Full Text MH-92-11


NIH GUIDE, Volume 21, Number 24, July 3, 1992

RFA:  MH-92-11

P.T. 34

  Family Health/Planning/Safety 
  Disease Prevention+ 

National Institute of Mental Health
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism

Letter of Intent Receipt Date:  August 15, 1992
Application Receipt Date:  September 15, 1992


The National Institute of Mental Health (NIMH), National Institute on
Drug Abuse (NIDA), and National Institute on Alcohol Abuse and
Alcoholism (NIAAA) are requesting research applications that address
family processes related to preventing and adapting to Human
Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency
Syndrome (AIDS).  This Request for Applications (RFA) is critical
because little information is currently available about family
processes on a wide variety of family configurations, including those
that are at high risk for HIV infection.  Results from studies funded
under this RFA will be used to develop effective prevention efforts
aimed at high-risk individuals and their families or to enhance
treatment efforts for families already coping with HIV infection.

The urgency of the AIDS crisis demands that top priority be given to
research with implications for preventive interventions that reduce the
incidence of HIV infection.  Even if a vaccine were to be identified in
the next few years, prevention efforts would continue to be the primary
way to stop the further spread of HIV infection.  Because HIV-positive
individuals may not experience AIDS symptoms for as long as 10 years,
secondary prevention efforts aimed at maintaining physical and mental
health status are needed also.  A tertiary prevention goal is to
prevent excess disability in those individuals already infected by
minimizing affective, anxiety, or cognitive disorders.  Therefore, the
role of the family in promoting healthy behaviors that reduce the
incidence of infection, slow the onset of symptoms, and minimize excess
disability related to the disease are all of interest.  Because family
members also experience stress in the caring for AIDS patients,
additional research efforts should also be directed to understanding
effective coping strategies used by family members.  Promoting adaptive
strategies may be a viable prevention target in the next stage of


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 effort is
in accordance with the specific objectives 18.1 to 18.6, 18.8, 18.9,
and 18.12.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-783-3238).


Applications may be submitted by public and private non-profit or
for-profit organizations such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible
agencies of the Federal Government.  Women and minority investigators
are encouraged to apply.


Support for applications submitted in response to this announcement
will be through individual research grants (R01) of up to three years
in duration.


In fiscal year 1993, a minimum of $1.8 million has been set aside for
this RFA.  The NIMH will provide a minimum of $1.4 million; the NIDA
and the NIAAA will each contribute a minimum of $.2 million to support
three to five awards.  Support may be requested for a period of up to
three years.  Continuation, noncompeting awards will be made, subject
to availability of funds and progress achieved.



The Department of Health and Human Services has identified AIDS as the
foremost public health problem in the United States.  As of September
1991, 195,718 cases of AIDS had been reported, with approximately one
million Americans estimated to be seropositive for HIV.  An estimated
40,000 persons become infected each year.  In the last decade, over
126,000 Americans died of AIDS.  Although homosexual and bisexual men
still account for the largest number of persons infected with HIV, the
groups with the most rapid increase in rates are women, adolescents,
and children.

Subpopulations may experience differences in disease course, but a
large number of persons infected with HIV experience brain, cognitive,
emotional, and behavioral changes.  It is now accepted that HIV enters
the central nervous system (CNS) early in the course of the disease,
producing a range of nervous system impairments.

Researchers, health professionals, and family practitioners have
increasingly recognized the importance of the family in health
promotion and disease prevention.  Researchers have begun to examine
the effectiveness of social support from family and friends in
promoting adherence to medical regimes, making lifestyle changes,
extending life, and providing comfort for sick individuals.  Other
studies have examined the repertoires used by families coping with a
terminal, socially stigmatized disease.

While the role of families with respect to other diseases (e.g.,
cancer, asthma, cardiovascular disease) has received some attention,
only limited attention has been devoted to the potent role that
families may play in preventing and adapting to HIV infection.  Efforts
are needed to identify family processes that may be used to develop or
enhance prevention strategies.  Furthermore, to plan effective
strategies, it is necessary to understand the diverse nature of the
at-risk groups who may vary by race, gender, age, culture, and
socioeconomic status.

The HIV epidemic not only takes a toll on the health of those directly
infected but also affects the health and well-being of those close to
them.  Family members are likely to experience the stress of being
caregivers or confidants while the AIDS patient is ill and experience
grief upon the patient's death.  Several examples from existing
literature illustrate the potential radiating effects of AIDS on family
members:  parental death has been found to have adverse effects on
surviving children's mental health; family members caring for older
persons with dementia have been found to suffer depression and
compromised immune functioning.

