NIMH COLLABORATIVE HIV/STD PREVENTION TRIAL

Release Date:  April 15, 1999

RFA:  MH-99-011

P.T.

National Institute of Mental Health

Letter of Intent Receipt Date: May 15,1999
Application Receipt Date: June 23, 1999

PURPOSE

The National Institute of Mental Health (NIMH) is requesting co-operative
agreement applications for AIDS Collaborative Teams (ACTs) to participate in an
international multi-site, multi-population prevention study to be conducted in
four different countries in the developing world (low- and middle-income
countries).  Applications are also being sought for a Data Coordinating Center
(DCC) which must be based in the U.S.

The United States has a vital and direct interest in the health of people
globally.  This interest derives from a long and enduring tradition of
humanitarian concern and the increased participation of the U.S. population in
a global environment.  Because of international mobility, disease and illness
respect no political borders.  International collaborations can have a bi-
directional benefit and lead to scientific advances in biomedical and behavioral
research that can improve the health of U.S. citizens as well as global health
generally.

Many of the countries in which there is an expected increase in HIV
seroprevalence in the next five years are in resource-poor areas (e.g.,
developing countries (low- and middle-income countries) in Eastern Europe,
Africa, Asia, and South America).  Many of these countries have populations that
are illiterate and live in areas without adequate communication systems.  This
RFA solicits applications to adapt a community-level public opinion leader
intervention that is an excellent prevention strategy for these conditions.

This approach has been tested in the U.S. with multiple populations (Kelly et
al., The Lancet, 350(90), 1500-1505, 1997.)  In this intervention public opinion
leaders who already exist in the community are trained to spread effective
culturally appropriate HIV/STD prevention messages adapted to their neighbors. 
This is an HIV/STD prevention program that can be adapted to different cultural
conditions, can be delivered by members of the community, and relies on word of
mouth and social influence.  The program is also cost-effective.
Based on ethnographic studies conducted during the first phase of the study in
each of the four site countries, the intervention will be adapted to the
different cultural conditions in the countries and pilot tested.  Then, a full
study will be conducted and evaluated.  This multisite effort will permit
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.

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 Program Announcement (PA), NIMH
Collaborative HIV/STD Prevention Trial, 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://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

Applications for AIDS Collaborative Teams (ACTs) 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.  The study must be
conducted in a developing country (low- and middle-income) and U.S. organizations
that apply must have considerable collaborative experience in the site.  An
application from a non-U.S. organization must be based in the developing country
where the study is proposed to be conducted.  Applications for the Data
Coordinating Center (DCC) must be a U.S.-based organization with experience in
clinical/prevention research in (low- and middle-income) countries. Applications
from racial/ethnic minority and women investigators are strongly encouraged. 

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be a
cooperative agreement (U10).  Details of the responsibilities, relationships, and
governance of the study to be funded under this cooperative agreement are
discussed later in this document under the sections entitled "Terms and
Conditions of Award."

The total project period for applications submitted in response to the present
RFA may not exceed 5 years. The anticipated award date is September 30, 1999. 
Awards and level of support depend on receipt of a sufficient number of
applications of high scientific merit.  Although this program is provided for in
the financial plans of the Institute, awards pursuant to this RFA are contingent
upon the availability of funds for this purpose.  This RFA is a one-time
solicitation.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.2 million in total support in FY 1999
to fund a total of four new awards to support AIDS Collaborative Teams (ACTs)
(either domestic or foreign organizations) to conduct this study in four
different international sites (non-U.S.).  It is also anticipated that one award
for approximately $500,000 in total support will be made for one Data
Coordinating Center (DCC) which must be a U.S. based organization.

RESEARCH OBJECTIVES

Background

Most theories of individual behavior change emphasize the importance of social
norms as determinants of behavior.  Community-level interventions using opinion
leaders are an effective means of changing social norms within a community
(Rogers, E. M., Diffusion of Innovation, 1983).  One strategy--based on the
theory of diffusion of innovations--has proven effective for promoting changes
in risk behavior associated with HIV transmission (Kelly, et al., Lancet,
350(90), 1500-1505, 1997).  This approach identifies and trains natural opinion
leaders in a community in four sessions to endorse the benefits of HIV risk
behavior change to community members during everyday conversations.

