OMB Control No:
ICR Reference No:
201507-0925-003
Status:
Historical Inactive
Previous ICR Reference No:
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
The effectiveness of donor notification, HIV counseling, and linkage of HIV positive donors to health care in Brazil
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:
Improperly submitted
Conclusion Date:
11/05/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/07/2015
Terms of Clearance:
The package is missing a Supporting Statement Part B. The complete ICR (containing SSB) has been re-submitted into ROCIS on 11/5/15.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
Expiration Date 36 Months From Approved
Responses 0
0
0
Time Burden (Hours) 0
0
0
Cost Burden (Dollars) 0
0
0
Abstract:
Surprisingly, little is known about the consequences for donors themselves of identifying HIV infection through blood donation, or the potential public health implications of HIV-infected donor notification and counseling on efforts to control the HIV epidemic. In non-donor settings, HIV counseling and testing (HCT) is the entrée to care for infected persons and when successful provides direct and indirect prevention benefits. However, before a blood donor can be linked to HCT, the donor must come back to the blood center for notification and counseling related to the donation testing results. Approximately 60% of HIV-positive donors in Brazil (4) do return for notification and counseling, but there are no published data showing how many of these 60% subsequently attend the HCT centers for follow up care and treatment. This also means that 40% do not return and may unknowingly contribute to the transmission of HIV and other infections in the broader community. Persons with HIV identified in settings outside of the blood bank may reduce their risk of transmitting the virus to others through viral load suppression by antiretroviral therapy (ART), behavior change following risk reduction counseling, and referrals to other preventive and social services. However, the evidence of the impact of HIV counseling and testing on subsequent high-risk sexual behavior has been mixed. While some studies have found significant declines in the reporting of multiple sex partners and unprotected sex, other studies have found limited or negative effects of testing on behavior change. The first objective of this study is to formally measure donor notification rates in Brazil. The second objective of this study relates to HIV follow-up after notification. Specifically, we will seek to enroll a cohort of HIV-positive donors in this follow-up study to assess linkage to health care and risk behaviors following notification of donation testing results. Our findings should yield insights into improved methods for donor selection and qualification that can increase rates of self- and on-site deferral and therefore decrease the frequency that higher-risk persons are accepted as donors. HIV-positive donors will come from two sources, a study conducted in the NHLBI-sponsored Retrovirus Epidemiology Donor Study-II (REDS-II), and a study currently enrolling in the Recipient Epidemiology and Donor Evaluation Study (REDS-III). Specifically, we will seek to enroll a cohort of HIV-positive donors in this follow-up study to assess linkage to health care and risk behaviors following notification of donation testing results. Results of the proposed study will have significance beyond the immediate benefit of improving blood safety at the REDS-III Brazil blood centers. The greatest potential impact may be for other developing countries, particularly in Latin American, with similar HIV disease epidemiology, few options for counseling and treatment centers, and limited resources for donation screening by NAT. However, our findings on improved methods for donor notification and linkage to health care services will also be generalizable to developed countries such as the US where improved notification and counseling strategies may result in an increased number of HIV-positive donors seeking medical care promptly. It is now increasingly apparent that receiving medical care (i.e., antiretrovirals) as early as possible after HIV infection may be an extremely important factor in helping suppress and control the virus.
Authorizing Statute(s):
US Code:
42 USC 285bâ1
Name of Law: National Heart, Blood Vessel, Lung and Blood Diseases and Blood Resources Program
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN: Stage of Rulemaking: Federal Register Citation: Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
80 FR 18853
04/08/2015
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 37277
06/30/2015
Did the Agency receive public comments on this ICR?
No
Reginfo record details
Number of Information Collection (IC) in this ICR:
2
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 ICR.
Annual Cost to Federal Government:
$131,724
Does this IC contain surveys, censuses, or employ statistical methods?
No
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
Agency Contact:
Mikia Currie 3014350941
Reginfo record details
Common Form ICR:
No
Form 1 ACASI Questionnaire Informed Consent
SSA_Brazil_HIV_Notification_6_2015_V_24.0.docx
ACASI Questionnaire Informed Consent