Methodology development may be necessary to capture meaningful data on
non-traditional family relationships and structures in terms of
membership, relationship roles, and patterns of interaction and
communication.  Study designs may need to clarify the nature of
interactions between a family of origin, family of choice, and intimate
support networks.  Innovations in statistical analysis approaches may
also be required to describe clearly these family processes.

Areas of Interest

The following sections suggest areas of research to meet the health
promotion and disease prevention objectives outlined above.
Researchers responding to this RFA, however, need not limit themselves
to these topics.

Ethnic and Cultural Considerations

Cross-cultural variables deserve special consideration because of the
rapidly increasing rates of HIV infection in ethnic minority
populations.  The explicit investigation of cultural factors as an
aspect of family adaptation to HIV infection is encouraged.  In such
research, operational definitions of cultural factors should move
beyond merely identifying people according to researcher-defined social
categories (e.g., race and gender) and should include consideration of
racial identity theory.  In addition, assessments should be culturally
competent and should measure dimensions of acculturation.  Specific
areas of interest include:

o  Methods for defining cultural, geographic, and ethnic background
influences in family process in terms of knowledge, attitudes, and
behaviors toward HIV infection are needed.  Information on how personal
decisions about HIV risk behaviors, the mode of transmission in
acquiring HIV, acceptance of infected individuals, and caretaking
responsibilities vary by cultural contexts is needed.

o  Identification of adaptive strategies of families and individuals
belonging to different ethnic groups who are coping with HIV infection
is needed. This may include patterns of communication and adaptive
behavioral techniques that are related to cultural background such as
the relative value of extended kinship support or religion.

Family Processes and the Course of Illness

Basic information on family systems and processes for all
subpopulations of persons infected with HIV is needed to determine what
family factors serve to increase or decrease risk factors for becoming
infected, and to minimize symptomatology (physical and mental health
outcomes) at all points in the course of the illness.  Specific areas
of interest include:

o  Determination of family stress factors and coping strategies in
dealing with (a) high risk-taking behaviors; (b) knowledge of HIV
infection and issues related to the stigma of the disease; and/or (c)
progressive decline in physical and mental health of the person with

o  Studying the influence of pre-existing family dynamics, current
dynamics, or changes in family processes on family member risk-taking
behaviors, the patient's reaction to learning about the infection, as
well as the patient's mental and physical health throughout the
progressive stages of the disease

o  Studying interrelationships between alcohol-related behavior and
high risk behaviors for HIV infection (e.g., unsafe sexual practices
and/or injection drug use) and identifying family strategies (e.g.,
social control, education, and family modeling) to reduce the influence
of alcohol as a risk factor for HIV exposure

o  Assessing the impact of a family member's risk-taking behaviors, HIV
infection and progressive decline in health on family dynamics,
communication patterns, roles, and relationships, including further
description of how these family processes change in relation to the
various manifestations of the disease

o  Identifying effective coping strategies used by families in dealing
with the risk of infection and course of the disease; the role of
religion and spirituality in families at various points in the course
of the illness, including adaptation to the death of the patient

o  Studying older generation family members as primary supports in
several AIDS subpopulations, where maternal incapacitation or death has
occurred due to AIDS, and in situations where the family of choice is
no longer willing or able to provide support; identifying stressors
associated with older family members who provide care for a family
member with AIDS; and evaluating how pre-existing intergenerational
relations affect the process of care after diagnosis

Populations At-risk for HIV Infection

In the second decade of AIDS, several at-risk population groups, each
with its own needs and characteristics with respect to HIV prevention
and intervention efforts, have been identified.  Relevant family
processes may vary, depending on the relationship or role (parent
versus child) of the member who is at risk or is infected with HIV;
however, there are clearly overlapping areas of interest for different
populations.  The following sections describe some research questions
for specific groups who may be at high risk or infected with HIV.

Homosexual and Bisexual Men

While work in the last few years has provided good descriptive studies
of homosexual culture and subcultures, there is a need for description
of the homosexual man's family of origin and his family of choice.
These studies should consider the contextual factors (e.g., urbanicity,
ethnicity) that influence the way these two family groups respond to
issues of homosexuality and HIV illness and the concomitant emotional,
cognitive, and physical manifestations.  The availability of resources
(e.g., health services, family economics) within contexts may influence
both disease course and caregiver stress.  Specific areas of interest

o  Studies on conflictive and/or supportive relationships between the
families of origin (e.g., older parents, adult siblings) and families
of choice with respect to decisions about:  primary and secondary
prevention of infection; being tested for HIV; treatment of HIV
disease; relationships with the health care system and its members;
life-sustaining procedures; bereavement rituals; and disposition of

o  Studies of how social networks are formed and maintained that may
contribute to homosexual men's health-promoting behavior and
psychological well-being including both formal components (e.g., health
care services and support groups) and informal components (e.g.,
friends and partners)

o  Studies on the potential differences between self-identified
homosexual men and men who have sex with men in practicing high-risk
behaviors; the influence of social and familial contextual factors on
the likelihood of engaging in risky sexual behavior and its effect on
psychological well-being and mental health

o  Studies of the impact of alcohol-related behavior on unsafe sexual
practices among homosexual men and strategies that can reduce the
impact of alcohol as a risk factor for unsafe sex

