[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69683-69684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28471]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-16CM; Docket No. CDC-2015-0097]
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. CDC is requesting a new three-year approval for
``The Cooperative Re-engagement Controlled Trial (CoRECT)'' information
collections.
DATES: Written comments must be received on or before January 11, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0097 by any of the following methods:
Federal eRulemaking Portal: Regulation.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
The Cooperative Re-engagement Controlled Trial (CoRECT)--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Division of HIV/AIDS Prevention (DHAP) requests a new three-year OMB
approval for information collection for a new research study entitled
``The Cooperative Re-engagement Controlled Trial (CoRECT)''. The
purpose of the study is to evaluate a combined health department and
clinic intervention to improve engagement in HIV care.
[[Page 69684]]
Increasing the number of people living with HIV who access HIV care and
achieve viral load suppression addresses one of the priorities of the
National HIV/AIDS Strategy.
The CoRECT Study data collection is comprised of six core
components: 1. Electronic clinic data abstraction (Electronic Medical
Record (EMR) abstraction will be conducted by project clinic staff at
each project clinic to develop the clinic-based ``Out of Care'' list;
2. electronic surveillance data abstraction (Electronic surveillance
data abstraction will be conducted by project health department staff
at each health department to develop the health department based ``Out
of Care'' list); 3. a ``Barriers to Care'' survey (These surveys will
provide information regarding barriers to accessing healthcare (e.g.,
transportation, financial assistance, housing, substance abuse
services, etc.); 4. ``Standard of Care'' survey (Investigators will
administer this survey to clinic managers, at baseline and every six
months during the study period to assess how the delivery of health
services has evolved over time) 5. Preliminary Case Investigations form
(a listing of potential out-of-care patients will be reviewed to
determine those who appear to be out-of-care, as determined by study
eligibility, versus those who meet criteria for exclusion); and 6) Case
Conference form (project health department staff will determine if
potentially eligible patients met criteria for inclusion in the study
and if so randomization will occur).
Prospective data collection will provide information about
participant's baseline characteristics including sex, race/ethnicity,
HIV exposure risk category, CD4 and viral load test results, date of
first clinic visit, and insurance status.
HIV antiretroviral therapy (ART) can durably suppress the plasma
HIV viral load, which improves individual survival and dramatically
reduces further HIV transmission. Increasing the number of people
living with HIV who access HIV care and achieve viral load suppression
is a priority of the National HIV/AIDS Strategy. Within the continuum
of HIV care in the United States, improvements in linkage to and
retention in effective care provide the greatest opportunity to improve
rates of HIV viral suppression. It is estimated that of the 1.2 million
persons living with HIV in 2011, only 40% were engaged in HIV medical
care and only 30% achieved viral suppression.
HIV clinical trials with enhanced case management have demonstrated
that interventions provided by the health department can improve
linkage to HIV care and interventions provided by the clinic can
improve retention in HIV care. Although linkage to care has improved in
many health department jurisdictions, being linked to care is not
enough. There is a need to ensure that: (i) People diagnosed with HIV
and linked to care are engaging medical care (i.e., attending their
enrollment appointment and returning for follow-up medical
appointments); and (ii) people who have disengaged from HIV care (i.e.,
have missed medical appointments and have not been seen in clinic for
more than 6 months) are able to efficiently re-engage in care. There
have been no randomized controlled studies using a Data-to-Care
approach to identify and re-engage out of care persons. Controlled
studies such as the CoRECT study are critical to determine the
effectiveness of HIV prevention interventions.
The CoRECT study is a randomized controlled trial that seeks to
establish a data-sharing partnership between health departments and HIV
care clinical providers to identify HIV-infected persons who are out of
care and evaluate an intervention that aims to have randomized
participants: (a) Link to an HIV clinic; (b) remain in HIV medical
care; (c) achieve HIV viral load suppression within 12 months; and (d)
achieve durable HIV viral load suppression over 18 months.
The study is funded by CDC through cooperative agreements with the
Connecticut State Department of Public Health (in collaboration with
Yale University School of Medicine), the Massachusetts State Department
of Public Health, and the Philadelphia Department of Public Health.
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 (in hours) hours
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Study Coordinator............. Electronic 3 4 1 12
transmittal of
surveillance
variables.
Clinic data manager........... Electronic 46 4 1 184
transmittal of
clinical
variables.
CoRECT study Participants..... Barriers to Care 1,200 1 30/60 600
Survey.
Clinical Nurse Coordinator.... Standard of Care 46 2 45/60 69
Survey.
Clinic data manager........... Case Conference 46 12 1 552
Session.
CoRECT study Coordinator Case Conference 3 12 1 36
(health department). Session.
CoRECT study Coordinator Preliminary Case 3 12 1 36
(health department). Investigation.
Clinic Data Manager........... Preliminary Case 3 12 1 36
Investigation.
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Total..................... ................ .............. .............. .............. 1,525
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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. 2015-28471 Filed 11-9-15; 8:45 am]
BILLING CODE 4163-18-P