OVERCOMING BARRIERS TO TREATMENT ADHERENCE IN MINORITIES AND PERSONS LIVING 
IN POVERTY

Release Date:  January 25, 2001

RFA:  RFA-HL-01-005

National Heart, Lung, Blood Institute
 (http://www.nhlbi.nih.gov)
National Cancer Institute
 (http://www.nci.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)
National Institute of Nursing Research
 (http://www.ninr.nih.gov/)

Letter of Intent Receipt Date:  February 22, 2001
Application Receipt Date:       March 22, 2001

PURPOSE

The National Heart, Lung, and Blood Institute, the National Cancer 
Institute, the National Institute of Diabetes and Digestive and Kidney 
Diseases, and the National Institute of Nursing Research invite 
applications for research project (R01) grants to evaluate interventions 
in clinical care settings designed to improve adherence to medically 
prescribed lifestyle and medical regimens used to treat heart, lung, 
blood or sleep diseases, disorders or conditions, cancer, or diabetes.  
The populations targetted by this RFA are racial and ethnic minorities 
and/or persons living in poverty.   The burden of disease is not borne 
equally by all population groups in the United States, for example, 
differences in disease morbidity and mortality exist as a function of 
race, ethnicity, and socioeconomic status.  A key aspect of this program 
is to encourage research to evaluate innovative yet practical methods 
that overcome patient, provider and medical systems barriers which 
impede or erode treatment adherence among racial and ethnic minorities 
and persons living in poverty in the United States.  

To be responsive to this RFA, an application must meet the following 
criteria:

o  The adherence intervention(s) must be designed to improve patient 
adherence to a behavioral or medical regimen used to prevent progression 
or  recurrence of an existing heart, lung, blood or sleep disease, 
disorder, or condition, cancer or diabetes.  Studies that focus on 
cancer may also involve interventions designed to promote the adaptation 
of healthful behavior post-treatment.

o  The study population must consist of one or more racial or ethnic 
minority groups or groups and/or persons living in poverty.

o  The objective of the adherence intervention(s) tested and the primary 
outcome of interest must be patient adherence to a behavioral or medical 
regimen.  
 
o  The primary measure(s) of adherence proposed must be one or more 
well-defined, valid and reliable assessments of individual-level patient 
adherence behavior.

o  The adherence intervention(s) must be designed to improve patient 
adherence by targetting the individual patient, his/her formal or 
informal health-care providers, the health care system or environment, 
or a combination of these. 

o  The application must propose a specific randomized design to evaluate 
the effectiveness of one or more adherence interventions.

o  The adherence intervention(s) to be tested must be grounded in an 
explicit theoretical framework.

o  Evidence of the feasibility of the intervention(s), its acceptability 
to the target population used, and its ability to address the particular 
barrier or barriers relevant to the population selected,  must be 
provided.

This RFA is responsive to Congressional Report Language for the FY 2001 
Appropriations that encourages research on health disparities, and that 
encourages "expanded research on innovative theories about behavioral, 
cultural, social, psychological, and environmental methods to increase 
adherence to lifestyle and medical regimens" (see 
http://www.nih.gov/news/#special).  The RFA is based on recommendations 
made by a recent NHLBI Working Group on Adherence to Medical and 
Lifestyle Interventions, by a recent NIDDK Working Group and Conference 
on Behavioral Science Research and Diabetes, and by advisory groups to 
NHLBI and the NIDDK.  

This RFA is also responsive to the challenge raised by the President"s 
Cancer Panel and more recently in a report by the Institute of Medicine, 
Ensuring Quality of Cancer Care, to understand and address those factors 
affecting "why specific segments of the population (e.g., members of 
certain racial or ethnic groups, older patients) do not receive 
appropriate cancer care."  In addition, the RFA is responsive to the 
request raised by the recent Progress Review Groups on Prostate, Breast 
and Colorectal Cancer to test behavioral interventions to improve the 
disease-free survival of and other health outcomes for survivors.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas.  This Request for 
Applications (RFA), Overcoming Barriers to Treatment Adherence in 
Minorities and Persons Living in Poverty, is related to one or more of 
the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

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.   However, foreign organizations may participate if they 
are components of domestic, U.S. organizations or via contractual or 
consortium agreements with domestic, U.S. organizations.  Racial/ethnic 
minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) regular 
research grant (R01) award mechanism. Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of 
the applicant.  The total project period for an application submitted in 
response to this RFA may not exceed four (4) years.  This RFA is a one-
time solicitation.  Future unsolicited competing continuation 
applications will compete with all investigator-initiated applications 
and be reviewed according to the customary peer review procedures.  The 
anticipated award date is September 30, 2001.

