Full Text HL-95-003

BEHAVIORAL INTERVENTIONS FOR CONTROL OF TUBERCULOSIS

NIH GUIDE, Volume 23, Number 35, October 7, 1994

RFA:  HL-95-003

P.T. 34

Keywords: 
  Pulmonary Diseases 
  Disease Prevention+ 
  Behavioral/Social Studies/Service 


National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  February 15, 1995
Application Receipt Date:  March 29, 1995

PURPOSE

The purpose of this solicitation is to encourage research to develop,
implement, and evaluate behavioral interventions for the control of
tuberculosis.  Plans that include the development, implementation, and
evaluation of programs that can serve as models for other areas of the
country will be given priority for consideration.

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 Request
for Applications (RFA), Behavioral Interventions for Control of
Tuberculosis, is related to the priority area of immunization and
infectious diseases.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (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 for-profit and
non-profit institutions, 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, women, and new investigators are encouraged.

All current policies and requirements that govern the research grant
programs of the NIH will apply to grants awarded under this RFA.
Awards under this RFA to foreign institutions will be made only for
research of very unusual merit, need and promise, and in accordance
with Public Health Service policy governing such awards.

This solicitation may be of interest to investigators from a broad
range of disciplines, including pulmonary medicine, infectious disease
medicine, behavioral sciences, public health, biostatistics, and health
education.  Multidisciplinary approaches will be needed to meet the
goals of the research.  Applicants must demonstrate access to target
and comparison or control populations, and expertise within the
research team to conduct research that is sensitive to socio-cultural
elements of the study population.

MECHANISM OF SUPPORT

The support mechanism for this program will be the National Institutes
of Health (NIH), individual research grant (R01).  While
multidisciplinary approaches are encouraged, it is not the intent of
this RFA to solicit applications for large studies encompassing a
variety of individual subprojects, i.e., program projects.  If
collaborative arrangements through subcontracts with other institutions
are planned, consult the program staff listed under INQUIRIES.

Since the emphasis of this program is on behavioral interventions, it
is recommended that applicants refer to "The Guidelines for
Demonstration and Education Research Grants" (revised 9/87, with 2/93
supplement), which are  available from the program administrator,
listed under INQUIRIES.

Upon initiation of the program, the NHLBI will sponsor periodic
meetings to encourage exchange of information among investigators who
participate in this program.  In the budget for the grant application,
applicants should request travel funds for a two-day meeting each year,
most likely to held in Bethesda, Maryland.  Applicants should also
include a statement in their applications indicating their willingness
to participate in these meetings and cooperate with other researchers
in this program.

Applicants are expected to furnish their own estimates of time required
to achieve the objectives of the proposed research; however, the award
period for this activity must not exceed five years.  Because a variety
of approaches would represent valid responses to this RFA, it is
anticipated that there will be a range of costs among individual grants
awarded.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications may be submitted for peer review and
competition for support through the regular grant program of the
National Institutes of Health (NIH).  It is anticipated that support
for this program will begin in September 1995.  Administrative
adjustments in project period and/or amount may be required at the time
of the award.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a case, a letter of agreement from either the GCRC
program director or principal investigator should be included with the
application.

The National Institute of Nursing Research (NINR) also has interest in
behavioral interventions for tuberculosis control.  Therefore,
applications that are of mutual interest are likely to be given a
secondary assignment to NINR in accordance with the NIH referral
guidelines.

FUNDS AVAILABLE

Although financial plans for fiscal year 1995 include approximately
$1,840,000 for the total cost of the program for the first year, award
of grants pursuant to this RFA is contingent upon receipt of funds for
this purpose.  It is anticipated that no more than five awards will be
issued under this program.  The specific number to be funded will,
however, depend on the merit and scope of the applications received and
the availability of funds.

RESEARCH OBJECTIVES

Background

Tuberculosis was on the decline from the 1950s until the mid 1980s;
however, the United States is now experiencing a resurgence of
tuberculosis. In 1992, approximately 27,000 new cases were reported, an
increase of approximately 20 percent from 1985 to 1992.  Not only are
tuberculosis cases on the increase, but a serious aspect of the problem
is the recent occurrence of outbreaks of multidrug resistant (MDR)
tuberculosis, which poses an urgent public health problem and require
rapid intervention.

