EARLY DETECTION OF HIV: IMPLICATIONS FOR PREVENTION RESEARCH

Release Date:  January 6, 2000

RFA:  MH-00-008

National Institute of Mental Health

Letter of Intent Receipt Date:  February 10, 2000
Application Receipt Date:  March 10, 2000

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS RFA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The role of HIV testing and its implications for prevention and clinical care 
is changing rapidly.  New technologies for HIV testing provide high 
sensitivity, specificity and results within ten minutes.  Early detection 
creates the possibility of access to early antiretroviral therapy and its 
potential treatment benefits.  In addition, testing has shifted from blood 
banks and anonymous testing sites to mainstream health care settings.  These 
shifts will present a series of challenges for government agencies involved in 
HIV surveillance, prevention research and treatment.

Approximately one-third of HIV-infected individuals do not know their HIV 
status.  Efforts must be made to find out the reasons why people do not get 
tested and why many who are tested fail to return for the results.  Research 
is needed to understand the strategic prevention implications of: 

o  rapid, low cost, client controlled testing methods; 

o  innovations in methods and modes of counseling associated with HIV testing; 
and 

o  health care provider and organizational level interventions to increase 
client testing.

This RFA will solicit applications to study new approaches to increase HIV 
testing and communication of test results for at-risk individuals, as well as 
to develop and evaluate innovative prevention strategies associated with 
emerging technologies in the early detection of HIV.

HEALTHY PEOPLE 2000

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), 
Early Detection of HIV: Implications for Prevention Research, is related to 
the priority areas of Mental Health and Mental Disorders, STDs and AIDS.  
Potential applicants may obtain a copy of "Healthy People 2000" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000/

ELIGIBILITY REQUIREMENTS

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 
the NIMH Small Grant program.  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) Research Project 
Grants (R01) and Small Grants (R03).  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 5 years for an R01 application and 2 years for an 
R03 application.  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.

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 Small Grant Program is found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html 

For all R03s and competing 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: 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Applications that 
request more than $250,000 in any year must use the standard PHS 398 (rev. 
4/98) application instructions.  R03s are not renewable.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1,000,000 in FY 2000 to fund up to 
five new and/or competitive continuation grants in response to this RFA. 

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 
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 competing renewal 
applications will be accepted and/or if this RFA will be reissued.  R03s are 
not renewable.

RESEARCH OBJECTIVES

As we enter the millennium, the promise of living with HIV as a chronic, 
rather than lethal disease, has never been greater.  From its initial 
appearance, HIV/AIDS has been regarded not only as a medical issue, but also 
as a health problem beset by numerous complex ethical, social and policy 
issues.  Developing a policy consensus on HIV counseling and testing is 
extremely sensitive and complicated.  Policies on surveillance, access to care 
and prevention remain unresolved.  The following four developments have helped 
intensify and shape the debate on these issues.  They are:

o  the advent of highly active anti-retroviral therapy (HAART), which prolongs 
the life of HIV-positive individuals and increases the importance of early 
detection;

o  the development of antiretroviral therapy to prevent the prenatal 
transmission of HIV;

o  the finding that HIV counseling and testing result in safer sexual 
behaviors, especially among HIV-positive individuals; and

o  the emergence of new HIV testing technologies that are consistent, 
inexpensive, quick and easy to administer.

These developments are having a major impact on the ways we approach HIV 
prevention, treatment, surveillance and early detection.  Current estimates of 
the HIV prevalence in the United States are between 650,000 and 900,000 
individuals.  HIV incidence has remained steady for several years at 40,000 
individuals per year.  The estimate for the number of Americans who are HIV 
positive and unaware of it is approximately 200,000.  Given the large number 
of individuals infected with HIV who are unaware of their status, it is 
extremely important that we identify barriers to testing, counseling and care 
and also devise new strategies to overcome these barriers.  New strategies 
must examine the critical role of early detection and improve the linkages 
between testing, counseling and care.  In addition, an estimated 19 million 
Americans are tested for HIV each year.  Of those tested, more than half are 
tested in hospitals and clinics, about one third are tested in blood donation 
centers and only about ten percent are tested in publicly funded sites.  Most 
of the information gained about counseling and testing comes from analysis of 
publicly funded sites. Research is needed to investigate the role and 
effectiveness of counseling and testing in sites other than those that are 
publicly funded.

