82 FR 52309 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Assessing Client Factors Associated With Detectable HIV Viral Loads; and Models of Care and the Ryan White HIV/AIDS Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 217 (November 13, 2017)

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52309-52311]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Assessing Client Factors 
Associated With Detectable HIV Viral Loads; and Models of Care and the 
Ryan White HIV/AIDS Program

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
has submitted an Information Collection Request (ICR) to the Office of 
Management and Budget (OMB) for review and approval. Comments submitted 
during the first public review of this ICR will be provided to OMB. OMB 
will accept further comments from the public during the review and 
approval period.

DATES: Comments on this ICR should be received no later than December 
13, 2017.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Assessing Client Factors 
Associated with Detectable HIV Viral Loads and Models of Care and the 
Ryan White HIV/AIDS Program.
    OMB No.: 0906-xxxx--NEW.
    Abstract: The Ryan White HIV/AIDS Program (RWHAP), first authorized 
by the U.S. Congress in 1990, is administered by HRSA's HIV/AIDS Bureau 
(HAB). The RWHAP provides medical services, treatment, and/or support 
services to 533,036 clients in 2015; 97.0 percent of these clients were 
living with HIV. This information collection request covers two 
distinct evaluation studies with RWHAP provider sites that will share 
components of data collection instruments through shared variables. 
Sharing data collection instruments will minimize burden for RWHAP 
provider sites collecting this data and will increase the sample size 
for data analysis thus resulting in more robust data and greater 
generalizability of results.
    The first evaluation study, Assessing Client Factors Associated 
with Detectable HIV Viral Loads, will explore individuals' specific 
facilitators and barriers to achieving and sustaining viral 
suppression. Early and effective treatment for HIV has been shown to 
greatly reduce associated morbidity and mortality, and prevents 
transmission of HIV. In spite of the known benefit of treatment, many 
individuals remain out of care or access care only intermittently; the 
CDC estimated that in 2013, approximately 45 percent of people living 
with HIV (PLWH) in the United States were not virally suppressed, 
indicating a significant gap in the percentage of PLWH who are being 
successfully engaged and retained in care. In spite of the increased 
attention on retention in care and the overarching goal of viral 
suppression, little data exist regarding the specific individual 
factors that are associated with sub-optimal viral suppression. Such 
information is valuable for targeting programs to reach populations 
that are currently not achieving HIV viral suppression.
    The second evaluation study, Models of Care and the Ryan White HIV/
AIDS Program, seeks to answer the critical questions of what individual 
and system-wide factors, including the models of care employed among 
RWHAP provider sites, contribute to better health outcomes for PLWH. 
While advances in treatment have improved survival in patients with 
HIV, longer lives are associated with increased prevalence of adverse 
effects of HIV infection and therapeutic complications, concurrent with 
medical conditions related to aging processes that would occur in the 
absence of HIV. These long-term complications amplify chronic disease 
management as a major issue for the HIV population and a challenge for 
the delivery of effective health care. Yet little is known about how 
the method of health services delivery (the ``model of care'') 
contributes to better health outcomes, including HIV-related outcomes. 
For example, does it make a difference if a patient receives HIV care 
from a primary care provider, a

[[Page 52310]]

