In-Depth Interview Consent

IRB APPROVED

Jun 26, 2023

Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP)

Attachment 5c. In-Depth Interview Consent English

Emory University

Oral Consent and Script/Information Sheet

For a Research Study – Interview Sub-study Addendum

TITLE: Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP Study)

Protocol No.: None

WCG IRB Protocol #20225896

STUDY00005355

Sponsor: Centers for Disease Control and Prevention

INVESTIGATOR: Patrick Sullivan, DVM, PhD

1518 Clifton Rd NE

CNR 2nd Floor - PRISM

Atlanta, Georgia 30322

United States

STUDY-RELATED

PHONE NUMBER(S): 404-712-8630 (24 hours)

This form has more information about the research study. It may add to or change the information in the consent form you signed at the start of this study. You will receive a copy of this consent form addendum for your records.

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

Participating in the interview portion of this study is optional. Your decision not to participate will not affect your participation in the main study.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

Introduction and Study Overview

You are being asked to be in a research study. This information sheet is designed to tell you everything you need to think about before you decide if you want to be a part of the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, you will not lose any services you would otherwise receive from us.

Before making your decision:

• Please carefully read this information sheet or have it read to you

• Please listen to the study staff explain the study to you

• Please ask questions about anything that is not clear

You can take a copy of this information sheet, to keep. Feel free to take your time thinking about whether you would like to participate. You may wish to discuss your decision with family or friends. Do not agree to participate unless you have had a chance to ask questions and get answers that make sense to you. By agreeing to participate, you will not give up any legal rights.

What is the purpose of this study?

The purpose of this interview portion of the study is to understand men’s experience of PrEP, explore their preferences for PrEP and other HIV prevention products, and to continue to inquire about their reactions to HIV prevention messages.

What will I be asked to do?

If you choose to be in this portion of the study, we will ask you to talk about your views, thoughts and opinions on PrEP for HIV prevention. We may ask you to expand upon things you mention, or why you made certain choices or comments. All thoughts and ideas are valid, and all opinions will be considered. We will also ask you to provide feedback on PrEP messages, your candid thoughts on what makes any given message better than others, and how each message can be made most appealing to you. We will ask you to participate in three of these conversations, each approximately 6 months apart. Each talk will take about 60 minutes. It will be held in a private venue (virtually or in-person), so you can more openly discuss your views. These interviews will be digitally audio-recorded, transcribed, and transcriptions will be de-identified (meaning that any information identifying you will be removed). The recording will be destroyed once it is transcribed.

Who owns my study information and samples?

If you join this study, you will be donating your thoughts and opinions. You will not receive any token of appreciation if your samples or information are used to make a new product. If you withdraw from the study, data and samples that were already gathered may still be used for this study.

What are the possible risks and discomforts?

We believe this study poses minimal risk to you as a participant. You may feel nervous, shy or feel discomfort talking about sex acts and beliefs. You do not have to answer questions that you do not wish to answer. We will not collect any information from you other than your voice on the audio recording. There is the risk of a loss of confidentiality of your research-related information.

It is possible that the study team will learn something new during the study about the risks of being in it. If this happens, they will tell you about it. Then you can decide if you want to remain in this study or not. You may be asked to read a new information sheet and provide new verbal consent if you decide to stay in the study.

Will I benefit directly from the study?

This interview portion of the study is not designed to benefit you directly. Doing this research study may not benefit you personally. We may learn about how to promote prevention services that can help reduce the health burden of HIV among MSM.

Will I be compensated for my time and effort?

You will receive $75 for each interview you take part in as a token of appreciation to you for your time and effort, for a total of $225 for all three interviews. All payments will be provided in the form of an electronic gift card that will be emailed to you.

You will be asked to fill out a tax form, including your Social Security or Taxpayer Identification Number, in order to be reimbursed, depending on the amount and method of payment. Some payment methods involve mail coming to your house, which may be seen by others in your household. You can decline payment if you are concerned about confidentiality, or you can talk to the study team to see if there are other payment options.

How will you protect my private information that you collect in this study?

Whenever possible, a study number, rather than your name, will be used on study records. Your name and other identifying information will not appear when we present or publish the study results.

Certificate of Confidentiality

This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT protect your information if a federal, state, or local law says it must be reported. For example, some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used for other research if allowed by federal regulations.

Researchers may release your information when you say it is okay. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the research. The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information.