Utilizing opinion leaders is an intervention that focuses on community members
as the solution rather than the problem.  This strategy is appropriate for
communities where there are not sophisticated systems delivery capability that
is usually required to mount an effective primary prevention effort.  This
intervention model adapts to community needs and mores because it is delivered
by community insiders--the opinion leaders--in the language of the community. 
The most direct influences on perceived norms of appropriate behavior are the
actions of friends and the values they endorse.  While in most cultures sexual
practices are considered private, people can talk about safer sex and influence
others' beliefs about the norms, values, and acceptance of safer sex.  In
addition to being feasible in diverse communities, this prevention strategy is
also cost-effective because few resources are needed to reach large numbers of
people.

While most diffusion studies prior to 1962 were conducted in U.S. and Europe, in
the later 1960s there was an explosion of diffusion investigators who effectively
conducted studies in developing areas in Latin America, Africa, and Asia.  The
classical diffusion model was applied to the process of socioeconomic development
and was used to evaluate agriculture, family planning, public health, and
nutrition programs.  NIMH now wants to take advantage of ten years of experience
with HIV/STD diffusion studies in the U.S. by testing the intervention in
different geographic and cultural settings.

Objectives

The objectives of this RFA are to: (1) adapt this public opinion leader
community-level intervention model in four different developing countries (low-
and middle-income countries); (2) develop a draft protocol for the intervention
study that will be modified based on the results of the ethnographic and pilot
studies; (3) assess the effectiveness of this intervention strategy using both
behavioral and biological outcomes (HIV/STD incidence); and (4) document the
procedures to adopt and adapt a community-level intervention to different
cultural groups and settings that will be a prototype for the technology transfer
process for this intervention internationally.

Investigators submitting an application to become an AIDS Collaborative Team are
encouraged to address the following components in their application: a literature
review that demonstrates an understanding of the theory of diffusion and the
public opinion leader intervention; identification of a target population and
defined recruitment community; the epidemiology of HIV/STDs in the target
population; and a well-designed ethnographic study.  For more details, see the
section on the APPLICATION PROCESS.

Applicants submitting an application to become the Data Coordinating Center
should provide a detailed plan for data collection, data management, and data
analysis; a proposal for a communication system to link all the ACTs, site
countries, Project Scientist, and DCC. For more details, see the section on
APPLICATION PROCESS.  Applicants should apply ethnographic findings to an
appropriate adaptation of the intervention.

Study Management Components

The following study management components will be responsible for conducting the
trial; they are defined below and in greater detail in the section on Terms and
Conditions:  (1) AIDS Collaborative Teams (ACTs); (2) Data Coordinating Center
(DCC); (3) Project Scientist; and (4) Steering Committee.

1.  AIDS Collaborative Teams (ACTs).  This is the designation for each of the
four awardees for this RFA and includes the PI and his/her research team both in
the U.S. and in the site country where the study is being conducted.

2.  Data Coordinating Center (DCC). The DCC provides overall study coordination,
including data management and analysis and training in common procedures.

3.  Project Scientist.  This the designation of the NIMH program person who
participates in the conduct of the study as defined in the Terms and Conditions.

4.  Steering Committee. This is the primary governing body of the trial and is
composed of the principal investigator of the DCC, the principal investigators
of each ACT, a co-Principal Investigator from the site country of each of the
ACTs, and the NIMH Project Scientist

Timetable

The following activities will be distributed over the five years of the study. 
Phase I: conduct ethnographic studies in each country where study will be
conducted; develop draft study protocol for trial, including intervention
sessions, baseline survey, etc.  Phase II: conduct pilot study of intervention;
finalize study protocol.  Phase III: Conduct trial.  Phase IV: Data analysis and
preparation of publications.

TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award statement
and provided to the Principal Investigator(s) as well as the institutional
official at the time of award:

The administrative and funding instrument used for this program is a cooperative
agreement (U10), an assistance mechanism in which substantial NIH scientific and
programmatic involvement with the awardee is anticipated during performance of
the activity.  Under the cooperative agreement, the NIH purpose is to stimulate
the awardee's activity and work collaboratively in a partner role, but it is not
to assume direction, prime responsibility, or a dominant role in the activity. 
Consistent with this concept, the dominant role and prime responsibility for the
activity resides with the awardees for the project as a whole, although specific
tasks and activities in carrying out the studies will be shared among the
awardees and the NIMH Project Scientist.

1.  Awardee Rights and Responsibilities

AIDS Collaborative Teams (ACTs). Each of the Principal Investigators of the four
AIDS Collaborative Teams (ACTs) will have primary and lead responsibilities for
the conduct of the study in their sites, including research design and protocol
development, ethnographic study, recruitment of Community Public Opinion Leaders
(C-POLs), training, baseline and 12-month survey, data collection, quality
control/quality assurance, interim data and safety monitoring, final data
analysis and interpretation, preparation of publications with assistance from the
NIMH Project Scientist.  All participating ACTs 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.  They are responsible for obtaining all clearances required by the
country where the study is being conducted.  Data will be submitted centrally to
the Data Coordinating Center.  The study protocol will define rules regarding
access to data and publications. Awardees will retain custody of and have primary
rights to the data developed under these awards, subject to Government rights of
access consistent with current HHS, PHS, and NIH policies.

Data Coordinating Center (DCC). The DCC 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 DCC
coordinates the pilot testing of the multisite study and the full implementation
of the study.  The DCC will develop and maintain a common data repository,
containing common data files needed by the study participants.  If possible, the
DCC will develop Audio-CASI (Audio Computer-Assisted Self-Interviewing
System)programs to ensure efficient, accurate, and cost effective data
collection.  The DCC must be prepared to establish teleconferencing or other
technical means to facilitate rapid and easy communications among members of the
Steering Committee and the ACTs within country sites.  The DCC will conduct all
the data analysis required to prepare reports and papers.  The DCC will present
an oral progress report at each of the meetings scheduled by the Data Safety and
Monitoring Board (DSMB)(probably twice a year).

NIMH staff (Director and Program Officer, Office of AIDS Research, NIMH) will
work with and monitor the DCC.  The DCC will work closely with the Steering
Committee but will have the primary responsibility for convening meetings of the
Steering Committee and ensuring that the meetings are efficient and meet the
planning objectives.

2.  Staff Responsibilities

Project Scientist.  The NIMH Project Scientist will have substantial scientific
and programmatic involvement during conduct of this Trial, through technical
assistance, advice and coordination above and beyond normal program stewardship
for grants.  The dominant role and prime responsibility for the activity resides
with the awardees for the project as a whole, although specific tasks and
activities in carrying out the Trial will be shared among the ACTs, DCC, and the
Project Scientist.  The NIMH Project Scientist will have voting membership on the
Steering Committee and will  participate in the development of the study
protocol, quality control/quality assurance procedures, data analysis and
interpretation, and the preparation of publications.  The NIMH Project Scientist
and all other participants are subject to the publication and authorship policies
that are developed by the Steering Committee as part of the final study protocol
as well as publication policies.

Program Officer.  The NIMH Program Officer has usual stewardship responsibility
for monitoring the conduct and progress of the project.  The Program Officer
carries primary responsibility for periodic review and approval of the study
protocol in relation to stated objectives and recommendations regarding
continuance of the program.  The Program Officer monitors the DCC, receives all
required reports, and determines that satisfactory progress is being made.  The
Program Officer seeks Data Safety and Monitoring Board (DSMB) consultation on
issues concerning the conduct and progression of the study.

NIMH retains the right to terminate or curtail the study in the event that, e.g.,
recruitment goals are not achieved in a timely fashion, quality control
procedures are not adhered to, or other major breach of the study.

