kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/13/91)
$$XID RFA MH9106 MH-91-06 P1O1 *****************************************
REQUEST FOR APPLICATIONS
RFA: MH-91-06
P.T. 34; K.W. 0715008, 0755015, 0404000, 0745027
COOPERATIVE AGREEMENT FOR MULTI-SITE TRIALS OF BEHAVIORAL
STRATEGIES TO PREVENT THE FURTHER SPREAD OF HIV INFECTION
National Institute of Mental Health
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institute of Child Health and Human Development
Centers for Disease Control
Health Resources and Services Administration
Application Receipt Date: May 22, 1991
(Catalog of Federal Domestic Assistance 93.242)
Under statutory authorities of Section 301 and 504 of
the Public Health Service Act, (42 U.S.C. 241 and
290aa), the National Institute of Mental Health will
accept applications in response to this request under
the single receipt of May 22, 1991
INTRODUCTON
The National Institute of Mental Health (NIMH) is
requesting applications for additional Extramural
Research Groups (ERG) to enter into an existing multi-
site, multi-population collaborative study to test
behavioral interventions to prevent the further spread
of HIV infection.
In Fiscal Year 1990, NIMH funded three ERGs and
a Coordinating Center, using the cooperative agreement
as the support mechanism. Fiscal Year 1991
appropriations allow for the continuation and expansion
of the study through the addition of three to five
ERGs to those initially funded. The National Institute
on Drug Abuse (NIDA), the National Institute on Alcohol
Abuse and Alcoholism (NIAAA), the National Institute of
Child Health and Human Development (NICHHD), the
Centers for Disease Control (CDC), and the Health
Resources and Services Administration (HRSA) have
program interests and expertise related to this study.
Each of these agencies has an ex-officio program
representative on the Steering Committee who is
actively participating as a resource person in this
collaborative effort.
This request for applications (RFA) solicits
applications from ERGs to enter into an existing multi-
site study. Part I of the RFA describes the study's
Background and Rationale, Structure, Phases, Roles, and
Terms, and the Role and Application Characteristics.
Part II addresses the Review Criteria, Award Criteria,
Budget, and Review and Application Processes.
This multi-site study fills a critical scientific gap
and addresses a high priority public health concern.
It is designed to test the efficacy of promising HIV-
prevention interventions across multiple populations
and different geographic locations. Implementation of
a coordinated multi-site, multi-population prevention
trial, which includes development of a common protocol,
requires substantial programmatic involvement of the
NIMH staff to facilitate communication and coordination
across the funded ERGs, the Coordinating Center, and
the Federal government. Because of the complexity of
the project, the cooperative agreement was selected as
the funding mechanism. This collaborative, multi-
site, multi-population approach is essential to ensure
the generalizability of the research findings and to
answer questions about the effectiveness of HIV
prevention approaches across populations and geographic
locations.
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,
"Cooperative Agreement for Multi-Site Trials of Behavioral Strategies
to Prevent and Further Spread of HIV Infection,"
is related to the priority area of HIV infection.
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, D.C. 20402-9325 (telephone 202-783-3238).
PURPOSE
The purpose of this collaborative study is to support a
coordinated multi-site, multi-population prevention
trial to develop effective HIV-prevention strategies.
Interventions to be tested may include approaches aimed
at several levels, including individuals/small groups,
institutions, and communities, as well as
interventions currently being implemented with Federal
funds. This collaborative effort will provide critical
information for the development of a model(s) of
prevention that can be applied to diverse populations
at risk for HIV infection.
Applications are being solicited for additional ERGs to
join the existing multi-site, multi-population
cooperative study of HIV-risk reduction. The goals are
to: 1) develop behavioral intervention strategies for
groups that have not been reached effectively by
existing prevention efforts, 2) assess existing
intervention efforts and improve the existing
strategies that have shown some effectiveness, 3)
develop an overall effective intervention program to
promote behavior change that will prevent the further
spread of the HIV epidemic, and 4) establish causal
links between behavioral interventions and behavior
change across populations.
Applicants should recruit persons from understudied,
at-risk populations as participants for this
collaborative study. These populations include young
gay men, intravenous drug users (IVDUs), sex partners
of IVDUs, persons who exchange sex for drugs or money,
persons with HIV infection and their sex partners (such
as concordant and discordant couples), men who have sex
with men but do not self-identify as gay or bisexual,
and persons from racial and ethnic minority
populations, the homeless, the chronically mentally
ill, and adolescents who continue to engage in high risk
behaviors.
A key objective of this announcement is to identify HIV
prevention approaches that are both effective and
efficient. Effectiveness, or establishing that a
preventive intervention produces the desired outcomes,
is essential to curtailing the HIV epidemic. A major
purpose of this collaborative study is to assess and
compare effectiveness of prevention activities across
populations and sites. Efficiency of effort is another
critical component of a successful public health
strategy to prevent new HIV infections. A second major
purpose of this study is to identify efficient
strategies to maximize the use of HIV prevention
resources. This means that limited resources need to
be used where they can maximize prevention outcomes.
Applicants are encouraged to consider the prevention
efforts currently being funded by other Federal
agencies (e.g. CDC, HRSA) and to propose studies
designed to evaluate the effectiveness and efficiency
of these interventions.
SUMMARY OF FIRST YEAR ACTIVITIES FOR MULTI-SITE STUDY
In Fiscal Year 1990, NIMH funded three ERGs and one
Coordinating Center. The three ERGs are located in the
Northeast and proposed to direct their efforts
primarily toward inner-city Black populations. The
theoretical framework that guided development of their
prevention interventions was Social Cognitive Theory.
