[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5682-5684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18AQQ]


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 ``HIV prevention among Latina transgender 
women: Evaluation of a Locally Developed Intervention (ChiCAS)'' 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 23, 2018 to obtain 
comments from the public and affected agencies. CDC did not receive 
comments 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:

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    (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

    HIV prevention among Latina Transgender Women: Evaluation of a 
Locally Developed Intervention (ChiCAS)''--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention is requesting approval for 20-months of data collection 
entitled, ``HIV prevention among Latina transgender women: Evaluation 
of a locally developed intervention.'' The goal of this study is to 
evaluate the efficacy of ChiCAS (Chicas Creando Acceso a la Salud 
[Chicas: Girls Creating Access to Health]), a locally developed and 
culturally congruent two-session Spanish-language small-group 
combination intervention designed to promote consistent condom use, and 
access to and participation in pre-exposure prophylaxis (PrEP) and 
medically supervised hormone therapy by HIV seronegative Hispanic/
Latina transgender women who have sex with men.
    The information collected through this study will be used to 
evaluate whether the ChiCAS intervention is an effective HIV-prevention 
strategy by assessing whether exposure to the intervention results in 
improvements in participants' health and HIV prevention behaviors. The 
study will compare pre- (baseline) and post-intervention (6-month) 
levels of HIV risk among participants who have received the 
intervention and participants who have not yet received the 
intervention (delayed-intervention group).
    This study will be carried out in five metropolitan areas in North 
Carolina: Ashville, NC; Charlotte, NC; Research Triangle (metropolitan 
area of Greensboro, Winston-Salem and High Point NC); Raleigh, NC; and 
Wilmington, NC. The study population will include 140 HIV-negative 
Spanish-speaking transgender women. Participants will be adults, at 
least 18 years of age, self-identify as male-to-female transgender or 
report having been born male and identifying as female, and report 
having sex with at least one man in the past six months. We anticipate 
participants will be comprised mainly of racial/ethnic minority 
participants under 35 years of age, consistent with the epidemiology of 
HIV infection among transgender women.
    Intervention participants will be recruited to the study through a 
combination of approaches, including traditional print advertisement, 
referral, in-person outreach, and through word of mouth. A quantitative 
assessment will be used to collect information for this study, which 
will be delivered at the time of study enrollment and again at 6-month 
follow up. The assessment will be used to measure differences in sexual 
risk knowledge, perceptions and behaviors including condom use, PrEP 
use and use of medically supervised hormone therapy. Intervention 
mediators, including healthcare provider trust and communication 
skills, self-reported health status and healthcare access, community 
attachment and social support will also be measured. All participants 
will complete the assessment at baseline and again at 6-month follow-up 
after enrolling in the study. The intervention group will participate 
in ChiCAS after completing the baseline assessment and the delayed 
intervention group will participate in ChiCAS after completing the 6-
month follow up assessment.
    We will also examine intervention experiences through in-depth 
interviews with 30 intervention group participants. The interviews will 
capture participants' general experiences with the ChiCAS intervention, 
as well as their experiences and perceptions specific to the main study 
outcomes: PrEP knowledge, awareness, interest and use; condom skills 
and use; and hormone therapy knowledge, awareness, interest and use.
    It is expected that 50% of transgender women screened will meet 
study eligibility. We expect the initial screening to take 
approximately four minutes to complete. The assessment will take 60 
minutes (one hour) to complete and will be administered to 140 
participants a total of two times. The interview will take 90 minutes 
(one and one-half hours) to complete and will be administered to 30 
participants from the intervention group one time. There are no costs 
to the respondents other than their time. The total number of burden 
hours is 344 across 23-months of data collection. The total estimated 
annualized burden hours is 172.

                                        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 hours)
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General Public--Adults................  Eligibility Screener....             140               1            3/60
General Public--Adults................  Contact Information.....              70               1            1/60
General Public--Adults................  Assessment..............              70               2           60/60
General Public--Adults................  Interview...............              15               1           90/60
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[[Page 5684]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-03099 Filed 2-21-19; 8:45 am]
 BILLING CODE 4163-18-P