Release Date:  December 15, 1998

PA NUMBER:  PA-99-026


National Institute of Mental Health
National Institute on Drug Abuse
National Institute of Nursing Research


The efficacy of potent regimens combining protease inhibitors and antiretroviral
drugs is a remarkable achievement in HIV medicine.  As a result of these new
treatments, people with HIV or AIDS, having come to terms with the prospect of
imminent death, now have the potential of many more years of life.  Managing the
mental, emotional, and medical challenges of living with HIV/AIDS as a chronic
illness is a new area for research study and intervention.


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 PA, Coping with AIDS as a Chronic
Long-Term Illness, is related to the priority areas of mental health, drug abuse,
and mental disorders, and HIV Infection.  Potential applicants may obtain a copy
of "Healthy People 2000" at


Applications may be submitted by foreign and 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 institutions are not eligible for small grants (R03)
or program project grants (P01s).  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as principal investigators.


Applications may submitted in response to this program announcement using
individual research project grant (R01) mechanism.



The new and potent HIV treatments have created experiences in which, after having
come to terms with imminent death, Persons Living with HIV or AIDS (PLHIV/AIDS)
have the potential of many more years of life.  Confusion and trauma may result
from this situation, which stems from the difficulty of reconciling two
contradictory life orientations: an acceptance of a premature death and
reenergizing life with new possibilities.  Living with HIV/AIDS as a chronic
illness (like diabetes), which like other serious illnesses intrudes on and
reshapes a person's life and priorities, is a new and once unthinkable area for
research. The following four sections suggest areas of research to meet the
health promotion and disease prevention of PLHIV/AIDS. The four broad areas of
research include: (1) medical decision making and adherence; (2) practicing safer
HIV-related sexual behaviors; (3) stress, and coping; and (4) quality of life.
Researchers need not limit themselves to these topics.

Medical Decision Making and Adherence

Background Issues

Patients and their treating physicians need to make critical medical decisions
about when to begin anti-retroviral therapy and which combination of HIV
phamacotherapies will be most effective.  Combination therapies can inhibit viral
replication and reduce virus load to barely detectable levels in the blood of
seropositive persons.  However, the benefits from combination medication regimens
can be maintained only if taken properly, and the directions for taking
antiretroviral therapy are extremely complex.

Research is needed to develop effective methodologies for measuring direct and
indirect adherence to treatment regimens.  Studies might identify the effect of
collaborative decision making, appropriate informed consent, and cognitive
functioning on adherence to medications.  The role of families and other social
support systems in ensuring treatment adherence might be assessed.  Predictors
of safer sex and drug use practices, as well as adherence to medication might be
identified, as might beliefs about viral load reduction and infectivity.

Potential Research Areas

o  Develop effective methodologies for measuring direct and indirect adherence
to treatment regimens

o  Support research on adherence to treatment regimens, including communication
techniques to improve shared decision making between health care providers and
HIV-infected individuals, and behavioral strategies to manage symptoms secondary
to treatment protocols and disease progression

o  Study role of cognitive functioning in medical decision making and adherence

o  Identify critical components in process of understanding informed consent and
its effects on adherence to medication regimens

o  Assess the role of patients in medical decision making and adherence and their
satisfaction with treatment

o  Study the effect of patient education and different modes of instruction in
dosing regimens on adherence to treatment therapies

o  Identify the role of families and other social support systems in ensuring
that well thought out medical decision making and treatment adherence occur

o  Assess the predictors of both practicing safer sexual and drug using behaviors
and adherence to medication regimens and beliefs about reduction in viral load

o  Identify the relative contribution of inadvertent non-adherence (e.g.,
forgetting, sleeping through doses) versus deliberate modification of the regimen
by the patient (e.g., extending the duration between doses or omitting doses for
scheduling reasons, or reducing dosages because of concerns about symptoms)

o  Identify and treat mental disorders, neurocognitive deficits, and other
psychopathology that negatively impact on the level of functioning and feeling
of well being of people with AIDS.  Examples of such conditions include:
depression, anxiety, concentration and memory deficits, and chronic pain

o  Identify drug-drug interactions that are potentially clinically significant
for patients with AIDS receiving multiple medications, and in particular of the
interactions between antiretroviral agents and psychotropic medications (e.g.,
antidepressants, anxiolytics).  Development and testing of strategies to avoid
or minimize the clinical impact of these interactions

o  Study the role of "Stages of Change" and other models as predictors of
adherence to HIV treatment regimens

o  Develop interventions that target medical decision making in PLHIV with co-
occurring mental disorders and/or drug abuse.