From a policy perspective, the number of states that mandate name reporting 
has increased significantly this year. Research is needed to examine the 
effect of name reporting laws on voluntary testing and early detection of HIV.  
Also, does HIV surveillance influence test-seeking behavior and, if so, how?  
Investigations undertaken before the advent of HAART found that name-based 
reporting had a destructive effect, while post-HAART studies have had mixed 
findings.

This RFA solicits applications to study the implications of the development of 
early detection technologies on HIV prevention, counseling and access to care, 
and on test seeking behaviors as they relate to HIV surveillance policies.  
Examples of additional research include, but are not limited to:

o  Determine the reasons why the reported one-third of HIV-infected 
individuals who do not know their status have not been tested; 

o  Identify the reasons why many individuals who have been tested do not 
return for the results and develop strategies to deal with this problem;

o  Develop and test innovative techniques to locate individuals at high risk 
for HIV, and then generate and test new approaches to encourage these 
individuals to be tested;

o  Evaluate the impact of name reporting policies on HIV testing behaviors;

o  Develop and test new approaches to provide counseling to individuals at 
high risk for HIV who seek testing in primary care settings;

o  Generate and test new approaches and develop models to train health care 
providers in a variety of settings to adopt behaviors which will maximize HIV 
test seeking behaviors by those at high risk for HIV, including pregnant 
women;

o  Investigate the degree to which early detection technologies may be better 
linked to counseling and care;

o  Develop and assess HIV testing, counseling and prevention programs in 
managed care environments;

o  Investigate the degree to which provider behaviors may influence test-
seeking behaviors;

o  Identify real and/or perceived social consequences of HIV disclosure and 
develop and test strategies to minimize these consequences.

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 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:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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 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.

LETTER OF INTENT

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. Louis H. Steinberg,  listed under 
INQUIRIES, by February 10, 2000.

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) 435-0714, Email: 
GrantsInfo@nih.gov.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

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.

BUDGET INSTRUCTIONS

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.

DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 4 of 
the PHS 398 (rev 4/98).  It is not required nor will it be accepted at the 
time of application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
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 http://grants.nih.gov/grants/funding/modular/modular.htm 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:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- 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-00-008. A sample modified mailing label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in pdf0 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, Early Detection of HIV: 
Implications for Prevention Research, MH-00-008, 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:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
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 to:

Louis H. Steinberg, Ed.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Blvd., Room 6201, MSC 9621
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email: lsteinbe@nih.gov

Applications must be received by March 10, 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.

REVIEW CONSIDERATIONS

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 Institute's National 
Advisory Council.

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 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?

(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.

Schedule

Letter of Intent Receipt Date: February 10, 2000
Application Receipt Date: March 10, 2000
Peer Review Date: April 2000
Council Review: September 2000
Earliest Anticipated Start Date: September 29, 2000

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:

Louis H. Steinberg, Ed.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Blvd., Room 6201, MSC 9621
Telephone:  (301) 443-6100
FAX:  (301) 443-9719
Email: lsteinbe@nih.gov

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
Email:  Diana_Trunnell@nih.gov

Although not a co-sponsor of this RFA, the National Institute on Drug Abuse 
has a strong interest in supporting studies on issues pertaining to early 
detection of HIV in drug abusing populations, e.g., studies which seek to 
identify and develop methods for circumventing barriers to early detection of 
HIV in drug abusing populations; research on the impact of name-based 
reporting in drug abusing populations; research on developing methods to 
circumvent barriers to retesting among drug abusers with a prior negative test 
and development and testing of innovative strategies for promoting early 
detection in child and adolescent drug abusers.  For further information, 
contact Sander Genser, M.D., M.P.H., Center on AIDS and Other Medical 
Consequences of Drug Abuse, National Institute on Drug Abuse, telephone: 301 
443-1801; E-mail: sg73f@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
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 people.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.