[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76590-76591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17CA]; Docket No. CDC-2016-0105]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project entitled ``Positive Health Check 
Evaluation Trial.'' CDC is requesting a three-year approval for a data 
collection effort designed to evaluate effectiveness of the Positive 
Health Check (PHC) online tool created by RTI and CDC. This CDC and 
Research Triangle Institute (RTI) developed tool delivers tailored 
evidence based prevention messages to HIV positive patients, on 
improving clinical outcomes and retention in care of HIV positive 
patients with unsuppressed viral loads. This data collection is also 
designed to assess the feasibility of implementing the intervention in 
clinics and the cost of the intervention.

DATES: Written comments must be received on or before January 3, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0105 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Positive Health Check Evaluation Trial--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    HIV transmission continues to be an urgent public health challenge 
in the United States. According to CDC, approximately 1.2 million 
people are living with HIV, with close to 50,000 new cases each year. 
Antiretroviral therapy (ART) suppresses the plasma HIV viral load (VL) 
and people living with HIV (PLWH) who are treated with ART--compared 
with those who are not--have a substantially reduced risk of 
transmitting HIV sexually, through drug sharing, or from mother to 
child. However, it is estimated that only 19% to 28% of people who are 
infected with HIV in the United States have an undetectable HIV VL. To 
enhance HIV prevention efforts, implementable, effective, scalable 
interventions are needed that focus on enhancing prevention and care to 
improve the health of and reduce HIV transmission risk among PLWH. The 
Positive Health Check (PHC) intervention is based on earlier computer-
based interventions that were proven efficacious for HIV prevention.
    The PHC intervention approach is innovative in multiple ways. 
First, it uses an interactive video doctor to deliver tailored messages 
that meet specific patient needs related to adherence, sexual risk 
reduction, engagement in care, mother-to-child transmission, and drug 
use. Second, this intervention is designed specifically to support 
patient behavior change by providing useful tips to practice between 
visits. These tips are patient driven and populated on a handout while 
patients use the PHC intervention, thereby increasing engagement and 
the likelihood of success. Third, PHC supports patient-provider 
communication by also generating a set

[[Page 76591]]

of questions that patients would like to ask their provider. These 
behavior change tips and questions are also populated on a Patient 
Handout that patients may share with their provider. As such, PHC 
supports patients and providers during their clinical encounter and 
promotes communication. Finally, the PHC intervention has been designed 
from the onset for wide-scale dissemination. Its flexible digital 
strategy provides access on multiple devices and platforms. This 
approach makes PHC an important intervention strategy to improve public 
health in communities that have a high incidence of HIV infection.
    This data collection has four primary aims: (1) Implement a 
randomized trial to test the efficacy of the PHC intervention for 
improving clinical health outcomes, specifically viral load and 
retention in care; (2)conduct a feasibility assessment to determine 
strategies to facilitate implementation and integration of PHC into HIV 
primary care clinics; (3) collect and document data on the cost of PHC 
intervention implementation; and (4) document the standard of care at 
each participating clinic. The awardee of this cooperative agreement is 
RTI. RTI has subcontracted with four clinical sites to implement the 
trial. The sub-contractors are the Atlanta VA Medical Center (Atlanta, 
Georgia), Hillsborough County Health Department (Tampa, Florida), 
Rutgers Infectious Disease Practice (Newark, New Jersey), and Crescent 
Care (New Orleans, Louisiana). The four clinical sites are well suited 
for this work, given the high rates of patients with elevated viral 
loads.
    During the 24-month implementation period, 1,010 patients will be 
enrolled into the trial (505 intervention arm and 505 control arm) 
across the four clinics to evaluate the effectiveness of the PHC 
intervention. To assess the effectiveness of the PHC intervention, 
patients randomized to the intervention arm will provide their 
responses to the patient tailoring questions embedded within the 
intervention and all enrolled patients will consent to have their de-
identified clinical values be made available via passive data 
collection via the electronic medical record. In addition to the main 
trial, three to five key staff at each clinic site will be selected to 
participate in the PHC feasibility assessment which includes an online 
survey and qualitative interviews.
    Finally, clinic staff who participate in the implementation of the 
PHC intervention will provide data on the cost of implementing the PHC 
intervention. It is estimated that the total burden hours for all data 
collection activities is 315.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Number of      Average burden   Total response
               Type of respondent                              Form name                 Number of      responses per     per response      burden (in
                                                                                        respondents       respondent       (in hours)         hours)
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Persons eligible for study......................  PHC intervention trial consent....              505                1             5/60               42
                                                  Staff online survey consent.......               20                1             5/60                2
Enrolled participants...........................  PHC tailoring questions...........              505                3             5/60              126
                                                  Online clinic staff survey........               20                3            15/60               15
                                                  Clinic staff qualitative interview               20                3            40/60               40
                                                  Non-research labor cost                          12                3            75/60               45
                                                   questionnaire.
                                                  PHC labor cost questionnaire......               12                3            75/60               45
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    Total.......................................  ..................................  ...............  ...............  ...............              315
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Leroy A. 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. 2016-26501 Filed 11-2-16; 8:45 am]
 BILLING CODE 4163-18-P