[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]


=======================================================================
-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                   Form name             respondents    responses per     response
                                                                                    respondent        (hours)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P