FUNDS AVAILABLE

The National Heart, Lung, and Blood Institute, National Cancer 
Institute, National Institute of Diabetes and Digestive and Kidney 
Diseases and National Institute of Nursing Research intend to commit 
approximately $5,750,000 in total costs in FY 2001 to fund 8 - 9 new 
grants in response to this RFA.  The NHLBI will provide $3 million per 
year in total costs, the NCI will commit $1 million in total costs per 
year, the NIDDK $1 million in total costs per year, and the NINR, up to 
$750 K in total costs per year.  The participating Institutes will fund 
research projects in their areas of responsibility. An applicant may 
request a project period of up to 4 years.  Budgets in excess of 
$500,000 direct costs per year must be strongly justified.  Because the 
nature and scope of the research proposed may vary, it is anticipated 
that the size of each award will also vary.  Although the financial 
plans of the participating Institutes provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious 
applications.  At this time, there is no plan to reissue this RFA.

RESEARCH OBJECTIVES

Background

The steady decline in morbidity and mortality from coronary heart 
disease, stroke, and tuberculosis, as well as recent progress in 
reducing the morbidity associated with asthma and various blood 
disorders and diabetes, can be attributed to advances in the prevention 
and treatment of these diseases and disorders over the past 50 years.  
Unfortunately, the full impact of these medical advances is often not 
realized because they are not adopted by patients or are not 
consistently maintained over time.  Rates of patient noncompliance with 
prescribed treatments range from 30% to 60%, and estimates are that 50% 
of patients prescribed medication do not receive the full benefits of 
treatment because of inadequate adherence (Rogers & Bullman, 1995).  

At the same time, survival of persons diagnosed with cancer is also 
improving.  Today, almost 60% of adults diagnosed with cancer will be 
alive in five years (ACS, Facts and Figures, 2000).  For those diagnosed 
with early stage or localized prostate, breast or colon cancer 5 year 
survival is even higher (92%, 77% and 65 %, respectively).  Some of the 
success in treating these cancers is attributable to the growing use of 
effective screening methods and hence diagnosis of earlier, more 
treatable forms of the disease, more effective adjuvant treatments have 
also contributed to better prognoses.  Despite the seriousness of a 
cancer diagnosis, some patients do not adhere to or face health care 
systems barriers to obtaining recommended therapies and fail to receive 
any or a complete course of adjuvant chemotherapy, radiation or hormonal 
therapy.  Further, with the number of cancer survivors growing, research 
is needed to test whether or not adjuvant therapies or health behavior 
change during what is often considered a "teachable moment" can be 
useful in reducing risks of cancer recurrence or other chronic health 
problems (e.g., heart disease, pulmonary dysfunction, osteoporosis).  
Testing these hypotheses will require intervention programs that yield 
long-term adherence to treatment regimens or maintenance of health 
behavior change.

Diseases of the heart, lungs, and blood and sleep disorders.  The 
evidence for poor utilization of medical treatments for heart, lung and 
blood diseases and for sleep disorders is striking.  In the case of 
antihypertensive therapy, recent studies show that, despite the 
availability of convenient, once-daily dosing regimens with relatively 
few side effects, only 27% of known hypertensives in the U.S., and 55% 
of treated hypertensives, maintain target blood pressures (JNC-VI, 
1997).   Further, it is estimated that up to 50% of patients who begin 
antihypertensive therapy drop out of care within one year (Haynes, 
1995), and of those who remain in treatment, about one-half take less 
than 80% of their medication (Haynes et al., 1980).  Since blood 
pressure control has been found to be significantly better in patients 
taking at least 80% of their medication compared with those taking less 
than 50%, the low adherence rates reported for antihypertensive regimens 
have important implications for the management of  hypertension and 
associated cardiovascular complications. 

Another area of need concerns sickle cell disease (SCD).  Newborn 
screening programs are in place to identify newborns with sickle cell 
disease, and prophylactic penicillin is recommended until about age 
seven, but this regimen requires periodic visits to healthcare 
providers.  Sickle cell patients who have been placed on transfusion 
regimens with subsequent need to undergo chelation therapy face 
treatments which can be frightening, painful, and otherwise burdensome, 
resulting in potential adherence problems.  Hydroxyurea, the only proven 
effective therapy for SCD, can effect substantial improvements in sickle 
cell crises and complications.  However, appropriate use of hydroxyurea 
is of particular concern, when used inappropriately, its benefits may 
not be realized, and when taken in too great a quantity, patients may be 
at risk for malignancies or birth defects.  Finally, adolescent sickle 
cell patients face potential adherence problems when transitioning from 
pediatric to adult care because they are removed from the supportive 
umbrella of parent and pediatric health care providers.

Nonadherence to treatment has also been found to be a problem for beta-
blockers prescribed for patients post-myocardial infarction, lipid-
lowering agents used to treat high blood cholesterol, anticoagulation in 
atrial fibrillation, angiotensin converting-enzyme inhibitors in heart 
failure, anti-inflammatory therapy in asthma, and treatments for chronic 
obstructive pulmonary disease and sleep apnea.  Lack of adherence to 
treatment regimens for tuberculosis has been documented, and presents 
the additional consequence of contributing to the development of multi-
drug resistant strains that are more difficult to control and may lead 
to spreading infection.  With respect to behavioral interventions, many 
studies have demonstrated good initial success with major lifestyle 
changes for preventing and managing heart, lung, and blood diseases, but 
maintenance of such changes beyond 1-2 years is much less satisfactory.

