REPLICATION OF COMMUNITY-BASED HIV INTERVENTIONS FOR YOUTH

Release Date:  October 22, 1998

RFA:  HD-98-015

P.T.

National Institute of Child Health and Human Development
National Institute of Mental Health

Letter of Intent Receipt Date: December 15, 1998
Application Receipt Date:  February 17, 1999

PURPOSE

This Request for Applications (RFA), jointly issued by the National Institute
of Child Health and Human Development and the National Institute of Mental
Health, invites research on the replication of community-based behavioral
interventions to reduce risks of HIV among youth.  The RFA invites researchers
to select an HIV intervention program that has been demonstrated to be
effective for an adolescent population and to replicate it in a new community
or population.  This replication is to be done while systematically studying
those processes and aspects of the intervention hypothesized to be critical to
the development of community based, culturally sensitive programs, in order to
assess the variations necessary to gain cooperation, produce behavior change
and evaluate the outcomes in the new setting.  The primary goals of the
research are to gain insight into how interventions may be adapted to new
communities while preserving or indeed maximizing the effectiveness of key
mechanisms through which they reduce behavioral risks 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 RFA, Replication of Community-Based
HIV Interventions for Youth, is related to the priority areas of family
planning and the prevention of HIV infection and STDs.  Potential applicants
may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

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.  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
grant (R01) 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.  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 earliest anticipated award date is July 1, 1999.

FUNDS AVAILABLE

The NICHD intends to commit approximately $2 million (total costs, including
direct and indirect) and NIMH intends to commit approximately $1 million
(total costs) in first year costs to fund four to five grants in response to
this RFA.  An applicant may request a project period of up to five years. 
Although this program is provided for in the financial plans of NICHD and
NIMH, awards pursuant to this RFA are contingent on the availability of funds
and the receipt of a sufficient number of applications of outstanding
scientific and technical merit.

RESEARCH OBJECTIVES

Summary

This RFA calls for the selection, transfer, implementation and evaluation of 
interventions targeted to people under the age of 19 and designed to bring
about changes in HIV risk-related sexual behaviors in those populations. 
Applicants are invited to propose strategies to evaluate and discriminate
between the essential components of interventions and the components which
must be changed in order to attain success in settings in which the original
intervention was not tested.  Proposed research should be designed to
systematically study elements of the intervention that are hypothesized to be
central to community acceptance, cultural sensitivity, and effectiveness in
the new setting, while preserving elements through which the intervention is
thought to produce behavior change regardless of setting.  Applicants should
propose designs that will permit the testing of hypotheses regarding the
contributions of specific program elements or processes to intervention
outcomes.

Background

Over the past several years, intervention research on HIV prevention has
produced some programs which have been evaluated and shown to be effective in
reaching individuals and in changing risk behavior (NIH, 1997; CDC, 1997). 
One component of the success of these programs has been said to be the fact
that they were "community-based," designed with the input and skills of the
particular community in which they were implemented (Schwab and Syme, 1997). 
A second component is thought to be that the programs were "culturally
sensitive"; that is, they reflected the needs and cultures of the individuals
expected to participate in the intervention, using media and messages relevant
to those individuals and their lives (Freudenberg and Zimmerman, 1996). 
Issues relating to the tensions between specificity and generalizability seem
to occur across a wide range of innovations (Rogers, 1995).  While individual
tailoring may account for success at a given location, there is pressing need
for theoretically grounded interventions that will be effective in a wide
range of communities (DesJarlais and Padian, 1997; Frost and Forrest, 1995). 
Therein lies a challenge.  On the one hand, "replication" implies fidelity to
the original, while on the other hand, "community-based and culturally
sensitive" implies expectation of variation and sensitivity to that variation.
Endless creation of new approaches with limited generalizability may be as
wasteful of scarce resources as is the cookbook replication of programs found
to be successful elsewhere.  It is not clearly understood which elements of a
given intervention are essential to success and which must be changed in order
for the intervention to be of value elsewhere or with other populations.

