AppendixK_2 Adult consent form for small group

Appendix K2: Adult Consent Form

Consent Form for Adults

Introduction and Purpose:

You have been asked to be in a small group interview as part of a research study. The purpose of the research study is to improve HIV care and treatment. RTI International, a research company in North Carolina is doing the study. The Health Resources and Services Administration, or HRSA, a federal health agency, is sponsoring this project.

Procedures:

We are organizing small groups of up to 4 people each to get together to talk about a topic and share their opinions. During the group, the facilitator will invite you to share your opinions about using text messages to help young people living with HIV stay healthy. We will also ask you to look at some text messages we have created and give us your opinions. The group will take up to 2 hours. A facilitator and one assistant will be there to guide the talk and take notes.

We will be doing 8 small group interviews in North Carolina. In total, about 32 people will be in the study.

Risk/Discomforts:

There is no known physical risk to you from being in the study. You might feel embarrassed or upset by the things that are talked about in the group. If that happens, we will refer you to someone who can talk with you about your concerns. You can refuse to talk about any topic for any reason. You can stop being in the study at any time.

For this study, you have to reveal your HIV status. Only people who are also HIV positive will be in your group. Someone you know could be in the group. We will ask everyone in the group to not talk about who is in the group or what is said. We cannot be sure that this information will be kept private. We request that you do not tell anyone who is not in the group what you talk about today.

Benefits:

There is no direct benefit to you for being in this study. What we learn will help us develop text messages to send out to people with to encourage HIV care and treatment. The information will help people with HIV to live longer and healthier lives.

ConfidentialityRespect for your Privacy:

There will be one note taker sitting in the discussion room. We will also audio-record the group discussion. Audio files and notes will be saved to a password protected computer. We will never refer to people by name in the notes, and you do not have to use your real name during the discussion. Data will be kept private to the extent allowed by lawStaff will keep information about you as private as possible. There are limits to this privacy. For example, we will need to report some things to the proper authorities. These include:

• Child abuse

• Intentions to harm oneself or others

• Elder or dependent adult abuse

We will keep study forms that contain identifying information in a locked file cabinet accessible only to authorized staff. We will move these forms to a locked storage building at the end of the study. We will destroy everything three years after the study ends except for your contact information, which will be destroyed two weeks after the group. Your name and other facts that might identify you will not appear when we present the study results. However, there is still a small risk that your privacy could be broken by another member of the group.

Reimbursement:

We will give you $50 cash to thank you for your time and effort. If only one person comes to the scheduled group, we will not conduct the group interview. However, you will be given $25 for travel costs.

Right to Refuse or Withdraw:

It is your choice to be in this study. You can refuse to talk about any topic. You can leave the study at any time. If you decide not to be in this study or if you drop out, you can still be in other studies.

Persons to Contact:

If you have questions about the study, you can call Jennifer Uhrig at 1-800-334-8571 extension 23311. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday – Friday. If you have questions about your rights as a research participant, you can call RTI’s Office of Research Protection at 1-866-214-2043.

Do you have any questions?

Your Consent:

I have read this consent form (or it was read to me). I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the study (mark one):  YES  NO

RTI Staff Signature and Date