Cancer.  With regard to cancer treatment, patients who fail to receive a 
full course of prescribed cancer therapy have an increased chance of 
recurrence and potentially poorer survival outcomes (Richardson et al., 
1990).  For example, McCready et al. found that the rate of recurrence 
among postmenopausal women who underwent lumpectomy without adjuvant 
therapy was 24%, compared to those compliant with adjuvant therapy 
(McCready et al., 2000).  Similarly, de Csepel et al. also found a 
higher lifetime rate of recurrence (22%) among elderly women treated 
with breast conservation surgery without adjuvant therapy who did not 
fully adhere to recommendations for radiation therapy following breast 
cancer surgery (de Csepel et al., 2000).

Between 15-30% of women treated with breast conserving surgery do not 
undergo postoperative radiotherapy (Athas et al., 2000).  Follow-up to 
adjuvant treatment for women receiving breast conserving surgery is 
lower among rural, elderly and other underserved populations.  For 
example, only 36% of women treated with breast conserving surgery at a 
rural southern institution fully adhered to the recommendation for 
radiation therapy and clinical follow-up after breast conserving surgery 
which led to higher local failure rates (Li et al., 2000). 

Once treatment ends, cancer survivors need to be carefully followed for 
potential late effects of disease.  Because of their treatments, many 
are at increased risk of developing secondary tumors or other chronic 
conditions, such as osteoporosis, diabetes and cardiovascular diseases. 
 Cancer survivors are thus an important target population for health-
promotion interventions.  To date, there is limited information about 
the health behaviors of patients beyond the active cancer treatment 
period.  Demark-Wahnefried and colleagues (2000) found that 55% of their 
sample of 978 survivors ate fewer than 5 daily servings of fruits and 
vegetables.  Prostate cancer survivors ate even fewer servings than 
breast cancer survivors.  Over 30% indicated they did not adhere to a 
low fat diet, with prostate cancer patients again indicating worse 
practice than breast cancer survivors in this area.  42% of survivors 
did not engage in routine exercise and 8% were current smokers.  In this 
study, receptivity of the survivors to interventions to promote 
lifestyle changes was stated to be high.  Physical activity can 
significantly improve functional (i.e., fatigue, nausea, functional 
capacity) and emotional (i.e., mood, distress, self-esteem) quality of 
life of cancer patients (Courneya & Friednereich, 1999).  It is not 
known to what extent changes in health-related behavior contributes to 
reduced risk of recurrence or other co-morbid illnesses.  Trials are 
underway to test whether dietary changes increase survival from breast 
cancer (Pierce et al., 1997, Rock et al., 1997).  However, it is 
reasonable to assume that changes in health-related behavior can 
contribute to an overall improved quality of life.

Diabetes.  Health care practices demonstrated to improve diabetes 
outcomes have recently been shown to be significantly underutilized.  
Self-monitoring of blood glucose, glycemic control, regular foot care, 
and ophthalmic examinations have all been shown to markedly reduce the 
incidence and progession of diabetic complications.  These findings have 
resulted in the American Diabetes Association (ADA): Standards of 
Medical Care for Patients with Diabetes Mellitus.  However, less than 2% 
of adults with diabetes receive the full level of care that has been 
recommended by the ADA.  Self-monitoring of blood glucose, following the 
ADA guidelines, is performed by only one in five adults with diabetes.  
Only four in ten individuals that saw their health care provider for 
diabetes care had their feet examined or received a dilated eye exam 
during the previous year.  And according to the NHANES, only 42% of 
individuals achieve the ADA recommended HbA1c level of 7 or lower.  
Behavioral interventions clearly need to be developed to improve 
adherence to demonstrated mechanisms that improve diabetes outcome. 

More than 25 years ago, nonadherence of patients to medical and 
behavioral treatments was identified by Sackett and Haynes (1976) as a 
major public health problem.  In the intervening time period, numerous 
studies have been conducted to identify factors that predict 
nonadherence and strategies that improve adherence, defined as following 
medical, behavioral or other health-related recommendations made by a 
healthcare professional.  The most robust finding is that aspects of the 
therapeutic regimen (regimen complexity, difficulty or ease of use of 
medication, dosing frequency, duration of therapy) are the best 
predictors of patient adherence (Dunbar-Jacob & Stunkard, 1979).  In 
addition, interpersonal factors, such as social support and provider 
behaviors (Dunbar-Jacob & Stunkard, 1979), as well as  psychological 
distress (i.e., depression and anxiety, Colleoni et al., 2000, Ayres et 
al., 1994), more serious mental disorders, and substance abuse (Rand & 
Weeks, 1998), affect adherence.  However, personality traits have not 
been consistently shown to predict adherence (Dunbar-Jacob et al., 
1998).   

