, and

January 2 of each year.  Applicants are encouraged to apply by the

earliest possible submission date.



REVIEW CONSIDERATIONS



Upon receipt, applications will be reviewed for completeness by the

referral office, DRG.  Incomplete applications will be returned to

the applicant without further consideration.  Review criteria for

AHCPR, NIAAA, NIDA, and NIMH grant applications are significance and

originality from a scientific and technical viewpoint; adequacy of

the method to carry out the project; availability of data or the

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.



Applications will be reviewed for scientific and technical merit by

an initial review group (IRG) composed primarily of non-Federal

scientific experts.  Final review is by the appropriate National

Advisory Council; review by Council may be based on policy

considerations as well as scientific merit.  For NIH, by law, only

applications recommended by the Council for consideration for funding

may be supported.  Summaries of IRG recommendations are sent to

applicants as soon as possible following IRG review.



AWARD CRITERIA



Applications will compete for available funds with all other

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 balance.  The earliest

possible dates of award for applications are six months from the date

of submission.



INQUIRIES



Those considering an application in response to this PA are strongly

encouraged to discuss their project with AHCPR, NIAAA, NIDA, and/or

NIMH program staff before formal submission.  Staff members of these

respective agencies welcome the opportunity to clarify any issues or

questions from potential applicants.  Copies of a Grant Announcement

based upon this PA will be available in the Fall from the AHCPR

Publications Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907,

(1-800-358-9295); or NIAAA, NIDA, and NIMH program staff listed

below.  Applicants may direct inquiries regarding programmatic issues

to:



Melford J. Henderson, M.P.H, M.A.

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. 122



Kendall Bryant, Ph.D.

Division of Clinical and Prevention Research

National Institute of Alcohol Abuse and Alcoholism

5600 Fishers Lane, Room 13C-06

Rockville, MD  20857

Telephone:  (301) 443-1677



Harry W. Haverkos, M.D.

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-38

Rockville, MD  20857

Telephone:  (301) 443-6697



Leonard Mitnick, Ph.D.

Office on AIDS

National Institute of Mental Health

5600 Fishers Lane, Room 15-99

Rockville, MD  20857

Telephone:  (301) 443-7281



Direct inquiries regarding fiscal matters to:



Ralph Sloat

Grants Management Branch

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852-4908

Telephone:  (301) 594-1447



Joseph Weeda

Grants Management Branch

National Institute on Alcohol Abuse and Alcoholism

5600 Fishers Lane, Room 16-86

Rockville, MD  20857

Telephone:  (301) 443-4703



Jack Manischewitz

Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



Diana Trunnell

Grants Management Branch

National Institute of Mental Health

5600 Fishers Lane, Room 7C-15

Rockville, MD  20857

Telephone:  (301) 443-3065



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance Nos. 93.226, 93.242, 93.273, and 93.279.  Awards are made

under authorization of Section 301 and Titles IV and IX of the Public

Health Service Act.  Awards are administered under the PHS Grants

Policy Statement; and Federal Regulations 42 CFR 67 Subpart A, 42 CFR

52, 45 CFR Part 74 (45 CFR Part 92 for State and local governments),

45 CFR Part 46, and 42 CFR Part 2.  This program is not subject to

the intergovernmental review requirements of Executive Order 12372.



.


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