Federal Register - February 25, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
other forms of information technology, e.g., permitting electronic submissions of responses.
5. Assess information collection costs.
Proposed Project HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention OMB Control No. 0920
1266, Exp. 6/30/2021Revision National Center for HIV/AIDS, Viral Hepatitis, STED, 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 a two-year extension of a currently approved ICR, 09201266 entitled, HIV prevention among Latina transgender women who have sex with men: 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 preexposure 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-
healthcare access, community attachment and social support will also be measured. All participants will complete the assessment at baseline and again at six-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 six-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 and contact information gathering to take approximately four minutes to complete. The baseline assessment will take 60 minutes one hour to complete and will be administered to 140 participants. The follow up assessment will take 45
minutes 0.75 hours to complete and will be administered to 140 participants one time. 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 310 across 39-months of data collection. The total estimated annualized burden hours are 155.
baseline and post-intervention sixmonth 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 metropolitan areas in and around North Carolina including Ashville, NC;
Charlotte, NC; Research Triangle metropolitan area of Greensboro, Winston-Salem and High Point NC;
Raleigh, NC; Wilmington, NC; and Greenville, SC. The study population will include 140 HIV-negative Spanishspeaking transgender women.
Participants will be adults, at least 18
years of age, self-identify as male-tofemale 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 six-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
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
General General General General General
PublicAdults PublicAdults PublicAdults PublicAdults PublicAdults
Number of respondents
Form name
Number of responses per respondent
Average burden per response in hours
Total burden in hours
Eligibility Screener
Contact Information
Baseline Assessment
Follow-up Assessment
Interview
140
70
70
70
15
1
1
1
1
1
3/60
1/60
1.0
45/60
1.5
7
2
70
53
23
Total
155
Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
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