Specifically, one intervention was derived from Social
Learning Theory; another used the Health Belief Model
augmented by Protection-Motivation Theory; and the
third reviewed various Health Behavior Theories.
All three ERGs plan to intervene at the
individual/small group level and to use peer educators
as change agents. The three ERGs proposed using
repeated measures experimental designs with random
assignment to experimental and control conditions. Two
ERGs plan to use an ethnographer to guide them through
the formative phase of the study. Multiple outcome
variables were delineated by the three sites, including
incident sexually transmitted diseases (STDs), HIV-1
seroconversions, number of sexual partners, changes in
sexual behaviors, frequency of condom use, and others.
Activities have centered on the development of a
standardized protocol. The Steering Committee
envisions that each ERG will implement both the
collaborative, standardized protocol developed during
Phase I, as well as ancillary studies allowing each ERG
to test additional and situation specific hypotheses.
ERGs will agree to abide by the study design and policy
recommendations developed by the Steering Committee.
DEFINITIONS OF TERMS IN THIS ANNOUNCEMENT
Definitions are provided in this section for key terms
as they are used in this announcement:
community: all the people living in a particular
geographic location, such as a neighborhood, town, or
city; or, a group of people living together as a
smaller social unit within a larger one and having
interests in common, such as a college community, an
ethnic or racial group in a geographic area (e.g.,
Hispanics in Harlem), or a community of gay/bisexual
men (e.g., Black bisexual men in San Francisco)
community-based approaches: prevention strategies
using indigenous members of the community as change
agents to prevent HIV infection
community-level intervention: a prevention strategy
aimed at changing HIV risk behaviors or social norms of
a community (A community-level intervention may contain
multiple components including, but not necessarily
limited to, mass media messages as well as organized
community action at the institutional and individual
level.)
cooperative agreement: a funding mechanism that
reflects an assistance relationship between the Federal
Government and the awardee in which substantial
programmatic involvement is anticipated by the Federal
agency in collaboration with the recipient during the
performance of the activity
coordinating center: a single awardee to provide
overall study coordination, including data management
and analysis, training in common procedures, and
distribution of necessary materials to all study sites
(ERGs)
data-monitoring board: an independent board of
external experts to oversee the conduct of the study
and assist NIMH in reviewing and commenting on the
final protocols of and any modifications to the study
extramural research group (ERG): awardee that will be
responsible for conducting the research activities of
the study (In the first year of the collaborative
study, ERGs will reach agreement on a common research
design that will permit comparisons of outcomes across
projects and intervention strategies.)
further spread of HIV infection: to prevent new cases
of HIV infection. To do this, intervention strategies
can be aimed at 1) persons with HIV infection (to
reduce the further transmission of the virus to
uninfected individuals), 2) individuals who engage in
high risk behaviors (to prevent acquisition of HIV
infection), 3) populations in common institutions
(e.g., schools, worksites, churches), 4) environmental
conditions in institutions (e.g., prisons), and 5)
communities (e.g., cities, neighborhoods)
individual level intervention: prevention strategies
aimed at individuals at high risk of infection, or
small groups of individuals at risk
institutional level intervention: behavioral strategies
aimed at populations in institutional settings, e.g.,
schools, worksites, prisons, psychiatric hospitals
intervenor: the change agent who is delivering the
prevention program, e.g., therapist, peer, teacher
multi-population: more than one population, because the
intent of this announcement is to compare behavioral
HIV prevention strategies in different populations,
e.g., ethnic groups disproportionately represented
among AIDS cases to date, intravenous drug users
(IVDU), women, adolescents, persons with severe mental
illness, prisoners
multi-site: more than one site, because the intent of
this announcement is to compare behavioral HIV
prevention strategies in different geographic areas and
settings of intervention, e.g., cities, communities,
schools, hospitals, prisons
population: people residing or working in the same
geographic area, setting, or site; or a group of people
who share common heritage or common interest in the
same geographic area, setting, or site
site: the location of the intervention
steering committee: the primary governing body of the
collaborative study, composed of the Principal
Investigator of the Coordinating Center, the Principal
Investigators of each of the ERGs, and the NIMH Staff
Collaborator
target behavior(s): the behavior(s) which the HIV-
prevention strategy is designed to prevent or reduce.
BACKGROUND AND RATIONALE
The HIV epidemic has had a particularly severe impact
on gay and bisexual men, IVDUs, and minority
populations. Concerns exist regarding the further
spread of HIV infection among some members of these and
other groups who continue to engage in risky behaviors
or practices that spread HIV infection. Special
efforts are needed to develop targeted prevention
programs to avoid the further spread of HIV infection.
There is evidence that an unprecedented level of
behavior change has occurred among some populations of
gay men in major cities such as San Francisco and New
York. Recent epidemiologic data suggest that these
trends are not generalizable to other groups such as
young gay men, IVDUs, sex partners of IVDUs, persons
who exchange sex for drugs or money, persons with HIV
infection, regular sex partners of persons with HIV
infection (e.g., discordant couples), and men who have
sex with men but do not self-identify as gay or
bisexual. Many persons who belong to these groups
continue to engage in behaviors and practices that
place them at high risk of becoming infected with HIV
or of transmitting HIV infection to others. There are
promising data which indicates that some populations of
IVDUs, particularly those in drug abuse treatment
programs and those reached by street outreach workers,
have adopted safer behaviors (e.g., needle hygiene and
reduced drug use and needle sharing). However,
evidence suggests many IVDUs continue to engage in
risky sexual and drug-using practices.
