[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9923-9924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03196]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-13GX]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA
30333 or send an email to [email protected].
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Assessment of a Comprehensive Human immunodeficiency virus (HIV)
Clinic-Based Intervention to Promote Patients' Health and Reduce
Transmission Risk--New--National Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is requesting Office of Management and Budget (OMB) approval to
collect data that will be used to evaluate an HIV clinic-based
intervention to increase the number of HIV patients who (1) have
undetectable levels of HIV in their blood, (2) adhere optimally to
antiretroviral therapy (ART), (3) attend clinic regularly for primary
care, and (4) practice safer sex. These are objectives of the National
HIV/AIDS Strategy and goals of the strategic plan of the Division of
HIV/AIDS Prevention, Centers for Disease Control and Prevention.
The project will be conducted at six HIV clinics in the United
States. This proposed data collection will occur over 3 years.
The intervention that is part of this project focuses primarily on
HIV patients who have a detectable viral load, i.e., their viral load
is not as low as it can be and is not fully controlled. The
intervention components include: (1) Brief counseling from medical
providers during primary care visits informed by a behavioral screener
completed by patients; (2) a computer-based intervention (CBI) in which
patients see short videos of HIV medical providers (not their own
providers) talking about the importance of regular clinic attendance,
adherence to ART, and safer sex; and (3) one-on-one counseling from a
prevention specialist if needed.
The following data will be collected in this project:
A data manager at each clinic will electronically transmit
patient clinical data to CDC using a unique study identification code
as the only means of identifying a patient's data. The data files sent
to CDC will not contain any medical record numbers, names, or social
security numbers. The information will be encrypted and stored in a
secure CDC server. The data
[[Page 9924]]
collected from patients include (1) a behavioral screener self-
administered by patients each time they have a primary care visit.
Patients complete the screener in the waiting room before seeing their
primary care provider. (2) CBI assessment items on demographic factors,
clinic attendance, ART status, ART adherence, and sexual risk behavior
that are completed before patients see the CBI videos. Patients with
detectable viral loads will be asked to do the CBI three times, spaced
approximately three months apart. Patients' CBI responses are not
shared with their clinic providers. (3) On a quarterly basis, 50
patients at each clinic will be asked to complete a brief exit survey
after their medical exam, asking about topics that the provider may
have discussed with them at their medical visit (e.g., adherence,
clinic attendance).
Data collected from primary care medical providers
includes a quarterly survey asking them to indicate the types of
topics/issues they discussed with their HIV patients.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (hours) hours
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Data manager at clinic......................... Electronic transmittal of clinical 6 4 24 576
variables archived in clinic databases
(no form).
Patient........................................ Behavioral screener (patients with 6,315 4 5/60 2,105
detectable or undetectable VL; paper
form).
Patient........................................ CBI assessment items for patients with 2,069 3 10/60 1,035
detectable VL (electronic form).
Patient........................................ Patient exit survey (electronic form).. 1,200 1 5/60 100
Primary care provider.......................... Provider survey (electronic form)...... 120 4 10/60 80
Total...................................... ....................................... .............. .............. .............. 3,896
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Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-03196 Filed 2-11-13; 8:45 am]
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