HEARING IMPAIRMENT AND OTHER COMMUNICATION DISORDERS ASSOCIATED WITHCMV INFECTION, HIV INFECTION, AND AIDS



NIH GUIDE, Volume 21, Number 34, September 25, 1992



PA NUMBER:  PA-92-107



P.T. 34



Keywords:

  Communicative Disorders, Hearing 

  AIDS 



National Institute on Deafness and Other Communication Disorders



PURPOSE



The Division of Communication Sciences and Disorders of the National

Institute on Deafness and Other Communication Disorders (NIDCD)

encourages grant applications seeking support for innovative research

in the area of hearing impairment and other communication disorders in

persons with cytomegalovirus (CMV) infection, human immunodeficiency

virus (HIV) infection or with acquired immunodeficiency syndrome

(AIDS).  Research is needed to clarify the role of CMV, HIV, AIDS, and

therapeutic agents used in the treatment of these diseases in the

etiology of hearing loss and other communication disorders.



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 (PA), Hearing Impairment and Other Communication Disorders

Associated with CMV Infection, HIV Infection, and AIDS, is related to

the priority area of HIV infection.  Potential applicants may obtain a

copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-11474-0

or Summary Report:  Stock No. 017-001-11473-1) 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, 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.

Applications from minority individuals and women are encouraged.



MECHANISM OF SUPPORT



Support mechanisms for the announcement include the individual research

project grant (R01) and the First Independent Research Support and

Transition (FIRST) Award (R29).  Foreign institutions are not eligible

for the FIRST Award.



RESEARCH OBJECTIVES



Background



Congenital CMV infection is the leading cause of nonhereditary deafness

in children.  The most frequent sequela associated with congenital CMV

infection is hearing loss.  It has been estimated that congenital CMV

infection accounts for about 40,000 cases of sensorineural hearing loss

per year in the United States.



Some studies have shown that more than 90 percent of AIDS patients are

co-infected with CMV.  Current estimates from the Centers for Disease

Control indicate that over 1.7 million Americans are infected with HIV.

During the course of the disease, the infection progresses in stages

from an initial asymptomatic state, to AIDS-related complex, and AIDS

characterized by systemic immune deficiency and opportunistic

infection.  Case reports indicate that auditory and vestibular

dysfunction may occur in HIV-infected persons and the symptoms may

develop in early stages of infection.  Although infection of the

central nervous system by HIV is well documented, the pathophysiology

of auditory impairment in HIV-infected individuals is not known.

Hearing disorders in AIDS patients could be caused by infection of the

cochlea and auditory nerve with CMV or HIV.  Additionally, hearing loss

in these patients could be due to other opportunistic infections or

treatment with ototoxic antimicrobial therapeutic agents.  Studies are

needed to document auditory abnormalities in CMV- and HIV-infected

persons so that appropriate early treatment might be provided.



In addition to auditory and vestibular disorders, patients with AIDS

may experience other communication difficulties.  Kaposi sarcomas often

occur in the mouth, pharynx, and larynx and can cause respiratory,

swallowing, phonatory and articulatory difficulties.  Neurogenic

components associated with AIDS may include both motor speech and

language disorders.  An estimated 20,000 to 30,000 children in the

United States are HIV positive; thus, speech-language pathologists,

audiologists, and otolaryngologists are inevitably involved in the

diagnosis and treatment of CMV- and HIV-positive children.



Research Goals and Scope



Improved treatment for AIDS patients has increased the postdiagnosis

quality and expectation of life.  Disorders of hearing, balance, smell,

taste, speech, voice, and language represent a quality of life issue

that increases in importance as the survival period is extended in

HIV-infected individuals.



The ultimate goal of this announcement is to increase the understanding

of the etiology and pathophysiology of communication impairments during

CMV infection, HIV infection, and AIDS and to use this information to

improve treatment and quality of life.  Innovative, state-of-the-art,

multidisciplinary clinical and basic studies are encouraged.



