The effectiveness of donor notification, HIV, counseling, and linkage of HIV positive donors to health care in Brazil

ICR 201511-0925-001

OMB: 0925-0726

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0925-0726 201511-0925-001
Historical Active
HHS/NIH
The effectiveness of donor notification, HIV, counseling, and linkage of HIV positive donors to health care in Brazil
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 11/13/2015
Retrieve Notice of Action (NOA) 11/04/2015
  Inventory as of this Action Requested Previously Approved
11/30/2018 36 Months From Approved
550 0 0
229 0 0
0 0 0

This proposed study, “The effectiveness of donor notification, HIV counseling, and linkage of HIV positive donors to health care in Brazil” (The Brazil Notification Study)”, addresses this significant information gap with three objectives. The first objective formally measures donor notification rates in Brazil. The second objective measures HIV follow-up rates and donor behavior in relation to activities, such as linkage to health care resources and behavioral risk reduction through monitoring and counseling after donor notification. The third objective seeks to find ways to improve the disclosure of HIV risks during donor eligibility assessment at the time of blood donation. We will enroll a cohort of HIV-positive donors to assess these three objectives. Our findings will yield insights into improved methods for donor self-selection and qualification post donation, which will serve to decrease the frequency of higher-risk persons acting as donors. Our findings on improved methods for Brazilian donor notification and linkage to health care services may also be applicable to developed countries, including the US. Results of the Brazil Notification Study will identify how to improve notification and counseling strategies that increase the number of HIV-positive donors seeking prompt medical care. This might ultimately boost strategies to prevent secondary HIV transmission and reduce the risk of transfusion-transmission.

US Code: 42 USC sect 285b-1 Name of Law: National Heart, Lung and Blood Institute
  
None

Not associated with rulemaking

  80 FR 18853 04/08/2015
80 FR 37277 06/30/2015
No

  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 550 0 0 550 0 0
Annual Time Burden (Hours) 229 0 0 229 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
New ICR

$131,724
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  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.
11/04/2015


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