[Federal Register Volume 63, Number 22 (Tuesday, February 3, 1998)]
[Notices]
[Pages 5555-5562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 813]
Research Studies Evaluating Demonstration Projects on Feasibility
of STD Treatment for HIV Prevention in the United States
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for a cooperative agreement
program for demonstration projects on the feasibility of STD treatment
for HIV prevention.
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of HIV Infection. (To
order a copy of ``Healthy People 2000,'' see the section WHERE TO
OBTAIN ADDITIONAL INFORMATION.
Authority
This program is authorized under Sections 301(a) and 317(k)(2) of
the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(2)], as
amended.
Applicable program regulations are set forth in 42 CFR Part 52,
entitled ``Grants for Research Projects.''
Smoke-Free Workplace
CDC strongly encourages all cooperative agreement recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products, and Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities that receive
[[Page 5556]]
Federal funds in which education, library, day care, health care, and
early childhood development services are provided to children.
Eligible Applicants
Eligible applicants are the direct recipients of Federal Sexually
Transmitted Disease/Accelerated Prevention Campaign (STD/APC) project
grants or HIV Prevention cooperative agreements. Eligibility is further
limited to areas with a gonorrhea case rate of more than 200 per
100,000 or a syphilis case rate of more than 9 per 100,000 (based on
National Surveillance Data) for calendar year 1996. The HIV prevention
program and STD prevention program within the same locale must
collaborate with each other and submit one application. These areas
are: Alabama, Arkansas, Baltimore, Chicago, Delaware, Georgia,
Louisiana, Maryland, Mississippi, North Carolina, Philadelphia, San
Francisco, South Carolina, Tennessee, Virgin Islands, and Washington,
D.C. These applicants have access to STD clinic and other clinic
populations at risk for HIV and other STDs and have continuing high
incidence of syphilis or gonorrhea.
Availability of Funds
Approximately $400,000 is available in FY 1998 to fund up to two
awards for demonstration projects on the feasibility of STD treatment
for HIV prevention. It is expected that the average new award will be
approximately $200,000 and will begin on or about April 1, 1998. Awards
will be funded for a 12-month budget period within a project period of
up to 2 years. Funding estimates are subject to change. Continuation
awards within the project period will be made on the basis of
satisfactory progress and the availability of funds.
Use of Funds
Funds are awarded for a specifically defined purpose and may not be
used for any other purpose or program. Funds may be used to support
personnel and to purchase equipment, supplies, and services directly
related to project activities. Funds may not be used to supplant State
or local health department funds or for inpatient care, medications, or
construction.
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352 (which has been in effect since
December 23, 1989), recipients (and their sub-tier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1998 Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act (Pub.
L. 105-78) states in Section 503(a) and (b) that no part of any
appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the preparation, distribution, or
use of any kit, pamphlet, booklet, publication, radio, television, or
video presentation designed to support or defeat legislation pending
before the Congress or any State legislature, except in presentation to
the Congress itself or any State legislature. No part of any
appropriation contained in this Act shall be used to pay the salary or
expenses of any grant or contract recipient, or agent acting for such
recipient, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.
Background
The AIDS epidemic continues in the United States with over 548,102
cases of AIDS, including 78,654 cases in females and 7,296 cases in
children reported to the CDC as of June 30, 1996. More than 275,000
persons are reported to be living with HIV infection. Both HIV cases
and HIV-associated deaths are expected to continue to increase over the
next decade. Surveillance data indicate that heterosexual transmission
accounts for an increasing number of new infections in the U.S. Among
women, heterosexual transmission was the most common exposure category
for new cases of AIDS reported in 1995-96, accounting for 41 percent of
cases. In addition, African Americans, Hispanics, women, adolescents,
and persons living in the Southeastern U.S. are increasingly
represented in both AIDS cases and new HIV infections.
Current evidence suggests that the growth in the heterosexual HIV
epidemic, particularly among the most vulnerable populations is, in
part, fueled by other STDs that increase transmission efficiency. STDs
in the HIV-uninfected increase their susceptibility to HIV; STDs in the
HIV-infected increase their likelihood of transmitting HIV to others.