Data Safety and Monitoring Board (DSMB).  The Director of the Office of AIDS
Research and the Program Officer will establish a Data Safety and Monitoring
Board (DSMB) to serve as an independent and external expert board that
periodically reviews the conduct of the study.  The Board assists NIMH in
reviewing the final study protocol and recommending modifications to the study
protocol during the conduct of the study in order to meet its scientific
objectives.  Additionally, the Board monitors progress on the data and technical
aspects and assists the Program Officer in dealing with operational aspects of
the study.

NIMH will conduct an independent review of the protocol prior to the beginning
of Phase III of the project; the protocol will require NIMH approval before
implementation.

3.  Collaborative Responsibilities

Steering Committee. The primary governing body of the study is the Steering
Committee, composed of the principal investigator of the DCC, the principal
investigators of each ACT, a co-Principal Investigator from the site country of
the ACTs, and the NIMH Project Scientist.  It is the intention to have
representation from each of the four country sites on the Steering Committee. 
If the PI of the ACT is from the United States, a designated Co-PI from the site
country will participate on the Steering Committee.  If the award is to a PI in
the developing (low- and middle-income) country where the study is being
conducted, both the PI and a designated Co-PI will participate on the Steering
Committee.  The Steering Committee has primary responsibility for developing the
study protocol, facilitating the conduct of the study, and preparing written
reports of  the study results for the Program Officer, Director of the NIMH
Office of AIDS Research and the DSMB.  The Steering Committee also develops
policies on the data sharing and on access to data and materials subject to NIMH
review.

All decisions by the Steering Committee on the scientific and policy aspects of
the study are made by majority vote.  The Steering Committee will be convened as
soon as possible after the awards are made (probably in October, 1999 in
Washington, DC).  In years 1 and 2 it is estimated that as many as six three day
meetings in the four sites where the Trial is being conducted and two in
Washington, DC will be needed to plan the ethnographic studies, adapt the
intervention, and develop the study protocol.  In years 3, 4, and 5, meetings
will be held approximately four times each year.  This schedule of meetings may
be modified based on the requirements of the scientific management of this study.

Publications will be written and authorship decided by using procedures developed
by the NIMH Multisite HIV Prevention Trial.  The authorship of the principal
papers of this study will be published under the masthead of the NIMH
Collaborative HIV/STD Prevention Trial.  The quality of publications resulting
from the study will be the responsibility of authors; no NIMH clearances will be
required.

The Steering Committee, working with the DCC, is required to prepare reports for
submission to the Program Officer, Director of the Office of AIDS Research, and
the DSMB when requested.  An annual progress report on all activities is required
to be prepared by the Steering Committee annually.

4.  Arbitration Process

Any disagreement that may arise in scientific/programmatic matters, which is not
resolved by the normal deliberations of the Steering Committee, regarding
collaboration among the DCC, ACTs, and the NIMH Project Scientist on programmatic
issues may be brought to arbitration.  An arbitration panel will be composed of
three members, one selected by the Steering Committee (with the NIMH Project
Scientist 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  NIH grant administration policy requirements.

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).

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:
https://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:
https://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 for ACTs and DCC are strongly encouraged to submit a
letter of intent that includes the following: (1) the title of study (NIMH
Collaborative HIV/STD Prevention Trial); (2) the name, address, and telephone
number of the Principal Investigator; and (3) the identities of other key
personnel.  Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information that it
contains allows Institute staff to estimate the potential review workload and
avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Willo Pequegnat listed under INQUIRIES
by the letter of intent receipt date listed in the heading of this RFA.

Supplemental material is also available to assist prospective applicants in
preparation of their research proposal by contacting Dr. Pequegnat.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  Application kits 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:
[email protected].  Applications are also available on the World Wide Web at:
https://grants.nih.gov/grants/forms.htm.

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.  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, "NIMH Collaborative HIV/STD Prevention Trial," MH-99-011, 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  20816 for express/courier service)

At the time of submission, two additional copies of the application should be
sent to:

Willo Pequegnat, Ph.D.
Associate Director for Prevention and Translational Research
Office of AIDS Research
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 6205, MSC 9619
Rockville, MD  20852-9619

Applications must be received by June 23, 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
announcement 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 a substantial revision of an application
already reviewed, but such an application must follow the guidance in the PHS
Form 398 application instructions for the preparation of revised applications,
including an introduction addressing the previous critique.

