Release Date:  February 3, 2000

RFA:  MH-00-009

National Institute of Mental Health

Letter of Intent Receipt Date:  April 24, 2000
Application Receipt Date:  May 24, 2000



The National Institute of Mental Health (NIMH) is requesting research 
applications that address family-process interventions to enhance the ability of 
families to prevent the spread of HIV/AIDS and/or its consequences.  In this 
Request for Applications (RFA), the term "family" refers to the breadth of 
family configurations, including biological kin networks and non-related persons 
who consider themselves to be family through a "network of mutual commitment."  
Thus, family level of analysis may include the family of origin, family of 
choice, or a combination of these.  Prevention efforts aimed at high-risk 
individuals and their families, as well as enhanced treatment efforts for 
families already coping with HIV infection, are still critically needed for the 
myriad of families being infected and affected by HIV/AIDS.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2000," a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA), 
Family Interventions to Prevent and Adapt to HIV/AIDS, is related to the 
priority areas of Mental Health and Mental Disorders, STDs, and HIV.  Potential 
applicants may obtain a copy of "Healthy People 2000" at


Applications may be submitted by domestic and foreign, 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 (R03) 
grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.


This RFA will use the National Institutes of Health (NIH) research grant (R01) 
award mechanism and the small grant (R03) 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 five years for an R01 award and two years 
for an R03 award.  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 29, 2000.

For all competing R03 applications and for R01 applications requesting up to 
$250,000 direct costs per year, specific application instructions have been 
modified to reflect “MODULAR GRANT” and “JUST-IN-TIME” streamlining efforts 
being undertaken at NIH.  More detailed information about modular grant 
applications, including a sample budget narrative justification pages and a 
sample biographical sketch, is available via the Internet at:  Applications that 
request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) 
application instructions.

Because the small grants have special eligibility requirements, application 
formats, and review criteria, applicants are strongly encouraged to consult with 
program staff (listed under INQUIRIES) and to obtain the appropriate additional 
announcements for those grant mechanisms.  Special instructions and information 
for the NIMH Small Grants Program is found at  R03 awards are 
limited to $50,000 direct cost for each of the two years and are not renewable.


The NIMH intends to commit approximately $1.2 million in FY 2000 to fund three 
to four new grants in response to this RFA.  An applicant may request a project 
period of up to five years for an R01 award or up to two years for an R03 award.  
Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary.  It is expected that the 
direct costs will be awarded in modules of $25,000; however program and grants 
management adjustments may be necessary prior to award.  Although the financial 
plans of the Institute 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 applications of outstanding scientific and technical merit.  
At this time, it is not known if this RFA will be reissued.  R03s are not 



The urgency of the AIDS crisis demands that top priority be given to research 
addressing preventive interventions that reduce the incidence of HIV infection 
and minimize its negative consequences.  Although the role of families with 
respect to diseases (e.g., cancer, asthma, cardiovascular disease, HIV/AIDS, 
etc.) has received some attention, additional efforts are needed to identify 
effective family process prevention strategies relative to HIV/AIDS.  These 
include the role of the family in (1) family-oriented primary prevention efforts 
to promote healthy behaviors that reduce high-risk HIV/STD-related behaviors and 
incidence of HIV/STD infection, (2) family-oriented secondary prevention efforts 
aimed at maintaining physical and mental health status among infected 
individuals in order to slow the onset of symptoms (e.g., enhancing quality of 
life, maintaining medical regimens, etc.), and (3) tertiary prevention to 
mitigate excess disability in symptomatic individuals by minimizing affective, 
anxiety, or cognitive disorders, and ameliorating general health outcomes.  
Because family members also experience stress in the caring for AIDS patients--
especially in this new, uncertain treatment environment--additional research 
efforts should also be directed at identifying strategies to promote effective 
coping by family members.  Families affected by HIV/AIDS must often deal with 
additional stressors, such as alcohol and drug abuse and mental illness.

Methodology development may be necessary to capture meaningful data on 
nontraditional 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 among 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 and the efficacy of preventive interventions.

Areas of Interest

In the following sections are suggested areas of research that meet the health 
promotion and disease prevention objectives outlined above.  They are advisory 
only and researchers should not limit themselves to these topics.

