[Federal Register Volume 78, Number 210 (Wednesday, October 30, 2013)]
[Notices]
[Pages 64942-64943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-14-13GX]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to [email protected]. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
by fax to (202) 395-5806. Written comments should be received within 30
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
This research is funded by the CDC and the National Institute of
Mental Health (NIMH). The purpose of the project is to implement and
evaluate an HIV clinic-based intervention, the goals of which are to
increase the percentage of patients who have an undetectable viral
load, who are adherent to antiretroviral therapy (ART), who attend
clinic regularly for primary care, and practice safer sexual behaviors.
Realizing these goals will promote HIV patients' health and reduce risk
of transmitting HIV to others. 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 university-affiliated HIV
clinics in the United States: (1) Baylor College of Medicine, Houston,
(2) Boston Medical
[[Page 64943]]
Center, (3) University of Alabama, Birmingham, (4) University of
California at San Diego, (5) University of Miami Medical School, and
(6) University of Washington in the state of Washington. 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 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. The total
annualized burden hours are 3,378.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response
respondent (hours)
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Data manager at clinic............. Electronic transmittal of 6 4 24
clinical variables
archived in clinic
databases (no form).
Patient............................ Behavioral screener 6,315 4 5/60
(patients with detectable
or undetectable VL; paper
form).
Patient............................ CBI assessment items for 2,069 3 5/60
patients with detectable
VL (electronic form).
Patient............................ Patient exit survey 1,200 1 5/60
(electronic form).
Primary care provider.............. Provider survey (electronic 120 4 10/60
form).
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LeRoy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2013-25711 Filed 10-29-13; 8:45 am]
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