Full Text HL-93-02-P


NIH GUIDE, Volume 21, Number 35, October 2, 1992

RFA:  HL-93-02-P

P.T. 34

  Social Psychology 
  Community/Outreach Programs 
  Health and Safety Education 

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  November 30, 1992
Application Receipt Date:  February 16, 1993


The Division of Epidemiology and Clinical Applications (DECA) invites
applications for demonstration and education projects aimed at
improvements in hypertensive care among inner city minority
populations.  The awards will be for a funding period of four years.
The program will focus on community-based health education and/or other
approaches for enhancing compliance and improving blood pressure
control in urban minority populations.  The intervention models should
be widely applicable and economical.  While hypertension is the focus
of the program, a multiple risk factor approach may be used to assess
changes in other cardiovascular risk factors.


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,
Improving Hypertensive Care for Inner City Minorities, is related to
the priority area of heart disease and stroke.  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).


Applications may be submitted by 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.  Foreign organizations are
not eligible to apply and domestic applications may not include
international components.  Applications from minority individuals,
particularly African Americans, Hispanics, and women are encouraged.


The support mechanism for this RFA will be the National Institutes of
Health (NIH) demonstration and education (D&E) research grant (R18).
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
project period for applications submitted in response to this RFA may
not exceed four years.  The anticipated award date is September 30,


It is anticipated that three to five Centers will be supported over the
four year period of this program.  An estimated total cost (direct and
indirect) of $2,500,000 will be available for the first year of funding
for the entire program, with an estimated four year total cost of
$10,600,000.  This level of support is dependent upon the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the National
Heart, Lung, and Blood Institute (NHLBI), awards pursuant to this RFA
are contingent upon the availability of funds for this purpose.



Hypertension is a major independent risk factor for the development of
cardiovascular disease, the leading cause of death in the U.S.  Despite
improvements in the treatment and control of hypertension in recent
years, African Americans continue to experience higher morbidity and
mortality from hypertension than the white population.  Hypertension is
more likely to appear earlier in life in African Americans.  Adequate
treatment is often hampered by socioeconomic factors.

Complications of uncontrolled hypertension, including stroke and
end-stage renal disease, occur earlier and more frequently in African
Americans than in whites.  In 1986, the age-adjusted stroke mortality
rate was 83 percent higher in African Americans than in whites.  While
age-adjusted mortality rates for stroke are declining for both African
Americans and whites, both for males and females, the rate of decline
is lower for African Americans.  The African American to white ratio of
age-adjusted stroke mortality increased from 1.85 in 1980 to 1.93 in
1988 for males and from 1.75 to 1.83 over the same time for females

Although based on single blood pressure measurements, data regarding
the prevalence, awareness, treatment, and control of hypertension in
the U.S. are available from the 1976-80 National Health and Nutrition
Examination Survey (NHANES II) (3).  African Americans collectively
have a higher prevalence of hypertension, based upon a 140/90 mm Hg
cutpoint or taking antihypertensive medication, than whites (38 vs. 29
percent).  Severe hypertension is four times as prevalent among African
American males relative to white males.  The following data on
awareness, treatment, and control are for blood pressure cutpoints of
140/90 mm Hg; similar trends exist for the higher cutpoints of 160/95
mm Hg.  Of those with hypertension, African Americans were shown to be
slightly more aware of their hypertension (65.6 vs. 52.3 percent) than
whites, and slightly more received pharmacologic therapy (38.5 vs. 32.6
percent).  Nonpharmacologic therapy was not included in this analysis.
While control rates for African Americans collectively were slightly
better than for whites (13.3 vs. 10.9 percent), the hypertension of
African American males was slightly less controlled than that of white
males (5.8 vs. 6.1 percent).  It is also noteworthy that these control
rates were very low for all race-sex groups.

An inverse relationship between socioeconomic status and health exists
for a number of disease entities, findings that come primarily from
studies of non-minority populations.  Although data are somewhat
limited for comparison between differing levels of socioeconomic status
among African-Americans, a number of studies reveal that African
Americans of lower socioeconomic status have a higher level of
hypertension-related disease burden than more advantaged African
Americans (6).  The Hypertension Detection and Follow-Up Program
(HDFP), which screened over 40,000 African Americans and entered over
4800 African Americans into the study, showed an inverse relationship
between level of education, used as a measure for socioeconomic status,
and severity of hypertension for both African Americans and whites.
This inverse relationship between education and hypertension was more
pronounced within the highest stratum of blood pressure.  The gradient
was essentially eliminated by stepped care antihypertensive drug
therapy (7).