To date, HIV prevention research has focused primarily
on gay and bisexual men. Certain populations, such as
racial and ethnic minorities who are disproportionately
represented among U.S. AIDS cases and have a
disproportionately high seroprevalence rate in some
communities, as well as the previously mentioned
groups, have been understudied. Little empirical
evidence exists that causally links specific
interventions or program components to positive
behavioral outcomes for many of these populations.
Controlled behavioral trials, along with evaluation of
existing interventions such as peer education models
conducted by community-based organizations, street
outreach programs for drug users, and counseling and
testing efforts, offer the opportunity to test
interventions derived from a specific conceptual
framework and increase understanding of the behavior
change process related to sexual and drug-using risk
behaviors for HIV infection. Also, they pinpoint how
and when to intervene to facilitate HIV-related
behavior change, test planned variations in
interventions, evaluate strategies in multiple
populations and geographic settings, and determine
outcomes based on a validated core assessment battery.
In addition to controlled experiments, prevention
studies using ethnographic approaches may provide
essential information necessary to design appropriate
interventions for hard-to-reach populations at risk for
HIV infection.
There is a critical need for systematic information
concerning HIV-prevention strategies in diverse
populations and to determine the effectiveness and
efficiency of the types of interventions currently
being implemented with Federal funds. In response,
NIMH initiated this cooperative agreement designed to
determine the effectiveness of behavioral strategies to
prevent the further spread of HIV infection. A multi-
site, multi-population, collaborative approach was
selected to make maximum use of available resources and
time. Implementation of this type of a study is a
complex undertaking that is based on strong cooperation
and collaboration among multiple research groups and
Federal agencies. It requires establishing a common
research design and developing and collecting a set of
core measures which permit cross-site comparisons.
Findings concerning the most effective approaches to
prevent the spread of the HIV epidemic should be made
available to policy-makers and program planners.
This multi-site study was designed to test the efficacy
of promising HIV prevention intervention(s) across
multiple populations and sites. This study fills a
critical scientific gap and addresses a top priority
public health concern. This collaborative, multi-
site, multi-population approach is essential to ensure
generalizability of the research findings and to answer
questions about the effectiveness of HIV-prevention
approaches across populations and geographic locations.
The use of a multi-site, multi-population strategy
facilitates recruitment of large samples from diverse,
often understudied populations, reduces error, and
allows for statistical analyses that assess the effects
of multiple factors on behavioral outcomes. By using
standardized research protocols, the multi-site effort
permits comparison of intervention effects for
different populations in diverse geographic locations,
thereby greatly enhancing the generalizability of the
results and the scientific relevance of the study.
Finally, the multi-site trial permits simultaneous
testing of more than one strategy and the investigation
of interaction between strategies.
This announcement conceptualizes HIV-prevention
programs at the individual/small group, institutional,
and community level. Prevention strategies may include
more than one level. A number of clinical intervention
studies to reduce high-risk sexual and drug-using
behaviors at the individual/ small group level are
using cognitive behavior therapy, including techniques
of assertiveness training, skill training, and stress
reduction. Individual/small group or therapeutic
interventions (e.g., one-on-one counseling, small
groups) are costly and should focus on populations that
are hard to reach through other channels or who are
unable to change risk-behavior patterns through less
intensive approaches.
Research is also underway to develop and test
interventions at the institutional level, such as at
schools. Successful institutional interventions (e.g.,
prevention programs in churches, worksites, and
prisons) provide another opportunity to increase the
impact of prevention programs on groups of persons at
risk.
It is essential to develop effective community-level
HIV-prevention efforts to reach the maximum number of
people possible. Insufficient systematic experimental
research has focused on interventions at the community
level, including mass-media techniques. Carefully
targeted messages and multiple channels of
communication may be necessary to achieve behavior
change through this approach. Community-level programs
may require coordination of efforts at different levels
throughout the community, such as development of
community groups and policy development to create a
normative "environment" for safe behaviors and
"neutralize" the stigma associated with being HIV
positive.
STRUCTURE AND PHASES OF THE MULTI-SITE TRIAL
The study involves the cooperation of scientists from
(1) a Coordinating Center, (2) cooperative agreement
awardee sites (ERGs), (3) the office of the Director of
the NIMH AIDS Programs, (4) an NIMH Staff Collaborator,
and (5) ex-officio representatives from the NIMH, NIDA,
NIAAA, NICHD, CDC, and HRSA extramural research
programs.
Awards will be made for a project period of 5 years.
For planning and budgeting purposes, the study can be
envisioned as proceeding in four phases.
Phase I Incorporating newly funded ERGs into the
multi-site study including, but not
limited to, refinement of common
methodological procedures and
instruments (baseline and outcome);
training in the common field procedures,
draft and pilot instruments
(approximately 12 months)
Phase II Conducting pilot test of
intervention(s), analyzing results, and
revising as necessary (approximately 12
months)
Phase III Implementing full-scale multi-site,
multi-population preventive intervention
trial with follow-up (approximately 24
months)
Phase IV Completing follow-up, analyzing data,
and reporting results (approximately 12
months)
CURRENT ROLES OF THE NIMH EXTRAMURAL STAFF AND STAFF
FROM OTHER FEDERAL AGENCIES
NIMH staff actively participate in all aspects of the
cooperative agreement. NIMH staff serve as scientific
collaborators with investigators in the ERGs. NIMH
staff assist with the overall aspects of the study
which includes monitoring the Coordinating Center and
directing the Data Monitoring Board.