Research shows that adherence is enhanced when regimens are simple, easy 
to follow, of short duration, do not involve disruptions in lifestyle 
and are linked to reductions in symptoms or pain (Dunbar-Jacob & 
Stunkard, 1979).  More intensive, comprehensive approaches (e.g., 
combining several types of adherence-promoting strategies) appear to be 
more successful (Mullen et al., 1992, Roter et al., 1998), and tailoring 
the intervention to address the individual=s reasons for not adhering 
also may be helpful. However, even more limited educational 
interventions also may be effective.  For example, Richardson and 
colleagues (1990) found that a one-hour educational session with a nurse 
and additional hospital and/or home component was associated with 
improved allopurinol compliance in newly diagnosed hematologic 
malignancy.  Finally, physicians= communicative skills and rapport with 
the patient are associated with better adherence (Becker, 1985, Hall et 
al., 1988, Stewart, 1996).

However, gaps remain in our knowledge of how best to improve patient 
adherence to therapeutic strategies for diseases of the heart, lung, and 
blood vessels, cancer, diabetes and sleep disorders.  This is especially 
true for certain population groups, such as racial and ethnic minorities 
and individuals living in poverty, which often demonstrate poorer 
adherence rates relative to other segments of the population.  In fact, 
many of the disparities that exist in health outcome based on cultural, 
ethnic and socioeconomic factors may to some extent reflect disparities 
in the adoption and maintenance of healthy lifestyles and adherence to 
medical regimens. 

Racial and SES disparities in adherence to prescribed behavioral and 
medical regimens are often based on financial, logistical and cultural 
barriers that, while not unique to minorities and the poor, often occur 
more frequently or have greater impact in poor and minority communities. 
 Examples of barriers frequently encountered by these groups when 
attempting to follow recommended health and treatment recommendations 
include the following:
  
(1) Financial constraints.  Many individuals from lower socioeconomic 
strata lack health insurance and are unable to afford required medical 
devices and medications.  The cost of therapy, the medical visit and/or 
the time off from work for the same may significantly reduce disposable 
income.  Good health may become a low priority for the patient and/or 
the patient"s family because of competing needs and limited resources.

(2) Logistical barriers.  Health care resources may be inconveniently 
located, transportation and/or dependent care may be unavailable or 
difficult to obtain, or obtaining health care conflicts with work 
requirements. 

(3) Cultural barriers.  These include mistrust by some minority groups 
of medical personnel and medical systems, lack of cultural sensitivity 
on the part of health care providers, and differences between patients 
and health care providers regarding the meaning and importance of an 
illness, its causes, consequences and treatment.  Cultural practices, 
and health knowledge and beliefs are all important determinants of the 
effectiveness of patient-physician interactions.  Physicians may not 
fully recognize educational, social, cultural, or economic barriers to 
routinely prescribed therapy.  Similarly, a patient"s expectations and 
understandings of the physician or health provider"s role may present 
additional obstacles.  Issues such as the legacy of racial segregation, 
stigma associated with disease and mistrust of health care facilities 
tend to alienate minorities from medical systems.  

(4) Environmental stressors.   Minority groups and individuals living in 
poverty encounter many stressors, both physical and psychological, on a 
daily basis.  The demands associated with survival in harsh environments 
B obtaining food, housing, work, and ensuring the physical safety of 
one"s self and family -- cause strain and tax the psychological 
resources needed to deal with health concerns.  The types of jobs held 
by lower SES workers often involve stressful conditions and even 
physical hazards.  Shift work, which is performed by disproportionate 
numbers of minorities and individuals from lower socioeconomic strata, 
frequently results in sleep deprivation.  Lack of sleep is emerging as 
an important contributing factor to cardiovascular disease, increased 
severity of inflammatory disease, diminished mental and physical health, 
and may also play an important role in adherence to prescribed health 
recommendations.

Given the presence of these chronic, multiple barriers to adherence, it 
is not surprising that following prescribed health recommendations poses 
a special challenge for ethnic minority and lower socioeconomic groups. 
 A major research priority is therefore the development of effective 
interventions in clinical care settings for improving adherence to 
medical and lifestyle regimens for these underserved groups so that the 
full benefits of medical advances in the treatment of heart, lung and 
blood diseases, cancer, diabetes and sleep disorders can be realized for 
all segments of the U.S. population. 

Criteria for Responsiveness 

Applicants responding to this solicitation must propose a study which 
evaluates the effects of an adherence intervention strategy or 
strategies on treatment adherence in a minority and/or low SES 
population.  To be considered responsive, studies must meet all of the 
following criteria:

(1) The adherence intervention must be designed to improve patient 
adherence to either a behavioral or medical regimen, or both, used to 
prevent recurrence or progression of an existing heart, lung, blood or 
sleep disease, disorder, or condition, cancer, or diabetes.
  