Investigators submitting an application to become an AIDS Collaborative Team are
encouraged to address the following components in their application.  There
should be a discussion of the relevant research literature and theory of
diffusion of innovations and how it would fit in the culture of the country.  The
application should discuss the epidemiology of HIV/STD in the community and site
in which they would propose to conduct the study and why it is well suited for
the community-level public opinion intervention.  The application should
demonstrate some understanding of the risk behaviors of the target population and
some evidence that it will be possible to collect baseline and follow up survey
data from this population.  There should be a discussion of the process by which
community public opinion leaders would be identified in this community. 
Applicants should also present plans for disseminating findings and participating
in a data archive.

The application should present a well-designed ethnographic study that can be
completed during the first phase of the study that will specifically elucidate
HIV/STD risk behaviors in the group, suggest norm change messages, and
appropriate trial outcomes.

The draft protocol for the Public Opinion Leader Model Intervention should
include general objectives and types of activities to be included in the
intervention.  Sample size must be sufficient to provide adequate statistical
power to the study.

The qualifications of the principal investigator (U.S. or site country), co-
principal investigator from the site country, and proposed staff should be
described.  There should be special attention to their qualifications to conduct
HIV prevention research, community-level interventions in HIV prevention, and/or
community-level interventions in other health behavior areas.  There should be
evidence that some members of the team have experience tailoring assessment
measures and interventions to different cultural groups.

The application should demonstrate an active willingness to work collaboratively
to implement this community-level intervention in different countries.  There
should be strong evidence that in the host country the Ministry of Health and
other significant gatekeepers that can facilitate conduct of the study support
this effort.  The application should provide an understanding of the clearances
that are required to conduct research in the site country and to collect
biological specimens.  There should be a clear recognition of potential problems
of conducting research in this setting and alternative tactics for resolving
problems.

There should be a description of the existing and proposed facilities and
resources of the country where the study will be conducted to handle a research
team.  The budget, staffing plan, and resources to complete the trial should be
described and fully justified.

Applicants submitting an application to become the Data Coordinating Center
should address the following issues.

The application should demonstrate previous experience and an understanding with
large-scale data collection efforts for a behavioral prevention study, especially
that in international settings.  The plan for data management for this
international collaborative trial should be described in detail.  A plan to
demonstrate the safeguarding of confidentiality of the data should be detailed.
The application should propose a communication system that can be implemented in
developing countries in order to network the study sites on a continuous basis
for conference calls and exchanging data.  The application should also describe
the plans for coordination and training of site personnel and the implementation
of quality control/quality assurance procedures.

The qualifications and experience of the principal investigator and proposed
staff in statistics, data analysis, and training in common research procedures
should be described.  The adequacy of existing and proposed facilities and
resources of the applicant organization should be discussed.  An appropriate
budget, staffing plan, and time frame to carry out the proposed activities should
be proposed.

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, all applications will receive a written critique and may undergo
a process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review by the
National Advisory Mental health Council.

Review Criteria for AIDS Collaborative Teams (ACTs)

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 the willingness to
collaborate with other ACTs and NIMH.  The specific criteria are:

(1) Significance:  How does the application address the goals of the RFA?  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, and appropriate to the aims of the project and state of the
art?  Does the proposal provide evidence of an understanding of the theory of
innovations?  Is the ethnographic study well grounded in theory?  Is the most
rigorous research design possible proposed, given that a full range of research
proposals, from preliminary research to large scale studies, has been encouraged? 
Does the applicant acknowledge potential problem areas and consider alternative
tactics?

(3)  Study Samples: Are the samples sufficiently rigorously defined to permit
complete independent replication at another site?  Have the criteria for
selecting the target population been adequately articulated?  Does the population
and venue lend itself to the intervention proposed in the RFA?

(4)  Innovation:  Does the project employ novel concepts, approaches or methods? 
Are the aims consonant with the RFA?