The theoretical basis for the need to vary interventions to achieve cultural
sensitivity and community acceptance is widely accepted, but has been
systematically developed and articulated only occasionally (e.g., Catalano,
1997).  Concepts of cultural competence or cultural sensitivity are rarely
fully developed and are often defined inconsistently.  The formal theories
most often used in the design of intervention programs have been variations on
the Health Belief Model, the Theory of Reasoned Action, the Stages of Change
model, and Social Learning Theory (Sonenstein, 1997).  These theories usually
contain a rationale as to why a given approach is expected to work for a
particular behavior, but not often for a particular cultural or community
context.  To the extent that the potential for behavior change is influenced
not only by intra-individual psychological factors but also by characteristics
of the social and cultural context, such theories may provide an incomplete
basis for the design of effective intervention programs.

Research Considerations

Since this RFA calls for replication of interventions, a primary basis for the
proposal will be the selection of the intervention to be used. The
intervention to be replicated must have been reported or accepted for
publication in a refereed journal, and it must have demonstrated statistically
significant behavior change related to at least one of these risk factors:
sexual initiation, numbers or types of partners, the frequency of sexual
intercourse and/or the consistent and correct use of condoms.  In addition,
the population and setting in which the intervention was implemented must have
been described in detail. Interventions which have been demonstrated to be
effective in the prevention of adolescent pregnancy or other adolescent
health-risk behaviors may be appropriate for use in response to this RFA, if
they can be shown to have an impact on one or more of the risk factors
enumerated above (see Moore et al., 1995; Frost & Forrest, 1995; Kirby, 1997;
Sociometrics, 1998).  The original intervention need not have been implemented
in the United States.  A successful application will present a compelling
rationale for the transfer of the intervention, demonstrating that there is
reason to believe that the intervention (or a specified modification thereof)
might be effective in a different setting or with a different population.

Applicants are strongly encouraged to present a theoretical model for the
proposed research which addresses the following elements:

o  How the intervention works to produce behavior change;

o  How the cultural, political and social context in which the intervention is
implemented may influence its success, through interactions between its core
mechanisms of action and the local context, or through affecting the process
of implementation;

o  Differences between the original and proposed sites/populations that are
relevant to the operation of the intervention in the new setting (e.g.,
differences in the determinants of risky sexual behaviors across sites,
differences in meanings attributed to sexual behaviors, differences in the
location of relevant opinion leaders and gatekeepers within community
institutions, etc.); and

o  Alterations in the program content, design or implementation that are
hypothesized to be necessary for the successful replication of the
intervention.

The research should be designed to provide a test of the theoretical model
motivating alterations to the original intervention.

Applicants are also encouraged to provide a strong theoretical rationale for
the choice of the new setting or population, based on the model set forward
and the differences and similarities between the original and new sites.  The
replication location must be different from the original site OR involve a
substantially different population (e.g., different race, ethnicity, age,
gender, or income level).  In either case, the replication should be carried
out in a community that is demonstrably dissimilar along theoretically
relevant cultural, social, economic or political dimensions from that in which
the original intervention was conducted.  The applicant is encouraged to
consider whether the participation, cooperation or collaboration of
individuals involved in the original intervention could improve the quality of
the replication (NIH, 1997).  In addition, the applicant must provide evidence
that the appropriate organizations, agencies or individuals at the selected
site are willing and able to participate in the study.

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 are 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 were published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994, available on the web at:
https://grants.nih.gov/grants/guide/notice-files/not94-105.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 or 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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies 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, by December 15, 1998, 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 of 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
NICHD staff to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be sent to the program staff listed under
INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) 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
grantsinfo@nih.gov.

The RFA label available in the PHS 398 (rev. 5/95) application form must be
affixed to the bottom of the face page of the application.  Failure to use
this label could result in delayed processing of the application such that it
may not reach the review committee in time for review.  In addition, the RFA
title and number must be typed on line 2 of the face page of the application
form and the YES box must be marked.

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:

Scott Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)

Applications must be received by February 17, 1999.  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 to this RFA by NICHD and NIMH staff.  Incomplete applications
will be returned to the applicant without review.  If the application is not
responsive to the RFA, CSR staff may contact the applicant to determine
whether to return the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.

