Development and Testing of an HIV Prevention Intervention Targeting Black Bisexually-Active Men

Forms and Documents

Document Name	Status
10BA_Sup Sta_B.doc Supporting Statement B	2010-05-05
10BA_Att 7_ CAB members.doc Supplementary Document	2010-05-05
10BA_Att 6_Meeting Attendees.doc Supplementary Document	2010-05-05
10BA_Att 5_IRB.pdf Supplementary Document	2010-05-05
10BA_Att 5_IRB approval-CSU.doc Supplementary Document	2010-05-05
10BA_Att 5a IRB_PHMC.pdf Supplementary Document	2010-05-05
10BA_Att 4_Consent_Forms.doc Supplementary Document	2010-05-05
10BA_Att 2_60d FRN.pdf Supplementary Document	2010-05-05
10BA_Att 1_Legislation.doc Supplementary Document	2010-05-05
SS Part Arevised.doc Supporting Statement A	2010-08-30

IC Document Collections

IC ID	Document Title	Status
193034	MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - CSU Other-WORD	New
193033	MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - NOVA Other-WORD	New
193032	MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - PHMC Other-WORD	New
193031	IMMEDIATE POST Follow-Up Assessment - CSU Other-WORD	New
193030	IMMEDIATE POST Follow-UP Assessment - NOVA Other-WORD	New
193029	Acceptability Survey by Site - PHMC Other-WORD	New
193028	IMMEDIATE POST Follow-UP Assessment - PHMC Other-WORD	New
193027	Acceptability Survey by Site -CSU Other-WORD	New
193026	Acceptability Survey by Site - NOVA Other-WORD	New
193025	CROSS-SITE Baseline Assessment - CSU Other-WORD	New
193024	CROSS-SITE Baseline Assessment - NOVA Other-WORD	New
193023	CROSS-SITE Baseline Assessment - PHMC Other-WORD	New
193022	Locator Forms by Site Other-WORD	New
193021	CROSS-SITE Screening Instrument Other-WORD	New

ICR Details

OMB Control No: 0920-0863	ICR Reference No: 201005-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Development and Testing of an HIV Prevention Intervention Targeting Black Bisexually-Active Men
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: 09/19/2010
	Date Received in OIRA: 05/24/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2013	36 Months From Approved
Responses	4,775	0	0
Time Burden (Hours)	2,042	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Black men who have sex with men (MSM) have been identified as the population segment with the highest rates of HIV infection in the U.S. and as a population in need of new HIV prevention interventions. Evidence suggests that up to 40% of Black MSM also have female sex partners. Interventions developed for gay men may not be appropriate for men who have sex with men and women (MSMW), many of whom do not self-identify as gay and who may need different prevention strategies for their male and female partners. There are no interventions with demonstrated efficacy in reducing HIV related sexual risk behaviors available for African-American MSMW. The purpose of this study is to develop and pilot test three novel behavioral interventions to reduce sexual risk for HIV infection and transmission among African-American MSMW who do not inject drugs. Three independent sites will develop, implement and test distinct interventions. Each site will enroll 240-260 African-American MSMW and use a randomized controlled trial design. Participants will complete behavioral assessments at baseline, immediately following the intervention, and three months later. The studies will establish the preliminary effectiveness of each intervention. If the results indicate these interventions are promising, they can be more rigorously evaluated. Ultimately, agencies that implement risk-reduction interventions would be able to use these curricula.

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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:
	75 FR 7399	01/27/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 25860	05/10/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
CROSS-SITE Screening Instrument
Locator Forms by Site
CROSS-SITE Baseline Assessment - PHMC
CROSS-SITE Baseline Assessment - NOVA
CROSS-SITE Baseline Assessment - CSU
Acceptability Survey by Site - NOVA
Acceptability Survey by Site -CSU
IMMEDIATE POST Follow-UP Assessment - PHMC
Acceptability Survey by Site - PHMC
IMMEDIATE POST Follow-UP Assessment - NOVA
IMMEDIATE POST Follow-Up Assessment - CSU
MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - PHMC
MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - NOVA
MULTI-SITE INSTRUMENT 3-Month Follow-Up (Assessment) - CSU

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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	4,775	0	0	4,775	0	0
Annual Time Burden (Hours)	2,042	0	0	2,042	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 information collection.

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Annual Cost to Federal Government: $817,541

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]? Uncollected

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: 05/24/2010

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