HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men
0920-10CM
Attachment 4a
Flesch-Kincaid grade level = 8.5 Protocol #09-047 Page #1
Appendix F: Pilot Consent Form |
CONSENT FORM
Intervention Pilot test
Arthur Ashe Institute for Urban Health, Inc.
State University of New York, Downstate Medical Center
BARBERSHOP TALK PROJECT
We are asking if you want to be in a research study. This study is for African American men who receive services at barbershops in Central Brooklyn and Flatbush. The purpose of this study is to see whether an HIV prevention program can be used to help reduce HIV risks among men. While we review this form, you may read along.
What you should know about research studies:
This consent form tells you about the study. It tells you about the purposes, risks, and benefits of this research study.
You do not have to be in this research study; your participation is voluntary. You can agree to be in the study now and change your mind later.
There may be risks for being in this study. The risk involves feeling uncomfortable about being asked personal questions. You can refuse to answer any question that you do not want to answer.
Please read this consent form with care. Ask any questions you have before you make a decision.
1) Why is this research being done?
African American heterosexual men are at higher risk than some other groups of people for different health problems, including HIV. HIV is the virus that causes AIDS. We want to design programs that can help reduce these risks and that can reach African American men. One way to do this is to have HIV prevention in barbershops. We have developed an HIV prevention program that we are testing in barbershops, and are asking men who receive services at barbershops to participate in this testing.
2) Who is doing the study?
Dr. Tracey E. Wilson at SUNY Downstate and Dr. Ruth C. Browne at the Arthur Ashe Institute for Urban Health, Inc. are in charge of this study at this location. About 15-20 people will be in the study at this location; 60-80 people will be in the study overall.
Protocol #09-047 Page #2
3) You cannot be in this study if you:
Are younger than 18
Are more than 45 years old
Are a woman
Do not consider yourself as Black or African American
Are not sexually active
Have been part of a research study related to drug use or to HIV in the past 12 months
Participated in the formative or pre-pilot phase of this study
4) What will happen to you if you decide to be in this study?
If you agree to be in this study, you will be participating in a two-part HIV prevention intervention session. We are asking you to complete two study visits. The first study visit will take place either now or in the next few days, and the second one will take place in three months. During the first study visit, you will be asked to answer a series of questions about yourself. Some of these questions will be personal; you have the right not to answer any questions that you do not want to answer. These questions will be asked and answered on the computer. The questions will be asked through a set of headphones and you will press a number or letter on the computer based on your answer. No one will be able to hear the questions or see your answers while you complete these questions except you. A study staff person will show you how to use the computer and will be there to help you if you need. The computer survey will take about twenty minutes. After you answer the questions, our trained study staff will be talking with you individually for about forty-five minutes about ways to protect yourself from HIV. The first study visit will take place at this barbershop. We are studying whether our education program is helpful to people to help them reduce their risk of HIV. We will be audiotaping this intervention session.
During your second study visit, you will be asked to answer a set of questions about yourself. Just like before, these questions will be asked and answered on the computer. The questions will be asked through a set of headphones and you will press a number or letter on the computer based on your answer. No one will be able to hear the questions or see your answers while you complete these questions except you. This will take about twenty minutes. This second study visit will take place either at the barbershop or at SUNY Downstate.
5) What are the possible risks of being in the study?
Some people feel uncomfortable about being asked personal questions. Remember that you can refuse to answer any question that you do not want to answer.
6) What are the possible benefits of being in the study?
There are no medical benefits to being in this study. However, by being in this study, you may learn about important ways to help keep yourself healthy.
Protocol #09-047 Page #3
7) What are your other choices?
The alternative to being in this study is to not participate.
8) If you have any questions or problems, whom can you call?
If you have any questions about this study or think that you have been injured because of the research, you can call Dr. Tracey Wilson at (718) 270-2105 or Dr. Ruth Browne at (718) 222-5953. Dr. Wilson is with SUNY Downstate Medical Center and Dr. Browne is with the Arthur Ashe Institute of Urban Health, Inc. If you are interested in finding out about the results of this study, you can call either Dr. Wilson or Dr. Browne.
If you have questions about your rights as a research subject, you can call the IRB office at (718) 270-2680.
