[Federal Register Volume 66, Number 146 (Monday, July 30, 2001)]
[Notices]
[Pages 39318-39319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 01191]


Human Immunodeficiency Virus Prevention Intervention Research 
Studies--Efficacy of Condom Skills Building; Notice of Availability of 
Funds; Amendment

    A notice announcing the availability of Fiscal Year 2001 funds for 
Human Immunodeficiency Virus Prevention Intervention Research Studies--
Efficacy of Condom Skills Building was published in the Federal 
Register on July 23, 2001, (Vol. 66, No. 141, pages 38283-38285). The 
notice is amended as follows:
    On page 38284, Second Column, Under Section G. Evaluation Criteria, 
change to read:

    The quality of 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 applicant demonstrates knowledge in the area of condom use and 
skills-building demonstrations and understands the evaluation 
methodology (i.e., randomized controlled trial) that would be used 
in the project.
    The application should include 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 application should also include 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 applicant 
demonstrates adequate capacity to conduct the research study, 
including:
    a. Access to one or two existing clinical settings with a 
waiting room;
    b. Sufficient patient volume of ``new'' (i.e., not follow-up) 
visits among both men and women who are infected with either 
gonorrhea or chlamydia to allow evaluation of the intervention with 
urine-based nucleic acid amplification tests; and
    c. Access to an experienced laboratory capable of conducting 
urine-based nucleic acid amplification test for detection of 
gonorrhea and chlamydia.
    The application should include 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 application should also include a description of the 
collaborating laboratory and its capabilities, including experience 
with new urine-based nucleic acid amplification technologies. The 
application should include 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 appropriateness of the methods 
presented for developing, implementing, and evaluating the 
intervention.
    The goals and objectives for the proposed research study should 
be clearly stated and should 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 application should include 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 proposed intervention condition(s) should include supporting 
data on: the appropriateness of the intervention for the

[[Page 39319]]

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. Potential barriers to implementing the intervention and 
how these will be overcome should be discussed.
    The application should also include 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 well as discussion of appropriateness of the 
sample size (separate evaluation for men and women). In addition, 
the application should include description of the outcome measures 
planned including urine-based, nucleic acid amplification tests 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). (25 points)
    In addition, (5 points)
    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 experience of the 
applicant in similar clinical interventions, condom research, and 
HIV/STD prevention research, and availability of qualified and 
experienced personnel.
    The application should include 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 
applicant includes time-phased and measurable objectives for all 
phases of the proposed study (formative, intervention, and 
evaluation phases).
    The application should include a detailed discussion of 
objectives for the pilot studies, and separate discussion for the 
intervention phase including enrollment and follow-up objectives. 
Clear plans for enrollment should be outlined, and discussion of 
means to reduce recidivism in follow-up should be 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 up to 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 Title 45 CFR Part 46 for the protection 
of human subjects?

    Dated: July 24, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-18865 Filed 7-27-01; 8:45 am]
BILLING CODE 4163-18-P