Studies have demonstrated the increased risk of HIV seroconversion to
be associated with both genital ulcer disease (GUD) and non-ulcerative
STDs. HIV transmission has been associated with concurrent infection
with syphilis, herpes, chancroid, gonorrhea, chlamydia, or
trichomoniasis. STDs increase both the prevalence of HIV shedding and
the magnitude of HIV RNA in semen and cervico-vaginal secretions.
Treatment of the STD reduces the prevalence and magnitude of viral
shedding. For example, gonococcal infection increases quantitative
shedding of HIV RNA among men by about 10-fold, and treatment restores
HIV shedding to near baseline levels. Similar effects have been
demonstrated in HIV infected women with gonorrhea, chlamydia and
cervico-vaginal ulcers. The Mwanza trial, which randomized communities
in rural Tanzania to either their existing standard of care or an
intervention that established an infrastructure to diagnose and treat
STDs, found a 42 percent reduction in HIV incidence over 2 years in the
intervention communities. Sexual behavior and condom use remained
unchanged in the communities. Thus, there is compelling individual and
community-level evidence that treating STDs can decrease HIV
transmission.
Despite sound scientific evidence for treating STDs to prevent HIV,
the question remains how best to structure such an intervention in the
U.S. To effectively target STD treatment for HIV prevention in the
U.S., an intervention must target populations with a high incidence of
STDs and HIV. Because STDs increase both infectivity and
susceptibility, detection and treatment should target both HIV-infected
and HIV-uninfected persons. These projects will focus on both persons
infected with STDs who are reached by the health care system but not
diagnosed and treated (e.g., patients in clinical situations who do not
receive STD screening, diagnosis and treatment), and on persons not
reached by the health care system (e.g., because of asymptomatic
infection or problems of accessing health services). In this program we
are particularly interested in structural or other interventions aimed
at changing the environment. An intervention might include such program
elements as referral of HIV-infected and HIV-uninfected-at-risk persons
for STD care (e.g., screening, diagnosis and treatment for STDs),
increasing access to STD care, promoting risk assessment and screening
of persons asymptomatically
[[Page 5557]]
infected with STDs, diagnosing symptomatic STDs, ensuring effective
treatment and follow-up for STDs, including STD risk-reduction
counseling, and partner management for persons with STDs. Because
populations-at-risk may access health care settings that are not
providing the full array of services, study sites might include health
care settings that serve those at high risk. Additionally, since
populations-at-risk may not access health care, study sites might also
include non-health care venues where high-risk persons may be found.
The National Center for HIV, STD, and TB Prevention (NCHSTP) goals
are to:
1. Increase public understanding of, involvement in, and support
for, HIV, STD, and TB prevention.
2. Ensure completion of therapy for persons identified with active
TB or TB infection.
3. Prevent or reduce behaviors or practices that place persons at
risk for HIV and STD infection or, if individual is already infected,
place others at risk.
4. Increase individual knowledge of HIV serostatus and improve
referral systems to appropriate prevention and treatment services.
5. Assist in building and maintaining the necessary State, local,
and community support infrastructure and technical capacity to carry
out the necessary prevention programs.
6. Strengthen current systems and develop new systems to accurately
monitor the HIV epidemic, STDs, and TB, as a basis for assessing and
directing prevention programs.
Purpose
The purpose of this program is to evaluate the feasibility of
establishing an HIV prevention program in the U.S. that incorporates
effective STD screening, diagnosis and treatment, in addition to
existing HIV prevention services. Following the identification of
existing problems in HIV and STD services, those problems will be
prioritized, a protocol will be designed and implemented in a pilot
fashion to establish the feasibility of a health service intervention
package (focusing on STD treatment), and a set of evaluation tools will
be developed to measure the intervention's effectiveness. The
demonstration projects will likely form the basis for an expanded
future multi-site initiative, and provide important information on such
operational and evaluation issues as implementation, longitudinal
follow-up, data collection, and assessment of outcomes.
