Evaluating Locally-Developed HIV Prevention Interventions for African-American MSM in Los Angeles

Forms and Documents

Document Name	Status
Supporting Statement B - LA Homegrown 6.15.11.docx Supporting Statement B	2011-10-13
Attachment 5b Project determination approval Center.pdf Supplementary Document	2011-10-14
Attachment 5a MLMS final IRB approval 2011-03-25.pdf Supplementary Document	2011-10-13
Attachment 2 60-day FRN 6.15.11.docx Supplementary Document	2011-10-13
Attachment 1 Public Health Service Act 6.15.11.docx Supplementary Document	2011-10-13
Attachment 4b Success Case Study Informed Consent Form 6.15.11.docx Supplementary Document	2011-10-14
Att 3j Follow-up interview log 082511.docx Supplementary Document	2011-10-14
Att 3j Follow-up interview log 082511.docx Supplementary Document	2011-10-14
Att 3i Participant Contact Log 082511.docx Supplementary Document	2011-10-14
Attachment 4a MyLife, MyStyle Informed Consent Form 6.15.11.docx Supplementary Document	2011-10-14
SupSta A - 100611.docx Supporting Statement A	2011-10-13

IC Document Collections

IC ID	Document Title	Status
199775	Success Case Study Interview Other-WORD	New
199774	6-Month Follow-up Questionnaire Other-WORD	New
199773	3-Month Follow-up Questionnaire Other-WORD	New
199772	Client Satisfaction Survey Other-WORD	New
199771	Participant Contact Information Form Other-WORD	New
199770	Baseline Questionnaire Other-WORD	New
199769	Limited Locator Form Other-WORD	New
199768	Outreach Recruitment Assessment Other-WORD	New

ICR Details

OMB Control No: 0920-0913	ICR Reference No: 201110-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Evaluating Locally-Developed HIV Prevention Interventions for African-American MSM in Los Angeles
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 without change	Conclusion Date: 01/16/2012
	Date Received in OIRA: 10/18/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2015	36 Months From Approved
Responses	3,984	0	0
Time Burden (Hours)	1,662	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The data to be collected for this study will be used to establish the preliminary efficacy of MyLife MyStyle an HIV prevention intervention for young African American MSM 18-29 years of age in Los Angeles County. The goal is to provide important information about sexual risk behaviors and the context in which they occur. We will use a randomized controlled trial designed to determine if men who are assigned to the experimental condition report less frequent HIV risk behavior three-months and six-months following the intervention compared to men in the control condition. The intermediate outcomes to be measured are unprotected anal sex with male partners, increase frequency of communication with partner(s) about safer sex, HIV status, STD status, decrease unprotected sex because condom was not available, decrease number of sexual partners, increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings. The secondary objective of this study is to conduct a comprehensive program evaluation to identify intervention elements associated with program success, such as: a) intervention components, processes, and characteristics; b) recruitment and retention strategies; and c) requirements of the organization's infrastructure necessary to deliver the intervention. Data to be collected includes eligibility, baseline survey, 3 month follow up survey, 6 month follow up survey, limited locator information in order to retain participants and schedule follow up assessment, client satisfaction surveys, and success case study qualitative interview.

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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:
	76 FR 46813	08/03/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 63925	10/14/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Outreach Recruitment Assessment
Limited Locator Form
Baseline Questionnaire
Participant Contact Information Form
Client Satisfaction Survey
3-Month Follow-up Questionnaire
6-Month Follow-up Questionnaire
Success Case Study 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	3,984	0	0	3,984	0	0
Annual Time Burden (Hours)	1,662	0	0	1,662	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 data collection.

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Annual Cost to Federal Government: $663,908

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? No

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: 10/18/2011

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