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
NICHD in accordance with the review criteria stated below.  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
NICHD and NIMH National Advisory Councils.

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
their 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?

Review criteria specific to this RFA are:

o The strength of the theories used as basis for the design of an effective
replication of the selected intervention.

o The ability of the design to provide an effective test of the intervention.

o The cooperation evidenced among all agencies participating in the
application, as demonstrated both in written form from the cooperating
organization directors and in the body of the application.

o The knowledge and experience pertaining to the site-specific component of
the study and the targeted population(s).

o The definition of and access to an appropriate population.

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.

The scientific review group will also examine the provisions for the
protection of human subjects and the safety of the research environment.

Schedule

Letter of Intent Receipt Date:    December 15, 1998
Application Receipt Date:         February 17, 1999
Council Review:                   May/June 1999
Earliest Anticipated Start Date:  July 1, 1999

AWARD CRITERIA

Awards will be made based on scientific merit as determined by peer review, on
programmatic priorities and on the availability of funds.

INQUIRIES

Written, email, and telephone 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:

Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07
Bethesda, MD  20892
Telephone:  (301) 496-1174
FAX:  (301) 496-0962
Email:  sn19y@nih.gov

Willo Pequegnat, Ph.D.
National Institute of Mental Health
Parklawn Building, Room 18/101
Bethesda, MD  20892
Telephone:  (301) 443-6100
Email:  wpequegn@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Melinda Nelson
Grants Management Branch
National Institute of Child Health and Human Development
Building 61E, Room 8A17K
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  mn23z@nih.gov

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-3065
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.864, 93.121,  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 grant policies and
Federal Regulations, 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive Order 12372,
or to Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility ) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Sources

Catalano, Richard. 1997. My Health, My Community: A free, reproducible
adaptable curriculum for community-based adolescent health education,
available from Social Development Research Group, 146 N. Canal Street #211,
Seattle WA 98103.

CDC, Division of Adolescent and School Health. 1997. "Research to Classroom
Project: Programs that Work." Information available from DASH/CDC 
770.488.5360

DesJarlais, Don and Nancy Padian.1997. "Strategies for universalistic and
targeted HIV prevention." Journal of Acquired Immune Deficiencies Syndrome and
Human Retrovirology. 16:127-136.

Fishbein, Martin and Roel Coutinho, editors. 1997 "NIMH Multisite HIV
Prevention Trial" AIDS. Volume 11, supplement 2, December.

Freudenberg, Nicholas and Marc A Zimmerman. 1996. AIDS Prevention in the
Community. Washington, D.C.: American Public Health Association.

Frost, Jennifer and JD Forrest. 1995. "Understanding the Impact of Effective
Teenage Pregnancy Prevention Programs." Family Planning Perspectives
27(5):188-195.

Ikovics, Jeanette and Hiorkazu Yoshikawa.1998. "Preventive interventions to
reduce heterosexual HIV risk for women: current perspectives, future
directions." AIDS 12(supplA):5197-5208.

Kirby, Douglas. 1997. No Easy Answers: research findings on programs to reduce
teen pregnancy. A report to the National Campaign to Prevent Teen Pregnancy.
Washington, D.C.

Moore, Kris, Barbara Sugland, Connie Blumenthal, Dana Glei and Nancy Snyder.
1995. Adolescent Pregnancy Prevention Programs: Interventions and Evaluations.
Washington, D.C.: Child Trends.

NIH. 1997 Interventions to prevent HIV Risk Behaviors. NIH Consensus Statement
1997 February 11-13:15(2)

Rogers, Everett M. 1995. The Diffusion of Innovation (4th edition). New York:
Free Press.

Schwab, Michael & SL Syme. 1997. "On paradigms, community participation and
the future of public health."  American Journal of Public Health.87(12):2049-
2051.

Sociometrics Corporation.1998. PASHA 170 State Street, suite 260, Lost Altos
CA 94022

Sonenstein, Freya. 1997. "Using self reports to measure program impact."
Children and Youth Services Review 19(7):567-585.

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