This project is conceived as a pilot effort to assess the
feasibility and likely prevention effectiveness of improving access to,
and the quality of, STD services for heterosexuals at risk of
transmitting HIV and of becoming infected with HIV. This project will
describe the feasibilities and barriers to improving and better linking
STD diagnostic and treatment services and HIV counseling, testing and
treatment services within a variety of settings (e.g., drug treatment
sites, STD clinics, HIV counseling and testing sites, prenatal and
family planning clinics, correctional facilities including juvenile
detention facilities, emergency medical and urgent care facilities,
adolescent clinics, school clinics, primary care settings in the
private sector, community health centers, existing outreach settings,
and potential new outreach settings).
In a defined population where high levels of HIV and STD coexist,
this project will have three phases consisting of: (I) An assessment
and prioritization phase; (II) an intervention and protocol development
phase; and (III) an implementation and evaluation phase.
In Phase I (to be accomplished in the first year of the project), a
community-based assessment will be conducted to determine who is at
highest risk within the community (i.e., who has HIV and STD, and who
has STD and is at risk for acquiring HIV), and how best to reach them.
This phase would focus on a review of the epidemiology of HIV and STD
trends in the community, on identifying where high-risk persons are
currently accessing health care and other social services, what types
of services are available (e.g., screening, diagnosis and treatment,
and counseling), and what are the gaps in available services. This
assessment could draw on existing data (e.g., through HIV community
planning data collection) or on newly collected data, and may include
data derived from public and private sources of care. Arising from this
assessment, a local prioritization process would be used to develop
Phase II activities. If most high-risk persons are utilizing health
care services but are not being screened, diagnosed, or treated, then
interventions will focus on improving the quality of STD care
(increasing screening and treatment in existing sites and developing
referral networks). If high-risk persons are not accessing health care
(for reasons including: asymptomatic infections, lack of knowledge
about STD status and need for care, perceived or actual barriers to
health care, etc.), then interventions will focus these specific
problems and include establishing new opportunities for provision of
services to expand access and utilization (e.g., increasing screening
and health services at correctional facilities, drug treatment centers,
or outreach settings).
In Phase II (to be accomplished by the end of the first year of the
project, with the exception of developing and testing the evaluation
criteria which is expected to extend into the second year of the
project), the intervention and protocol development phase,
interventions will be developed to address the specific priority needs.
Following development of the intervention, a study protocol will be
designed to test the feasibility, acceptability, operational
requirements of the interventions, and to develop an evaluation plan
including appropriate process and outcome measures for the
interventions. The protocol will include choice of sites,
implementation methods, use of comparison groups, and details of the
evaluation plan.
In Phase III (to be accomplished by the end of the second year of
the project), the implementation and evaluation phase, the model
intervention(s) will be implemented and evaluated in a pilot
feasibility study.
Program Requirements
In conducting activities to achieve this program, the recipient
shall be responsible for the activities listed under A. (Recipient
Activities), and CDC shall be responsible for conducting activities
listed under B. (CDC Activities).
A. Recipient Activities
1. Collaborate on Study Design for the Three Phases: Recipients
will meet together with CDC to discuss potential study designs and
formative research required to develop the study protocol, process, and
operations procedures.
2. Collaborate with Other Recipient and CDC During the Three Study
Phases: Collaboration will begin with approaches to study design aimed
at content, operations, and process of ultimately conducting the three
study phases. Collaboration will include (a) communication with CDC
staff and the other recipient, and (b) development of common study
protocols, common data collection instruments, common specimen
collection protocols, and common data management procedures. Recipients
will collaborate with each other in all quality control procedures, and
in regularly scheduled meetings and conference calls.
3. Conduct Productive and Scientifically Sound Studies: Recipients
will identify, recruit, obtain informed
[[Page 5558]]
consent forms, and enroll and follow to completion, a minimum of 500
participants as determined by the study protocol and the program
requirements. Recipients will perform laboratory tests as determined by
the study protocol, and will follow study participants over time as
determined by the protocol.