Tuberculosis is an infectious diseases caused by Mycobacterium
tuberculosis, which is spread almost exclusively by airborne
transmission.  While the disease can affect any site in the body, it
most often affects the lungs.  Persons with a pulmonary tuberculosis
cough and produce tiny droplet nuclei that contain tuberculosis
bacteria that can remain suspended in the air for prolonged periods of
time.  Persons breathing the air containing these droplet nuclei can
become infected with tuberculosis.  Those who become infected with the
tuberculosis bacillus remain infected for years.  Those who have a
healthy immune system usually do not become ill, however,
antituberculosis drugs are often necessary in order to eliminate the
infection.  Persons with latent tuberculosis infection, as this
condition is called, are asymptomatic and cannot spread tuberculosis to
others.  Generally, a positive tuberculosis skin test is the only
evidence of infection.  An estimated 10-15 million persons in this
country are infected with M. tuberculosis.  About 10 percent of the
otherwise healthy persons who have latent tuberculosis infection will
become ill with active tuberculosis at some time during their lives.

Control programs involve two major components. First, and of highest
priority, is to detect persons with active tuberculosis and treat them
with effective antituberculosis drugs, which prevents death from
tuberculosis and stops the transmission of infection to others persons.
Treatment of active tuberculosis involves taking multiple
antituberculosis drugs daily or several times weekly for at least six
months.  Failure to take the medications for the full treatment period
may mean that the disease is not cured and may recur.  If sufficient
medications are not prescribed early and taken regularly, the
tuberculosis organisms can become resistant to the drugs and the drug
resistant tuberculosis then may be transmitted to other persons.  Drug
resistant disease is difficult and expensive to treat, and in some
cases cannot be treated with available medications.

The second major goal of control efforts is the detection and treatment
of persons who do not have active tuberculosis, but who have latent
tuberculosis infection.  These people may be at high risk of developing
active tuberculosis.  The only approved treatment modality for
preventive therapy requires treatment daily or twice weekly for minimum
of six months and many patients do not complete a full course of
therapy.

Tuberculosis control poses special problems for a number of groups.
One of these is the HIV infected, among whom the risk of tuberculosis
is considerably greater than in the general population.  Because of the
breakdown of the immune system in HIV positive persons, the traditional
tuberculin skin test may be unreliable and existence of other pulmonary
infections in such persons may complicate the diagnosis, making it
difficult to distinguish tuberculosis on chest X-rays.  Failure to
diagnose tuberculosis rapidly in HIV infected persons has led to higher
mortality rates and more rapid transmission among that population.

Penal institutions pose another special problem for tuberculosis
control.  Not only has the population in these institutions doubled,
causing severe overcrowding and general decline in living conditions,
but inmates generally come from lower socio-economic strata, tend to
have poor health status, and are at higher risk for AIDS and
tuberculosis as well as other medical conditions.  The incidence of
tuberculosis among incarcerated persons in 1984 and 1985 has been
estimated at more than three times the rate in the general population.
The existence of HIV positive inmates, the constant transferring of
persons, lack of adequate health services and infrastructures,
inadequate communication of medical information, and poor ventilation
and overcrowding have contributed to making the transmission of
tuberculosis a major medical problem.  Not only is transmission of
tuberculosis among prisoners a health problem for prisons, but also for
the communities into which inmates are released.

The disenfranchised are also being particularly hard hit by the
resurgence of tuberculosis.  The poor, the homeless, and drug users are
among the most likely to contract and transmit tuberculosis.  The
influx of immigrants and refugees from countries with high tuberculosis
rates also poses problems in control.  Finding and coordinating
treatments for individuals without a fixed address, such as migrants,
is difficult, but assuring adherence to treatment plans is even more
so.

Recent outbreaks of multidrug resistant tuberculosis in large city
hospitals have indicated the special needs to control tuberculosis in
hospitals, nursing homes, and similar facilities.

When tuberculosis was a common problem a generation ago, most health
care providers had experience in treating the disease.  Indeed a survey
by the Centers for Disease Control in 1992 indicated that many
physicians may not be aware of recommended treatment for tuberculosis.
Thus, there is a need to educate and/or to reeducate physicians and
other health care providers in modern tuberculosis control methods.  In
addition, public and patient programs are needed to increase the
awareness of the problem among the general population, to promote early
diagnosis and treatment, and to encourage adherence to therapy.

