Supporting Statement B

Injection Behaviors among Young Persons in Rural/Suburban Settings

Generic Information Collection request under 0920-0840

Expiration 2/29/2016

Section B: Supporting Statement

March 31, 2014

CONTACT

Jon E. Zibbell, PhD

Centers for Disease Control and Prevention

Division of Viral Hepatitis

Prevention Branch

Phone: 404.718.8851

Fax: 404.718.8595

Email: jzibbell@cdc.gov

Statistical Methods

Collection of Information Employing Statistical Methods If statistical methods will not be used to select respondents and item 17 on Form 83-I is checked “No” use this section to describe data collection procedures.

1. Respondent Universe and Sampling Methods

Information collection activities will target a specific population that meets the following inclusion criteria:

• Individuals ages 18-29 years of age;

• Have used a needle to inject illicit street drugs within the past 12 months;

• Have a state issued photo ID or other credible form of photo identification; and

• Are able to complete a survey in the English language.

A Respondent Driven Sampling (RDS) approach will be used to recruit participants into the study. RDS is an established method for accessing hard to reach populations in a manner that allows statistical inferences to be drawn from the sample. Detailed descriptions of RDS can be found at the RDS website of Douglas Heckathorn, originator of Respondent Driven Sampling (http://www.respondentdrivensampling.org)

RDS is the survey method of choice for accessing so-called hidden populations that cannot be accurately sampled through random selection. RDS is especially desirable when a hidden population is heterogeneous in person-level characteristics that are important to the study goals. In the case of this study, frequency and duration of drug use/abuse is likely to be the most important source of heterogeneity, with the population roughly stratified between heavy/daily users, and more episodic users.

This study will collect data at SSPs. Heavy drug users are much more likely to access SSPs than episodic drug users who often obtain injecting equipment secondarily from heavy users. Therefore, a recruitment process that samples only among individuals that use the SSP is likely to suffer from selection bias and over-represent heavy drug users as a result. RDS represents a solution to mitigate the risk of selection bias and produce a sample that more accurately reflects the balance of heavy and episodic users in the community of interest.

2. Procedures for the Collection of Information

This collection of information will follow approved procedures, detailed below:

1. NORC laptops will be set up in a secure and confidential setting to conduct the online study survey. Up to two respondents can be complete the survey during the same time period since 2 survey laptops will be available.

2. Field staff will ask interested individuals their permission to be asked four yes/no questions to determine study eligibility: 1. Date of Birth (to confirm between ages 18-29); 2. Whether they have injected drugs in the last 12 months; 3. Whether they could complete a survey in English; and 4. If they have a photo ID with them.

3. For eligible participants (answer yes to all 4 eligibility questions listed in Step 2), the field staff will review the informed consent with the potential participant, answer any questions the potential participant has, and ask the potential participant to verbally consent to participate in the study. The field staff will check Yes/No on whether verbal consent has been obtained and the participant will check Yes/No on whether they agree to complete the survey and the HCV test.

4. After verbal consent, the participant will supply field staff with the following identifying information: First Name and Last Name which will be encoded with a seed number into a unique identification number/participation code.

5. Field staff will then administer the hepatitis C test using the OraQuick Step-by Step Test Administration Guidelines. Field staff will place a sticker that will match the test result to the survey that the individual is filling out.

6. After the hepatitis C test has been administered, participants will complete the online IDU survey on the NORC laptop, which will take up to 45 minutes.

7. Upon completion of the survey, the participant will be notified that their hepatitis C result is available and will have the option to receive their test result.

8. Upon completion of the survey, the participant will receive a $15 honorarium and they will receive 3 coupons (and their coupon number) to distribute to 3 drug using contacts for study enrollment. The referred individuals can bring in the coupon or bring in the coupon number to one of the recruitment/data collection locations. For all successful referred individuals (success = study completion), the referring participant will receive $10 per referred individual (for up to 3 referrals).

All data collection and analysis will be performed in compliance with OMB, Privacy Act, and Protection of Human Subjects requirements.

3. Methods to Maximize Response Rates and Deal with Nonresponse

Several procedures proven effective in previous studies will be used to maximize response rates:

• Potential respondents will be informed about the importance of these studies and encouraged to participate through a variety of methods, including letters of support from key individuals

• Experienced, highly-trained staff will conduct the study (HCV test and oversight of online data collection)

• Field staff will participate in a thorough training session prior to study implementation

• Should a respondent interrupt the survey for any reason, such as needing to attend to a personal matter, the field staff will inform the respondent that they can come back to complete the survey

4. Tests of Procedures or Methods to be Under Taken

Prior to implementation, the survey will be piloted. Lessons from the pilot test will be identified, and changes as necessary will be incorporated into the instrument and method. All pilot tests will involve no more than a minimal number of individuals unless OMB clearance is sought for a larger number.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Daniel Raymond

Policy Director

Harm Reduction Coalition

22 W. 27^th Street, 5^th Floor

New York, NY 10001

Greg Scott, PhD

Director, Social Science Research Center

Associate Professor of Sociology

990 West Fullerton Avenue, Suite 3100

Chicago, Il 60614-2458

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