Storing and Sharing your Information

The data you provide will be stored securely, with all names and data that could be used to identify you removed. The data you provide are to be used only by study staff. Your contact details will be stored securely, for use only when contacting you for study activities described in this information sheet. The data you provide will not be used for other research.

Costs

There will be no costs to you for participating in this study, other than basic expenses like transportation. You will not be charged for any of the research activities.

Withdrawal from the Study

You have the right to leave a study at any time without penalty. The study team also have the right to remove you from in this study without your consent for any reason. The study team may remove you from the study if they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.

Confidentiality

Certain offices and people other than the researchers may look at study records. Government agencies and Emory employees overseeing proper study conduct may look at your study records. These offices include the Office for Human Research Protections, the funder(s), the Emory Institutional Review Board, the Emory Office of Compliance, and WCG IBR. Study funders may also look at your study records. Emory will keep any research records we create private to the extent we are required to do so by law. A study number rather than your name will be used on study records wherever possible. Your name and other facts that might point to you will not appear when we present this study or publish its results.

People Who will Use/Disclose Your Information:

The following people and groups will use and disclose your information in connection with the research study:

• The Principal Investigator and the research staff will use and disclose your information to conduct the study.

• Emory may use and disclose your information to run normal business operations.

• The Principal Investigator and research staff will share your information with other people and groups to help conduct the study or to provide oversight for the study.

• The following people and groups will use your information to make sure the research is done correctly and safely:

  • Emory offices that are part of the Human Research Participant Protection Program and those that are involved in study administration and billing. These include the Emory IRB, the Emory Research and Healthcare Compliance Offices, and the Emory Office for Clinical Research.

  • Other researchers and centers that are a part of this study.

  • Government agencies that regulate the research including: Office for Human Research Protections.

  • Public health agencies.

  • Research monitors and reviewer.

  • Accreditation agencies.

Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, your information may be shared with that new institution and their oversight offices. Information will be shared securely and under a legal agreement to ensure it continues to be used under the terms of this consent.

Contact Information

If you have questions about this study, your part in it, your rights as a research participant, or if you have questions, concerns or complaints about the research you may contact the following:

Contact study coordinator Rebecca Moges-Banks at 404-712-8630 or principal investigator Patrick Sullivan at 404-727-2038.

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:

• You have questions, concerns, or complaints that are not being answered by the research team.

• You are not getting answers from the research team.

• You cannot reach the research team.

• You want to talk to someone else about the research.

• You have questions about your rights as a research subject.

Do you have any questions about anything in the informational sheet? Were there any parts that seemed unclear?

Do you agree to take part in the study?

[Participant agrees to participate (circle one): Yes No ]

[If Yes:]

Signature of Person Conducting Informed Consent Discussion Date Time

Name of Person Conducting Informed Consent Discussion

San Diego State University

Oral Consent and Script/Information Sheet

For a Research Study – Interview Sub-study Addendum

Title: Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP Study)

Protocol No.: None

WCG IRB Protocol #20225896

Sponsor: Centers for Disease Control and Prevention

Investigator: Keith Horvath, PhD

6363 Alvarado Court

Suite 250

San Diego, California 92120

United States

STUDY-RELATED

PHONE NUMBER(S): 619-594-3346

404-712-8630 (24 hours)

This form has more information about the research study. It may add to or change the information in the consent form you signed at the start of this study. You will receive a copy of this consent form addendum, as well as a signed and dated copy of the Experimental Subject’s Bill of Rights for your records.

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

Participating in the interview portion of this study is optional. Your decision not to participate will not affect your participation in the main study.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

Introduction and Study Overview

You are being asked to be in a research study. This information sheet is designed to tell you everything you need to think about before you decide if you want to be a part of the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, you will not lose any services you would otherwise receive from us.

Before making your decision:

• Please carefully read this information sheet or have it read to you

• Please listen to the study staff explain the study to you

• Please ask questions about anything that is not clear

You can take a copy of this information sheet, to keep. Feel free to take your time thinking about whether you would like to participate. You may wish to discuss your decision with family or friends. Do not agree to participate unless you have had a chance to ask questions and get answers that make sense to you. By agreeing to participate, you will not give up any legal rights.

What is the purpose of this study?

The purpose of this interview portion of the study is to understand men’s experience of PrEP, explore their preferences for PrEP and other HIV prevention products, and to continue to inquire about their reactions to HIV prevention messages.

