[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8962-8963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03687]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16OJ]
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 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
The Girl Power Project Efficacy Trial--New--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
The 60-day Federal Register Notice, published on August 12, 2015,
was titled ``Efficacy Study of a Mobile Application to Provide
Comprehensive and Medically Accurate Sexual Health Information for
Adolescent Girls.'' On January 19, 2016, a 30-day Federal Register
Notice was published under the revised title ``The Girl Power Project
Efficacy Trial.'' The burden table in the 30-day Notice was incorrect
due to omission of information collection conducted to screen potential
study participants for eligibility. This Notice corrects the error and
provides an updated estimate of total burden to respondents.
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 years,
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 their 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 at three
points in time: at baseline, and at three- and six-month follow-ups.
Efficacy testing will respond to the following research questions:
1. Does exposure to Crush increase consistent contraception use
among participants?
2. Does exposure to Crush increase clinic utilization rate among
participants?
3. Is media content more attractive to participants than text-based
content?
For research questions 1 and 2, we hypothesize that participants in
the intervention group will report increased intent to use effective
contraception and 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. We hypothesize that participants in the intervention group
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. Interested participants
will initially complete screening questions to confirm their
eligibility. CDC estimates that 3,000 respondents will be screened in
order to reach the target number of 1,200 enrolled study participants.
Information collection for enrolled participants consists of three
self-administered online surveys at conduct at baseline, three months
after baseline, and six months after baseline. Survey questions will
assess behavior, attitudes, social norms about sexual behavior,
contraception use 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 5-15 minutes. Survey responses will be matched by each
participant's unique identifying
[[Page 8963]]
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 visits
and duration of each visit by User Identification (ID) and Internet
Protocol (IP) address. Web analytics will only be collected from
participants navigating Crush and only when they are logged in as
users. 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. The total
estimated annualized burden hours are 802.
Estimated Annualized Burden Hours
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Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
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Girls 14-18 years old................. Screener Questions...... 3,000 1 1/60
Enrollment Questions.... 1,200 1 5/60
Intervention Group.................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
Control Group......................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
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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. 2016-03687 Filed 2-22-16; 8:45 am]
BILLING CODE 4163-18-P