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

Forms and Documents

Document Name	Status
Form 0920-1266 Follow Up Questionnaire Form and Instruction	New
Interview Form and Instruction	Modified
Baseline Questionnaire Form and Instruction	Modified
Contact Information Form and Instruction	Modified
Eligibility Screener Form and Instruction	Modified
SSA ChiCAS_06.21.21_Revised.docx Supporting Statement A	2021-06-24
SSB ChiCAS 22Jan2021_Clean_CAG_02.04.21.docx Supporting Statement B	2021-06-24
Att 10b_ChiCAS Appointment Card Spanish.docx Supplementary Document	2021-06-21
Att 10a_ChiCAS Appointment Card English.docx Supplementary Document	2021-06-21
Att 9b_ChiCAS Stay in Touch Spanish.docx Supplementary Document	2021-06-21
Att 9a_ChiCAS Stay in Touch English.docx Supplementary Document	2021-06-21
Att 8_PIA 0920-18AQQ.pdf Supplementary Document	2021-06-21
Att 7_ChiCAS Data Use Plan.docx Supplementary Document	2021-06-21
Att 6h_ChiCAS IRB Amendment Catchment.pdf Supplementary Document	2021-06-21
Att 6g_ChiCAS IRB Amendment Lewis.pdf Supplementary Document	2021-06-21
Att 6f_ChiCAS IRB Amendment Virtual and OraQuick.pdf Supplementary Document	2021-06-21
Att 6e_ChiCAS IRB Amendment Token.pdf Supplementary Document	2021-06-21
Att 6d_ChiCAS IRB Assessment Amendment.pdf Supplementary Document	2021-06-21
Att 6c_ChiCAS IRB UNC Agreement.pdf Supplementary Document	2021-06-21
Att 6b_ChiCAS IRB Triad Agreement.pdf Supplementary Document	2021-06-21
Att 6a_ChiCAS IRB Approval.pdf Supplementary Document	2021-06-21
Att 5b_ChiCAS Consent Spanish.docx Supplementary Document	2021-06-21
Att 5a_ChiCAS Consent English.docx Supplementary Document	2021-06-21
Att 3b_ChiCAS Recruitment Materials Spanish.pdf Supplementary Document	2021-06-21
Att 3a_ChiCAS Recruitment Materials English.pdf Supplementary Document	2021-06-21
Att 2a_Public Comments.docx Supplementary Document	2021-06-21
Att 2 60 day FRN Published 2-25-2021.pdf Supplementary Document	2021-06-21
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 1_Authorizing Legislation.docx Supplementary Document	2019-02-25

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0920-1266	ICR Reference No: 202106-0920-005
Status: Received in OIRA	Previous ICR Reference No: 201902-0920-019
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1266
Title: HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/24/2021

	Requested	Previously Approved
Expiration Date	24 Months From Approved	06/30/2021
Responses	365	365
Time Burden (Hours)	154	171
Cost Burden (Dollars)	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). 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.

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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:
	86 FR 11533	02/25/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 33297	06/24/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Baseline Questionnaire	0920-1266, 0920-1266, NA, NA, NA, NA	ChiCAS Questionnaire - English ,   ChiCAS Questionnaire - Spanish ,   ChiCAS Questionnaire - English ,   ChiCAS Questionnaire - Spanish ,   ChiCAS Baseline Questionnaire - English JUN2021 ,   ChiCAS Baseline Questionnaire - Spanish JUN2021
Contact Information	0920-1266, 0920-1266, NA , NA, NA, NA	Contact Information_ChiCAS Screener - English ,   Contact Information_ChiCAS Screener - Spanish ,   Contact Information ChiCAS Screener - English ,   Contact Information ChiCAS Screener - Spanish ,   ChiCAS Contact Information - English JUN2021 ,   ChiCAS Contact Information - Spanish JUN2021
Eligibility Screener	0920-1266, 0920-1266, NA, NA, NA, NA	ChiCAS Screener - English ,   ChiCAS Screener - Spanish ,   ChiCAS Screener - English ,   ChiCAS Screener - Spanish ,   ChiCAS Eligibility Screener - English JUN2021 ,   ChiCAS Eligibility Screener - Spanish JUN2021
Follow Up Questionnaire	0920-1266, 0920-1266	ChiCAS Follow Up Questionnaire - English JUN2021 ,   ChiCAS Interview - Spanish JUN2021
Interview	0920-1266, 0920-1266, NA, NA	ChiCAS Interview - English 05JUN2019 ,   ChiCAS Interview - Spanish 05JUN2019 ,   ChiCAS Interview - English JUN2021 ,   ChiCAS Interview - Spanish JUN2021

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ICR Summary of Burden

	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

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Revision of 0920-1266 includes removal of redundant questions and division of survey into Baseline and FollowUp resulting in decreased burden.

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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? No

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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: 06/24/2021

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