Adult Consent

“Evaluating a HIV/AIDS Focused Video Game for Young People”

Generic Information Collection request under 0920-0840

(exp. 02/29/2016)

Attachment 2c. Adult Consent

Flesch-Kincaid Grade Level 8.0

Centers for Disease and Control Prevention

Consent to be in a Research Study

Thank you for your interest in this research study. Before you decide whether to agree to be in this study, please read this form along with me as I read it aloud and ask as many questions as you need to be sure you know what you will be asked to do.

Introduction: This study is being conducted by researchers from the Centers for Disease Control and Prevention.

What is the purpose of this study? The purpose of this study is to test an HIV/AIDS educational video game designed to be an effective method for HIV/AIDS and Sexually Transmitted Infections (STI) prevention for youth ages 11 and 24. This study is important because youth are at higher risk for HIV/AIDS particularly African American and Hispanic heterosexual youth.

Why am I being asked to be in this study? We are asking you to be in this study because you are a youth between the ages of 18 and 24.

What is going to happen during the study?

You will complete 2-3 surveys and possibly play an HIV/AIDS prevention video game. Participants will be chosen to play the game based on the age, race, and sex of participants recruited at a site. You will be able to play the game once the study is over. You will be asked to complete up surveys with questions about HIV/AIDS knowledge, sexual behaviors and the video game if you played it. If you play the game you will take 2 surveys the day you begin the study. You will take another survey 30 days after you complete the first survey. If you do not play the game, you will take a survey the day you begin the study and second one 30 days after. The questions will be about HIV/AIDS knowledge and sexual behaviors.

What do you want me to do if I decide to be in this study? If agree to participate you will be are asked to complete surveys and possibly play the HIV/AIDS focused video game. We would like for you to respond to the questions in the survey. On the survey, you will be asked questions about HIV/AIDS knowledge, their sexual behaviors and your impressions on the video game if you play it.

How long will you need me? How long we will need you depends on if you are chosen to play the game during the study. If you are chosen to play the game, we will need you for up 60 minutes. If you are not chosen to play the game we will need you for 30 minutes.

If you are selected to play the game, we expect it will take up to 45 minutes to take 2 surveys and play the game. We expect it will take you up 15 minutes to take the take another survey 30 days after playing the game.

If you do not play the game, you will take 1 survey that should take up to 15 minutes the day you begin the study and another 30 days after taking the first survey. If you do not play the game during the study, you will be able to play it after the study ends.

Are there any risks to me if I decide to be in this study? There is low risk to you if you decide to be in this study. Since we may ask personal questions during the surveys, you may feel uneasy or have some concerns. You do not have to respond to any questions you do not want on the survey.

Are there any benefits from being in this study? By being in this study you will learn more about HIV/AIDS and how to prevent it. You will be helping to test an educational video game that can help other young people in the community and the nation.

Will the things I tell you be kept private? What you tell us will be kept private to the extent allowed by law. Your responses to the survey will be kept secure by the research staff. We will safeguard you identity and information that they supply. That is, we will not tell anyone what you said and we will not tell anyone that you completed a survey about the study. However, if we think there may be abuse or that you may cause harm to yourself or others, we are required by law to report this concern to the proper authorities.

What if I want to know about the responses of the other participants?

The researcher does not plan to share the specific information with anyone. However, the overall, summary findings of the study will be shared with you, if requested. If this makes you uncomfortable, you have the option of refusing to participate in the study. Participants will not be forced to answer any questions, and participants may elect to discontinue their participation in the survey if they are uncomfortable at any time.

What will you do with the responses to the surveys?

The responses to the surveys will be used to write papers on what we have found. We will share our findings with the people working on the study. These people will review the survey responses to help us understand what we have found. We also hope to make public our findings in a journal magazine, so that we can share what we found with other people. At no time, will anyone be able to know what they said or that they were in this study from anything that we write. We will also use the responses to improve the video game.

We will also share our overall findings with you if you would like. You may also have a copy of any of the overall reports by getting in touch with us or giving us a number where we can call you.

Is there any cost if I take part in this study? The only cost to you for being in this study is your time for coming to this location today and again in 30 days.

Is there any reimbursement if I take part in this study? There is no reimbursement for taking part in this study, although you will receive a token of appreciation of $10 if you participate in the study, complete the 1-2 surveys and/or play the video game and an additional $15 if you complete the 30 day follow up survey. The tokens of appreciation will be in the form of gift cards.

Who should I call if I have questions about this study or think I may have been harmed by this study? If you have any questions about this study you may call Dr. Leigh Willis, 404-639-8447. If you have questions about your rights for being in this study, you may call the CDC Institutional Review Board at 1- 800-584-8814.

Do I have to be in this study? You do not have to be in this study, it is up to you if you want to or not. You can stop being in this study at any time without any penalty or loss of benefits.

Do you have any further questions about this study?

Please print and sign your name below if you agree to be in this study. By signing your name you also agree that you have read this form and have had a chance to ask any questions you may have about the study. You will be given a copy of this consent form for you to take with you.

__________________________________

Print your Name Date

Sign your Name Date

Will you allow us to keep your contact information so we can provide you the results of the study? Circle yes or no.

Yes No (Please do not contact me again)

I observed the process of consent. The prospective participant read or was read this form, was given the chance to ask questions, appeared to accept the answers, and signed to enroll in the study.

Signature of Research Staff Date