The regimen must involve either a behavioral treatment or treatments 
(e.g., counseling for smoking cessation or to reach dietary or physical 
activity goals) or medical therapies (e.g., medication regimens or 
devices used to treat the disease or condition), or combinations of the 
two.  The following describes Institute-specific areas of focus:

National Heart, Lung, and Blood Institute:  The National Heart, Lung, 
and Blood Institute is interested in studies that evaluate adherence 
interventions in minority and lower SES patients who have been diagnosed 
with and are being treated for a broad range of heart, lung, blood and 
sleep diseases, disorders or conditions.  A list of therapies and 
conditions relevant to this RFA (these are examples only, not an 
exhaustive list) include: antihypertensive and cholesterol-lowering 
medications, medications used to treat myocardial infarction and 
congestive heart failure, weight loss regimens in obese individuals, 
lifestyle change (e.g., smoking cessation, dietary and physical activity 
regimens for persons with hypertension, high blood cholesterol, 
myocardial infarction), and treatments for asthma, chronic obstructive 
pulmonary disease, tuberculosis (latent and active), sickle cell 
disease, and sleep disorders such as sleep apnea.

National Cancer Institute:  The National Cancer Institute is interested 
in applications for research in persons diagnosed with cancer, focusing 
on racial/ethnic minorities and persons living in poverty.  Studies of 
persons with breast, colon and prostate cancer would be most feasible, 
as these are high incidence cancers with relatively high, long-term 
survival following treatment. The research study should evaluate 
interventions designed to increase compliance with and/or overcome 
barriers to receiving adjuvant therapy (chemotherapy, radiation or 
hormonal therapy), to facilitate earlier diagnosis of recurrent cancer 
through increased adherence to recommendations for follow-up care, or to 
reduce the risk of other co-morbid conditions (e.g., osteoporosis, 
cardiovascular disease, or other cancers) through adoption of lifestyle 
changes.  Thus, the research should address either (1) interventions 
designed to improve adherence to adjuvant treatment recommendations 
known to improve survival, such as the use of tamoxifen for breast 
cancer, or (2) maintenance of lifestyle changes that could increase 
long-term survival, enhance quality of life, or reduce co-morbidity.  
Appropriate behavioral interventions would include, but not be limited 
to weight control, physical activity, dietary change, and smoking 
cessation.  Of particular interest is the development and evaluation of 
theory based models to guide interventions to promote long-term 
adherence to treatment regimens and/or maintenance of healthful 
behavior.  

National Institute of Diabetes and Digestive and Kidney Diseases:  The 
National Institute of Diabetes and Digestive and Kidney Disease is 
interested in development and translation of effective interventions to 
increase adherence to medical regimens for diabetes, obesity, genetic 
metabolic diseases and endocrine, renal, urologic, hematologic, 
digestive and liver diseases for ethnic minorities and persons living in 
poverty.  Examples of topics of interest to NIDDK include: interventions 
to increase adherence to medications used to treat hyperglycemia and 
behaviors affecting glycemic control and other diabetes outcomes, 
interventions to improve post-transplant medication compliance, improved 
treatment of depression in patients with diabetes or on dialysis, 
interventions targeted at increasing compliance in adolescents, and 
studies of interactions between care providers and patients leading to 
improved adherence and outcome. 

National Institute of Nursing Research:  For the purposes of this RFA, 
NINR is interested in research studies that involve nursing 
interventions or have a direct impact on patient care by a health team, 
or studies that involve nursing, patient, or health care system 
strategies to improve appropriate patient adherence to pharmacological 
and behavioral treatments, as well as to health care practices and 
regimens provided by nurses and health care providers other than 
physicians, and that are targetted to minority or low income persons.  
The NINR is especially interested in funding meritorious applications by 
nurse investigators where such applications are in concert with the 
mission of NINR.

(2) The study population must consist of a racial or ethnic minority 
group or groups and/or persons living in poverty.

Applicants must target as their study population a minority group or 
groups or a population living in poverty, or both.   For the purposes of 
this program, racial/ethnic minorities include African Americans, 
Hispanics, Asians/Pacific Islanders, and Native Americans.  With regard 
to poverty, the purpose of the program is to identify and employ 
interventions which effectively reduce economic and other barriers to 
adherence.  Therefore, poverty is broadly defined to include measures 
beyond FY 2000 HHS poverty guidelines (i.e., $17,050 for a family of 
four) and may also include persons eligible for federal assistance 
programs (e.g., food stamps, welfare, Head Start, earned income credit, 
supplemental security income, block grants, temporary assstance for 
needy families) and persons without health insurance.  Applicants must 
provide detailed information describing the population to be studied.  
Detailed justification for the proposed sample size is required, as is 
evidence that the projected sample size is attainable.  Documentation of 
access to sufficient numbers of study participants to satisfy power 
requirements of the study must be provided.  