Injection-Drug Users

Injection-drug users (IDUs) are often in conflict with their family of
origin; their peer group is often more influential in changing their
high-risk behavior.  With respect to the relationships between the
family and IDU or potential IDU members, research and study are needed
on the following key issues relating to psychosocial variables and the
basic determinants of behavior:

o  Studies of the extent to which IDUs (and crack users) participate in
family relationships and the feasibility of developing preventive
interventions with their families

o  The role of families in the care of IDUs with asymptomatic and
symptomatic HIV disease and the difficulties in engaging these families
in the caregiving process

o  The relationship between family support of IDUs with HIV infection
and physical and mental health outcomes


Impoverished women of all ages have limited access to mental health
treatment, and this broader problem likely impacts formal support
resources to women who are caregivers of AIDS victims.  Younger women
who may be at risk for HIV infection are particularly vulnerable to
minimal access to services, given the limited number of drug treatments
programs available to them.  Research in the following areas is needed:

o  How women's traditional roles as health educators and health
caretakers in the family can be engaged for prevention, specifically,
the impact of the caretaking role on the levels of stress, mental
health, and physical health, particularly in older women when several
members of a family are infected, and this role is continued over a
long period of time

o  How women experience reproductive decision making when they are HIV
positive, and how these decisions affect their relationships with
partners and family

o  Studies on the experience of women who have relationships with men
who engage in high-risk behaviors, factors that contribute to the
maintenance or dissolution of the relationship and the practice of
high-risk behaviors

Infants and Children

Medical advances may prolong the lives of children (defined as birth to
13 years) infected with HIV infection, but they will remain susceptible
to opportunistic infections and neurodevelopmental problems.  There is
considerable evidence in the literature on other chronic childhood
illnesses that parent functioning, family stressors, and family
resources are all related to the expression of psychological and
physiological symptoms in both ill children and their healthy siblings.
Such family stressors include chronic poverty, isolation from
communities of the healthy, prejudice, misunderstanding in the schools,
loneliness, boredom, and depression.  Unlike most children with other
chronic diseases, many HIV-infected children are exposed to illness or
death in at least one parent and experience major disruptions in their
family.  Children's dependence on adults for basic survival makes it
difficult to study them in isolation from their families.

Research is needed that will provide:

o  Identification of the factors in families that may contribute to the
rate of disease progression in children (e.g., kinship support,
stability of living arrangements)

o  Information on the relationship between effective family functioning
and minimization of developmental disabilities in children with HIV
infection, such as exploring how successful existing interventions with
at-risk infants (e.g., premature, drug-addicted) have involved family
members, and how such interventions may be adapted for children with

o  Information on bereavement in families that are amenable to
intervention where a parent has died of AIDS need to be identified.
Descriptive information on the short- and long-term effects of these
interventions on the children who are seropositive and seronegative is

o  Information on parental death from a stigmatized disease such as
AIDS, and its effects on a child; information on how immediate and
extended family members react and adjust to the parent's death, and how
these family processes relate to the child's mental and physical health


During adolescence (defined here as ages 14 to 21), youths can engage
in clusters of interrelated high-risk behaviors that put them at risk
for HIV infection, such as sexual activity, alcohol use, drug use, and
delinquency.  This fact has important implications for understanding
sexual behavior within the context of the adolescent's life as a whole
and for understanding the nature of the culture in which that behavior
is embedded.  Specific family research issues regarding adolescents
might include:

o  Identifying characteristics of families that are successful in
preventing or curbing HIV risk-taking behavior such as unprotected
sexual activity or intravenous drug use

o  Identifying characteristics of families of adolescents who remain
sexually inactive and do not engage in other high-risk behaviors
despite environmental conditions in which there are high levels of
these behaviors

o  Identifying factors in a "family of choice" network that may reduce
risk taking in very high-risk groups, such as run-away or "throw-away"
adolescents, need to be identified.