Ethnic and Cultural Considerations

To plan effective strategies, it is necessary to understand the diverse nature 
of the at-risk groups that may vary by ethnicity, gender, age, acculturation, 
and socioeconomic status.  Operational definitions of cultural factors should 
move beyond merely identifying people according to researcher-defined social 
categories (e.g., race and gender) and include consideration of racial identity 
theory.  In addition, assessments should be culturally competent and should 
measure dimensions of acculturation.  Of particular need are studies of gay and 
heterosexual men and the role of families in their risk behaviors.  A culturally 
competent system of care acknowledges and incorporates -- at all levels -- the 
importance of culture, the assessment of cross-cultural relations, and 
acknowledgement of dynamics that result from cultural differences.

Phase I Studies:  Family Processes, Risk of HIV Infection, and Course of Disease

At-risk individuals have unique needs and characteristics with respect to HIV 
prevention and intervention efforts.  Relevant family processes may vary, 
depending on the relationship, role (e.g., parent versus child), and context 
(e.g., high crime neighborhoods, detention centers and prisons, drug treatment 
centers, mental hospitals) of the family member who is at risk or is infected 
with HIV; however, there are clearly overlapping areas of interest for different 
populations.  The following sections illustrate some intervention research 

In designing or adapting family interventions aimed at decreasing HIV-infection 
risk and minimizing adverse physical and mental outcomes throughout the course 
of illness, data from studies of family process are critical.  Studies are 
needed to:

o  Examine family stress and enhance coping strategies of male and female family 
members in dealing with (a) high-risk drug and sexual behaviors; (b) knowledge 
of HIV infection and issues related to the stigma of the disease; (c) issues of 
self-disclosure of disease and to whom these disclosures are made; and/or (d) 
the progressive decline in physical and mental health of the person with 

o  Describe the interrelationships between alcohol-related behavior and high- 
risk behaviors for HIV infection among men and women and enhance family 
strategies (e.g., social control, education, and family modeling) to reduce the 
influence of alcohol as a risk factor for HIV exposure.

Phase II/Phase III Studies:  Primary Preventive Interventions

Studies should be designed to:

o  Reduce the conflictive and enhance the 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, testing for 
HIV, treatment of HIV disease, relationships with the health care system and 
other family members, life-sustaining procedures, bereavement rituals, and 
disposition of property;

o  Develop strategies to enhance and maintain social networks that contribute to 
both heterosexual and gay men's health-promoting behavior and psychological 
health, including both formal components (e.g., health care services and support 
groups) and informal components (e.g., friends and partners);

o  Mitigate the impact of alcohol-related behavior on unsafe sexual practices 
among heterosexual and gay men and develop strategies that can reduce the impact 
of alcohol as a risk factor for unsafe sex;

o  Enhance the role of the family in promoting safer sexual and drug-using 

o  Support family roles in enhancing the woman's ability to negotiate and 
maintain safer sexual behaviors;

o  Develop primary prevention programs for enhancing women’s ability to 
negotiate safer sex and use of female-control measures;

o  Support effective family functioning, parental monitoring of children's 
activities and provision of information that encourages abstinence and later 
initiation of sexual behavior; 

o  Enhance characteristics of families that are successful in preventing or 
curbing HIV risk-taking behavior such as unprotected sexual activity, 
non-injection drug use, and the initiation of drug injection;

o  Strengthen the role of families in supporting adolescents who remain sexually 
inactive and do not engage in other high-risk behaviors despite environmental 
conditions in which there are both perceived and actual high levels of these 

o  Teach middle-aged and older family members to be agents of behavioral change 
in their interactions with younger family members.

Phase II/Phase III Studies:  Secondary Preventive Interventions

Of interest are studies to:

o  Improve the role of families in the care of drug users with asymptomatic and 
symptomatic HIV disease and support the caregiving process of these families in 
order to ameliorate physical and mental health outcomes; 

o  Enhance the effectiveness of families in promoting utilization of, and 
adherence to, medical, mental health, and drug abuse treatment;

o  Support HIV seropositive men and women who are experiencing stress in regard 
to reproductive decision making, and mitigate negative effects on their 
relationships with partners and family;

o  Enhance access to and utilization of drug treatment, mental health services, 
and primary and prenatal care by seropositive women and their families;

o  Reduce the impact of the caretaking role on stress, mental health, and 
physical health, particularly when multiple members of a family are infected and 
this role is continued over a long period of time;

