Supporting Statement B

Request for Sub-collection Under the

Generic ICR: Formative Research and Tool Development

OMB No. 0920-0840, Expiration 02/29/2016

Pilot Test Study for the HIV Risk Reduction Educational Tool

Supporting Statement B

December 11, 2014

Contact Person:

Jocelyn Taylor

1600 Clifton Rd. NE
Mailstop E-49

Atlanta, GA 30329

Telephone: (404) 639-8815

Fax: (404) 639-2007

E-mail: [email protected]

B. Collections of Information Employing Statistical Methods

This information collection request does not employ statistical methods. The following is a description of data collection procedures.

B.1 Respondent Universe and Sampling Methods

This study will be conducted with up to 1,500 English speaking individuals aged 18 to 64. The sample will be a non-probability based purposive sample. We will recruit individuals who are actively seeking HIV/AIDS information online through Google paid search terms (called Google AdWords). The AdWords, predetermined by the study team, will include keywords such as “HIV,” “HIV risk,” “HIV prevention” and “condoms.”

B.2 Procedures for the Collection of Information

B.2.1 Recruitment

Internet users who enter a keyword as a Google search term (see Section B.1) will be presented with a brief recruitment advertisement (Attachment 6). The brief advertisement will appear next to or above Google search results (Attachment 7). Those who click on the link in the brief advertisement will be routed to the study’s website where they will be presented with the full advertisement which describes the study in more detail (Attachment 6). Individuals interested in determining their eligibility for participation will be directed to click on a hyperlink which will launch the consent for screening (Attachment 2).

B.2.2 Screening and Scheduling Procedures

The screening survey will launch automatically on the study’s secure Website once individuals indicate their consent to be screened (Attachment 2). Those who do not consent to be screened will be thanked for their time and asked to close their browser window. The screener includes questions to assess eligibility and adequately describe the sample. To be eligible for the study, participants must be aged 18 to 64. Eligible individuals will be invited to participate and asked to click on a hyperlink to launch the consent form for the pilot study to encompass the pretest survey, exploration period, and posttest survey.

The consent will inform potential participants of the private and voluntary nature of the study and provide general information about the study, the topics to be covered in the surveys, potential risks, and the token of appreciation available for completing the study. After reading the informed consent, each participant must check either a box labeled “I have read this consent form and agree to participate in the study” or “I have read this consent form and do not want to participate in the study.” Only those who agree to participate will enter the pretest survey. People who elect not to participate will be thanked for their time and asked to close their browser window.

B.2.3 Data Collection Methods

After providing consent, participants will be provided with instructions for discontinuing the exploration period (“Quit Exploring”) as well as the study entirely (“Quit Study”). They will then be directed to the 15 minute pretest survey (Attachment 3a) after which they will have time to explore the tool (attachment 10). The exploration period will last 15 minutes on average if participants do not terminate exploration prematurely. They will have the option to customize the tool based on their gender, their sexual orientation, the gender of sex partner, and their HIV status. HRRET topics include “What is HIV?,” “HIV testing,” “Can I get or transmit HIV from…?,” “What affects my HIV risk,” and “Test my knowledge.” There are various messages within each topic area. For example, messages on acute HIV infection, HIV Superinfection, and undetectable viral load are part of the “What is HIV?” topic. The messages organized by topic area are shown in Attachment 8. At the end of the exploration period, participants will be automatically directed to complete the 15-minute posttest survey (Attachment 3b).

Once participants complete the posttest survey, they will be able to redeem their $25 Amazon gift card. The redemption process will be managed by Qualtrics through a separate fulfillment partner; thus, the link between RTI and participants will be severed after they initiate the redemption process. Amazon provides boilerplate text and a Web template for the redemption page, known as the delivery template. The delivery template provides instructions on how to redeem and manage the gift card. See a sample delivery template for email redemption in Attachment 9. Since gift-card redemption will be facilitated by Qualtrics' fulfillment partner, after participants click on the redemption link included in the delivery template, which routes participants to Amazon’s website, the link between participants and Qualtrics terminates. Redemption options are provided by Amazon, and they provide complete instructions for how to redeem the gift card. Participants with existing Amazon accounts can choose to spend their gift card immediately or apply it as credit to their account. Those without an Amazon account have three options: (1) Spend the amount immediately; (2) create an account and apply the gift card as a credit for redemption at a later date, or (3) write down the Amazon gift code and redeem the gift card at a later date.

Qualtrics has some safeguards in place to help ensure that individuals do not participate in the study more than once. First, as mentioned previously, Qualtrics will ask participants for their email addresses at the beginning of the survey. Should duplicates be identified, participants will be told that the survey is closed at this time and asked to close their browser window. Second, Qualtrics will track participants’ IP addresses. As participants enter the study website, their IP addresses will be compared to a running list of IP addresses to identify duplications. If an IP address matches one that is already on the list, the participant will be told that the survey is closed at this time and asked to close their browser window. Email and IP addresses will be maintained by Qualtrics; CDC and RTI will not have access to this information, thus preserving participants’ privacy. The email and IP addresses will be destroyed at the conclusion of the study.

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

The following procedures will be used to maximize cooperation and achieve the desired participation rates:

A $25 Amazon gift card will be offered to participants who complete the study.

RTI will provide a toll-free telephone number for the RTI project director and a toll-free telephone number for the RTI IRB hotline should participants have any questions about the study or their rights as study participants as well as contact information for CDC Info and AIDS.gov should they have questions or concerns about HIV or wish to locate HIV-related or other services.

Qualtrics will maintain records of participants’ email addresses and will email participants asking them to complete the study should they break off early. Email addresses will be destroyed once participants complete the study.

B.4 Test of Procedures or Methods to Be Undertaken

This submission is a request for authorization to conduct a pilot test study of new technology-based HIV prevention materials which is a typical component of the technology development process.

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

Jo Ellen Stryker

CDC Associate Chief, Science

1600 Clifton Rd, NE

Atlanta, GA 30333

[email protected]

(404) 639-2071

Jocelyn Taylor

CDC Behavioral Scientist

1600 Clifton Rd, NE

Atlanta, GA 30333

[email protected]

(404) 639-8815

[email protected]

Jennifer D. Uhrig
RTI Project Director
RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709
[email protected]
(919) 316-3311

Megan Lewis

RTI Task Leader

RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709
[email protected]
(919) 541-6834

Jennie Harris

RTI Task Leader

RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709
[email protected]
(919) 485-2770

Carla Bann

Statistician

RTI International

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

[email protected]

919-485-2773

Mark Koyanagi

RTI Lead Developer

RTI International

3040 Cornwallis Rd.

Research Triangle Park, NC 27709

[email protected]

919-541-6682