What will I be asked to do?

If you choose to be in this portion of the study, we will ask you to talk about your views, thoughts and opinions on PrEP for HIV prevention. We may ask you to expand upon things you mention, or why you made certain choices or comments. All thoughts and ideas are valid, and all opinions will be considered. We will also ask you to provide feedback on PrEP messages, your candid thoughts on what makes any given message better than others, and how each message can be made most appealing to you. We will ask you to participate in three of these conversations, each approximately 6 months apart. Each talk will take about 60 minutes. It will be held in a private venue (virtually or in-person), so you can more openly discuss your views. These interviews will be digitally audio-recorded, transcribed, and transcriptions will be de-identified (meaning that any information identifying you will be removed). The recording will be destroyed once it is transcribed.

Who owns my study information and samples?

If you join this study, you will be donating your thoughts and opinions. You will not receive any token of appreciation if your samples or information are used to make a new product. If you withdraw from the study, data and samples that were already gathered may still be used for this study.

What are the possible risks and discomforts?

We believe this study poses minimal risk to you as a participant. You may feel nervous, shy or feel discomfort talking about sex acts and beliefs. You do not have to answer questions that you do not wish to answer. We will not collect any information from you other than your voice on the audio recording. There is the risk of a loss of confidentiality of your research-related information.

It is possible that the study team will learn something new during the study about the risks of being in it. If this happens, they will tell you about it. Then you can decide if you want to remain in this study or not. You may be asked to read a new information sheet and provide new verbal consent if you decide to stay in the study.

Will I benefit directly from the study?

This interview portion of the study is not designed to benefit you directly. Doing this research study may not benefit you personally. We may learn about how to promote prevention services that can help reduce the health burden of HIV among MSM.

Will I be compensated for my time and effort?

You will receive $75 for each interview you take part in as a token of appreciation to you for your time and effort, for a total of $225 for all three interviews. All payments will be provided in the form of an electronic gift card that will be emailed to you.

How will you protect my private information that you collect in this study?

Whenever possible, a study number, rather than your name, will be used on study records. Your name and other identifying information will not appear when we present or publish the study results.

Certificate of Confidentiality

This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT protect your information if a federal, state, or local law says it must be reported. For example, some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used for other research if allowed by federal regulations.

Researchers may release your information when you say it is okay. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the research. The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information.

Storing and Sharing your Information

The data you provide will be stored securely, with all names and data that could be used to identify you removed. The data you provide are to be used only by study staff. Your contact details will be stored securely, for use only when contacting you for study activities described in this information sheet. The data you provide will not be used for other research.

Costs

There will be no costs to you for being a part of this study, other than basic costs like travel. You will not be charged for any of the research activities.

Withdrawal from the Study

You have the right to leave a study at any time without penalty. The study team also have the right to remove you from in this study without your consent for any reason. The study team may remove you from the study if they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.

Contact Information

If you have questions about this study, your part in it, your rights as a research participant, or if you have questions, concerns or complaints about the research you may contact the following:

Keith Horvath: 619-594-3346 or 404-712-8630 (24 hours)

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:

• You have questions, concerns, or complaints that are not being answered by the research team.

• You are not getting answers from the research team.

• You cannot reach the research team.

• You want to talk to someone else about the research.

• You have questions about your rights as a research subject.

Do you have any questions about anything in the informational sheet? Were there any parts that seemed unclear?

Do you agree to take part in the study?

[Participant agrees to participate (circle one): Yes No ]

[If Yes:]

Signature of Person Conducting Informed Consent Discussion Date Time

Name of Person Conducting Informed Consent Discussion

The UNIVERSITY OF CHICAGO

The Division of the Biological Sciences  The University of Chicago Medical Center

Oral Consent and Script/Information Sheet

For a Research Study – Interview Sub-study Addendum

TITLE: Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP Study)

Protocol No.: None

WCG IRB Protocol #20225896

Sponsor: Centers for Disease Control and Prevention

INVESTIGATOR: John Schneider, MD

5841 South Maryland Ave, MC5100

Chicago, IL 60637

USA

STUDY-RELATED

PHONE NUMBER(S): (773) 702-8349

This form has more information about the research study. It may add to or change the information in the consent form you signed at the start of this study. You will receive a copy of this consent form addendum for your records.