o  Slow disease progression in children by using kinship support and maintaining 
the stability of living arrangements;

o  Support effective family functioning that minimizes developmental 
disabilities in children with HIV infection, such as family-focused 
interventions that have been effective with at-risk infants (e.g., premature, 
drug-exposed) and with other diseases;

o  Address bereavement in families in which a parent has died of AIDS and 
mitigate short- and long-term negative effects on both seropositive and 
seronegative children; reduce the negative effects on the child of parental 
death from a stigmatized disease such as AIDS;

o  Support the role of older generation family members who have become primary 
caretakers because of AIDS-related incapacitation or death, or when the family 
of choice is no longer willing or able to give care; reduce stressors associated 
with older family members who provide care for a family member with AIDS.

Phase IV Studies:  Effectiveness Studies of Interventions with Demonstrated 

The aim is to:

o  Conduct studies translating primary preventive interventions for families 
that have been demonstrated to have efficacy under controlled conditions; and

o  Conduct studies translating secondary interventions for families that have 
been demonstrated to have efficacy under controlled conditions.


The awardees from this RFA are expected to attend the Annual NIMH Conference on 
the Role of Families in Preventing and Adapting to HIV/AIDS, and, therefore, the 
budget should include provision for this Conference, which is traditionally held 
during the third week of July.  Awardees should assume that it will be held in 
the Washington, D. C. area.


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).  It is also NIH policy 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 Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research," which was 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:


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 

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


Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel and 
participating institutions, and the number and title of the RFA in response to 
which the application may be submitted.  Although a letter of intent is not 
required, is not binding, and does not enter into the review of a subsequent 
application, the information that it contains allows Institute staff to estimate 
the potential review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Willo Pequegnat, listed under 
INQUIRIES by April 24, 2000.


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, Email:  The application is also available at


The modular grant concept establishes specific modules in which direct costs may 
be requested as well as a maximum level for requested budgets. Only limited 
budgetary information is required under this approach.  The just-in-time concept 
allows applicants to submit certain information only when there is a possibility 
for an award.  It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and Institute staff.  The 
research grant application form PHS 398 (rev. 4/98) is to be used in applying 
for these grants, with the modifications noted below.


Modular Grant applications will request direct costs in $25,000 modules, up to a 
total direct cost request of $250,000 per year.  (Applications that request more 
than $250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) costs] for the initial budget period.  Items 8a and 8b 
should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

the PHS 398 (rev 4/98).  It is not required nor will it be accepted at the time 
of application.

categorical budget table on Form Page 5 of the PHS 398.  It is not required and 
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See for sample 
pages.) At the top of the page, enter the total direct costs requested for each 
year.  This is not a Form page.

o  Under Personnel, List key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and the role 
on the project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall qualifications 
of the research team.  A biographical sketch is required for all key personnel, 
following the instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at: 

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on research 
projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of agreement 
and the date.  All appropriate exclusions must be applied  in the calculation of 
the F&A costs for the initial budget period and all future budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information is 
necessary following the initial review.

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 and must display the 
RFA number MH-00-09. A sample modified mailing label is available at:  Please note this is 
in pdf format.  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, Family Interventions to Prevent 
and Adapt to HIV/AIDS, RFA MH-00-009, must be typed on line 2 of the face page 
of the application form and the YES box must be marked. 

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

BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must be sent 

Willo Pequegnat, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209, MSC 9619
Bethesda, MD 20892-9619

Applications must be received by May 24, 2000.  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.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIMH staff.  Incomplete and/or non-responsive 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 
NIMH in accordance with the review criteria stated below.  As part of the 
initial merit review, a process will be used by the initial review group in 
which applications 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 the applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the National Advisory 

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 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 methods?  
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?

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

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


Letter of Intent Receipt Date: April 24, 2000
Application Receipt Date: May 24, 2000
Peer Review Date: August 2000
Council Review: September 2000
Earliest Anticipated Start Date: September 29, 2000


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 concerning this RFA 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.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6209, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-6100
FAX:  (301) 443-9719

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885

The National Institute of Child Health and Development (NICHD) is also 
interested in these issues. For further details, please refer to the information 
on the HIV Research Agenda of the Demographic and Behavioral Sciences Branch at or information on the Child Development and 
Behavior Branch at


This program is described in the Catalog of Federal Domestic Assistance No. 
93.242.  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 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 

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