Studies may include, but are not limited to, the topics listed below as

they relate to the communication disorders of hearing, balance, taste,

smell, voice, speech, and language:



o  development of quantitative, objective techniques for early

detection, evaluation, and prognosis of developing communication

dysfunction in CMV- and HIV-infected persons;



o  establishment of an epidemiological surveillance system to estimate

the incidence and prevalence of communication disorders due to these

viral infections in different populations;



o  development of the means for identifying and classifying

communication disorders in CMV- and HIV-infected children and adults;



o  examination of the potential ototoxic properties of antifungal,

antibacterial, and antiviral agents (such as zidovudine, zalcitabine,

and didanosine);



o  determination of the pathophysiology of these viral infections

within the peripheral and central auditory nervous system;



o  identification of the cellular and molecular mechanisms specific to

these viral infections of sensory cells;



o  identification of the specific intra- and extracellular biochemical,

metabolic, enzymatic, and protein changes associated with these viral

infections of sensory cells;



o  development of animal or in vitro models to address the viral

pathogenesis in sensory cells and tissues in immunocompetent and

immunodeficient subjects;



o  examination and correlation of the interactions between primary

infection and opportunistic cofactors in exacerbating damage to sensory

cells and tissues (including cytomegalovirus, pneumocystis carinii, and

candidiasis);



o  examination of maternal immunosuppression effects on the

pathogenesis of CMV infection in the placenta and fetal auditory

system;



o  assessment of CMV infection, HIV infection, or AIDS on communication

disorders throughout the life cycle, including critical developmental

periods and aging; and



o  determination of appropriate communicative and sensory therapeutic

and rehabilitative protocols for communication disorders associated

with CMV infection, HIV infection, and AIDS.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements are required 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 the need for

inclusion of minorities and women in studies of diseases, disorders and

conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale must be provided.



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 must be addressed in developing a research design

and sample size appropriate for the scientific objectives of the study.

This information must be included in the form PHS 398 in Sections 1-4

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

NIH 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., Native Americans

[including American Indians or Alaskan Natives], Asian/Pacific

Islanders, Blacks, Hispanics).  The rationale for studies on single

minority population groups should be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



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.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether or not the research

plan in the application conforms to these policies.  If the

representation of women or minorities in a study design is inadequate

to answer the scientific question(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 reflected

in assigning the priority score to the application.



All applications for clinical research submitted to the NIH are

required to address these policies.  NIH funding components will not

award grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.  The receipt dates for

applications for AIDS-related research differ from the standard

deadlines and are found in the PHS 398 instructions.



Application kits are available at most institutional business offices

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449, Bethesda, MD 20892, telephone 301-496-7441.  The title and number

of this announcement must be typed in Section 2a on the face page of

the application.



The completed original application and five exact copies must be sent

or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be reviewed for scientific and technical merit by

study sections of the Division of Research Grants, NIH, in accordance

with the standard NIH peer review procedures.  Following

scientific-technical review, the applications will receive a

second-level review by the appropriate National Advisory Council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered as funding decisions

are made:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



For additional information regarding programmatic issues, investigators

are encouraged to call or write to NIDCD staff responsible for grants

in the investigator's particular area of scientific interest:



Dr. Beth Ansel (voice,speech)                   (301-402-3461)

Dr. Judith Cooper (language)                    (301-496-5061)

Dr. Amy Donahue (hearing)                       (301-402-3458)

Dr. Jack Pearl (taste)                          (301-402-3464)

Dr. Rochelle Small (smell)                      (301-496-3464)

Dr. Daniel Sklare (balance/vestibular)          (301-402-3461)



Division of Communication Sciences and Disorders

National Institute on Deafness and Other Communication Disorders

Executive Plaza South, Suite 400-B

6120 Executive Boulevard

Rockville, MD  20892



Direct inquiries regarding fiscal matters to:



Sharon Hunt

Grants Management Officer

Division of Extramural Activities

National Institute on Deafness and Other Communication Disorders

Executive Plaza South, Suite 400-B

6120 Executive Boulevard

Rockville, MD  20892

Telephone:  (301) 402-0909



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.173.  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 administered under PHS grants

policies and Federal Regulations 42CFR 52 and 45 CFR Part 74.  This

program is not subject to the intergovernmental review requirements of

Executive Order 12372 or Health Systems Agency review.



.

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