[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29861-29863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-17CA]
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
[[Page 29862]]
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
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 the Centers for Disease Control and
Prevention (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
enhanced clinical outcomes and a substantially reduced risk of
transmitting HIV sexually, through drug sharing, or from mother to
child. However, it is estimated that only 30% 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 ART initiation, adherence,
sexual risk reduction, engagement in care, mother-to-child
transmission, and drug use. Second, this intervention is designed
specifically to support improved health outcomes by providing useful
behavior-change tips for patients to practice between clinic visits.
These tips are generated by the tool and selected by the patient and
populated on a handout that is delivered to the patient upon completing
the PHC intervention. The handout has no patient-identifying
information. Third, PHC supports patient-provider communication by also
generating a set of questions that patients may select to ask their
provider. These PHC behavior-change tips and questions are populated on
a Patient Handout to guide patients' conversations with their providers
and if desired, patients may choose to share their handout with their
provider. As such, PHC supports the interactions between patients and
their providers during their clinical encounter and is intended to
improve communication. Finally, the PHC intervention has been designed
from the onset for wide-scale dissemination. This web-based
intervention can be easily updated and is accessible on multiple mobile
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.
The PHC Evaluation Trial has four primary aims: (1.) Implement a
randomized trial to test the effectiveness 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 the
workflow of 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--Research Triangle International (RTI)--has
subcontracted with four clinical sites to implement the trial (Atlanta
VA Medical Center (Atlanta, GA), Hillsborough County Health Department
(Tampa, FL), Rutgers Infectious Disease Clinic (Newark, NJ) and
Crescent Care (New Orleans, LA). The four clinical sites) are well
suited for this work, given the high rates of patients with elevated
viral loads.
During the 36-month study 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.
Upon enrollment, participants will be asked their date of diagnosis. To
assess the effectiveness of the PHC intervention (Aim 1), 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 (EMR). 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 (Aim 2) which includes an online survey and
qualitative interviews. Clinic staff will provide data on the cost of
implementing the PHC intervention (Aim 3). Finally, the medical
director of each clinic will collect data on their clinic's standard of
care (Aim 4).
OMB approval is requested for three years. Participation in this
study is voluntary. The total estimated annualized burden hours are
419.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Patients Enrolled in the PHC Date of diagnosis 337 1 1/60
Evaluation Trial. question.
PHC tailoring questions. 168 3 5/60
Staff in PHC Evaluation Clinics....... Electronic Medical 4 4 16
Record (EMR).
Online clinic staff 20 4 15/60
survey.
Clinic staff qualitative 20 4 40/60
interview.
Non-research labor cost 4 1 1.5
questionnaire.
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PHC labor cost 4 1 1.5
questionnaire.
Standard of Care 4 1 1.5
Questionnaire.
PHC non-labor cost 4 12 30/60
questionnaire.
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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. 2017-13735 Filed 6-29-17; 8:45 am]
BILLING CODE 4163-18-P