Hispanics represent the second largest minority population in the U.S.,
and this group is rapidly growing.  The Hispanic population is
heterogenous. The Hispanic Health and Nutrition Examination Survey
(HHANES) was conducted among three Hispanic subgroups (of Mexican,
Cuban, and Puerto Rican origins) in the U.S. from 1982 to 1984 (8).
Data from this survey reveal that Hispanics have lower prevalence of
hypertension, higher awareness, higher treatment rates, and higher
control rates compared to the rates for both whites and African
Americans in NHANES II.  It should be noted that the HHANES data are
more recent than NHANES II.

The San Antonio Heart Study provides additional data regarding
hypertension among Mexican Americans.  Data presented for four
different definitions of hypertension (isolated and combined elevations
using 160/95 and 140/90 mm Hg cutpoints) show a lower prevalence among
Mexican Americans relative to non-Hispanic whites, although only two of
the eight pairwise comparisons (four hypertensive definitions by
gender) were statistically significant.  After adjustment for age, body
mass index, and non-insulin-dependent diabetes mellitus, Mexican
Americans were shown to have a statistically significant lower
prevalence of hypertension (9).

Certainly these data indicate substantial room for improvement in the
awareness, treatment, and control of hypertension for all Americans.
African Americans, with both an increased burden of disease and
problems with access to care, require special attention.  While the
data for Hispanics populations do not indicate excess disease burden,
socioeconomic factors are likely to put many Hispanics at a
disadvantage for optimal hypertension detection and management.

Several investigators have shown improvement in the care for inner-city
minority hypertensives.  As an example, Levine and colleagues designed
a long term program using a population-based intervention, administered
under the direction of a task force of community leaders and
organizations and the Johns Hopkins Medical Institutions.  Five-year
results demonstrate significant improvements in both behavioral
objectives and blood pressure control.

In summary, excess disease burden from hypertension in African
Americans, combined with numerous socio-economic barriers to optimal
care for many inner city individuals, provides a setting in which
substantial improvements are both urgently needed and likely

Objectives and Scope

The primary objective of this four year demonstration and education
research program is to develop, and to evaluate for feasibility,
acceptability, and effectiveness, methods to maintain therapy and
control of hypertension, for both newly and previously diagnosed
individuals, in inner city, primarily minority populations.  The focus
will be on community-based health education and other approaches for
enhancing compliance and improving blood pressure control among inner
city minority populations.  The delivery of and adherence to the
interventions is the main objective, rather than clinical algorithms
used to treat hypertension.  While the improvement of hypertensive care
is the focus of this program, other cardiovascular disease risk factors
may be included in the interventions, and changes in these factors
should be assessed.  The role of non-pharmacologic approaches to
reducing blood pressure, including drug and alcohol avoidance, should
be addressed.

Primary outcome measures to assess the interventions may include:
percentages aware of hypertension, screened for hypertension, treated
for hypertension, responding to treatment, and controlled to normal
levels of blood pressure; clinic attendance; and compliance with
therapy.  Secondary outcomes include the assessment of:  effects on
other CVD risk factors, e.g., cigarette smoking, overweight, lipid
profile, and diabetes; health quality of life measures; and cost
effectiveness of the interventions.

The experimental design is not restricted by this RFA.  Applicants
should develop their own independent design, and provide justification
for the proposed design.  The designs should focus on an integrated
approach including various management factors that have previously been
shown to be effective.  Health education and other approaches for
enhancing compliance and improving blood pressure control must be
adequately described.  A randomized design, comparing special
interventions against usual care would be one appropriate study design
to test intervention models.  If justified by the nature of the
proposed intervention, i.e., delivery of an intervention to a social
group (e.g., neighborhood or employee group), other designs will be
considered responsive.