9) What information do we keep private?
In this study we will keep your personal information private to the extent allowed by law. We will hold your identity confidential and all data will be kept in a secure, limited access location. We will not reveal your identity in any publication or presentation of the results of the study. Your name will not be listed on surveys or mentioned during the assessments. We have applied for a Certificate of Confidentiality for this study. This certificate helps researchers protect the privacy of human research participants enrolled in sensitive research. Certificates protect against certain legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. However confidentiality cannot be guaranteed; your personal information may be disclosed if required by the Federal Privacy law.
We will be audiotaping the intervention session so that staff will have a way to make sure the project procedures are being implemented as planned. This information will also help us improve future HIV prevention interventions using the barbershop setting. These tapes will be typed up so that we will have a written record of what was said during the session. Your name will not be attached to the tapes or typed up notes. The tapes will be stored in a secure location and will be erased after the study is complete. Only the study investigators working directly with the project will have access to the tapes.
Federal law protects your right to privacy concerning Individually Identifiable Health Information (IIHI). There are certain things you need to know, IIHI is any information from your medical record, or obtained from this study, that can be linked to you, and that refers to your mental or health conditions in the past, the present or the future.
For this study we will create, use or report the following IIHI:
Information obtained from this study, including information obtained from the consent form. The only identifiable information will be your name on this consent form. We will not store your consent form with any of the other information that you give us. Therefore, others will not be able to connect your identity with what you have said in the study.
The information that you give us will have an identification number on it, instead of your name. Your name and identification number are only linked on a secure, password-protected computer file, which also includes your contact information. Only our study staff will have access to this file. This file will be destroyed after the study is completed.
Protocol #09-047 Page #4
The researchers (Dr. Tracey E. Wilson, Dr. Michael A. Joseph), their staff and the staff of SUNY Downstate Medical Center (Yolene Gousse), and the Arthur Ashe Institute for Urban Health, Inc. (Dr. Ruth Browne, Dr. Marilyn White) participating in the research will use your protected IIHI for this research study.
We will have to use and report your health information for an indefinite period of time.
You can withdraw your authorization for the use or reporting of your IIHI. You have to write to us to withdraw (Tracey E. Wilson, PhD, Department of Community Health Sciences,SUNY Downstate Medical Center, Box 1240, 450 Clarkson Avenue, Brooklyn, NY 11203). If you withdraw we will stop collecting and accessing your IIHI, but we will collect and report any adverse event (bad effect) that you had in the study. Your IIHI collected before you withdraw your authorization will still be used and reported.
If you withdraw your authorization you cannot longer be in the study.
10) Can your being in the study end early?
Being in this study is voluntary. You can agree to be in the study now and change your mind later. There are no consequences to you if you decide to quit the study. If you want to quit the study, you should talk to Tracey E. Wilson or one of the study staff members.
Also, the sponsor of the study may end the study early.
11) What else do you need to know?
When you arrive for the first study visit, we will give you ten dollars cash, plus a twenty dollar gift certificate for a haircut as a token of appreciation. When you complete the second study visit, we will give you ten dollars cash, plus a twenty dollar gift certificate. If you do not show up for the second study visit, you will keep what we have already given you, but we will not provide the cash or gift certificate for the second study visit. You may keep what we have already given you, even if you decide to quit the study.
For the follow-up assessment, we will provide you with a metrocard to cover the costs of getting to and from the study. If public transportation is not convenient, we will give you the additional money for getting to and from the study, if you give us a dated receipt.
If you accept money or a gift certificate for being in the study, we may have to provide some information about you to professional auditors. This would be done for federal audit and reporting requirements. If you earn $600 or more in a year as a research subject, you may have to pay taxes on that money.
We will give you a copy of this consent form to keep.
Protocol #09-047 Page #5
12) Subject Consent
By signing this consent form you accept that you read this form, or had it read to you. We will give you a copy of this form.
______________________________ _______ ________________________
Signature of Subject (or Legal Guardian) Date Print name
________________________________ _______ __________________________
Signature of Witness Date Print name
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men |
| Author | Raekiela Taylor |
| File Modified | 0000-00-00 |
| File Created | 2021-02-02 |