(3) The objective of the adherence intervention(s) tested, and the 
primary outcome of interest, must be patient adherence to behavioral or 
medical regimens, rather than provider adherence to clinical guidelines. 
 
While physician or health care provider compliance to treatment 
guidelines is a major problem affecting translation of research findings 
to clinical practice, the focus of studies responsive to this RFA should 
be on improving the degree to which patients adhere to medical or 
behavioral regimens, rather than on improving the extent to which 
physicians or providers adhere to clinical guidelines.  Thus, the 
intervention(s) used should have as its(their) goal increasing the 
extent to which patients" adhere to the behavioral or medical regimens 
of interest.
 
(4) The primary measure(s) of adherence proposed must be well-defined, 
valid and reliable assessments of individual-level patient adherence 
behavior, not just broad indicators of health care utilization or health 
outcomes. 
 
Primary outcome measures should assess the adherence of individual 
patients, using one or more well-defined, reliable and valid adherence 
assessment tools (e.g., patient self-report, pill count, electronic 
monitoring). The specific adherence measures to be used should be well-
justified.  Use of multiple measures of adherence is encouraged, 
especially when self-report measures are employed.  If self-report is 
used, the measure must be previously validated.  The applicant is 
encouraged to make use of the most recent advances and/or innovations in 
adherence measurement (e.g., electronic monitoring systems), where 
feasible.   Applicants may also propose measurement of provider 
attitudes or behavior (e.g., provider self-report of patient adherence) 
and use of broader indicators of adherence, health care utilization and 
health outcomes (pharmacy records) as secondary measures of patient 
adherence.

(5) The adherence intervention(s) must be designed to improve patient 
adherence by targetting the individual patient, his/her formal or 
informal health-care providers, the health care system or environment, 
or a combination of these. 

Although the goal of the adherence intervention is to change patient 
behavior, the proposed intervention(s) may attempt to do so by 
targetting either the patient (e.g., through dissemination of 
information, provision of education, or use of behavioral, affective or 
cognitive techniques that enhance patient adherence), the health care 
provider (e.g., through the use of strategies that improve provider 
communication or rapport with patients or teach other skills that 
encourage patient adherence), the health care environment (e.g., by 
structuring the practice setting to support provider counseling of 
patients in adherence) or any combination of these.  For example, an 
intervention may seek to increase a patient=s motivation to adhere, 
improve a health care provider=s communication skills, and/or alter 
aspects of the practice setting to eliminate barriers and provide 
incentives for health care personnel to use communication/counseling 
skills to encourage patient adherence.  Where levels other than the 
patient are targetted by the intervention (e.g., both patients and 
providers receive an intervention, or there is an attempt to change both 
the provider=s behavior and the health care environment), the applicant 
must explicitly address any design issues or threats to validity that 
occur with such designs (e.g., rather than randomizing individual 
patients, randomization at the provider or even health care practice 
level may be required). 

(6) The application must propose a specific randomized design to 
evaluate the effectiveness of one or more adherence interventions.

The applicant should propose to use an experimental design in which the 
individuals or groups targetted by the intervention (e.g., individual 
patients, providers or health care practices) are randomly assigned to 
one or more adherence intervention conditions, and the effectiveness of 
the interventions in enhancing patient adherence is assessed relative to 
each other and/or to a usual care control group.  

(7) The adherence intervention(s) to be tested must be grounded in an 
explicit theoretical framework.

The proposed adherence intervention(s) must be based in a clearly 
explicated theoretical framework, and the applicant must describe in 
detail the theoretical underpinnings of the adherence intervention(s).  
 Innovative or novel approaches that enable minorities and people living 
in poverty to address barriers to adherence, either by tailoring a 
proven adherence intervention to the cultural/economic needs of the 
study group OR by using a novel intervention uniquely suited to the 
specific study population, are encouraged.

(8) Evidence of the feasibility of the intervention(s), its 
acceptability to the target population used, and its ability to address 
the particular barrier or barriers relevant to the population selected, 
must be provided.

The applicant must present evidence that the intervention(s) will be 
feasible and acceptable for the target population, e.g., data or prior 
literature supporting the use of the intervention with the target 
population and showing the potential for success of the intervention for 
the target group(s).  The applicant must also discuss how the 
intervention will be tailored to meet the particular needs of and 
address the specific barriers to adherence for the targetted group(s).  
A clear characterization and discussion of the barriers specific to the 
population targetted, and the plan and rationale for how the adherence 
interventions proposed will be tailored to overcome these barriers, are 
essential.  To ensure that the interventions can be translated directly 
to the clinical care setting, strategies that are relatively simple, 
practical and readily incorporated into medical settings that serve 
minority and lower SES populations are encouraged.

Project Schedule

The maximum duration of the research projects will be four years.  A 
project timetable is provided below, however, variations in project 
length within this period and variations of program phases may occur due 
to differences in the time needed for recruitment, intervention, and 
follow-up.  