Annual meetings, to be held in Bethesda, MD, are planned for the
exchange of information among investigators.  Applicants must budget
the travel costs associated with these meetings in their applications.


Because of their excess burden of hypertension, African Americans
should comprise a large proportion of the study population.  Although
there is no compelling evidence of excess burden from hypertension
among Hispanics compared to the population at large, socioeconomic
factors for inner-city members of this group may result in less than
optimal hypertension detection and treatment.  Therefore the inclusion
of Hispanics, which may be best accomplished by the inclusion of
Hispanics as the majority of the sample at one of the study sites, may
be proposed.  Investigators should also consider other minority groups,
as well as low socioeconomic whites, for inclusion.  The inclusion of
low socioeconomic status (SES) whites may provide some means to
separate the effects of SES and ethnicity.  As the lowest hypertension
control rates are seen in young African Americans, investigators should
address the advantages and disadvantages of oversampling this younger
segment of the population.


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 approximate percentages by 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 (rev. 9/91) 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,

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

If the required information is not contained in the application the
application will be returned.

Peer reviewers will address specifically whether 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


Prospective applicants are asked to submit, by November 30, 1992, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone number of the PI; 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 is helpful in planning for the review of applications.
It allows NHLBI staff to estimate the potential workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
Bethesda, MD  20892
Telephone:  (301) 496-7363
FAX:  (301) 402-1660


The research grant application form 398 (rev. 9/91) is to be used in
applying for this award.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)
496-7441; and from the NHLBI Program Administrator named below.

The RFA label available in the PHS 398 (rev. 9/91) application 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 RFA title and number must be typed on line 2a of the face
page of the application form and the YES box must be marked.

Submit the signed, typewritten original of the application, and three
signed photocopies in one package to:

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

At the time of submission, two additional copies must also be sent to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
Bethesda, MD  20892

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 February 16, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not accept
any application in response to this announcement 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.


Upon receipt, applications will be reviewed for completeness by DRG and
for responsiveness by the NHLBI.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NHLBI staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications that are found to be responsive will be reviewed for
scientific and technical merit by an initial review group, convened by
the Division of Extramural Affairs, NHLBI solely to review these
applications.  The initial review will include an evaluation to
determine scientific merit relative to other applications received in
response to this RFA (triage).  The NIH will withdraw from further
competition those applications judged non-competitive for award and
notify the applicant PI 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, including, if deemed appropriate, a reverse site
visit at the applicant's expense.  Secondary review of applications
will be conducted by the National Heart, Lung, and Blood Advisory

Review Criteria

The review group will assess the scientific merit of the study,

o  The documentation of the need for improving hypertensive care in
this segment of the population, and the soundness of the rationale for
the selection of the intervention methods.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research, including appropriate
determination and discussion of the required sample size and adequate
recruitment plans in accordance with sample size estimate.

o  Qualifications and research experience of the PI and staff,
including:  administrative abilities of the PI and co-PIs; experience
of the key investigators in the area of the proposed research,
including experience in adequate recruitment of participants into
research projects; ability of investigators and other key personnel to
devote adequate time for proper conduct of the study, over the duration
of the study; representation of minority individuals among
investigators and staff.

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

Applicants must describe in their application the potential for
involvement with one or more community service organizations and the
potential for the transfer of ownership of the interventional program
to these organizations.  It is hoped that longevity of the program
beyond the funded period can be achieved in this manner.  Although the
actual transfer of ownership to these organizations is not a
requirement of the study, the potential for transfer will be carefully
addressed in the review of applications, and those applications without
such a description will be considered to be non-responsive to this RFA.


Applications recommended by the National Heart, Lung, and Blood
Advisory Council will be considered for award based upon scientific and
technical merit (priority scores), programmatic priorities, and the
availability of funds.  The anticipated date of award is September 30,


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

P. Scott Allender, M.D.
Prevention and Demonstration Research Branch
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Federal Building, Room 604
7550 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-2465

Direct inquiries regarding fiscal matters to:

William W. Darby
Section Chief, Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A11
Bethesda, MD  20892
Telephone:  (301) 496-7536


This project is described in the Catalog of Federal Domestic Assistance
No. 93.837.  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 42 CFR 52 and 45 CFR Part 74.  This
project is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


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