4. Share Data and Specimens: Recipients will share data and
specimens (when appropriate) with CDC to answer specific research
questions.
5. Collaborate on Publication of Results: Recipient researchers
will work closely with CDC staff to develop at least one publication
recording results from both sites for a peer-reviewed journal on the
study findings. Recipients will also, as appropriate and relevant,
develop secondary study hypotheses or site-specific hypotheses and for
these, analyze data gathered over the course of the study and in
collaboration with CDC staff, present and publish data.
Recipient Activities Specific to the Study Phases Will Include:
During Phase I (assessment and prioritization):
6. Identify Those with STDs (among HIV-infected and HIV-uninfected
persons): Within a defined population or geographic area, existing data
will be reviewed and new information may be obtained through surveys to
determine the extent of STDs and HIV in a study area, the demographic
characteristics of these populations of infected persons, and trends in
the epidemiology of STD and HIV. The focus should be on persons at risk
for acquiring STDs heterosexually.
7. Assess How Good the Current Health Care System Is at Reaching
and Providing Care for HIV and STD Infected Populations: This activity
will include determining where the STD infected population are getting
care, and what care they are getting (e.g., type and quality of care),
what services are actually available at the site to which they are
referred, where they are getting other services (e.g., social services,
drug treatment), and where else they might be found (e.g., correctional
facilities). Determine what can be done to increase the numbers of
infected (asymptomatic or symptomatic) persons who are diagnosed and
treated for STDs within the existing organizational infrastructure.
(This work could be done through individual and community level
analysis, including site surveys, and interviews with at-risk persons
(HIV/STD infected or uninfected) and service providers.)
8. Identify and Prioritize Needed Services and the Venues for These
Services: Evaluate the opportunity for improving the quality of
existing services. If additional services are needed, should they be
through direct on-site provision or via referral? If referral, how can
linkages be developed between sites to better coordinate service
delivery? (This work could be done through site observations, in-depth
interviews with community members and service providers, literature
review on direct service vs. referral models vs. other approaches to
coordinated service delivery.)
9. Identify Important Barriers, Including Patients' and Potential
Patients' Perceptions of the Barriers, for Those with STDs (HIV-
infected and HIV-uninfected) to Access Needed Services: Determine what
can be done to increase the numbers of symptomatic infected persons
diagnosed and treated, and to decrease the time it takes to receive
diagnostic and treatment services within the existing organizational
infrastructure. Determine what can be done to increase the numbers of
asymptomatic infected persons screened, diagnosed and treated. (This
work could be done through individual interviews and focus groups with
at-risk (HIV/STD infected or uninfected) persons, and with health and
social service providers and community planners and community-based
organizations.)
During Phase II (intervention and protocol development):
10. In Collaboration with Other Recipient, Design Model
Intervention(s) Based on the Specific Needs, as Identified and
Prioritized in Phase I.
11. In Collaboration with Other Recipient, Develop a Protocol to
Implement and Evaluate the Intervention(s) that Will Include Specific
Outcome Measures.
Phase III (implementation and evaluation):
12. Implement and Assess the Feasibility of the Intervention(s) to
Improve Delivery of and Access to High Quality HIV/STD Services.
13. Develop, Implement, and Test Evaluation Techniques for
Assessing Outcomes of a Future, Full Scale Demonstration Project:
Explore the use of behavioral outcomes, biological disease-related
outcomes (incidence of STD/HIV), and health services measures (such as
cost, utilization, access).
B. CDC Activities
1. Provide Technical Assistance and Coordination: CDC staff may
assist in the design and conduct of the research and provide
coordination of the project. The final design will be determined by a
collaborative process.
2. Provide Scientific Expertise: CDC staff will provide current
scientific and programmatic information relevant to the project, and
may provide technical assistance in the design and conduct of the
research (including plan, operations, and evaluation) throughout the
project. CDC staff will assist in designing a data management system
and may coordinate research activities among the different study sites.
