[Federal Register Volume 66, Number 141 (Monday, July 23, 2001)]
[Notices]
[Pages 38283-38285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01191]


Human Immunodeficiency Virus Prevention Intervention Research 
Studies--Efficacy of Condom Skills Building Demonstrations for Human 
Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) 
Prevention Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for efficacy of condom skills building demonstrations for HIV/
Sexually Transmitted Disease (STD) prevention. This program addresses 
the ``Healthy People 2010'' focus area of HIV.
    The purpose of the program is to study condom use skills-building 
demonstrations for HIV/STD prevention.

Research Topic

    This announcement seeks research applications aimed at developing 
and evaluating brief (30 minutes or less), condom skills-building 
interventions that can be conducted with groups of patients in waiting 
room settings. Refer to Attachment II in the application kit for 
additional background information on the research topic.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations and by governments and their agencies; that 
is, universities, colleges, research institutions, hospitals, other 
public and private nonprofit and for-profit organizations, State and 
local governments or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the 
Commonwealth of Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations, small, 
minority, women-owned businesses.

Additional Eligibility Requirements

    Eligible applicants must demonstrate:
    1. Access to a clinical laboratory capable of conducting urine-
based nucleic acid amplification tests (NAATs) for gonorrhea and 
chlamydia.
    2. For this study, the clinic(s) must have at least 180 incident 
cases of STD over six months among men and at least 180 incident cases 
of STD over six months among women. STDs among men include gonorrhea, 
chlamydia, non-gonococcal urethritis (NGU), cervicitis, trichomonas or 
syphilis. STDs among women include gonorrhea, chlamydia, NGU, 
cervicitis, trichomonas or syphilis.

    Note: Title 2 of the United States Code, Chapter 26, Section 
1611 states that an organization described in section 501(c)(4) of 
the Internal Revenue Code of 1986 that engages in lobbying 
activities is not eligible to receive Federal funds constituting an 
award, grant, cooperative agreement, contract, loan, or any other 
form.

C. Availability of Funds

    Approximately $700,000 is available in FY 2001 to fund 
approximately two to three awards. It is expected that the average 
award will be $240,000 per year, ranging from $190,000 to $290,000. It 
is expected that the awards will begin on or about September 30, 2001 
and will be made for a 12-month budget period within a project period 
of up to three years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

1. 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 funds available for HIV Prevention. Funds may not be used to 
provide direct medical care or prevention case management.

2. Funding Preferences

    Funding preference may be given to achieve geographical diversity 
for condom use skills-building demonstrations in a variety of 
locations.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the under 1. (Recipient 
Activities), and CDC will be responsible for the activities listed 
under 2. (CDC Activities).
    1. Recipient Activities:
    a. Form a Coordinating Committee including all recipients, to 
design, implement and evaluate project activities, and wherever 
appropriate, include participation of State and local health 
departments.
    b. Review the literature on (1) new condom technologies and (2) 
existing brief, waiting room interventions that have been used in STD/
HIV prevention and other health-related areas (e.g., family planning, 
smoking cessation).
    c. Based on existing research, conduct formative research that 
involves (1) brief, pilot studies to help develop a single condom-use 
skills-building intervention that can be conducted in a waiting room 
setting, and (2) brief, pilot studies developing new, less costly ways 
of following study participants for STD outcomes over time. Prior to 
implementation, pilot study proposals must be submitted to the local 
and CDC Institutional Review Boards (IRBs) for review and approval or 
deferral.
    d. Based on the results recipient pilot studies, the Coordinating 
Committee will develop a single research study protocol, quality 
assurance mechanisms, training tools, data collection instruments and 
techniques, specimen collection protocols, and data management 
procedures that will be used across sites.

