HIV Prevention among Latino MSM: Evaluation of a locally developed intervention

Forms and Documents

Document Name	Status
Attachment 5a - 6 month follow-up assessment Spanish.docx Supplementary Document	2014-11-21
Attachment 2a - Public Comment.docx Supplementary Document	2014-11-21
Attachment 2 - 60 Day FRN.pdf Supplementary Document	2014-11-21
SupSta B_111814 tfs4.docx Supporting Statement B	2014-11-21
Attachments 6a-6b - Two Versions of Study Ads.docx Supplementary Document	2012-06-12
Attachment 11 - CAB membership list.docx Supplementary Document	2012-02-08
Attachment 10 - All-PI meeting participant list.docx Supplementary Document	2012-02-08
Attachment 9 - NCHHSTP project determination.pdf Supplementary Document	2012-02-08
Attachment 8 - Local IRB approvals.pdf Supplementary Document	2012-02-08
Attachment 1 - Public Health Service Act.docx Supplementary Document	2012-02-08
Attachment 7 - Consent forms.pdf Supplementary Document	2012-02-08
SupSta A_111814_tfs4.docx Supporting Statement A	2014-11-21

IC Document Collections

IC ID	Document Title	Status
201268	6-Month Follow-up Assessment Other-Attachment 5 - Six-Month Follow-Up Assessment	Unchanged
201267	Baseline Assessment Questionnaire Other-Attachment 4 Baseline Assessment questionnaire	Unchanged
201266	Participant Screening Form Other-Attachment 3	Unchanged

ICR Details

OMB Control No: 0920-0942	ICR Reference No: 201411-0920-007
Status: Historical Active	Previous ICR Reference No: 201202-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: HIV Prevention among Latino MSM: Evaluation of a locally developed intervention
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/02/2015
	Date Received in OIRA: 12/12/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	06/30/2016	06/30/2015
Responses	950	0	950
Time Burden (Hours)	883	0	883
Cost Burden (Dollars)	0	0	0

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Abstract: In 2009 Latinos represented 16% of the U.S. population but 20% of all new HIV infections. Latino men accounted for 79% of all new HIV infections among Latinos, and male-to-male sexual contact accounted for 81% of new infections among Latino males. Despite the high levels of HIV/STD infection risk that affect Latino men who have sex with men (MSM), no efficacious behavioral interventions are available to prevent HIV/STD infection among them. There is an urgent need for efficacious, culturally congruent prevention interventions for Latino MSM. This study is using a randomized controlled trial design to collect data needed to assess the efficacy of the Spanish-language, small-group HOLA en Grupos intervention compared to a general health comparison intervention. HOLA en Grupos is designed to increase participants' consistent and correct condom use, HIV testing and receipt of test results, decrease unprotected anal and vaginal sex with partners of unknown HIV serostatus or with HIV-positive partners and the numbers of their sexual partners, and increased discussion with their sexual partner about risk reduction. Latino MSM in rural central North Carolina are being recruited to the study. HOLA en Grupos will be delivered to 25 participants who are randomly assigned to the intervention condition during four 4-hour sessions on four separate days over a two week period. The general health comparison intervention will be delivered to 25 participants who are randomly assigned to the comparison condition during four 4-hour sessions on four separate days over a two week period. The study is collecting behavioral and related data from study participants at baseline before the interventions are delivered and six months later. Eligible participants are Spanish speaking males 18 years of age or older who self-identify as Latino or Hispanic, speak Spanish, and have sex with another man since attaining age 18.

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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:
	79 FR 50652	08/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 68446	11/17/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Participant Screening Form
Baseline Assessment Questionnaire
6-Month Follow-up Assessment

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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	950	950	0	0	0	0
Annual Time Burden (Hours)	883	883	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $155,174

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: 12/12/2014

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