Phase 1 (6 months): Protocol refinement, pre-tests of measures, staff 
training, study start-up activities.

Phase 2 (3 years):  Recruitment of participants, intervention, and 
follow-up activities, preliminary data analysis.

Phase 3 (6 months): Data analysis and reporting.

Investigators will meet at or near the beginning of Phase 1 to discuss 
study design and share problems and solutions prior to the beginning of 
recruitment, and annually thereafter until the end of the study.

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Influence of mood and adjustment to cancer on compliance with 
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Bastarrachea J, Hortobagyi GN, Smith TL, Shu-Wan CK.  Obesity as an 
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Colleoni M, Mandala M, Peruzzotti G, Robertson C, Bredart A, Goldhirsch 
A.  Depression and degree of acceptance of adjuvant cytotoxic drugs.  
Lancet 2000, 356, 1326-1327.

Courneya KS, Friedenreich CM.  Physical exercise and quality of life 
following cancer diagnosis: a literature review. Ann Behav Med 1999, 
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de Cespel J, Tartter PI, Gajdos C.  When not to give radiation after 
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Demark-Wahnefried W, Peterson B, Mcbride C, Lipkus I, Clipp E. Current 
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patient adherence: Patient characteristics. In Shumaker SA, Schron EB, 
Ockene JK, McBee WL (Eds.) The Handbook of Health Behavior Change, 2nd 
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Haynes RB, Taylor W, Sackett DL, et al.  Can simple clinical 
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Effectiveness of interventions to improve patient compliance.  Medical 
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SPECIAL REQUIREMENTS

(a) DATA SAFETY AND MONITORING.  A clinical trial entails a relationship 
between participants and investigators, both of whom must fulfill 
certain obligations for the effort to succeed. Participants must be 
fully informed of the study requirements throughout the conduct of the 
trial and should comply with the rigors of the research protocol or be 
allowed the opportunity to withdraw from participation. The 
investigators must protect the health and safety of participants, inform 
participants of information relevant to their continued participation, 
and pursue the research objectives with scientific diligence. In 1994, 
the NIH Office of Extramural Research established the Committee on 
Clinical Trial Monitoring to review the oversight and management 
practices of the ICs for phase III clinical trials. One of the outcomes 
of this Committee"s review was a strong recommendation that "all trials, 
even those that pose little likelihood of harm, should consider an 
external monitoring body." 

Applicants should describe the organizational structures and procedures 
they will employ to ensure the safety of participants and the validity 
and integrity of the data. (For a statement of issues and concerns, see 
"NIH Policy for Data And Safety Monitoring," NIH Guide to Grants and 
Contracts, Release Date: June 10, 1998, 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html). At the 
time of the award, applicants should be prepared to make adjustments to 
their procedures based upon NHLBI policy.

(b) ANNUAL MEETINGS.  Applicants funded under this RFA will be required 
to attend meetings in which study plans, findings and issues of common 
interest and concern will be shared and discussed.  Applications should 
include in their budgets funds for attending (1) an initial meeting at 
or near the time of the award and (2) an annual meeting thereafter until 
the end of funding. For budgeting purposes, applicants should assume 
that the meetings would be for two days in Bethesda, Maryland at the 
National Institutes of Health and require the attendance of at least the 
Principal Investigator. 

(c) USE OF EXISTING STUDIES.  Applications should consider taking 
advantage of other research projects (e.g., clinical trials about to be 
implemented) that could be expanded by adding a research component on 
adherence.  Such projects might provide access to subject populations or 
settings as well as reduce the costs of conducting research.

(d) FINAL REPORT.  At the completion of the project, the Principal 
Investigator (PI) must provide a report to the Project Office with: (a) 
detailed recommendations concerning the adherence intervention(s) 
evaluated, based on the study"s findings, (b) a complete description of 
the intervention(s) used in the study, to include a description of the 
rationale for and underlying theoretical bases for the intervention(s), 
a description of the intervention procedures used (e.g., manuals of 
procedures), and any intervention materials used, ( c) training, 
certification and quality control procedures for ensuring effective 
implementation of the recommended adherence intervention(s), and (d) how 
the theoretical approach used could be generalized to, and the 
interventions be tailored for, other modalities, populations or 
diseases.

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 sub-populations 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 policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should 
read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for Grants 
and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a 
complete copy of the updated guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to provide a 
description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable, and b/ all investigators to report accrual, and 
to conduct and report analyses, as appropriate, by sex/gender and/or 
racial/ethnic group differences. 

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

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

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no 
obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an Internet 
site.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 22, 2001, 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 this RFA. Although a letter of 
intent is not required, is not binding, and does not enter into the 
review of a subsequent application, the information that it contains 
allows NIH staff to estimate the potential review workload and plan the 
review.

The letter of intent is to be sent to Dr. Susan Czajkowski at the 
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most 
institutional offices of sponsored research and 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, e-mail: GrantsInfo@nih.gov. Applications are 
also available on the World Wide Web at 
http://grants.nih.gov/grants/forms.htm.