CDC staff may also provide technical guidance in the development and
dissemination of study protocols, consent forms, and questionnaires.
3. Analyze Study Data and Coordinate Publication: CDC staff may
assist in the analysis of data gathered over the course of the study in
each site and in cross-site comparisons and may assist the recipients
to develop at least one overall publication describing the project
results.
4. Share Data and Specimens: CDC staff may assist in the
dissemination of study results and distribution of specimens.
5. Monitor and Evaluate Scientific and Operational Accomplishments
of the Project: This will be accomplished through periodic site visits,
telephone calls, and review of technical reports and interim data
analysis.
Technical Reporting Requirements
An original and two copies of semi annual progress reports must be
submitted no later than 30 days after the end of each 6-month budget
period. An original and two copies of a financial status report (FSR)
are required no later than 90 days after the end of each budget period.
A final progress report and FSR are due no later than 90 days after the
end of the project period. All reports are submitted to the Grants
Management Branch, Procurement and Grants Office, CDC.
Application Content
Applications must be developed in accordance with PHS Form 5161-1
(OMB Number 0927-0189), information contained in the program
announcement, and the instructions and format provided below.
Applicants are required to submit an original and two copies of the
application. Number each page clearly and sequentially, and provide a
complete index to the application and its appendices. The original and
each copy of the application set must be submitted UNSTAPLED and
UNBOUND. All material must be typewritten, double spaced, with
unreduced type on 8\1/2\'' x 11'' paper, with at least 1'' margins,
headings and footers, and printed on one side only. Materials which
should be part of the
[[Page 5559]]
basic application will not be accepted if placed in the appendices. The
application should not exceed 25 pages (exclusive of official PHS
application pages and relevant attachments).
Applicants for demonstration projects on the feasibility of STD
treatment for HIV prevention must demonstrate in the application an
ability to access persons infected with STDs or HIV, and persons at
high risk for acquiring STDs or HIV. Applicants must also demonstrate
an ability to provide appropriate HIV and STD prevention counseling and
HIV and STD testing for persons with STDs or at risk of acquiring STDs.
In addition, applicants must demonstrate an ability to enroll at least
500 participants per year, of whom at least 35 percent are women.
Applicants must demonstrate high prevalence of STDs (>15 percent) and
high prevalence of HIV (>2 percent) in STD clinic settings, an ability
to complete high rates of participant follow-up, collection and
handling of laboratory specimens, and collection of other relevant
data. Applicants must demonstrate cost-efficient local availability of
staff to complete data entry and data management. Applicants must be
willing to participate collaboratively with each other and with CDC in
conducting this research study.
The application must address the following:
1. Background
a. Describe the STD clinical and preventive health services
available in the community through both public and private sources of
care, including current collaboration between STD and HIV prevention
programs. Describe availability of STD services in HIV counseling and
testing (C & T) sites.
b. Describe the epidemiology of HIV, gonorrhea, chlamydia, and
primary and secondary (P&S) syphilis in calendar year 1996 for the
proposed project area.
c. Describe those at risk for heterosexually acquired STDs and HIV,
and their access to health care. Information on the percentage
uninsured, unemployed, under the poverty level, and those receiving
public assistance is desirable.
d. Include additional background on any health care policies and
additional environmental and socio-demographic factors that may be
relevant to the study of STD services. Examples include privatization
of categorical STD clinics, existing or pending Federal Medicaid
waivers, existing contracts, memoranda of understanding, agreements or
arrangements between health plans and health departments.
2. Objectives
Provide a focused research agenda with long-term and short-term
objectives that are realistic, specific, measurable, time-phased, and
consistent with the objectives of the announcement.
3. Site Selection
Applicants must document access to populations with high syphilis
or gonorrhea rates and high HIV prevalence rates. High HIV prevalence
rates can be documented by surveys such as job corps, other
seroprevalence surveys (e.g., among patients attending STD clinics,
adolescent clinics, drug treatment centers, and among incarcerated
populations), or survey of child bearing women data.
