[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63512-63513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26634]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-1100]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Identification of Behavioral and Clinical
Predictors of Early HIV Infection (Project DETECT)'' to the Office of
Management and Budget (OMB) for review and approval. CDC previously
published a ``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on August 21, 2018 to obtain comments from the
public and affected agencies. CDC received one (1) comment related to
the previous notice. This notice serves to allow an additional 30 days
for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Identification of Behavioral and Clinical Predictors of Early HIV
Infection (Project DETECT) (OMB No. 0920-1100, Exp. 2/28/2019)--
Extension--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC requests a three-year OMB approval to continue information
collection for ``Project DETECT,'' an ongoing research study conducted
by the University of Washington (UW). Study sites initiated information
collection in 2016 and CDC is requesting OMB approval for three
additional years (2019-2022). The study is designed to (1) identify
behavioral and clinical predictors of early HIV infection, and (2)
characterize the performance of new HIV tests for detecting established
and early HIV infection at the point of care (POC), relative to each
other and to currently used gold standard, non-POC tests.
The primary study population is persons at high risk for, or
diagnosed with HIV infection, many of whom will be men who have sex
with men (MSM)
[[Page 63513]]
because the majority of new HIV infections occur each year among this
population. In each year of the study, an average of 1,667 participants
will be recruited from the Public Health--Seattle and King County
(PHSKC) STD Clinic, which serves as the primary study site, and an
additional 200 persons will be enrolled from other clinics in the
greater Seattle area. Information collection will be conducted in two
phases.
Phase 1: After a clinic client consents to participate, he/she will
be assigned a unique participant ID and will then undergo testing with
the seven new HIV tests under study. While awaiting test results,
participants will undergo additional specimen collections and complete
the Phase 1 Enrollment Survey.
Phase 2: All Phase 1 participants whose results on the seven tests
under investigation are not in agreement with one another
(``discordant'') will be considered to have a potential early HIV
infection. Nucleic amplification testing that detects viral nucleic
acids will be conducted to confirm an HIV diagnosis and rule out false
positives. Study investigators expect that each year, 50 participants
with discordant test results will be invited to participate in serial
follow-up specimen collections to assess the time point at which all
HIV test results resolve and become concordant positive (indicating
enrollment during early infection) or concordant negative (indicating
one or more false-positive test results in Phase 1).
The follow-up schedule will consist of up to nine visits scheduled
at regular intervals over a 70-day period. At each follow-up visit,
participants will be tested with the new HIV tests and additional oral
fluid and blood specimens will also be collected for storage and use in
future HIV test evaluations at CDC. Participants will be followed up
only to the point at which all their test results become concordant. At
each time point, participants will be asked to complete the Phase 2 HIV
Symptom and Care survey that collects information on symptoms
associated with early HIV infection, as well as access to HIV care and
treatment since the last Phase 2 visit. When all tests become
concordant (i.e., at the last Phase 2 visit) participants will complete
the Phase 2 behavioral survey to identify any behavioral changes during
follow-up. Of the 50 Phase 2 participants, it is estimated that no more
than 26, annually, will have early HIV infection.
All data for the proposed information collection will be collected
via an electronic Computer Assisted Self-Interview (CASI) survey.
Participants will complete the surveys on an encrypted computer, with
the exception of the Phase 2 Symptom and Care survey, which will be
administered by a research assistant and then electronically entered
into the CASI system. Data to be collected via CASI include questions
on sociodemographic characteristics, medical care, HIV testing, pre-
exposure prophylaxis, antiretroviral treatment, sexually transmitted
diseases (STD) history, symptoms of early HIV infection, substance use
and sexual behavior. Data from the surveys will be merged with HIV test
results and relevant clinical data using the unique identification (ID)
number.
CDC will use findings to update guidelines for HIV testing and
diagnosis in the United States. The guidelines will help HIV test
providers choose which HIV tests to use, and target tests appropriately
to persons at different levels of risk. Findings will also be
disseminated through articles in peer-reviewed journals and the
technical assistance provided by CDC to grantees that provide HIV
testing and diagnostic services.
There are no changes to the previously approved information
collection instruments or burden estimates. The participation of
respondents is voluntary and there are no costs to respondents other
than their time. The total estimated annualized burden for the proposed
project is 2,110 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Persons eligible for study............ Phase 1 Consent......... 2,334 1 15/60
Enrolled participants................. Phase 1 Enrollment 1,667 1 45/60
Survey A.
Phase 1 Enrollment 200 1 60/60
Survey B.
Phase 2 Consent......... 50 1 15/60
Phase 2 HIV Symptom and 50 9 5/60
Care survey.
Phase 2 Behavioral 50 1 30/60
Survey.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-26634 Filed 12-7-18; 8:45 am]
BILLING CODE 4163-18-P