Information Collection Request

HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention

ICR 202106-0920-005 · OMB 0920-1266 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1266 Follow Up Questionnaire Form and Instruction New Repair queued
Interview Form and Instruction Modified Available
Baseline Questionnaire Form and Instruction Modified Repair queued
Contact Information Form and Instruction Modified Repair queued
Eligibility Screener Form and Instruction Modified Repair queued
SSA ChiCAS_06.21.21_Revised.docx Supporting Statement A Uploaded 2021-06-24 Repair queued
SSB ChiCAS 22Jan2021_Clean_CAG_02.04.21.docx Supporting Statement B Uploaded 2021-06-24 Repair queued
Att 10b_ChiCAS Appointment Card Spanish.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 10a_ChiCAS Appointment Card English.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 9b_ChiCAS Stay in Touch Spanish.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 9a_ChiCAS Stay in Touch English.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 8_PIA 0920-18AQQ.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 7_ChiCAS Data Use Plan.docx Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 6h_ChiCAS IRB Amendment Catchment.pdf Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 6g_ChiCAS IRB Amendment Lewis.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 6f_ChiCAS IRB Amendment Virtual and OraQuick.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 6e_ChiCAS IRB Amendment Token.pdf Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 6d_ChiCAS IRB Assessment Amendment.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 6c_ChiCAS IRB UNC Agreement.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 6b_ChiCAS IRB Triad Agreement.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 6a_ChiCAS IRB Approval.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 5b_ChiCAS Consent Spanish.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 5a_ChiCAS Consent English.docx Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 3b_ChiCAS Recruitment Materials Spanish.pdf Supplementary Document Uploaded 2021-06-21 Repair queued
Att 3a_ChiCAS Recruitment Materials English.pdf Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 2a_Public Comments.docx Supplementary Document Uploaded 2021-06-21 Repair queued
Att 2 60 day FRN Published 2-25-2021.pdf Supplementary Document Uploaded 2021-06-21 Missing upstream
Att 10b_ChiCAS Appointment Card Spanish.docx Supplementary Document Uploaded 2019-02-25 Repair queued
Att 10a_ChiCAS Appointment Card English.docx Supplementary Document Uploaded 2019-02-25 Available
Att 9b_ChiCAS Stay in Touch Spanish.docx Supplementary Document Uploaded 2019-02-25 Repair queued
Att 9a_ChiCAS Stay in Touch English.docx Supplementary Document Uploaded 2019-02-25 Repair queued
Att 1_Authorizing Legislation.docx Supplementary Document Uploaded 2019-02-25 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
247989 Follow Up Questionnaire Form and Instruction New
235196 Interview Form and Instruction Modified
235195 Baseline Questionnaire Form and Instruction Modified
235194 Contact Information Form and Instruction Modified
235193 Eligibility Screener Form and Instruction Modified
ICR Details
0920-1266 202106-0920-005
Received in OIRA 201902-0920-019
HHS/CDC 0920-1266
HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention
Revision of a currently approved collection   No
Regular 06/24/2021
  Requested Previously Approved
24 Months From Approved 06/30/2021
365 365
154 171
0 0

The purpose of this study is to evaluate the efficacy of ChiCAS (Chicas Creando Acceso a la Salud [Chicas: Girls Creating Access to Health]), a Spanish language intervention that provides HIV prevention services to Hispanic/Latina adult transgender women. The information collected through this study will be used to evaluate whether exposure to the ChiCAS intervention results in improvements in participants' self-reported HIV prevention behaviors, beliefs and attitudes. This study will use a randomized delayed-intervention comparison group design to 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). The proposed Revision (2021) seeks approval to continue information collection activities that were halted due to the COVID pandemic, as well as for removal of redundant questions from the follow-up assessment, and for expansion of the recruitment area to metropolitan areas adjacent to North Carolina.

US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None

Not associated with rulemaking

  86 FR 11533 02/25/2021
86 FR 33297 06/24/2021
Yes

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 365 365 0 0 0 0
Annual Time Burden (Hours) 154 171 0 -17 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Revision of 0920-1266 includes removal of redundant questions and division of survey into Baseline and FollowUp resulting in decreased burden.

$695,535
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
No
Jeffrey Zirger 404 639-7118 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
06/24/2021