Define a research site based on specific information included in
the background. Provide information on participating clinics and
community programs in the project area. Include available information
on monthly and annual numbers of clinic patients and their STD and HIV
prevalence rates, and STD and HIV prevalence rates in persons
participating in community programs in the project area.
Emphasis will be placed on applicant's demonstration of access to
relevant clinic populations and community program populations such as
adolescents, women, minorities, and Medicaid populations.
4. Methods
Describe the methods and activities that will be undertaken to
accomplish the objectives, including, when possible, outcomes to be
evaluated (i.e., health services-related outcomes, program-related
outcomes, or STD and HIV specific health-related outcomes), the use of
appropriate comparison groups, the sampling scheme and sample size
calculations, qualitative and quantitative methods, and how data will
be accessed, collected, and used. The methods should address the
different phases (Phase I, II & III) of the project. Provide a detailed
time line with beginning and end dates for each phase, with the
anticipation of completing Phase I and part of Phase II in the first
year of the project and all of Phases II & III in the second year of
the Project.
5. Evaluation Plan
Provide an evaluation plan to monitor the effectiveness of the
project activities and the progress made toward meeting the objectives.
6. Research Capacity
Provide evidence of research capability. Describe past and current
research experience, including the experience of the proposed staff who
will participate in this project (include details of experience and
competence in research design, data collection, analysis and
dissemination). Attach the curriculum vitae of key staff. Describe your
plan for project administration including details of the proposed
collaboration between STD clinic and program staff and HIV program
staff. The research team should include qualified and experienced
personnel in epidemiology, health services research, and behavioral
science, and the team should have a demonstrable balance of experience
in STD management and HIV prevention. The eligible applicants are
encouraged to collaborate with other organizations such as colleges,
universities, research institutions, hospitals and other public and
private organizations to carry out project activities. Minimum
requirements for the research team are a principle investigator,
project supervisor, and staff capable of providing data collection,
data management, laboratory support, and clerical services.
7. Letters of Support
Because each eligible locale can submit only one application, a
Letter of Support is required by each Project Director, if the HIV
prevention program and STD prevention program are administered
separately.
8. Budget
Provide a detailed, line-item annualized budget for the first year
of the Project which should cover Phase I in its entirety (as defined
above) and part of Phase II and a budget narrative that justifies each
line-item. Provide a summary budget for the second year of the Project
covering the remaining part of Phase II and all of Phase III.
The budget should anticipate the need for appropriate staff (noted
above in ``6. Research Capacity''), travel for principal investigator
and project supervisor to meet with CDC two times per year, travel for
outreach, supplemental needs related to STD and HIV clients and their
longitudinal participation, and other needs. The budget should allocate
at least 50 percent of resources to the STD prevention program
activities (e.g., screening, diagnosis, treatment, and counseling for
STDs).
Evaluation Criteria
Applications for demonstration projects on the feasibility of STD
treatment for HIV prevention will be reviewed and evaluated according
to the following criteria:
[[Page 5560]]
1. Background and Objectives (5 Points)
Understanding of purpose and objectives of this research and its
relation to national program goals as reflected in the statement of
research background and research questions.
2. Site Selection (25 Points)
The extent to which the choice of the project area and specific
clinic and community sites to conduct this research will be
generalizable to other settings or populations, and is appropriate to
the local and national objectives, STD and HIV epidemiology, social
demography, and health care system. Emphasis will be placed on
demonstrated access to populations at high risk for heterosexual
transmission of STDs and HIV in the project area, particularly persons
who currently may not be reached by the health care system. Evidence of
high gonorrhea, syphilis, and HIV prevalence should be demonstrated.
Prevalence of other STDs might also be demonstrated. Highest points
will be given to applications demonstrating the capacity to enroll a
substantial number of participants at risk for STDs and HIV (>500
persons annually) and undertake longitudinal follow-up of these
persons.
