Clinical trial: NCT04089488
Section: Alternatives
Subsections: What Is The Usual Approach?

This study only involves collecting information about you and your cancer treatment. Taking part in this study will not change the way you are given care or treatment for your HIV/AIDS or your cancer.
Clinical trial: NCT04089488
Section: Confidentiality
Subsections: You Will Not Be Paid For Taking Part In This Study. Who Will See My Medical Information?|How Will Information About Me Be Kept Private?|Attatchment 1: Amc Certificate Of Confidentiality

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are. Some of your health information, such as your response to cancer treatment, results of study tests, and medicines you took, will be kept by the study sponsor in a central research database. However, your name and contact information will not be put in the database. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. There are organizations that may look at your study records. Your health information in the research database also may be shared with these organizations. They must keep your information private, unless required by law to give it to another group. Some of these organizations are:
- The study sponsor, the National Cancer Institute (NCI) in the United States, and the groups it works with to review research.  
- The IRB, which is a group of people who review the research with the goal of protecting the people who take part in the study.
- The AIDS Malignancy Consortium (AMC) and its representatives
- Any local regulatory authorities who may have access to the data Your study records also will be stored for future use. However, your name and other personal information will not be used. Some types of future research may include looking at your records and those of other patients to see who had side effects across many studies or comparing new study data with older study data. However, we don't know what research may be done in the future using your information. This means that:
- You will not be asked if you agree to take part in the specific future research studies using your health information.  
- You and your study doctor will not necessarily be told when or what type of research will be done.  
- You will not get reports or other information about any research that is done using your information.

Your privacy is very important to the study researchers. They will make every effort to protect it. Here are just a few of the steps they will take:  
1. They will remove identifiers, such as your initials, from your information. They will replace them with a code number. There will be a master list linking the code numbers to names, but they will keep it separate from the information.  
2. Researchers who study your sample and information will not know who you are. They also must agree that they will not try to find out who you are.  
3. Your personal information will not be given to anyone unless it is required by law. 4. If research results are published, your name and other personal information will not be used.

The NIH has given the AMC a Certificate of Confidentiality. The Certificate does not mean that the NIH or the U.S. Government recommend that you take part in this study. This Certificate helps us keep your health information private. Your records for this study will have information that may identify you. This Certificate lets us turn down legal demands for your study records. We can use the Certificate to turn down demands for records from a U.S. court. The Certificate can be used in any federal, state, or local legal matters in the United States. We will use the Certificate to turn down any demands for your study records. The cases where we cannot use the Certificate are explained below. We cannot use the Certificate to turn down a demand from the U.S. Government for study records. This applies to audits or reviews of the AMC. This also applies to study records that we have to report to the FDA. The Certificate does not stop you or your family members from sharing your health information. It does not stop you from talking about taking part in this study. You may give written permission for an insurer, employer, or other person to get copies of your study records. If you give permission, we cannot use the Certificate to say no to a request for your study records.
Clinical trial: NCT04089488
Section: Participant Responsibilities
Subsections: What Are My Responsibilities In This Study?

If you choose to take part in this study, you will need to:
- Keep your study appointments.  
- Tell your doctor about:
o all medications and supplements you are taking
Clinical trial: NCT04089488
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks And Benefits Of Taking Part In This Study?|Risks|What Risks Can I Expect From Taking Part In This Study? General Risks

There are both risks and benefits to taking part in this study. It is important for you to think carefully about these as you make your decision.

We want to make sure you know about a few key risks right now. We give you more information in the "What risks can I expect from taking part in this study?" section. If you choose to take part in this there may be a risk to your privacy. The researchers will make every effort to protect it and your data will be secured.

If you choose to take part in this study, you may have the following discomforts:
- Spend more time in the hospital or doctor's office.  
- Be asked sensitive or private questions about things you normally do not discuss.
Clinical trial: NCT04089488
Section: Procedures
Subsections: What Will Happen If I Decide To Take Part In This Study?|What Exams, Tests, And Procedures Are Involved In This Study?

If you decide to take part in this study the doctor will collect information about your current HIV
2 status and treatment, your cancer status and treatment and your current health status at your next visit. If further treatment for your cancer is planned, in about one to three (1-3) month(s) your doctor will follow-up and collect the same information again. This may happen at another visit, over the phone, or through your medical records.

Before you begin the study, your doctor will review the results of your exams, tests, and procedures. This helps your doctor decide if you can take part in the study. If you join the study, you will have more questions about your cancer care. Choosing to take part or not in this study will not affect the usual care you will receive.
Clinical trial: NCT04089488
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

The purpose of this study is to count how many people at your cancer center have HIV/AIDS and cancer and to understand how people are being treated and cared for. We expect to have up to 400 people take part in the trial. This will help researchers understand what new studies may be helpful for your area in the future.
Clinical trial: NCT04089488
Section: Voluntary Participation
Subsections: My Signature Agreeing To Take Part In The Study

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed and dated copy of this form. I agree to take part in the main study Participant's signature Date of signature Signature of person(s) conducting the informed consent discussion Date of signature
Clinical trial: NCT04089488
Section: Withdrawal from Study
Subsections: What Are My Choices If I Decide Not To Take Part In This Study?|If I Decide To Take Part In This Study, Can I Stop Later?|Are There Other Reasons Why I Might Stop Being In The Study?

- You may choose to take part in a different research study if one is available. - You may choose to continue your care without any research.

Yes, you can decide to stop taking part in the study at any time. If you decide to stop, let your study doctor know as soon as possible. Your study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

Yes. The study doctor may take you off the study if:
- New information becomes available and the study is no longer in your best interest.  
- You do not follow the study rules.  
- The study is stopped by the Institutional Review Board (IRB), Food and Drug Administration
(FDA), or sponsor (National Cancer Institute).
It is important that you understand the information in the informed consent before making your decision. Please read, or have someone read to you, the rest of this document. If there is anything you don't understand, be sure to ask your study doctor or nurse.