(5)  Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Specifically, is there evidence that the investigators have
experience tailoring assessment measures and interventions to different cultural
groups?  Is the work proposed appropriate to the experience level of the
principal investigator and other researchers in both the U.S. and in the site
country?  Is there demonstration of the willingness of the investigators to work
collaboratively to implement this cooperative study?

(6)  Feasibility:  Do plans for implementing the planned intervention include
procedures for: obtaining and maintaining the necessary community relations,
training and supervising staff, insuring implementation fidelity, securing
ongoing access to the subject population pool, recruiting a representative sample
of the target population, recruiting minorities for the staff of the research
intervention, and monitoring subject participation over time?  Is there evidence
of support in the host country from the Ministry of Health and other significant
gatekeepers that can facilitate conduct of the study and an understanding of the
clearances that are required to conduct research in the site country?

(7)  Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Does the proposed experiment take
advantage of unique features of the scientific and community environment, or
employ useful collaborative arrangements?  Is there evidence of institutional
support?

(8)  Dissemination:  What plans have been articulated for disseminating findings
and participating in a data archive?

In addition to the criteria listed above, the initial review group will examine
the appropriateness of the proposed budget and duration; the adequacy of plans
to include both genders, minorities (and their subgroups), and children as
appropriate for the scientific goals of the research, and plans for the
recruitment and retention of subjects; the provisions of the protection of human
and animal subjects; and the safety of the research environment.

With regard to ethical issues, what provision has been made for reporting
suspected abuse and/or neglect as governed by applicable laws and regulations? 
How does the applicant plant to handle issues of confidentiality and compliance
with mandated reporting requirements/

Review Criteria for Data Coordinating Center (DCC)

(1)  Qualifications and experience of the principal investigator and proposed
staff in statistics, data analysis, and training in common research procedures

(2)  Demonstration of previous experience with large-scale data collection
efforts for a behavioral prevention study

(3)  Appropriateness of plans for coordination and training of site personnel

(4)  Appropriateness of the plan for data management for this international
collaborative trial

(5)  Feasibility and efficiency of the communications system proposed to be
implemented in order to network the study sites on a continuous basis for
conference calls and exchanging data

(6)  Demonstration of a plan to safeguard confidentiality of data

(7)  Adequacy of existing and proposed facilities and resources

(8)  Appropriateness of the budget, staffing plan, and time frame to carry out
the proposed activities

AWARD CRITERIA

Award criteria that will be used to make award decisions for ACTs include:

(1)  Scientific and technical merit

(2)  Availability of funds

(3)  Comparability and balance of populations among international sites in order
to ensure a successful collaborative program

(4)  Geographic balance among sites (preference will be given to a combination
that has one ACT from each of the following areas: South America, Asia, Africa,
and Eastern Europe)

(5)  Comparability of the seroprevalence of HIV/STDs in the countries (low
seroprevalence with the potential of very high seroincidence)

Award criteria that will be used to make award decisions for DCC include:

(1)  Must be U.S. based organization

(2)  Quality of proposed center as determined during the review process

(3)  Evidence of capability and expertise in data collection, storage,
management, and analysis in behavioral prevention studies

(4)  Evidence of necessary training capability

(5)  Strong evidence of managing a multisite study and monitoring a quality
control/quality assurance program

(6)  Experience in international research with biological specimens

SCHEDULE

Letter of Intent Receipt Date:    May 15, 1999
Application Receipt Date:         June 23, 1999
Peer Review Date:                 August 1999
Council Review:                   September 1999
Earliest Anticipated Start Date:  September 30, 1999

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:

Willo Pequegnat, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6205, MSC 9619
Bethesda, MD  20892-9619
Telephone: (301) 443-6100
FAX: (301) 443-9719
Email: [email protected]

Direct inquiries regarding fiscal matters to:

William Caputo
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6123, MSC 9605
Bethesda, MD  20892-9605
Telephone: (301) 443-0004
FAX:  (301) 443-6885
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.242.  Awards are made under authorization of the Public Health Service 5600
Fishers Lane 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.  Awards will be administered under PHS policy as stated
in the NIH Grants Policy Statement (October 1, 1998).

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.

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