Applicants are advised to obtain from their institutions, a copy of
"Guidance for Institutional Review Boards (IRBs) for AIDS Studies,"
that was disseminated from the Office for Protection from Research
Risks (OPRR) on December 16, 1984.  OPRR may be consulted for advice on
how to deal with difficult human subjects protection issues in AIDS

These guidelines emphasize the special considerations that must be
heeded in AIDS research and stipulate some important protection that
should be considered in the design of AIDS research projects.  A major
one is the requirement that subjects be informed of the results of AIDS
antibody testing, if any such testing is done.


Applications for grants and cooperative agreements that involve human
subjects are required to include minorities and both genders 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 should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy applies to all research
involving human subjects and human materials, and applies to males and
females of all ages.  If one gender and/or minorities are excluded or
are inadequately represented in this research, particularly in proposed
population-based studies, a clear compelling rationale for exclusion or
inadequate representation should be provided.  The composition of the
proposed study population must be described in terms of gender and
racial/ethnic group, together with a rationale for its choice.  In
addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
and ADAMHA recognize that it may not be feasible or appropriate in all
research projects to include minority populations (i.e., American
Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks,
Hispanics).  Investigators must provide the rationale for studies on
single minority population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence) appropriate to
the scientific objectives of the research.  It is not an automatic
requirement for the study design to provide statistical power to answer
the questions posed for men and women and racial/ethnic groups
separately; however, whenever there are scientific reasons to
anticipate differences between men and women, and racial/ethnic groups,
with regard to the hypothesis under investigation, applicants should
include an evaluation of these gender and minority group differences in
the proposed study.  If adequate inclusion of one gender and/or
minorities is impossible or inappropriate with respect to the purpose
of the research, because of the health of the subjects, or other
reasons, or if in the only study population available, there is a
disproportionate representation of one gender or minority/majority
group, the rationale for the study population must be well explained
and justified.

The NIH/ADAMHA funding components will not make awards of grants and
cooperative agreements that do not comply with this policy.  For
research awards that are covered by this policy, awardees will report
annually on enrollment of women and men, and on the race and ethnicity
of subject.

Protection of Human Subjects

Research activities carried out under this RFA will be governed by HHS
Regulations for the Protection of Human Subjects in Research (45 CFR
46).  These regulations require the awardee to establish procedures for
the protection of subjects involved in any research activities.  Prior
to funding and upon request of the OPRR, prospective awardee must file
an Assurance of Compliance with OPRR and establish or identify an IRB
to review and approve the procedures for carrying out any research
activities occurring in conjunction with this award.  A formal request
for the required Assurance will be issued by OPRR at an appropriate
point in the review process, and examples of required materials will be
supplied at that time.  However, applicants may wish to contact OPRR
(telephone 301-496-7005 or 301-496-7041) to obtain preliminary guidance
on human subjects issues.  When calling OPRR, investigators should
identify themselves as applicants for RFA MH-92-11.

AIDS Human Subjects Certifications and Animal Subjects Verifications

If the applicant has an approved assurance covering the research
(multiple project assurance for human subjects/full assurance of
compliance for animal subjects), the applicant should provide, with the
application, certification of Institutional Review Board (IRB) approval
if humans are involved and verification of Institutional Animal Care
and Use Committee (IACUC) approval if animals are involved.  These
reviews and approvals should occur PRIOR TO SUBMISSION of the
applications and certifications and verifications should be SUBMITTED
WITH the applications.  Failure to provide required certifications and
verifications within applications could result in deferral or
rejection.  The latest date of approval by the IRB of proposed
activities must not be earlier than one year prior to the receipt date
in this RFA.

If animals or humans will be the subjects at PERFORMANCE SITES OTHER
THAN THE APPLICANT ORGANIZATION, the applicants must identify, within
the applications, the assurance status of each participant.  Failure to
provide this information within applications could result in deferral
or rejection.

If the applicant organization does not have on file with OPRR an
approved Multiple Project Assurance of Compliance, the applicant
organization, by signing the Face Page, is declaring that it will
comply with 45 CFR 46 by establishing an IRB and submitting a Single
Project Assurance of Compliance and certification of IRB approval
within 30 days of a specific request from OPRR.


Prospective applicants are encouraged to submit a letter of intent, by
August 15, 1992, describing the nature of the research proposal,
including hypotheses, research personnel, and estimated annual costs.
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 ICD staff to estimate the potential review workload and to
avoid conflicts of interest in the review.

The letter of intent is to be sent to:

Office of AIDS Programs
National Institute of Mental Health
5600 Fishers Lane, Room 17C-06
Rockville, MD  20857


Applicants are to use the grant application form PHS 398 (rev. 9/91).
The number (MH-92-11) and title (Role of Family in Preventing and
Adapting to HIV Infection and AIDS), of this RFA must be typed in item
number 2a on the face page of the PHS 398 application form.