Practicing Safer HIV-Related Sexual Behaviors

Background Issues

Lack of complete adherence to combination therapies can result in the development
of resistant strains of HIV, which can have devastating implications for the
ability to stem transmission and treat HIV-infected individuals.  In addition,
as new combination therapies bring HIV-infected individuals improved health and
a decline in detectable virus, they may believe they are less infectious and may
lapse into unsafe sexual and drug-using behaviors.  This could have the effect
of increasing HIV transmission, if the virus is still viable at undetectable
levels or mutates into a newly resistant virus.

Most of the HIV/STD prevention programs are aimed at encouraging seronegative
people to engage in safer sexual and drug-using behaviors so they will not become
infected.  Many of these programs could be used with seropositive individuals,
as well.  However, to ensure that the programs will be effective with people who
have HIV/AIDS, preventive interventions could be tailored to their altruism and
self-interest.  Predictors of high-risk sexual behavior of individuals on
combination therapies þ including beliefs about the role of protease inhibitors
and viral load levels on infectivity and risky behaviors þ might be identified. 
Determinants of unsafe sexual behaviors in serodiscordant couples might be
identified and prevention programs developed. Unsafe sexual behaviors related to
drug abuse, e.g., trading sex for drugs or money to buy drugs, engaging in unsafe
sex while intoxicated or during withdrawal, might be targeted.

Potential Research Areas

o  Develop effective AIDS prevention programs to change high risk sexual and drug
using risk behaviors in seropositive persons

o  Develop programs to enhance quality of life as a motivation to practice safer
sexual behavior

o  Develop interventions to promote safer sex among PLHIV with co-occurring
mental disorders

o  Determine predictors of high-risk sexual behavior of persons on combination
therapies, including examining the role of protease inhibitors and viral load
levels on beliefs about infectivity and risky behaviors

o  Identify determinants of unsafe sexual behaviors in serodiscordant couples

o  Assess the effects of early identification of HIV serotesting and counseling
on HIV risk behaviors

o  Identify the effect of behavioral interventions and HIV treatment on HIV-
related risk behaviors, the utilization of HIV prevention services and the
transmission of HIV

o  Develop programs to promote and maintain safer sexual behaviors in the context
of untreated or relapsed drug abuse.

Stress and Coping

Background Issues

In the past two decades, a large literature has grown up around the subject of
coping with life's stresses and crises, including chronic illness.  Good coping
skills can improve the quality of life, can be taught, and may bolster the immune
system.  Research is needed to examine successful coping styles and coping
repertoires among people with HIV/AIDS.  Studies might identify predictors of
failure to cope ("living in the empty present") or maladaptive coping and might
develop interventions to teach the identification of problems and effective
coping to seropositive persons, their family members, and caregivers.

Potential Research Areas

o  Examine successful coping styles and coping repertoires among PLHIV/AIDS

o  Identify predictors of failure to cope ("living in the empty present") or
maladaptive coping and develop interventions to teach the identification of
problems and effective coping

o  Investigate the role of hope and its components in effective coping

o  Identify positive changes and strengths in PLHIV/AIDS

o  Develop and test strategies for teaching more effective coping styles to

o  Develop and test interventions for teaching more effective coping styles to
family members and caregivers (e.g., families of pediatric AIDS survivors)

o  Identify biopsychosocial factors that predict which PLHIV/AIDS will survive
over long-term treatment with protease inhibitors and other new treatments

o  Examine whether survivors who respond well to protease inhibitors and cope
well with AIDS as an illness with chronic symptoms share certain personality
traits or have a particular type of "survivor personality"

o  Identify major organizing themes for issues important in the lives of

o  Develop and test interventions at various levels targeting issues/problems in
the ongoing stages of handling the chronicity of HIV/AIDS.

Quality of Life

Background Issues

Quality of life (QOL) has become an important area of outcome research among
long-term survivors of life-threatening illnesses.  The measurement of QOL must
take into account multiple variables in several dimensions.

Although extensive research has yet to be undertaken for the population of
interest in this Program Announcement, several areas of quality of life are
likely to be important: (1) the side effects and intrusiveness of medication
regimens; (2) return to work and financial concerns; (3) role resumption and role
retention (the ability to maintain valued social roles); (4) social support and
independence; and (5) sexuality and self-concept.

