[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67757-67759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27888]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15AEZ]
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
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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
Identification of Behavioral and Clinical Predictors of Early HIV
Infection (Project DETECT)--New--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC provides guidelines for HIV testing and diagnosis for the
United States, as well as technical guidance for its grantees. CDC will
use the HIV testing data collected for this project to update these
guidance documents to reflect the latest available testing
technologies, their performance characteristics, and considerations
regarding their use. Specifically, CDC will describe the information on
behavioral and clinical characteristics of persons with early infection
to help HIV test providers (including CDC grantees) choose which HIV
tests to use and target tests appropriately to persons at different
levels of risk. This information will primarily be disseminated through
guidance documents (and articles in peer-reviewed journals).
The primary study population will be persons at high risk for or
diagnosed with HIV infection, many of whom will be men who have sex
with men (MSM) because the majority of new HIV infections occur each
year among this population. The goals of the project are to: (1)
Characterize the performance of new HIV tests for detecting established
and early HIV infection at the point of care, relative to each other
and to currently used gold standard, non-POC tests, and (2) identify
behavioral and clinical predictors of early HIV infection.
Project DETECT will enroll 1,667 persons annually at the primary
study site clinic in Seattle, and an additional 200 persons will be
enrolled from other clinics in the greater Seattle area. The study 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 7 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 7 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 estimate 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 socio-demographics, medical care, HIV testing, pre-exposure
prophylaxis, antiretroviral treatment, sexually transmitted disease
(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 ID number. Data will be stored
on a secure server managed by the University of Washington Department
of Medicine IT Services. The participation of respondents is voluntary.
There is no cost to the respondents other than their time. The total
annual burden hours are 2,110.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
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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.
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[[Page 67759]]
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. 2015-27888 Filed 11-2-15; 8:45 am]
BILLING CODE 4163-18-P