The future of tuberculosis control will require more effective programs
to identify and adequately treat active tuberculosis cases and to
identify and prevent tuberculosis among those who have latent
tuberculosis infection.  Adherence to medical treatment, for example,
remains a major problem in both groups. Behavioral interventions should
contribute to solving the problems.

Objectives and Scope

The objective of this initiative is to seek ways of controlling the
spread of tuberculosis through behavioral interventions.  Studies
responsive to this solicitation may focus on a community at large or
upon specific population groups such as immigrants, migrants,
institutionalized groups, HIV positive individuals, and ethnic minority
populations or a combination of groups.  As a component of an overall
program, physicians and other health care providers as well as patients
and their families may also be the target of research efforts.  Systems
approaches to detection, diagnosis, treatment, and control may be
tested.  Programs that mobilize community resources to increase access
to care, integrate patient education into medical care, educate health
professionals about tuberculosis control including patients needs and
concerns, provide follow up as patients move among settings (e.g., from
long term institutions to community), and increase patient adherence
with treatment regimens are encouraged.

Examples of questions that could be answered by studies developed
through this solicitation include, but are not limited to, the
following:

o  What interventions are effective in bringing persons with
tuberculosis into treatment programs early?  Are different
interventions needed for different age, ethnic, or other special
population groups or for differing levels of awareness or concern?

o  How can provider adherence to environmental controls in hospitals,
penal institutions, nursing homes, and/or other sites contribute to
reducing the spread of tuberculosis?  What are the barriers to
adherence with infection control and how can they be overcome?

o  What interventions result in patient adherence to treatment
regimens?  What interventions result in persons who have latent
tuberculosis infection taking preventive therapy?

o  How can physicians and other health care providers best be trained
to diagnose and treat tuberculosis early?  What interventions change
provider practice behaviors?

o  How can interpersonal communications be improved between health care
providers and patients with tuberculosis?  How can communications
within and outside the health care organization contribute to community
control programs?

o  How can significant barriers to tuberculosis control be overcome?

o  What patient education interventions are most effective?

o  What roles can families, employers, lay advocates, volunteers, and
others play in helping to insure patient adherence to treatment
regimens?  How can these groups contribute effectively to local public
health services?  How can target populations be involved in educational
and control efforts?

o  How can patients be assessed for the need for directly observed
therapy?  Are different sequences or combinations of services more
effective in achieving adherence?  What are options to supervised
therapy to improve adherence?

o  What is the role of incentives?  Which are most effective for what
specific purposes?

o  What predictors (e.g., cultural, social, and personal factors) can
be used to identify the factors associated with poor adherence and the
development of multidrug resistant tuberculosis?

o  What are the relationships between interventions and medical
outcomes?

o  What interventions result in improved collaborative efforts between
private health care providers, health departments, and other health and
community organizations, etc. that ultimately improve control of
tuberculosis in the community?

Innovative interventions involving patients and their families, use of
community resources, special approaches (e.g., combination
inpatient/outpatient centers; community coalitions or consortia), and
program strategies based upon the cultural characteristics of the
population are encouraged.  Applications from minority scientists and
minority institutions are especially encouraged.  There is an interest
in obtaining model programs that can be readily adapted for use in
several sections of the country.

Research designs should include the following elements:

o  a specified, well-defined population;

o  reliable and valid assessment of tuberculosis and provisions for
monitoring changes, including laboratory services;

o  an appropriate theoretical basis for the intervention(s);

o  sufficient population to provide for a control or comparison group
and to permit evaluation of the efficacy of the program;

o  availability of required medical care services and resources,
including process data on quality of services;

o  evidence that the cultural and social characteristics of the study
population have been taken into account in the study design and
implementation of the program;

o  measurements of behavior change (e.g. adherence measures) related to
control of tuberculosis.  Assessment of other factors such as knowledge
about tuberculosis, quality of life, use of medical care services, and
cost effectiveness are also encouraged.

o  ability to obtain follow up data on patients for two years after
intervention(s) to assess the efficacy of the interventions over time;

SPECIAL REQUIREMENTS

Although the research design may build from an existing tuberculosis
control programs, the studies should test hypotheses specifically
related to the targeted population and assess innovative approaches to
interventions.  Funding requests for support of existing tuberculosis
control programs without a research component would not be considered
responsive to this solicitation.  Investigations of the effectiveness
of clinical therapies also will be excluded.