Consideration will also be given to the extent to which the
proposed site includes appropriate participation of women and racial
and ethnic minority populations.
3. Methods (25 Points)
The appropriateness and adequacy of the research design and
methodology proposed to answer the research questions. This includes:
(a) The selection of appropriate outcomes related to health services,
STD and HIV programs, and STD morbidity; (b) the use of appropriate
comparison groups; (c) the inclusion of appropriate sampling schemes,
sample size calculation, handling of sampling biases; (d) access to the
relevant data sources and the plan for data collection; and (e) the
description of the specific quantitative and qualitative analytic
technique to be used to answer the research questions.
4. Evaluation (20 Points)
The extent to which the applications present a sound evaluation
plan that includes aspects such as: Research progress measurements and
communications, baseline data collection; intervention(s) testing,
ability to measure specific intervention outcomes (including but not
exclusively STD and HIV outcomes); and economic evaluation.
5. Research Capacity (25 Points)
Overall ability to perform the technical aspects of the project
including: (a) The availability of qualified and experienced personnel
for a multi-disciplinary team in health services research including
level of education and training, and relevant research experience of
the principle investigator and key research personnel; (b) the
availability of adequate facilities, general environment, and resources
for the conduct of the proposed research; (c) assurance that staff can
be hired within 4 months of award of monies; (d) plans for the
administration of the project(s), including a detailed and realistic
time line for the specified activities; (e) details of the proposed
project-level collaboration between STD clinic and program staff and
HIV program staff; and, (f) demonstration of the applicant's ability,
willingness, and need to collaborate with CDC and researchers from
other study site in study design and analysis, including use of common
study protocols and data collection instruments, and (when appropriate)
sharing of data and specimens.
6. Budget (not Scored)
The appropriateness of budget estimates in relation to the proposed
research. The extent to which budget is reasonable, clearly justified,
and consistent with the intended use of funds. The budget should
allocate at least 50 percent of resources to the STD prevention program
activities. (e.g., screening, diagnosis, treatment, and counseling for
STDs).
7. Human Subjects (not Scored)
The extent to which the applicant complies with the Department of
Health and Human Services Regulations (45 CFR Part 46) regarding the
protection of human subjects.
Funding Preferences
CDC reserves the right to make final funding selections based on
geographic diversity and applicants with higher documented prevalence
of STDs and HIV in proposed clinic study sites.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local governmental review of proposed Federal
assistance applications. Applicants should contact their State Single
Point of Contact (SPOC) as early as possible to alert them to the
prospective applications and receive any necessary instructions on the
State process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on application submitted to CDC, they
should send them to Adrienne S. Brown, Acting Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE, Atlanta, Georgia 30305, no later than 60 days after the
application deadline date. The Program Announcement Number and Program
Title should be referenced on the document. The granting agency does
not guarantee to ``accommodate or explain'' State process
recommendations it receives after that date.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance Numbers are: 93.941, HIV
Demonstration, Research, Public and Professional Education Projects;
and 93.978, Preventive Health Services Sexually Transmitted Diseases
Research, Demonstration, and Public Information and Education Grants.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
Human Subjects
This program involves research on human subjects. Therefore, all
applicants must comply with the Department of Health and Human Services
Regulations, 45 CFR Part 46, regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
[[Page 5561]]
HIV Program Review Panel
Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires,
Survey Instruments, and Educational Sessions (June 1992) (a copy is in
the application kit). To meet the requirements for a program review
panel, recipients are encouraged to use an existing program review
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review
panel, at least one member must be an employee (or a designated
representative) of a State or local health department. The names of the
review panel members must be listed on the Assurance of Compliance form
CDC 0.1113, which is also included in the application kit. The
recipient must submit the program review panel's report that indicates
all materials have been reviewed and approved.
Patient Care
Applicants should provide assurance that all STD or HIV-infected
patients enrolled in the proposed studies will be linked to an
appropriate local care system that can address their specific needs
such as medical care, counseling, social services, and therapy.
