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