NIMH extramural scientist-administrators perform two
different functions, Project Officer and Staff
Collaborator, in research projects supported under the
cooperative agreement mechanism. The Project Officer
has overall responsibility for monitoring the conduct
and progress of the project. The Project Officer
carries primary responsibility for (1) periodic review
and approval of the progress of the protocols in
relation to stated objectives and (2) making
recommendations regarding continuance of the program.
The Project Officer oversees the Coordinating Center,
receives all required reports, and determines that
satisfactory progress is being made. The Project
Officer seeks Data Monitoring Board consultation on
issues concerning the conduct and progression of the
study (e.g., whether NIMH should proceed from Phase I
to Phase II) and approves moving from one phase to
another.
The NIMH Staff Collaborator participates in the
development of the final study plan, quality control,
and coordination as well as in data analysis and
interpretation and the preparation of publications.
The NIMH Staff Collaborator is subject to the
publication/authorship policies governing all
participants which are developed by the Steering
Committee.
The NIMH Office of AIDS Programs staff and the Staff
Collaborator, Dr. Isa Fernandez, have substantial
scientific input, in collaboration with award
recipients, both in the planning and conduct of the
study.
The Grants Management Branch, NIMH, retains the right
to terminate a cooperative agreement if specific terms
and conditions of the award are not met.
NIDA, NIAAA, NICHD, CDC, and HRSA each have an ex-
officio program representative on the Steering
Committee as a resource person for the respective
Institute's/agency's programmatic expertise. NIMH
continues to coordinate, as appropriate, with other
agencies/Institute staff.
ROLE OF STEERING COMMITTEE
The primary governing body of the study is the Steering
Committee. Currently, the Steering Committee is
composed of the Principal Investigator of the
Coordinating Center, the Principal Investigators of
each of the three ERGs, and the NIMH Staff
Collaborator. ERGs funded under this RFA will become
full voting members of this committee. The Chair of
the Steering Committee was appointed by the Director,
Office of AIDS Programs. The NIMH Staff Collaborator
participates in, but does not chair, the Steering
Committee and possesses only a single vote, not veto
power. Staff representatives from NIDA, NIAAA, NICHD,
CDC, and HRSA participate in the Steering Committee as
ex-officio members with no voting power.
The Steering Committee has primary responsibility for
developing the study protocol, facilitating the conduct
of the study and reporting the study results to the
Project Officer. The Steering Committee also develops
policies on the data sharing and on access to data and
materials.
The Steering Committee operates in a manner that
develops consensus agreement on major decisions. All
decisions by the Steering Committee on the scientific
and policy aspects of the project are made by majority
vote. The Steering Committee establishes, by majority
vote, criteria for decision-making in all areas of
responsibility. The section in this RFA on TERMS AND
CONDITIONS OF AWARD provides for an arbitration panel
to resolve disagreements that cannot be settled within
the Steering Committee.
Another meeting of the Steering Committee will be
convened as soon as possible after the new funding
decisions are made. It is estimated that up to six
meetings will be needed in the first year to
incorporate the newly funded ERG into the multi-site
study. In years 2 and 3, meetings will be held two to
four times each year, as needed. In years 4 and 5, the
Steering Committee will be likely to meet two times per
year.
The Chair of the Steering Committee may form
Subcommittees of the Steering Committee to consider
such topics as study design and execution for specific
populations, quality control, data collection, data
analysis, sharing of study data and materials, and
publication policies and procedures. The NIMH Staff
Collaborator participates as a full member on
subcommittees, and other NIMH staff and extramural
staff from other collaborating agencies may participate
as ex-officio members.
Publications will be written and authorship decided by
using procedures developed by the Steering Committee.
The quality of publications resulting from the study
will be the responsibility of authors; no NIMH
clearances will be required.
All participating research groups will agree to abide
by the study design and policy recommendations
developed by the Steering Committee and any required
NIMH approvals set forth in the terms and conditions of
the cooperative agreement.
The Steering Committee, working with the Coordinating
Center, prepares reports for submission to the Project
Officer. An annual progress report will be prepared by
the Chair of the Steering Committee on all activities.
ROLE OF COORDINATING CENTER
The Coordinating Center provides overall study
coordination, including data management and analysis
and training in common procedures, and assures
distribution of necessary materials to all study sites.
The Coordinating Center coordinates the pilot testing
of the common core batteries, if this is deemed
desirable in the planning phase.
NIMH staff work with and monitor the Coordinating
Center. The Coordinating Center is developing and will
maintain a common data repository, containing common
data files needed by the study participants. These
data will be used first by the study participants in
this research program. However, since they represent a
potential national resource, it is the intention of
NIMH that the data be made available to the larger
research community as soon as feasible. To accomplish
this, the Steering Committee will report, at the end of
each study year, on the status of the research program.
NIMH may determine that all or parts of the data should
be made available to the larger research community, in
accordance with PHS policy. The Coordinating Center,
with input from NIMH staff (the NIMH Staff
Collaborator, project officer, and Director, Office of
AIDS Programs) and the Steering Committee, has primary
responsibility for convening meetings of the ERGs.
ROLE OF THE DATA MONITORING BOARD
NIMH established a Data Monitoring Board (DMB) to serve
as an independent and external expert board that
oversees the conduct of the study. The Board assists
NIMH in reviewing and commenting on the final protocols
of the study and any modifications. Additionally, the
Board monitors progress on the data and technical
aspects of the study. The Board also assists the
Project Officer in dealing with operational aspects of
the study.
ROLE AND APPLICATION CHARACTERISTICS FOR ERGs
The ERGs are responsible for the conduct of the study.