[[Page 38284]]

    e. Identify, recruit, obtain informed consent, enroll, and follow 
for six months an adequate number of study participants as determined 
by the study protocol.
    f. Perform brief data collection as determined by the study 
protocol. Possible outcomes might include measures such as reported 
condom use in participants and sex partner(s), and characteristics of 
sex partners.
    g. Collaborate with one or more local clinical laboratories that 
have the capacity to conduct HIV tests and NAATs for detection of 
chlamydia and gonorrhea.
    h. Conduct data analysis with all collaborators and present and 
publish research findings.
    2. CDC Activities:
    a. Provide technical assistance, as needed, in the design and 
conduct of the research study.
    b. Submit the protocol to the CDC IRB for review and approval.
    c. Assist, as needed, in developing specific systems such as a 
randomization scheme, quality assurance and training procedures, and a 
data management system, as applicable, a single data set for the 
collaborators to use for data analysis.
    d. Collaborate, as needed, with investigators from the 
participating research sites to analyze, present and publish research 
findings.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to follow them in laying 
out your program plan. The narrative should be no more than 25 pages 
double-spaced, printed on one side, with one inch margins, and 
unreduced font.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget.

F. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB 0925-0001) 
(adhere to the instructions on the Errata Instruction Sheet for PHS 
398). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before August 27, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting 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 Special Emphasis Panel. (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 acceptable as proof of timely mailing.)
    Late: Applications which do not meet the criteria in 1. or 2. above 
will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
    1. Background and objectives (10 points): The degree to which the 
application includes a detailed review of the scientific and other 
literature pertinent to new condom technologies and condom skills-
building and other single session skills-building demonstrations for 
use in waiting room settings. The literature review should discuss the 
strengths and limitations of previous research in this area, including 
discussion of pros and cons of various research designs. The degree to 
which the application also includes one or more potential condom 
skills-building demonstrations from the literature that are brief (30 
minutes or less), feasible for use in waiting room settings, and 
acceptable for both men and women. Potential control conditions should 
also be described. Presentation of data on acceptability of the 
proposed intervention based on previous research, focus groups, or 
pilot studies would enhance the application.
    2. Site selection (25 points): The extent to which the application 
includes a description of the clinic in which the demonstrations are 
anticipated to be conducted, including waiting room characteristics, 
size of the clinic population (e.g., number of men and women aged 15-34 
years seen each month), and STD (gonorrhea, chlamydia, syphilis, NGU, 
cervicitis, or trichomonas) prevalence among men and women. Sufficient 
patient enrollment is estimated to be 60 to 80 STD-infected clients 
aged 15-34 years per month, of which at least 30 are women. Participant 
refusal should be taken into account. Previous research in STD clinic 
settings indicates that no more than 50% of eligible participants will 
enroll in a study with long-term follow-up for STD infection. 
Enrollment rates are typically lower for men than women; The extent to 
which the application also includes a description of the collaborating 
laboratory and its capabilities, including experience with new NAATs. 
The extent to which the application includes a description of the 
proposed investigators and their previous research in conducting brief, 
group interventions aimed at STD/HIV prevention, including condom-based 
interventions. Letters of support from cooperating organizations, 
including clinic, laboratory, and (if applicable) health department 
directors and other participating staff should be included, and these 
should detail the nature and extent of such cooperation. The letter 
from the clinic director should specifically address patient volume, 
STD control, and the number of patients that potentially could be 
enrolled in a specific time period.
    3. Methods (30 points): The extent to which the goals and 
objectives for the proposed research study are clearly stated and 
include a detailed discussion of the intervention(s) and control 
conditions, description of an appropriate study design, estimated 
sample size for men and women, and follow-up requirements using 
existing STD information.
    The extent to which the application includes a detailed description 
of: (a) One or more brief, waiting room interventions that involve 
condom use demonstrations that could potentially be studied; and (b) a 
control condition that could potentially be used.
    The extent to which the proposed intervention condition(s) includes 
supporting data on: The appropriateness of the intervention for the 
clinic and for the intended audience (including men and women), brevity 
(preferably less than 30 minutes), use of new condom technologies and a 
variety of condom types, use of appropriate and effective intervention 
techniques (e.g., role play scenarios, skills-building demonstrations 
as opposed to information-only approaches), feasibility and 
appropriateness of the intervention for waiting room settings, 
simplicity to allow existing staff to conduct the intervention, ease of 
the intervention in fitting in with current waiting room and clinic 
patterns, and discussion about how the proposed intervention(s) could 
be transferred to other high risk populations.
    The extent to which the application identifies potential barriers 
to implementing the intervention and how these will be overcome.
    The extent to which the application includes detailed methods for 
implementing and evaluating the intervention using a controlled design 
that minimizes bias (e.g., randomized controlled trial using group-
level or individual randomization). Sample size calculations should be 
presented, as