Women, Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian or Alaskan Native, Asian, Black or African American,
Native Hawaiian or Other Pacific Islander, and Hispanic or Latino.
Applicants shall ensure that women, racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist
that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to
research studies when the investigator cannot control the race,
ethnicity or sex of subjects. Further guidance to this policy is
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,
dated Friday, September 15, 1995.
Confidentiality
Recipients must have confidentiality and security provisions to
protect data collected through HIV/AIDS surveillance, including copies
of local data release policies; employee training in confidentiality
provisions; State laws, rules, or regulations pertaining to the
protection or release of surveillance information; and physical
security of hard copies and electronic files containing confidential
surveillance information.
Recipients must describe any laws, rules, regulations, or health
department policies that require or permit the release of patient
identifying information collected under the HIV/AIDS surveillance
system to entities outside of the public health department and measures
the health department has taken to ensure that the confidentiality of
individuals reported to the surveillance system is protected from
further or unlawful disclosure.
Application Submission and Deadlines
1. Preapplication Letter of Intent (LOI)
A non-binding letter of intent-to-apply is requested from potential
applicants. An original and two copies of a two-page, typewritten LOI
should be submitted to the Grants Management Branch, CDC (see
``Applications'' for address). It should be postmarked no later than
February 13, 1998. The letter should identify the announcement number,
title of the specific research activity for which application is being
submitted, the name and institutional affiliation of the principal
investigator, and the identity of other key participants and
participating institutions. No attachments, booklets, or other
documents accompanying the LOI will be considered. The letter should
also include the estimated total cost of the research activity and the
percentage of the total cost being requested from CDC. The LOI does not
influence review or funding decisions, but it will enable CDC to plan
more efficiently, and will ensure that each applicant receives timely
and relevant information prior to application submission.
2. Applications
An original and two copies of the application Form PHS 5161-1
(Revised 7/92, OMB No. 0937-0189) must be submitted on or before March
13, 1998 to Adrienne S. Brown, Acting Grants Management Officer,
Attention: Kathy Raible, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,
Mail Stop E-15, Atlanta, GA 30305.
3. Deadlines
A. Applications will meet the deadline if they are either:
1. Received on or before the deadline date; or
2. Sent on or before the deadline date and received in time for
submission to the objective review committee. (Applicants must request
a legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks shall not be accepted as proof of timely mailing.)
B. Applications that do not meet the criteria in 2.A.1. or 2.A.2.
above are considered late applications. Late applications will not be
considered in current competition and will be returned to the
applicant.
Where To Obtain Additional Information
A complete program description and information on application
procedures, are contained in the application package. Business
management technical assistance may be obtained from Kathy Raible,
Grants Management Specialist, Grants Management Branch, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., Room 300, Mail Stop E-15, Atlanta, Georgia
30305, telephone (404) 842-6649, or via email at: kcr8@cdc.gov>.
Programmatic technical assistance may be obtained from Mary Kamb,
Division of HIV/AIDS Prevention, National Center for HIV/STD/TB
Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC),
1600 Clifton Road; Mailstop E-46, Atlanta, Georgia 30333, telephone
(404) 639-2080, or via email at: mlk5@cdc.gov>, or Kathleen Irwin,
Division of STD Prevention, NCHSTP, CDC, 1600 Clifton Road; Mailstop E-
07, Atlanta, Georgia 30333, telephone (404) 639-8276, or via email at:
kli1@cdc.gov>.
Please refer to announcement number 813 when requesting information
and submitting an application.
The announcement will be available on one of two Internet sites on
the publication date: CDC's home page at http://www.cdc.gov>, or at
the Government Printing Office home page (including free access to the
Federal Register) at http://www.access.gpo.gov>.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full
[[Page 5562]]
Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' (Summary
Report, Stock No. 017-001-00473-1) referenced in the ``INTRODUCTION''
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: January 27, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-2571 Filed 2-2-98; 8:45 am]
BILLING CODE 4163-18-P