The awardees, in collaboration with the NIMH Office of
AIDS Programs, are responsible for development of the
final study plan, subject recruitment and followup,
data collection, preliminary and final data analysis
and interpretation, quality control, and preparation of
reports and publications. Each ERG will perform most,
if not all, of the research activities needed for the
study. However, a single ERG need not necessarily
possess the entire range of capabilities needed for the
collaborative study. Each ERG may contribute some
unique capabilities in addition to the core
capabilities identified in project criteria.
Applicants should propose a fully designed, carefully
justified intervention study. However, final protocols
will be determined collaboratively after awards are
made. Applicants must agree to revise their proposed
interventions and adopt the standardized protocol(s)
developed collaboratively by the Steering Committee.
Applicants must be willing to participate in extensive
work in the first year necessary to facilitate cross-
site comparisons. The final plan for the study will
be based on the successful proposals and will be
developed by the Steering Committee (composed of
principal investigators of the Coordinating Center and
each ERG and the NIMH Staff Collaborator) during the
first phase of the award. Each ERG may retain unique
characteristics and measures of the proposed study but
must agree to adopt common characteristics and measures
for the collaborative study.
Each ERG application may propose to test a single or
multiple preventive strategies in more than one
population and/or geographic setting. A prevention
study of a single strategy in a single population and a
single setting may be submitted in cases where the
target population has been previously understudied and
the proposed study will add important information to
the body of knowledge regarding preventing HIV
infection in at-risk groups. Applicants are encouraged
to consider the prevention efforts currently being
funded by other Federal agencies (e.g., CDC, HRSA) and
to propose intervention studies designed to evaluate
the effectiveness and efficiency. Applicants may
propose individual studies or multi-site studies, and
applications will be reviewed for scientific merit
based on the proposed research design and data
analysis.
Applicants proposing interventions at the
individual/small group level should include a
justification of why those individuals are at increased
risk for HIV infection. To prevent the further
transmission of HIV infection, it is important that
intervention studies at the individual/small group
level be directed at persons with HIV infection.
Applicants proposing interventions at the institutional
and community level will need to address how the
prevention strategy addresses the needs of both persons
who continue to engage in high risk behaviors (e.g.,
individuals at high risk) and the general population
(e.g., persons at general risk). It is also recognized
that applicants may propose a combination of
interventions at differing levels.
The recent National Academy of Sciences Volumes, AIDS:
Sexual Behavior and Intravenous Drug Use, and
Evaluating AIDS Prevention Programs (National Research
Council 1989), summarize several possible models for
consideration in the development of controlled HIV-
prevention trials, including marketing and advertising
models as well as models based on theories of behavior
and behavior change. In addition to using a conceptual
framework to develop HIV-prevention strategies,
programs should be based, to the maximum extent
possible, on findings from AIDS research to date, as
well as on lessons learned from other health education
efforts (e.g., smoking cessation, reduction of blood
cholesterol through changes in diet, exercise) that can
be successfully applied to this area. Applicants under
this announcement should demonstrate awareness of
ongoing HIV-prevention studies as well as emerging
findings regarding the effectiveness of HIV-prevention
strategies.
Investigators are encouraged to address in the
application the basis for the following:
o Description of and rationale for the theoretical
basis for proposed intervention(s)
o Specification of hypotheses to test the particular
theoretical approach selected
o Relation of proposed theory to population(s)
selected for intervention
o Possible tests of multiple theories with competing
hypotheses
o Relevance of proposed study, if applicable, to
existing federally funded HIV-prevention efforts.
TARGET POPULATIONS FOR INTERVENTION
Applicants should (1) demonstrate that they have access
to specific populations for participation in
experimental or quasi-experimental trials or (2)
propose a fully justified plan for recruiting or
sampling members of a specific population.
Investigators are encouraged to develop preventive
interventions for hard-to-reach, underserved,
understudied populations such as young gay men, IVDUs,
sex partners of IVDUs, persons who exchange sex for
drugs or money, persons with HIV infection and their
regular sex partners (e.g. concordant and discordant
couples), youth, men who have sex with men but do not
self-identify as gay or bisexual, and persons from
racial/ethnic minority populations, the homeless, or
the chronically mentally ill who continue to engage in
high risk behaviors.
During the course of the first year of the
collaborative study, a core set of measures developed
by the original three ERGs will be examined and revised
as necessary. The measures will be pilot tested for
each population as deemed necessary by the Steering
Committee. Investigators need to be ready to work
collaboratively to achieve this goal.
Investigators are encouraged to address in the
application the following:
o Justification for selection of group(s) or
community(s) for intervention
o Knowledge base concerning determinants and
patterns of HIV risk behaviors in the target
group(s)
o Relation of behavioral model chosen to the
culture-specific needs of the target population(s)
o Sample selection and retention methods, including
specification of exclusion criteria, anticipated
rate of refusal to participate, plans for
retaining sample in the study, anticipated
attrition, and statistical plans to handle
attrition
o Proposed sample's representativeness in relation
to the local population and the group as a whole
o Explanation and justification of procedures that
will be used to obtain participation and
information from hard-to-reach populations
o Measures of the current behavioral skills,
interpersonal interactions, and motivational
factors in the target population relevant to HIV-
related risk behaviors
o Plans for baseline assessments of relevant
demographic, psychosocial, psychiatric, and
behavioral risk factors and behaviors, including
description and justification of proposed measures
specific to individual, institutional, and
community level models
o Procedures for protecting the welfare of
participants, including protection of
confidentiality.
