Attachment 4b Success Case Study Informed Consent Form 6

Attachment 4b

MyLife MyStyle Project

Case Study Interviews

Jeffrey King, Co-Principal Investigator

In The Meantime Men’s Group, Inc.

Trista Bingham, MPH, PhD, Principal Investigator

HIV Epidemiology Program, Los Angeles County Department of Public Health

Informed Consent Form

A. PURPOSE OF THE STUDY

You are invited to take part in a face-to-face interview as part of the MyLife MyStyle research project. This substudy will include 36 men. The goal of the research is to find out if being part of the MyLife MyStyle group sessions helps young men to make healthier choices in their lives. The information on this form can help you make a good choice about taking part in the interview. We will use the information from this research to improve HIV services and programs for young African American or Black men in Los Angeles County. You are invited to be part of this study because you were asked to take part in the MyLife MyStyle group sessions about seven months ago. In The Meantime Men’s Group (ITMT), the Los Angeles County Department of Public Health (LACDPH), and the Centers for Disease Control and Prevention (CDC) are sponsoring this study.

B. PROCEDURES

If you agree to take part in this study, the following will happen:

1. A trained interviewer will ask you about your experiences and opinions about being in the MyLife MyStyle sessions. You will also be asked about where Black gay and bisexual men go to find sexual partners and ways you may have faced different types of discrimination. We will ask about strategies you may use to keep from getting HIV or giving HIV to others. We will also ask you about your own sexual behaviors. You may refuse to answer any question at any time for any reason. If you refuse to answer a question or want to end the interview, you will not be punished in any way.

2. The interview will take between 1 and 1½ hours to complete. It will be digitally recorded. Only study staff will be able to listen to the digital recording. The recordings are to help us make sure that we do not miss any of what you tell us today. A transcript (or typed notes) of our discussion will be made. Any mention of your name during the interview will be deleted from the typed transcript to protect your privacy. We will delete the digital recording once the transcript is accurate and complete.

C. RISKS

There are minimal risks from taking part in this interview:

Questions in the interview are about topics that may make you feel guilty or uncomfortable, and drug use that may be illegal. All answers you give will be kept secure . This information will not be shared with law enforcement except for things covered under the DUTY TO PROTECT section. Your name will not be connected to your answers in any way.

D. BENEFITS

You will not benefit personally for taking part in this interview. But, your answers may help us figure out ways to improve the MyLife MyStyle group sessions. This can lead to better HIV prevention programs for young Black men.

E. ALTERNATIVES

If you join the study, it will not affect your ability to take part in other groups or interviews. You have the option to not join the study.

F. TOKEN OF APPRECIATION

As a token of appreciation for being in this substudy, you will receive $50. You will receive this amount if you decide not to answer all the questions or if you decide to quit the study.

G. OFFER TO ANSWER QUESTIONS

This study is run by Jeffrey King at (323-733-4868) and Trista Bingham, MPH, PhD at (213-351-8175). You may call them with any questions about being in the study. If you are hurt as a result of being in this study, treatment will not be provided by LACDPH. LACDPH does not normally pay for harm done to you as a result of being in a research study. However, by signing this consent form and agreeing to be in this study, you are not giving up any of your rights. You can get referrals for free health care that are available in the county. If you believe that you have been harmed, please contact Olga Coronado at the Institutional Review Board Office at 213-250-8675 for information on your rights and advice on how to proceed.

You will get a copy of this form to keep.

H. Privacy STATEMENT

The information you give for this study is secure. No personal identifiers will be included in the typed transcript or the digital recordings. Your rights as a research subject in this study are in accord with US regulation 45CFR46 Subpart C.

Several steps will be taken to protect your privacy:

1. Completed digital recordings and transcripts will be stored in a password-protected computer at the HIV Epidemiology Program study office where they can only be accessed by project staff.

2. If you know the person who is reading this form to you, you may ask for another project staff person so that your privacy will be fully protected.

I. DUTY TO PROTECT

If you tell us about the sexual or physical abuse of a minor, we must report it to the authorities. Also, if you tell us that you plan to harm yourself or another person, we will contact the proper authorities.

J. VOLUNTARY PARTICIPATION AND WITHDRAWAL STATEMENT

This study is VOLUNTARY. Whether or not you join will not affect your right to take part in other services offered by ITMT or LACDPH. You are not giving up any legal claims or rights because of your participation in this study. If you do join, you are free to take back your consent and quit the study at any time.

California law states that you must know about:

1. The nature and purpose of the study.

2. The procedure in the study and any drug or device to be used.

3. Discomforts and risks to be expected from the study.

4. Benefits to be expected from the study.

5. Alternative procedures, drugs or devices that might be helpful and their risks and benefits.

6. Availability of medical treatment if complications occur.

7. The option to ask questions about the study or the procedure.

8. The option to withdraw without affecting your future care at this institution.

9. A copy of the written consent form for the study.

10. The option to consent freely to the study without the use of coercion.

11. Liability for research-related injury.

K. AGREEMENT

“I have read (or someone has read to me) the information provided above. I have been given the chance to ask questions and all of my questions have been answered to my satisfaction. The signature below shows that I have chosen to be part of the study, having read the information given to me.”

_______ _______ __________________________

Date Signature Person obtaining consent

_________________________________

Principal Investigator (or designee)