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

Participating in the interview portion of this study is optional. Your decision not to participate will not affect your participation in the main study.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

Introduction and Study Overview

You are being asked to be in a research study. This information sheet is designed to tell you everything you need to think about before you decide if you want to be a part of the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, you will not lose any services you would otherwise receive from us.

Before making your decision:

• Please carefully read this information sheet or have it read to you

• Please listen to the study staff explain the study to you

• Please ask questions about anything that is not clear

You can take a copy of this information sheet, to keep. Feel free to take your time thinking about whether you would like to participate. You may wish to discuss your decision with family or friends. Do not agree to participate unless you have had a chance to ask questions and get answers that make sense to you. By agreeing to participate, you will not give up any legal rights.

What is the purpose of this study?

The purpose of this interview portion of the study is to understand men’s experience of PrEP, explore their preferences for PrEP and other HIV prevention products, and to continue to inquire about their reactions to HIV prevention messages.

What will I be asked to do?

If you choose to be in this portion of the study, we will ask you to talk about your views, thoughts and opinions on PrEP for HIV prevention. We may ask you to expand upon things you mention, or why you made certain choices or comments. All thoughts and ideas are valid, and all opinions will be considered. We will also ask you to provide feedback on PrEP messages, your candid thoughts on what makes any given message better than others, and how each message can be made most appealing to you. We will ask you to participate in three of these conversations, each approximately 6 months apart. Each talk will take about 60 minutes. It will be held in a private venue (virtually or in-person), so you can more openly discuss your views. These interviews will be digitally audio-recorded, transcribed, and transcriptions will be de-identified (meaning that any information identifying you will be removed). The recording will be destroyed once it is transcribed.

Who owns my study information and samples?

If you join this study, you will be donating your thoughts and opinions. You will not receive any token of appreciation if your samples or information are used to make a new product. If you withdraw from the study, data and samples that were already gathered may still be used for this study.

What are the possible risks and discomforts?

We believe this study poses minimal risk to you as a participant. You may feel nervous, shy or feel discomfort talking about sex acts and beliefs. You do not have to answer questions that you do not wish to answer. We will not collect any information from you other than your voice on the audio recording. There is the risk of a loss of confidentiality of your research-related information.

It is possible that the study team will learn something new during the study about the risks of being in it. If this happens, they will tell you about it. Then you can decide if you want to remain in this study or not. You may be asked to read a new information sheet and provide new verbal consent if you decide to stay in the study.

Will I benefit directly from the study?

This interview portion of the study is not designed to benefit you directly. Doing this research study may not benefit you personally. We may learn about how to promote prevention services that can help reduce the health burden of HIV among MSM.

Will I be compensated for my time and effort?

You will receive $75 for each interview you take part in as a token of appreciation to you for your time and effort, for a total of $225 for all three interviews. All payments will be provided in the form of an electronic gift card that will be emailed to you.

How will you protect my private information that you collect in this study?

Whenever possible, a study number, rather than your name, will be used on study records. Your name and other identifying information will not appear when we present or publish the study results.

Certificate of Confidentiality

This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT protect your information if a federal, state, or local law says it must be reported. For example, some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used for other research if allowed by federal regulations.

Researchers may release your information when you say it is okay. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the research. The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information.

Storing and Sharing your Information

The data you provide will be stored securely, with all names and data that could be used to identify you removed. The data you provide are to be used only by study staff. Your contact details will be stored securely, for use only when contacting you for study activities described in this information sheet. The data you provide will not be used for other research.

Costs

There will be no costs to you for being a part of this study, other than basic costs like travel. You will not be charged for any of the research activities.

Withdrawal from the Study

You have the right to leave a study at any time without penalty. The study team also have the right to remove you from in this study without your consent for any reason. The study team may remove you from the study if they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.

Contact Information

If you have questions about this study, your part in it, your rights as a research participant, or if you have questions, concerns or complaints about the research you may contact the following:

Dr. John Schneider: (773) 702-8349

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:

• You have questions, concerns, or complaints that are not being answered by the research team.

• You are not getting answers from the research team.

• You cannot reach the research team.

• You want to talk to someone else about the research.

• You have questions about your rights as a research subject.

Do you have any questions about anything in the informational sheet? Were there any parts that seemed unclear?

Do you agree to take part in the study?

[Participant agrees to participate (circle one): Yes No ]

[If Yes:]

Signature of Person Conducting Informed Consent Discussion Date Time

Name of Person Conducting Informed Consent Discussion

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