TARGET BEHAVIORS FOR INTERVENTION
Applicants should specify carefully and justify fully
the behavior targeted for change by the proposed
intervention. High-risk sexual and drug-using
behaviors that transmit HIV are the definitive targets
for prevention or behavior change. Intermediate
targets may include, but are not limited to, the
following: perception of risk; choosing partner on the
basis of serostatus; intentions to change; skills
training; modeling of behavior; self-efficacy;
perceived control; providing HIV-prevention
intervention in the context of primary health care; and
social norms. The combination of drug and alcohol use
has been correlated with high-risk behavior for HIV
infection and may be another target for preventive
intervention.
PROPOSED INTERVENTION
Applicants should document and specify collaboration
and coordination, where appropriate, with State and
local health departments, drug abuse agencies,
community-based organizations, and other research
activities supported by the Federal Government.
Applicants will have the opportunity to conduct
individually some unique aspects of their proposed
research. Description of the proposed intervention
strategies should include:
o Detailed description of intervention content
o Plans for standardization of intervention programs
o Linking of intervention content with proposed
behavioral model
o Justification of proposed intervention content to
achieve behavior change in individuals, dyads,
groups, communities, or other relevant grouping of
individuals affected by HIV
o Justification of how proposed intervention will
facilitate the development of necessary skills to
reduce risk for further HIV transmission
o Description and justification for duration of
intervention (e.g. in terms of number(s) of
sessions required to achieve desired outcome; or
for existing intervention programs, the number(s)
needed to add to existing program
o Plans to measure that the intervention was
delivered as planned and was effective
o Specification of components of their interventions
that are unique to their setting or population,
and specification of likely components in common
with other proposals that may be used in the
collaborative study
o Plans for ongoing quality control so that the
intervention is truly standardized.
INTERVENOR CHARACTERISTICS AND TRAINING
Applicants are encouraged to address in the application
the following:
o Description and justification of
characteristics/training of the intervenor for
individual, social network, couples, and
institutional interventions
o Plans for training intervenors, including the
development of training manuals, or the use of
existing training materials.
OUTCOMES
Applicants are encouraged to address the need for
process, outcomes, and impact studies. Process studies
examine the extent to which the program has been
implemented as designed. Outcome studies assess the
extent to which the programs have achieved their
desired effects. Impact studies analyze the extent to
which the programs have altered behaviors at the group
and community level. Of particular interest is whether
any intervention given over short periods of time will
have an effect on HIV status over longer periods of
time. It is also important to note that HIV status is
not strictly an outcome measure for these studies but a
moderating variable as well as an impact measure.
Applicants are also encouraged to address in the
application the following:
o Description and justification of proposed measures
and timing of specific short- and long-term
outcomes, including specific plans to measure
adverse unintended consequences of the
intervention
o Plans for process studies to determine the degree
to which the intervention effected mediating
measures
o Plans for long-term monitoring and/or follow-up
o Biological outcomes such as HIV serostatus,
presence of other sexually transmitted disease(s),
and measures obtained through drug/urine screening
programs
o Discussion of psychometric properties of proposed
measures
o Suitability of proposed measures for special
subgroups (e.g., racial/ethnic, subculture)
o Specific plans for developing new measures, if
necessary, including methods for validation
o Analytic plan to link specific outcomes with
specific component(s) of the intervention.
RESEARCH DESIGN AND PLANS FOR DATA ANALYSIS
Applicants should describe fully the proposed research
design and plans for data analysis. Emphasis should be
given to tracking causal relationships through the
proposed data analysis. Data analysis will include a
"common" component which will be conducted by the
Coordinating Center and may include a "unique"
component that will be conducted by the ERG. It is
expected that applicants will discuss both aspects of
the data analysis of their own data, differentiating
between the expected "unique" and "common" components.
Applicants are encouraged to address in the application
the following:
o Justification of research design
o Justification of sample selection and sample size
o Description and justification of data analysis
appropriate to the proposed research design, with
justification for data analysis that is not
statistical (e.g., ethnographic studies)
o Plans to link the theoretical model driving the
intervention and the proposed data analysis plan
o Plan to link process, outcome, and impact
assessments
o Plan to ensure confidentiality of data
o Statistical plans to link specific outcomes to
intervention components and intervenor
characteristics
o Plans for increasing validity of self-report data.
REVIEW CRITERIA
Applicants will be judged primarily on the technical
and scientific merit of the application submitted, on
their proposed approach to the project as a whole, on
their documented ability to conduct the essential study
components as outlined in this RFA, on the experience
of the investigators, and on demonstrated willingness
to collaborate with other study participants and NIMH.
Criteria for scientific/technical merit review of
applications will include the following:
o Significance and originality from a scientific and
technical standpoint of the goals of the proposed
research
o Qualifications and experience of the Principal
Investigator and proposed staff
o Adequacy of the conceptual and theoretical
framework for the research
o Demonstration of willingness to work
collaboratively to design common elements of the
study
o Evidence of familiarity with relevant research
literature
o Scientific merit of the research design,
approaches, and methodology
o Evidence of commitment from relevant participating
agencies
o Access to target population(s)
o Adequacy of the data analysis plan
o Adequacy of the existing and proposed facilities
and resources
o Identification of unique and common components of
the project, and discussion of the relationship of
methodology, data analysis, theoretical framework,
instrumentation, and other related issues
o Appropriateness of the budget, staffing plan, and
time frame to complete the project
o Adequacy of proposed procedures for protecting
human subjects.
AWARD CRITERIA
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 populations
o Balance among geographic areas
o Balance among preventive approaches
o Ability of Principal Investigator to work in a
collaborative process
o Overall fit of individual studies into a
collaborative study.
