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

Forms and Documents

Document Name	Status
Interview Form and Instruction	New
Questionnaire Form and Instruction	New
Contact Information Form and Instruction	New
Eligibility Screener Form and Instruction	New
Chicas Supporting Statement B with comments CDC changes clean (05 June 2019)v2.docx Supporting Statement B	2019-06-06
Chicas Supporting Statement A with comments CDC changes clean (05 June 2019)v2.docx Supporting Statement A	2019-06-06
Att 7_ChiCAS Data Use Plan.docx Supplementary Document	2019-02-25
Att 8_PIA 0920-18AQQ FEB2018.pdf Supplementary Document	2019-02-25
Att 10b_ChiCAS Appointment Card Spanish.docx Supplementary Document	2019-02-25
Att 10a_ChiCAS Appointment Card English.docx Supplementary Document	2019-02-25
Att 9b_ChiCAS Stay in Touch Spanish.docx Supplementary Document	2019-02-25
Att 9a_ChiCAS Stay in Touch English.docx Supplementary Document	2019-02-25
Att 6c_ChiCAS IRB UNC Agreement.pdf Supplementary Document	2019-02-25
Att 6b_ChiCAS IRB Triad Agreement.pdf Supplementary Document	2019-02-25
Att 6a_ChiCAS IRB Approval.pdf Supplementary Document	2019-02-25
Att 5b_ChiCAS Consent Spanish.pdf Supplementary Document	2019-02-25
Att 5a_ChiCAS Consent English.pdf Supplementary Document	2019-02-25
Att 3b_ChiCAS Recruitment Materials Spanish.pdf Supplementary Document	2019-02-25
Att 3a_ChiCAS Recruitment Materials English.pdf Supplementary Document	2019-02-25
Att 2_60-Day FRN.pdf Supplementary Document	2019-02-25
Att 1_Authorizing Legislation.docx Supplementary Document	2019-02-25

IC Document Collections

IC ID	Document Title	Status
235196	Interview Form and Instruction	New
235195	Questionnaire Form and Instruction	New
235194	Contact Information Form and Instruction	New
235193	Eligibility Screener Form and Instruction	New

ICR Details

OMB Control No: 0920-1266	ICR Reference No: 201902-0920-019
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18AQQ
Title: HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/10/2019
	Date Received in OIRA: 03/11/2019
Terms of Clearance: Approved consistent with the understanding that CDC will not be conducting any general research on the information collected. When communicating findings from this collection, all publications will clearly describe the scope and limitations of the study findings.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved
Responses	365	0	0
Time Burden (Hours)	171	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45624	08/23/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5682	02/22/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Interview	NA, NA	ChiCAS Interview - English 05JUN2019 ,   ChiCAS Interview - Spanish 05JUN2019
Contact Information	NA, NA, NA , NA	Contact Information ChiCAS Screener - English ,   Contact Information ChiCAS Screener - Spanish ,   Contact Information_ChiCAS Screener - English ,   Contact Information_ChiCAS Screener - Spanish
Eligibility Screener	NA, NA, NA, NA	ChiCAS Screener - Spanish ,   ChiCAS Screener - English ,   ChiCAS Screener - Spanish ,   ChiCAS Screener - English
Questionnaire	NA, NA, NA, NA	ChiCAS Questionnaire - Spanish ,   ChiCAS Questionnaire - English ,   ChiCAS Questionnaire - Spanish ,   ChiCAS Questionnaire - English

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ICR Summary of Burden

	Total Approved	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	0	0	365	0	0
Annual Time Burden (Hours)	171	0	0	171	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Submission of 0920-18AQQ - HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention is a New ICR

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Annual Cost to Federal Government: $695,535

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/11/2019

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