HIV Study in Blood Donors from Five Chinese Regions (NHLBI)
Reinstatement with change of a previously approved collection
No
Regular
Approved without change
12/19/2014
11/14/2014
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2017
36 Months From Approved
01/31/2012
1,350
0
3,920
450
0
1,294
0
0
0
To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). The major objectives of the study will be to evaluate the proportion of blood donors in China who were tested positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV-1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status (http://www.unaids.org.cn/pics/20130521161757.pdf). The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad cross-section of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, as suggested by recent HBV and HCV data from US CDC (http://www.cdc.gov/immigrantrefugeehealth/guidelines/domestic/hepatitis-screening-guidelines.html), the study objectives have direct relevance for HIV control in the US and globally.
This HIV Risk Factor Survey constitutes a request for a reinstatement with change of a previous collection of information (OMB Number: 0925-0596 expiration date, January 31, 2012). Compared with the previous study, there are three changes:
1. Increased number of study sites from four to five: the previous study was conducted with blood donors at four blood centers (Kunming, Luoyang, Mianyang and Urumqi), while the current study collects data from a larger number of blood centers (Chongqing, Guangxi, Luoyang, Mianyang and Urumqi) thus increasing the study's geographic representation.
2. New survey questions to examine recently HIV infected donors: the questionnaire includes new questions about potential risk factors that may be associated with recently-acquired HIV infections and new questions probing detailed risks associated with increasing HIV prevalence in high risk groups. With this information captured and linked to the HIV test data and donor demographic characteristics, the study aims to establish the profiles of recently HIV infected donors and possibly identify new strategies to prevent window period blood donations.
3. Decrease amount of incentive for survey participants from 200 RMB to 100 RMB: based on the data collection team's experience with conducting similar surveys with this population in these regions in China, it was decided that this study does not need 200 RMB incentive.
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.
HIV Risk Factor Questionnaire Blood donors Control Peripheral Sites