Interdisciplinary approaches that include medicine, behavioral science,
and education are strongly encouraged.  If collaborative arrangements
through subcontracts with other institutions are planned, consult the
NHLBI Grants Operations Branch (301) 594-7420 regarding procedures.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of
minority groups and their subpopulations must be included in all NIH
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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and Concerning
the Inclusion of Minorities in Study Populations) which have been in
effect since 1990.  The new policy contains some new provisions that
are substantially different from the 1990 policies.

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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 28, 1994, Volume 23,
Number 11.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by February 15, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and 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 review of subsequent applications, the information
that it contains allows NHLBI staff to estimate the potential review
workload and to avoid conflict of interest in the review.  The letter
of intent is to be sent to Dr. C. James Scheirer, at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 435-0714.  Use the conventional format for research project grant
applications and ensure the points identified in the section REVIEW
CONSIDERATIONS are fulfilled.  To identify the application as a
response to this RFA, check "YES" on item 2a of page 1 of the
application and enter the title "Behavioral Interventions for Control
of Tuberculosis" HL-95-003.

The RFA label found in form PHS 398 application kit must be affixed to
the bottom of the face page of the original completed application form
PHS 398.  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.

Send or deliver the completed application and three signed photocopies
in one package to:

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

Send two additional copies of the application to the Chief, Centers and
Special Projects Review Section at the address listed under LETTER OF
INTENT.  It is important to send these two copies at the same time as
the original and three copies are sent to the Division of Research
Grants.  Otherwise the NHLBI cannot guarantee that the application will
be reviewed in competition for this RFA.

Applications must be received by March 29, 1995.  If an application is
received after this date, it will be returned to the applicant without
review.  The DRG will not accept any application in response to this
RFA that is essentially the same as one currently 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the DRG
and responsiveness to this RFA by the NHLBI.  Incomplete applications
will be returned without further consideration.  If an application is
judged unresponsive, the applicant will be contacted and given an
opportunity to withdraw the application or to have it considered for
the regular, investigator-initiated grant program of the NIH.

Applications judged to be responsive will be reviewed for scientific
and technical merit by an initial review group, which will be convened
by the Division of Extramural Affairs, NHLBI, solely to review these
applications.

Applications should be prepared so that they can be reviewed without
the necessity of interaction between applicants and reviewers since no
site visit or reverse site visit will be part of the technical merit
review.

At this initial review a preliminary evaluation will determine the
scientific merit relative to the other applications received in
response to this RFA (triage); the NIH will withdraw from further
consideration applications judged to be noncompetitive and promptly
notify the principal investigator and the official signing for the
applicant organization.  Those applications judged to be competitive
will be further evaluated for scientific/technical merit by the usual
peer review procedures.

Review Criteria.  The factors to be considered in the evaluation of
scientific merit of each application will be similar to those used in
the review of traditional research project grant applications including
the novelty, originality, and feasibility of the approach; the
training, experience, and research competence of the investigator(s);
the adequacy of the experimental design; the suitability of the
facilities; the appropriateness of the requested budget to the work
proposed; and the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals
of the research.

AWARD CRITERIA

The anticipated date of award is September 1995.  In addition to the
scientific merit of the applications, awards will be based on
responsiveness to the RFA and the availability of resources.

In order to more evenly distribute administrative workload and reduce
the number of awards with July 1 or September 30 start dates, the NHLBI
will award ten months of time and money for the first competing budget
period of this project.  This action results in a project period of 46
months rather than 48 months.  Investigators should plan their research
projects and budgets within these timeframes.

INQUIRIES

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

Mary S. Reilly, M.S.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Westwood Building, Room 640
Bethesda, MD  20892
Telephone:  (301) 594-7466
FAX:  (301) 594-7487

Direct inquiries regarding review matters and address the letter of
intent to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 557
Bethesda, MD  20892
Telephone:  (301) 594-7478
FAX:  (301) 594-7407

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A17
Bethesda, MD  20892
Telephone:  (301) 594-7420
FAX:  (301) 594-7492

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.838.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, amended
by Public Law 99-158, 42 USC 241 and 285) and administered under PHS
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or to review by a Health Systems
Agency.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use of
all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of American people.

.

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