[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48534-48536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15BBU]; [Docket No. CDC-2015-0069]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to
[[Page 48535]]
comment on proposed and/or continuing information collections, as
required by the Paperwork Reduction Act of 1995. This notice invites
comment on a proposed information collection request entitled
``Efficacy Study of a Mobile Application to Provide Comprehensive and
Medically Accurate Sexual Health Information for Adolescent Girls''.
The study will examine the efficacy of the mobile application in
achieving two behavioral outcomes: Use of effective contraception and
clinic utilization.
DATES: Written comments must be received on or before October 13, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0069 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. 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.
Proposed Project
Efficacy Study of a Mobile Application to Provide Comprehensive and
Medically Accurate Sexual Health Information for Adolescent Girls--
New--National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Despite drastic reductions in teen births across all racial and
ethnic groups, Black and Latino girls continue to have
disproportionately high rates of teen births. Increasing girls' access
to medically accurate and comprehensive sexual health information is
the first step in sustaining momentum in teen pregnancy reduction among
all racial and ethnic groups, and in promoting healthy sexual
behaviors, especially among minority girls.
CDC plans to collect the information needed to test the efficacy of
a comprehensive and medically accurate mobile application, titled
Crush, in increasing adolescent girls' contraception use and clinic
visitation for sexual and reproductive health services. The information
disseminated via Crush is similar to the sexual health information
youth can access via other Web sites, sexual health promotion
educational materials or in clinics.
The study will randomize a sample of 1,200 girls, ages 14-18, into
two groups: The intervention group and the control group. The
intervention group will have access to Crush and will receive weekly
sexual health information via text to the phones for six months. The
control group will have access to a fitness mobile application
(``app'') and will receive general health information via text to their
phones for six months. Participants are expected to access either app
frequently throughout a six month period. As part of the analysis,
sexual behavior and key psychosocial factors will be assessed three
points in time: At baseline, and at three- and six-month follow-ups.
Efficacy testing will respond to the following research questions:
Research Question #1 is: Does exposure to Crush increase consistent
contraception use among participants? We hypothesize that participants
in the intervention group will report increased intent to use effective
contraception at three and six months post-intervention. Research
Question #2 is: Does exposure to Crush increase clinic utilization rate
among participants? We hypothesize that participants in the
intervention group will report higher rates of intent to utilize clinic
services at three and six months post intervention.
The study will also include a usability testing component to
identify the content and features of Crush that are most attractive to
participants, the frequency in which Crush was used, and the navigation
patterns within Crush. Participants will create an account in the
Enrollment Database. This database will host participants' enrollment
information, basic demographic information, and will also track their
navigation pattern to monitor Crush visitation frequency and visit
duration. Navigation data will be used to assess intervention exposure
and dosage to specific content areas of Crush. To test real-world
utilization of Crush, control group participants will gain access to
Crush six months after enrolling into the study, but will not receive
weekly text messages. The study will track visitation frequency and
duration of each visit. Usability testing will respond to Research
Question #3: Is media content more attractive to participants? We
hypothesize that participants in the intervention group
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will spend more time using media features than text-based content.
All information will be collected electronically. This study will
collect data through two mechanisms: (1) Self-administered online
surveys, and (2) the Crush enrollment database. Participants will
complete a total of three self-administered online surveys at baseline,
three and six month follow-up. Survey questions will assess behavior,
attitudes, social norms about sexual behavior, contraception and clinic
utilization, and satisfaction with Crush.
The mobile response surveys will be sent to participants via text
message which they can complete on a smartphone. The estimated burden
per response is 13-20 minutes. Survey responses will be matched by each
participant's unique identifying number. Each participant will receive
up to two survey reminders starting one week after the initial survey
link is sent, for two consecutive weeks. There are minor differences in
survey content for the control and intervention groups.
Each participant will create a profile in the database upon
enrollment. This database will collect initial demographic and contact
information, informed consent signatures, and information about the
participant's navigation pattern through Crush. Any information entered
directly into Crush interactive features will not be stored in the
system. The database only collects web analytics data about page
visited and duration of each visit by User ID and IP address. Web
analytics are generated for any Web site and are a standard evaluation
mechanism for assessing the traffic patterns on Web pages. This
technology permits development of an objective and quantifiable measure
that tracks and records participants' exposure to Crush. This study
component does not entail any response burden to participants.
Findings will be used to inform the development and delivery of
effective health communications.
OMB approval is requested for one year. Participation is voluntary
and there are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hrs.)
respondent hrs.)
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Girls Ages 14-18 Years........ Enrollment...... 1,200 1 5/60 100
Consent......... 1,200 1 5/60 100
Control Group................. Baseline Survey. 600 1 13/60 130
3-Month Follow- 600 1 20/60 200
up Survey.
6-Month Follow- 600 1 20/60 200
up Survey.
Intervention Group............ Baseline Survey. 600 1 13 130
3-Month Follow- 600 1 20 200
up Survey.
6-Month Follow- 600 1 20 200
up Survey.
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Total..................... ................ .............. .............. .............. 1,260
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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. 2015-19860 Filed 8-12-15; 8:45 am]
BILLING CODE 4163-18-P