OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201411-0920-007 · OMB 0920-0942 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Attachment 5a - 6 month follow-up assessment Spanish.docx Supplementary Document Uploaded 2014-11-21 Repair queued
Attachment 2a - Public Comment.docx Supplementary Document Uploaded 2014-11-21 Repair queued
Attachment 2 - 60 Day FRN.pdf Supplementary Document Uploaded 2014-11-21 Available
SupSta B_111814 tfs4.docx Supporting Statement B Uploaded 2014-11-21 Available
Attachments 6a-6b - Two Versions of Study Ads.docx Supplementary Document Uploaded 2012-06-12 Repair queued
Attachment 11 - CAB membership list.docx Supplementary Document Uploaded 2012-02-08 Available
Attachment 10 - All-PI meeting participant list.docx Supplementary Document Uploaded 2012-02-08 Repair queued
Attachment 9 - NCHHSTP project determination.pdf Supplementary Document Uploaded 2012-02-08 Repair queued
Attachment 8 - Local IRB approvals.pdf Supplementary Document Uploaded 2012-02-08 Available
Attachment 1 - Public Health Service Act.docx Supplementary Document Uploaded 2012-02-08 Available
Attachment 7 - Consent forms.pdf Supplementary Document Uploaded 2012-02-08 Repair queued
SupSta A_111814_tfs4.docx Supporting Statement A Uploaded 2014-11-21 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0942 201411-0920-007
Historical Active 201202-0920-004
HHS/CDC
HIV Prevention among Latino MSM: Evaluation of a locally developed intervention
Extension without change of a currently approved collection   No
Regular
Approved without change 03/02/2015
Retrieve Notice of Action (NOA) 12/12/2014
  Inventory as of this Action Requested Previously Approved
03/31/2018 06/30/2016 06/30/2015
950 0 950
883 0 883
0 0 0
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.
US Code: 42 USC 301 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  79 FR 50652 08/25/2014
79 FR 68446 11/17/2014
No
3
IC Title Form No. Form Name
Participant Screening Form
Baseline Assessment Questionnaire
6-Month Follow-up Assessment
  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
No
No
$155,174
Yes Part B of Supporting Statement
Yes
No
No
No
Uncollected
Thelma Sims 4046394771
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
12/12/2014