TERMS AND CONDITIONS OF AWARD
1. The subsection entitled ROLE OF THE STEERING
COMMITTEE will be made a part of the Terms and
Conditions of Award.
2. The subsection entitled ROLE OF THE NIMH
EXTRAMURAL STAFF AND OTHER FEDERAL STAFF will be
made a part of the Terms and Conditions of Award.
3. The subsection entitled ROLE OF THE COORDINATING
CENTER will be made a part of the Terms and
Conditions of Award.
4. The subsection entitled ROLE OF THE DATA
MONITORING BOARD will be made a part of the Terms
and Conditions of Award.
5. Any disagreement that may arise in scientific
matters that is not resolved by the normal
deliberations of the Steering Committee, or a
disagreement regarding collaboration between award
recipients and the NIMH Staff Collaborator, may be
brought to arbitration. An arbitration panel will
be composed of three members, one selected by the
Steering Committee (with the NIMH members not
voting) or by the individual awardee in the event
of an individual disagreement, a second member
selected by NIMH, and the third member selected by
the prior two members. This special arbitration
procedure in no way affects the awardee's right to
appeal an adverse action in accordance with PHS
regulations at 42 CFR part 50, subpart D and HHS,
Grant Administration Regulations at 45 CFR part
74, and HHS regulations at 45 CFR part 16.
These special Terms of Award are in addition to and not
in lieu of otherwise applicable OMB administrative
guidelines, HHS Grant Administration Regulations at 45
CFR Parts 74 and 92, at 42 CFR Part 52 "Grants for
Research Projects," and other HHS, PHS, and ADAMHA
grant administration policy requirements.
Cooperative agreements are awarded directly to the
applicant institution. Funds may be used only for
those expenses clearly related to and necessary to
carry out the project and must be expended in
conformance with the Public Health Service Grants
Policy Statement
SPECIAL REQUIREMENTS/ELIGIBILITY FOR APPLICANTS
Applications may be submitted by public or private
nonprofit or for-profit organizations such as
universities, colleges, hospitals, laboratories, units
of State or local governments, and eligible agencies of
the Federal Government. Women and minority
investigators are encouraged to apply.
Applications to become an ERG will be accepted from
foreign institutions only if the applicants provide
evidence of unique data or other unique opportunities
not available in a U.S. population. Applications from
domestic institutions may include a foreign component
(subcontract), if such a component provides access to
unique data or opportunities not otherwise available in
a U.S. population.
REVIEW PROCESS
The Division of Research Grants, NIH, serves as a
central point for receipt of applications for most
discretionary PHS grant programs. Applications
received under this RFA will be assigned to an initial
review group (IRG) in accordance with established PHS
Referral Guidelines. The IRGs, consisting primarily of
non-Federal scientific and technical experts, 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 may be based
on policy considerations as well as scientific merit.
Only applications recommended for approval by the
Council may be considered for funding.
Applications submitted in response to this announcement
are not subject to the intergovernmental review
requirements of Executive Order 12372, as implemented
through Department of Health and Human Service
regulations at 45 CFR Part 100 and are not subject to
Health Systems Agency review.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH/ADAMHA POLICIES CONCERNING INCLUSION
OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
Applications/proposals for NIH/ADAMHA grants and
cooperative agreements are required to include both
women and minorities in study populations for clinical
research, unless compelling scientific or other
justification for not including either women or
minorities is provided. This requirement is intended
to ensure that research findings will be of benefit to
all persons at risk of the disease, disorder, or
condition under study. For the purpose of these
policies, clinical research involves human studies of
etiology, treatment, diagnosis, prevention, or
epidemiology of diseases, disorders or conditions,
including but not limited to clinical trials; and
minorities include U.S. racial/ethnic minority
populations (specifically: American Indians or Alaskan
Natives, Asian/Pacific Islanders, Blacks, and
Hispanics).
ADAMHA recognizes that it may not be feasible or
appropriate in all clinical research projects to
include representation of the full array of U.S.
racial/ethnic minority populations. However,
applicants are urged to assess carefully the
feasibility of including the broadest possible
representation of minority groups.
Applications should include a description of the
composition of the proposed study population by gender
and racial/ethnic group, and the rationale for the
numbers and kinds of people selected to participate.
This information should be included in the form PHS 398
in Section 2, A-D of the Research Plan AND summarized
in Section 2, E, Human Subjects.
Applications should incorporate in their study design
gender and/or minority representation appropriate to
the scientific objectives of the work proposed. If
representation of women or minorities in sufficient
numbers to permit assessment of differential effects is
not feasible or is not appropriate, the reasons for
this must be explained and justified. The rationale
may relate to the purpose of the research, the health
of the subjects, or other compelling circumstances
(e.g., if in the only study population available there
is a disproportionate representation in terms of age
distribution, risk factors, incidence/prevalence, etc.,
of one gender or minority/majority group).
If the required information is not contained within the
application, the review will be deferred until it is
complete. Peer reviewers will address specifically
whether the research plan in the application conforms
to these policies. If gender and/or minority
representation/justification are judged to be
inadequate, reviewers will consider this as a
deficiency in assigning the priority score to the
application.
All applications/proposals for clinical research
submitted to ADAMHA are required to address these
policies. ADAMHA funding components will not award
grants that do not comply with these policies.
To provide more precise information to the treatment
community, it is recommended that publications
resulting from ADAMHA-supported research in which the
study population was limited to one sex for any reason
other than that the disease or condition studies
exclusively affects that sex should state, in the
abstract summary, the gender of the population studied,
e.g., "male patients", "male volunteers", "female
patients", "female volunteers."
