Consent for Focus Group

Qualitative research to understand consumer opinions and preferences for emerging

HIV prevention products among MSM in Atlanta, Houston, and Miami

Attachment 3b: Consent for Focus Group

Prevention Products for MSM

Consent to be a Research Subject

Focus Group and Demographic Survey

Study Title: Prevention Products for MSM: Qualitative research to understand consumer opinions and preferences for emerging HIV prevention products among MSM in Atlanta, Houston, and Miami

Research Sponsors

The Centers for Disease Control and Prevention, in partnership with Research Support Services, Inc., IMPAQ International, LLC, and University of Nevada, Las Vegas, is asking you to take part in a research study.

Key Information

The purpose of this research study is to find out what you think about new HIV prevention products. This study is voluntary. If you join this study, you will be asked to take part in a 5-minute survey and a 90 minutes focus group. There may not be direct benefits to you as a participant in this study. There are two main risks if you take part in this study. The first is that your private information might get out even though we have measures in place to protect your private information. The second risk is that some of the questions might make you feel uncomfortable. You do not have to answer any questions that make you feel uneasy or uncomfortable.

Purpose

The purpose of this study is to find out what you think about new HIV prevention products. We want to learn what men think about pre-exposure prophylaxis (PrEP) as a daily pill, and how they might want to take PrEP in the future. We asked you to be in this study because you are a man who has sex with men, and you are eligible to take PrEP. We will talk to 120 men in the Atlanta, Houston, and Miami metropolitan areas. What you tell us will be used to make new PrEP options for gay, bisexual and other men who have sex with men.

If you join this study, you will be asked to take part in a 5-minute survey and a 90-minute focus group discussion. You will fill out the paper survey and will answer questions about who you are and what you know about HIV prevention. You will then participate in a focus group. This means that you will sit down with a study team member and up to four other men in a private room. The team member will show the group future PrEP products and ask for your opinions about them as well as ask you what you think about the daily PrEP pill. The study team member will record your conversation and take notes.

There are two main risks if you take part in this study. The first is that your private information might get out. We have measures in place to protect your private information, and we will use a number instead of your name on the focus group notes and survey. The second main risk is that some of the questions we ask you might make you feel uncomfortable. You do not have to answer any questions that make you feel uneasy. Also, something may come up for you that you want to know more about. If that happens, we will give you the names of services that are close to where you live that could help you.

You may not personally benefit from joining this study. What you tell us will help other men prevent HIV in the future.

It is completely up to you if you want to take part. You do not have to take part.

Confidentiality

We will do everything we can to protect your privacy to the extent allowed by law. In order to reach you, we may ask your name and contact information, and we will give you a study number. This information is kept in a locked file cabinet separate from our study records. This information will be destroyed at the end of the study.

The focus group notes and audio will be kept in a locked file cabinet in a secure place and are only accessible to study staff. When we type up the group discussion, we will remove any names you might use. Your answers to the survey questions will be kept in a database on secure servers and in password-protected files. Your name and other facts that might point to you will not appear when we present this study or publish its results. Other researchers may use this database after the study is over. They will not know who you are. After the study is over, we will destroy the focus group audio.

This study has been given a Certificate of Confidentiality. This means that your personal information will not be shared with anyone, even if a court orders us, unless you say it is okay to share the information. But under the law, we must report to the proper authorities if you tell us you are planning to cause serious harm to yourself or others.

Token of Appreciation

You will receive $60 in cash or gift card to thank you for your time participating in the focus group and survey.

What if I have questions?

If you have any questions about this study or feel you have been harmed, please call Dr. Alisú Schoua-Glusberg at 1-847-971-9068. If you have any questions about your rights as a participant in this study, please contact CDC/ATSDR’s Deputy Associate Director for Science at 1-800-584-8814. Leave a message with your name, phone number, and refer to CDC protocol # ____, and someone will call you back.

We will give you a copy of this consent form to keep.

If you are willing to volunteer for this research, please sign below.

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Subject’s Signature Date Time

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Person Obtaining Consent Date Time