[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12494-12496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05235]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-16CM]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

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).

[[Page 12495]]

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. 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 data collection is authorized under the Section 301 
of the Public Health Service Act (42 U.S.C. 241).
    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. a ``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. a Participant Eligibility 
Disposition 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. a 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. The 
total burden hours are 1,731.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
CoRECT Study Coordinator..............  Electronic transmittal                 3               4               1
                                         of surveillance
                                         variables.
Clinic Data Manager...................  Electronic transmittal                46               4               1
                                         of clinical variables.
CoRECT Study Participants.............  Barriers to Care Survey.           1,200               1           30/60
Clinical Nurse Coordinator............  Standard of Care Survey.              46               2           45/60
Clinic Data Manager...................  Case Conference Session.              46              12               1
CoRECT study Coordinator (health        Case Conference Session.               3              12               1
 department).
CoRECT Study Coordinator (health        Participant Eligibility                3              12               1
 department).                            Disposition form.
Clinic data manager...................  Cost analysis form--                  46               1               1
                                         baseline.
CoRECT Study Coordinator..............  Start-up cost analysis                 3               1               1
                                         form--Health department.
Clinic Data Manager...................  Start-up Cost Analysis                46               1               1
                                         form--Clinic.
CoRECT Study Coordinator..............  Annual Costs Analysis                  3               2             1.5
                                         form-Health department.
Clinic Data Manager...................  Annual Costs Analysis                 46               2             1.5
                                         form--Clinic.
----------------------------------------------------------------------------------------------------------------



[[Page 12496]]

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. 2016-05235 Filed 3-8-16; 8:45 am]
 BILLING CODE 4163-18-P