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
Office for Protection from Research Risks (OPRR),
prospective awardee must file an Assurance of
Compliance with OPRR and establish or identify an
Institutional Review Board (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
(301-496-7005, 301-496-7041) to obtain preliminary
guidance on human subjects issues. When calling OPRR,
applicants should identify themselves as NIMH
applicants for RFA MH-91-06 Cooperative Agreement for
Multi-Site Trials of Behavioral Strategies to Prevent
the Further Spread of HIV Infection.
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.
AIDS IRB GUIDELINES
Applicants are advised to obtain from their IRB, a copy
of the "Guidance for Institutional Review Boards for
AIDS Studies," which was disseminated from the Office
for Protection from Research Risks (OPRR) on December
16, 1984. If a copy is not available locally, one may
be obtained from OPRR, Building, 31, Room 4B09,
National Institutes of Health, Bethesda, Maryland
20892 and by phone on (301) 496-7005. This office may
be consulted for advice on how to deal with difficult
human subjects protections issues in AIDS research.
These guidelines emphasize the special considerations
which must be taken into account in AIDS research and
stipulate some important protections which need to be
taken into account in the design of AIDS research
projects. One particularly important one is a
requirement that subjects be informed of the results of
AIDS antibody testing, if any such testing is done.
BUDGET
In Fiscal Year 1991, a minimum of $1.5 million will be
available for the entire Cooperative Agreement RFA for
Multi-Site Trials of Behavioral Strategies to Prevent
the Further Spread of HIV Infection. It is expected
that a minimum of three to five awards will be made to
new ERGs in Fiscal Year 1991. Applicants should submit
an adequately justified budget for each research
component in each of 12-month segments of the 5-year
project.
Phase I activities (incorporation of newly funded ERGs
into the multi-site study) should require participation
of personnel relevant to these efforts, particularly in
the area of study design. Travel costs for key ERG
staff to attend up to six meetings in the first year
(in Rockville, Maryland) should also be budgeted.
For Phase II (identification and enrollment of
subjects; studies to validate the proposed instruments;
and data analysis), detailed budget estimates should be
based on the applicant's proposed research plan.
Applicants should include travel costs for up to four
meeting in (in Rockville, Maryland) their budgets.
Phase III activities for the ERGs include conducting
the full-scale, multi-site, multi-population preventive
intervention trial. Two meetings per year are
anticipated during this final phase.
Applicants who are already receiving support for
studies which they wish to incorporate into their
cooperative agreement application should discuss their
plans, both scientific and budgetary, for including
them in the cooperative agreement during Phases II and
III. The scientific aspects will be subject to
Steering Committee agreement. The budgetary aspects
will be negotiated with the Institute staff to ensure
that there is no overlap of funding.
Because of the need for extensive collaborative work in
Phase I and the availability of funds for the project,
it may be necessary to adjust budget levels prior to
each phase. Therefore, funding for the three phases
may be subject to renegotiation between the Institute
staff and each of the awardees prior to the final award
of funds.
APPLICATION PROCESS
All applicants must use the grant application form
PHS 398 (rev 10/88). The number and title of this RFA,
MH-91-06, Cooperative Agreement for Multi-Site Trials
of Behavioral Strategies to Prevent the Further Spread
of HIV Infection, must be typed in item number 2 on
the face page of the PHS 398 application form. Write
(ERG) after the title in item number 2. When using the
PHS 398 application form to respond to this RFA,
applicants must affix the RFA label available in the
398 to the bottom of the face page. 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.
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 material:
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-15
Rockville, MD 20857
Telephone: (301) 443-4414
The completed application with one signed original and
twenty-one (21) permanent legible copies of the
completed application should be sent to the address
listed below. The number of copies of appendix
materials remains at six (6). Applicants who do not
submit 21 copies of their applications will be
requested to do so. Applications must be sent or
delivered to:
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Applicants who use express mail or a courier service
are advised to follow the carrier's requirements for
showing a street address. The address for the Westwood
Building is:
5333 Westbard Avenue
Bethesda, Maryland 20816
IT IS RECOMMENDED THAT TWO ADDITIONAL COPIES OF THE
APPLICATION BE SENT TO DR. ISA FERNANDEZ AT THE ADDRESS
LISTED BELOW. IT IS IMPORTANT TO SEND THESE TWO COPIES
AT THE SAME TIME THE ORIGINAL AND TWENTY-ONE COPIES ARE
SENT TO THE DIVISION OF RESEARCH GRANTS IN ORDER TO
ENSURE THAT THE PROJECTED REVIEW SCHEDULE WILL BE MET.
Applications must be received by May 22, 1991.
Applications received after this date will be returned
to the applicant without review.
TIMETABLE FOR APPLICATIONS
Application Receipt Date May 22, 1991
Initial Review June/July 1991
NIMH Advisory Council Review September 1991
Earliest Possible Start Date September 1991
PROGRAM INFORMATION
Potential applicants should contact Dr. Isa Fernandez
for consultation concerning submission of proposed
projects in response to this request, at the addresses
listed below:
Isa Fernandez, Ph.D.
Staff Collaborator, Office of AIDS Programs
National Institute of Mental Health
5600 Fishers Lane
Room 11C-18, Parklawn Building
Rockville, MD 20857
Telephone: (301) 443-7281
For fiscal and administrative matters, contact:
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane
Parklawn Building, Room 7C-15
Rockville, MD 20857
Telephone: (301) 443-4414