[[Page 38285]]

well as discussion of appropriateness of the sample size (separate 
evaluation for men and women).
    The extent to which the application includes a description of the 
outcome measures planned including new NAATs for gonorrhea and 
chlamydia and use of other outcomes (e.g., behavioral outcomes such as 
condom appeal and correct and consistent use, and process outcomes 
including quality assurance plans).
    In addition, applications will be evaluated on the degree to which 
the applicant has met the CDC Policy requirements regarding the 
inclusion of women, ethnic, and racial groups in the proposed research. 
This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with communities and recognition of mutual benefits.
    4. Research Capacity (20 points): The extent to which the 
application includes a description of the capacity and experience of 
the research team in prior interventions, including clinical and 
prevention trials, condom use research, skills-building demonstrations, 
outcomes research (e.g., laboratory capacity for nucleic acid 
amplification testing). Curriculum vitae's and position descriptions 
for key staff and project participants should be included. (Note: 
Previous experience in testing of condom efficacy in laboratory or in 
vitro settings would not be considered relevant experience).
    5. Evaluation Plan (15 points): The extent to which the application 
includes a detailed discussion of objectives for the pilot studies, and 
separate discussion for the intervention phase including enrollment and 
follow-up objectives. The extent to which plans for enrollment are 
clearly outlined, and discussion of means to reduce recidivism in 
follow-up is included. A detailed time-line should also be included.
    6. Budget (not scored): The extent to which the budget is 
reasonable, clearly justified, and consistent with the intent of the 
announcement.
    The 12 month budget should anticipate the organizational and 
operational needs of the study. The budget should include staff, 
supplies, and travel (including two trips per year for two members of 
the study team to meet with CDC staff and other investigators).
    7. Human Subjects (not scored): Does the application adequately 
address the requirements of 45 CFR part 46 for the protection of human 
subjects? (Not scored; however, an application can be disapproved if 
the research risks are sufficiently serious and protection against 
risks is so inadequate as to make the entire application unacceptable.)

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original and two copies of:
    1. Annual progress reports to be submitted with subsequent 
continuation applications;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act 
sections 317 (42 U.S.C. 241(a) and 247b); 301 (42 U.S.C. 241); and 311 
(42 U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance 
number is 93.941.

J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documentation, business management technical assistance may be obtained 
from: Annie Camacho, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Mailstop E-15, 
Atlanta, GA 30341-4146, Telephone: (770) 488-2735, Email address: 
[email protected].
    For program technical assistance, contact: Cassandra Walker, MPH, 
Acting Deputy Chief, Prevention Services Research Branch, Division of 
HIV/AIDS Prevention, Surveillance & Epidemiology, National Center for 
HIV, STD, TB Prevention, Centers for Disease Control and Prevention, 
1600 Clifton Road, Mailstop E-46, Atlanta, GA 30333, Telephone Number: 
(404) 639-6191, Email address: [email protected].

    Dated: July 17, 2001.
John L. Williams,
Director, Procurement and Grants Office Centers for Disease Control and 
Prevention (CDC).
[FR Doc. 01-18286 Filed 7-20-01; 8:45 am]
BILLING CODE 4163-18-P