Because we expect that there will not be any applications requesting 
less than $250,000 in direct costs for all years, applications should be 
in the standard (non-modular) format with a detailed budget.

The RFA label available in the PHS 398 (rev. 4/98) application form must 
be affixed to the bottom of the face page of the application. Type the 
RFA number on the label.  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 2 of the face page of the application form 
and the YES box must be marked.

The sample RFA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies of the application in one package 
to: 

CENTER FOR SCIENTIFIC REVIEWNATIONAL INSTITUTES OF HEALTH6701 ROCKLEDGE 
DRIVE, ROOM 1040, MSC 7710BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

Applications must be received by March 22, 2001.  If an application is 
received after that date, it will be returned to the applicant without 
review. 

The Center for Scientific Review (CSR) 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 CSR 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 CSR and 
responsiveness by NIH staff.  Incomplete and/or nonresponsive 
applications will be returned to the applicant without further 
consideration. Applications that are complete and responsive to the RFA 
will be evaluated for scientific and technical merit by an appropriate 
peer review group convened by CSR in accordance with the review criteria 
stated below. 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 receive a second level review by the National 
Advisory Council for the relevant Institute.

Review Criteria

The goals of NIH-supported research are to advance our 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 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?  Does the application assess the 
fidelity of the adherence intervention  (i.e., delivery of the adherence 
intervention as intended) and provide a detailed, detailed, realistic 
project schedule?

(3) Innovation:  Does the application propose an innovative approach to 
overcoming the barriers to adherence encountered by minorities and/or 
people living in poverty, either by tailoring a proven adherence 
intervention to meet the special needs (i.e., cultural/economic needs) 
of the chosen study group OR by using a novel intervention that, while 
based in theory and supported by previous literature in the area, 
represents a new approach that is uniquely suited to the specific study 
population? 

(4) Investigators:  Is each 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 of the project? Do the 
proposed studies take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?

(6) Translation: Do the intervention strategies tested have the ability 
to be translated into everyday practice settings utilized by minority 
and/or low income patients (e.g., by using interventions that require a 
miniumum of expertise and training of personnel, that make use of 
providers other than physicians to carry out the intervention, and/or 
through use of cost-effectiveness analysis to demonstrate the 
feasibility of incorporating interventions into minority and lower-
income clinical practice settings)? 

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

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 or the environment, 
to the extent they may be adversely affected by the project proposed in 
the application.

Schedule

Letter of Intent Receipt Date:    February 22, 2001
Application Receipt Date:         March 22, 2001
Peer Review Date:                 June/July, 2001
Council Review:                   August, 2001
Earliest Anticipated Start Date:  September 30, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

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:

NHLBI

Dr. Susan Czajkowski
Behavioral Medicine Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 8114
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-0406
FAX: 301-480-1773 
e-mail: CzajkowS@nih.gov

Dr. Patrice Desvigne-Nickens
Heart Research Program
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 9158
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-0497
e-mail: DesvignP@nih.gov   

Ms. Virginia Taggart
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 10214
6701 Rockledge Drive

Bethesda, MD 20892
Telephone: 301-435-0202
e-mail: TaggartV@nih.gov

Dr. Ellen M. Werner
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 10182, MSC 7950
Bethesda, MD 20892-7950
Telephone: 301-435-0077
e-mail: wernere@nhlbi.nih.gov

Dr. Michael Twery
National Center for Sleep and Sleep Disorders Research
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 10018
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-0202
e-mail: TweryM@nih.gov

NCI

Dr. Linda Nebeling
Chief, Health Promotion Research Branch
National Cancer Institute
Division of Cancer Control and Population Sciences
6130 Executive Blvd., EPN 4080, MSC 7335
Bethesda, MD 20892-7335
Telephone: 301-496-8520
FAX: 301-480-2087
e-mail: linda_nebeling@nih.gov

NIDDK

Dr. Sanford A. Garfield
Senior Advisor for Biometry
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 685
Bethesda, MD 20892-5460
Telephone: 301-594-8803
FAX: 301-480-3503
e-mail: garfields@extra.niddk.nih.gov

NINR

Dr. Hilary Sigmon
Division of Extramural Activities
National Institute of Nursing Research
National Institutes of Health
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone: (301) 594-5970
FAX: (301) 480-8260
e-mail: hilary_sigmon@nih.gov

Direct inquiries regarding review issues to:

Dr. Michael Micklin
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 3178, MSC 7848
Bethesda, MD 20892-7848 (20817 for express mail)
Telephone: 301-435-1258
e-mail: MicklinM@csr.nih.gov

Direct inquiries regarding FISCAL MATTERS to:

Ms. Diane Drew
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 7157A
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-0179
e-mail: DrewD@nih.gov

AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance 
No. 93.937 (NHLBI).  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 
program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.

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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