Critical Thinking and Cultural Affirmation: Evaluation of a Locally Developed HIV Prevention Intervention

Forms and Documents

Document Name	Status
Exit Interview Form	New
Exit Survey Form	New
Form Attachment 10 6-month Assessment Form	New
Form Attachment 9 3-month Assessment Form	New
Participant Evaluation Form	New
Record Locator Form Form	New
Form Attachment 6 Baseline Assessment Form	New
Brief Locator Information Form	New
Full-screening Form	New
Pre-screening Form	New
Attachment 20 References for Raffle Studies.docx Supplementary Document	2012-07-25
Attachment 19 Example Health Messages.docx Supplementary Document	2012-07-25
Supporting Statement B_Comments July 19 2012_clean.docx Supporting Statement B	2012-07-25
CoC Dr. Wheeler Critical Thinkingand Cultural Affirmation Document (2).pdf Supplementary Document	2012-05-17
Attachment 17 Recruitment Flyer.docx Supplementary Document	2012-05-17
Attachment 16 Final PD Approval with signature.pdf Supplementary Document	2012-05-17
Attachment 15 IRB Approval - January 20 2012.pdf Supplementary Document	2012-05-17
Attachment 13 Informed Consent-RCT.docx Supplementary Document	2012-05-17
Attachment 1 Public Health Service Act.docx Supplementary Document	2012-05-17
Attachment 2 60 day FRN 3.26.docx Supplementary Document	2012-05-17
Attachment 14-Informed Consent for Exit Interview.docx Supplementary Document	2012-05-17
Supporting Statement A_revised 7.26.12.docx Supporting Statement A	2012-08-01

IC Document Collections

IC ID	Document Title	Status
202463	Exit Interview Form	New
202462	Exit Survey Form	New
202461	6-month Assessment Form	New
202460	3-month Assessment Form	New
202459	Participant Evaluation Form	New
202458	Record Locator Form Form	New
202457	Baseline Assessment Form	New
202456	Brief Locator Information Form	New
202455	Full-screening Form	New
202454	Pre-screening Form	New

ICR Details

OMB Control No: 0920-0945	ICR Reference No: 201205-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Critical Thinking and Cultural Affirmation: Evaluation of a Locally Developed HIV Prevention 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: 08/01/2012
	Date Received in OIRA: 05/24/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved
Responses	2,221	0	0
Time Burden (Hours)	588	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The study will test the efficacy of the Critical Thinking and Cultural Affirmation (CTCA) HIV risk behavior intervention in reducing HIV risk behaviors among a sample of AAMSM in Chicago. It aims to further explicate and develop the CTCA intervention, to evaluate efficacy and cost-effectiveness in reducing AAMSM HIV risk behaviors, and to expand the body of research on HIV prevention/risk reduction practices for AAMSM. The study uses a randomized-controlled trial design to compare receiving the intervention to receiving basic men's health and wellness messaging.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
  

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:
	77 FR 12057	02/28/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 29350	05/17/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Pre-screening	none	Pre-screening
Full-screening	none	Full-screening
Brief Locator Information	none	Brief Locator Information
Baseline Assessment	Attachment 6	Baseline Assessment
Record Locator Form	none	Record Locator Form
Participant Evaluation	none	Participant Evaluation
3-month Assessment	Attachment 9	3 month follow-up
6-month Assessment	Attachment 10	6-Month Assessment
Exit Survey	none	Exit Survey
Exit Interview	none	Exit Interview

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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	2,221	0	0	2,221	0	0
Annual Time Burden (Hours)	588	0	0	588	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: This is a new ICR.

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Annual Cost to Federal Government: $664,983

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 05/24/2012

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