Numerous QOL studies have found that the extent and richness of one's social
network is strongly related to good self-reported quality of life. Families,
however, are sometimes broken up by long-term illness, because of divorce or the
necessity of finding others to care for young children. Many women who are
PLHIV/AIDS have had to give their children to others to raise. Those who respond
to protease inhibitors may wish to resume the role of mother, and may require
special support. In addition, PLHIV/AIDS may have had their social networks
decimated by AIDS. Poverty and substance abuse among the survivor's family and
friends may make them undependable in terms of support.  It is relatively
recently that evidence has been found for the role of psychosocial factors, such
as emotional support from others, in increasing the likelihood of survival. The
stigma that is associated with AIDS may result in social isolation (both
community- and self-imposed), as has been found for cancer survivors and their
families, and can have a negative effect on treatment adherence and health

Potential Research Areas

o  Identify QOL measures specific to the needs and lives of PLHIV/AIDS receiving
long-term medical treatments

o  Examine expectations of PLHIV/AIDS in regard to maintaining past quality of
life and adapting to current quality of life and its impact on health status

o  Examine predictors of return to work and the role of returning to work in the
quality of life of PLHIV/AIDS on multiple treatment regimens

o  Identify workplace issues/problems related to the long-term illness and
solutions (e.g., the intrusion of medication schedules and/or side effects on
work performance)

o  Examine workplace discrimination in this population, especially for blue-
collar workers, and identify avenues for change

o  Identify social support needs specific to this population and examine
issues/problems regarding social support, role retention and resumption, family
burden, etc.

o  Develop and test interventions for improving stress and coping for PLHIV/AIDS
and its impact on QOL and disease progression

o  Develop and test interventions to enhance the development of social support
from families and friends

o  Develop and test interventions (job counseling, retraining, etc.) to enable
return to work by PLHIV/AIDS who are being successfully treated

o  Develop and test interventions for supporting the families of PLHIV/AIDS in
adapting to HIV/AIDS as a chronic condition

o  Identify the psychosocial variables that are predictors of adapting to HIV and
mediators of change associated with effective secondary prevention programs

o  Test the effectiveness of preventive interventions in improving quality of
life and promoting health-enhancing behavior of PLHIV/AIDS

o  Develop and test interventions to minimize the impact of stigmatization of
HIV-infected persons, including decisions regarding treatment and QOL

o  Support health services research and evaluation to assess the impact of
changes in the health care delivery system on care, disease progression, and QOL

o  Conduct research to identify and remove barriers to effective health care
utilization, including access, continuum of care, and health and social services
to improve treatment adherence and QOL.


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
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
"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 in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at the following URL address:


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:


Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard AIDS-related application deadlines as
indicated in the application kit.  Application kits are available at most
institutional offices of sponsored research and may be obtained 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; fax: (301) 480-0525 Email: GrantsInfo@NIH.GOV.  The title and number of the
program announcement must be typed in Section 2 on the face page of the

An applicant planning to submit a new (Type 1) investigator-initiated grant
application requesting $500,000 or more in direct costs for any year is advised
that he or she must contact Institute program staff (see INQUIRIES, below) before
submitting the application, i.e, as plans for the study are being developed. 
Furthermore, the applicant must obtain agreement from Institute staff that the
Institute will accept the application for consideration for award.  Finally, the
applicant must identify, in the cover letter that is sent with the application,
the staff member and Institute who agreed to accept assignment of the

The completed original application and five legible copies must be sent or
delivered to:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)


Applications will be assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate peer review group convened in accordance with the standard NIH
peer review procedures.  As part of the initial merit review, all applications
will receive a written critique and 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 appropriate national advisory council or
board, when applicable.

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 review, comments on the following aspects of the application will be made
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 the assignment of 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 important 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

(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?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the 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? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?

(6) Appropriateness of the proposed budget and duration in relation to the
proposed research;

(7) Adequacy of plans to include both genders, children and adolescents, and
minorities and their subgroups as appropriate for the scientific goals of the
research, or justification for their exclusion.  Plans for the recruitment and
retention of subjects will also be evaluated.

The initial review group will also examine the provisions for the protection of
human and animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of Women, Children and
Adolescents and Minorities as Subjects in Clinical Research.


Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer and national advisory
council review, availability of funds, and program priority.


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

Direct inquiries regarding programmatic issues to:

Willo Pequegnat, Ph.D.
Office of AIDS Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-101
Rockville, MD  20857
Telephone: (301) 443-6100
FAX: (301) 443-9719

Sander Genser, M.D.
Clinical Medicine Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-08
Rockville, MD 20857
Telephone:  (301) 443-1801
FAX:  (301) 443-6566

June R. Lunney, Ph.D., R.N.
Division of Extramural Activities
National Institute of Nursing Research
45 Center Drive, Room 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Bethesda, MD  20857
Telephone: (301) 443-3065
FAX:  (301) 443-6885

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847

Jeff Carow
Grants Management Office
National Institute of Nursing Research
45 Center Drive, Room 3AN-12, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260


This program is described in the Catalog of Federal Domestic Assistance No.
93.242 (NIMH), 93.279 (NIDA), and 93.361 (NINR).  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.  Awards will be administered under
PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998).

PHS strongly encourages all grant and contract recipients to provide a smoke-free
workplace and promote the nonuse 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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