specialist, or from a care team that includes both? Understanding the 
most effective models of care is important for HIV specialists, primary 
care physicians, and other clinicians who care for PLWH as they design 
and coordinate a full array of primary care and support services for 
their patients. These primary care and support services have a direct 
impact on HIV viral suppression, which in turn improves life expectancy 
and quality of life and prevents HIV transmission.
    The two studies inform each other in that the degree to which 
clients achieve and sustain viral suppression may be attributed partly 
to the model of care practiced at their clinic. Likewise, the degree to 
which its clients have achieved viral suppression may drive a clinic to 
practice a particular model of care. The two studies will collect 
several identical data elements through their individual collection 
instruments, allowing data to be aggregated across the two studies. The 
aggregation of data across the two studies will minimize burden for 
RWHAP provider sites collecting this data and will increase the sample 
size for data analysis thus resulting in more robust data and greater 
generalizability of results.
    A 60-day Federal Register Notice was published in the Federal 
Register on May 18, 2017 (Volume 82, page 22838) which solicited 
comments on this data collection. Four comments were received that 
focused on how facilities will be selected for participation and the 
importance of adequate nutrition for PLWH.
    Need and Proposed Use of the Information: The Assessing Client 
Factors Associated with Detectable HIV Viral Loads study will identify 
characteristics of RWHAP clients and health facilities that are 
associated with the ability to achieve and sustain an undetectable 
viral load as compared to the characteristics that are associated with 
sub-optimal viral suppression. This study will enable the development 
of better targeted services for improved viral suppression rates. The 
Models of Care and the Ryan White HIV/AIDS Program study will compare 
HIV and primary health outcomes across various models of care to 
determine which are most effective in responding to HIV to improve 
health outcomes for people living with HIV and to prevent HIV 
transmissions. The results from this study will enable improvements or 
redesigns of effective delivery of HIV care among Ryan White HIV/AIDS 
Program providers, which will in turn improve HIV clinical outcomes 
such as viral suppression.
    In both studies, an analysis of the perceptions of providers and 
clients will further support the understanding of the impact of 
individual and system-wide factors on achieving health outcomes. The 
two studies will share data to inform both studies' objectives, allow 
for a larger sample size from which to generalize conclusions, and 
reduce the overall burden of response on RWHAP providers and clients. 
The objectives of both studies will be achieved through collection of 
the following data:
     RWHAP client records abstraction--Medical chart and 
administrative records (e.g., service utilization and health outcomes 
data);
     RWHAP provider interviews--Site staff interviewees (in 
person);
     RWHAP client focus groups (Models of Care study sites 
only)--Clients at selected clinics that represent a given model of 
care;
     RWHAP client surveys (HIV Viral Suppression study sites 
only)--Clients with detectable and undetectable viral load at each 
clinic; and
     RWHAP client semi-structured interviews (HIV Viral 
Suppression study sites only)--Clients with detectable and undetectable 
viral load.
    These studies will build upon and complement HAB's study focusing 
on RWHAP outcomes within the context of the changing health care 
landscape; and will use the RWHAP site survey and chart abstraction 
instruments that were submitted as part of that study. The data will be 
collected by a HRSA contractor.
    Likely Respondents: RWHAP Administrators, RWHAP Service Providers, 
and RWHAP Clients.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. 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. The total annual burden hours estimated for 
this ICR are summarized in the table below. Both research studies are 
included in the table, with burden proportional to the number of RWHAP 
provider sites from which each study will collect data: 25 distinct 
facilities for Assessing Client Factors Associated with Detectable HIV 
Viral Loads and 50 distinct facilities for Models of Care and the Ryan 
White HIV/AIDS Program. The table below provides the level of burden 
inclusive of both studies.
    Total Estimated Annualized Burden--Hours.

                                                         12A--Estimated Annualized Burden Hours
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                                                                                             Number of                    Average burden
            Type of respondent                        Form name              Number of     responses per       Total       per response    Total burden
                                                                            respondents     respondent       responses      (in hours)         hours
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RWHAP Site Administrators (Private Sector)  Medical Records Sample                    75               1              75               1              75
                                             Selection Guide *.
RWHAP Service Providers (Private Sector)..  Provider Interview Guide                 125               1             125               2             250
                                             (HIV Viral Suppression).
RWHAP Service Providers (Private Sector)..  Provider Interview Guide                 250               1             250               2             500
                                             (Models of Care).
RWHAP Clients (Individual/Household)......  Focus Groups Guide..........             240               1             240             1.5             360
RWHAP Clients (Individual/Household)......  Client Survey...............             500               1             500             0.5             250
RWHAP Clients (Individual/Household)......  Client Semi-Structured                   150               1             150             0.5              75
                                             Interview.
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    Total.................................  ............................           1,340  ..............           1,340  ..............           1,510
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* The medical records sample selection instrument has been previously submitted as part of the RWHAP Outcomes Study proposed data collection project.

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection\burden.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-24491 Filed 11-9-17; 8:45 am]
BILLING CODE 4165-15-P