When using the PHS 398 form to respond to an RFA, applicants must affix
the RFA label available in the package to the bottom of the face page.
Failure to use this label could result in delayed processing of the
application so that it may not reach the review committee in time for

Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
universities, colleges, medical schools, and other major research
facilities.  If such a source is not available, the following office
may be contacted for the necessary application materials:

Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-05
Rockville, MD  20857
Telephone:  (301) 443-4414

Application Receipt and AIDS Expedited Review Schedule

                                   National Advisory
Receipt of        Initial          Mental Health         Earliest
Application       Review           Council Review        Start Date

Sep 15, 1992      Oct/Nov 1992     Jan/Feb 1993          Mar 1, 1993

Applications received after the above receipt date will be returned
without review.


Applicants must submit an adequately justified budget for each research
component in 12-month segments of requested support.  Applicants are
encouraged to include travel costs for three investigators from each
site to attend one meeting each year (in Rockville, Maryland) in the

Grant funds may be used for expenses clearly related and necessary to
conduct the proposed project.  All budget items must be fully justified
at the level requested.  Grantees are expected to be familiar with and
comply with applicable cost policies.

Submission of Application

Completed applications must contain all information needed for initial
and Advisory Council Review.  The completed application with one signed
original and five permanent legible copies of the completed application
(with five copies of appendices) must be sent to:

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


Review Process

Applications received in response to this RFA will be assigned to an
ADAMHA initial review group (IRG).  The IRG consists primarily of
non-Federal scientific and technical experts who will review the
applications for scientific and technical merit.  Notification of the
review recommendations will be sent to the applicant after the initial
review.  Applications will receive a second-level review by the
appropriate advisory Council whose review will be based on policy
considerations as well as scientific merit.  Only applications
recommended by the Council may be considered for funding.

Review Criteria

Criteria for scientific/technical merit review of applications will
include the following:

o  Significance and originality from a scientific or technical
standpoint of the goals of the proposed research

o  Qualifications and experience of the Principal Investigator and
demonstrated staff expertise in family processes, prevention research,
statistics, cultural competence, AIDS, and other areas specific to the
questions under investigation

o  Adequacy of the conceptual and theoretical framework for the
research, including cultural relevance to the target families and
evidence of familiarity with relevant research literature

o  Scientific merit of the research design, approaches, and methodology

o  Access to target population(s)

o  Sample selection and retention methods and efforts to determine
factors that influence refusal rate

o  Adequacy of the data analysis plan

o  Adequacy of the existing and proposed facilities and resources

o  Appropriateness of the budget, staffing plan, and time frame to
complete the project

o  Adequacy of plans to ensure adequate representation of women and
minorities in study population

o Adequacy of proposed procedures for protecting human subjects


In the decision to fund applications, the following will be considered:

o  Scientific merit as determined during the peer review process
o  Availability of funds
o  Balance among target populations with priority given to understudied
o  Balance among theoretical and multicultural approaches
o  Balance among geographic areas


Prospective applicants are strongly advised to contact an NIMH, NIDA,
or NIAAA staff member in order to discuss the proposed research project
prior to submission.

Staff consultation is available from:

Willo Pequegnat, Ph.D.
Office of AIDS Programs
National Institute of Mental Health
Parklawn Building, Room 17C-06
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6100

Vincent Smeriglio, Ph.D.
Clinical Medicine Branch
Division of Clinical Research
National Institute on Drug Abuse
Parklawn Building, Room 11A-33
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-1801

Kendall Bryant, Ph.D.
Program Director for AIDS Studies
Prevention Research Branch
National Institute on Alcohol Abuse and Alcoholism
Parklawn Building, Room 13C-23
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-1677

For further information of grants management issues, applicants may

Stephen J. Hudak
Chief, Grants Management Section
National Institute of Mental Health
Parklawn Building, Room 7C-23
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4456


This program is described in the Catalog of Federal Domestic Assistance
93.242, 93.273, and 93.279.  Under statutory authorities of Sections
301 and 504 of the Public Health Service Act, (42 U.S.C. 241 and
290aa), the National Institute of Mental Health, the National Institute
on Drug Abuse, and the National Institute on Alcohol Abuse and
Alcoholism will accept applications in response to this request under
the single receipt date of September 15, 1992.  Grants are administered
in accordance with the PHS Grants Policy Statement (revised October 1,
1990).  Federal regulations at 42 CFR Part 52, "Grants for Research
Projects," and Title 45 CFR Parts 74 and 92, generic requirements
concerning the administration of grants, are applicable to this award.


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