5 AppendixL_2_ControlConsent

Appendix L2: Consent Form for Controls

Adult Patients and Minors Who Provide

Consent for Their Own Treatment

THIS STUDY AND ITS PURPOSE

You are being asked to take part in a research study that is being conducted by RTI International. This study is funded by the Health Resources and Services Administration (HRSA) to test a text-messaging intervention program to help improve the health and wellbeing of young people with HIV. About 500 young people with HIV will be asked to take part in this study.

DO I HAVE TO JOIN THIS STUDY?

Being in this study is completely voluntary. You can refuse to answer any questions. You can stop at any time. Your decision to take part in this study will not affect your access to any services or benefits.

What we're asking of you

To take part in this 9-month study, you must agree to the following:

• The study coordinator will access your medical records four times during the study to verify your HIV status (when you enroll) and record your CD4 count and viral load, appointment attendance, and the medications you are taking to treat HIV.

• You will complete four surveys on a computer. The surveys will ask you about your background; use of computers and cell phones; how you take your HIV meds; support you get from friends and family; how people with HIV are treated by others; what you know, think or believe about HIV; how you manage your HIV; your sexual behaviors; your smoking and substance use; and your satisfaction with your health care.

RISKS OF PARTICIPATION

There is a small risk that completing the surveys may make you feel uncomfortable or upset. If this happens, contact the onsite study coordinator, NAME, at [xxx-xxx-xxxx]. He/she will meet with you to find out if you need additional counseling, and if necessary, refer you to a social worker or other mental health provider at the clinic. However, this study will not pay for the cost of these services.

BENEFITS OF PARTICIPATION

You might help other people with HIV by the knowledge gained from this study.

COMPENSATION

You will be given $25 when you enroll in the study and complete the first survey and then $25 for completing each additional survey at 3-, 6-, and 9-months (up to $100 total).

RESPECT FOR YOUR PRIVACY

Any personal information (e.g., your name and telephone number) will be kept in locked file cabinets or on a password protected computer. When you enroll, we will assign you a special ID number that you will use to enter your answers to the surveys. All of your answers will be recorded under the ID number and not your name or anything else that can identify you. All forms with a study ID number will also be kept in locked file cabinets. All documents will be destroyed at the end of the study.

Anyone who is working with any of the information you give us has to sign an agreement with RTI International to protect the privacy of the people in the study.

Data will be kept private to the extent allowed by lawYour personal information will be kept private as permitted by law. This means that if you tell us that you are about to hurt yourself or someone else, or you are involved in the neglect and/or abuse of a child, then we must report that information to the appropriate authorities.

terminating participation

To stop taking part in this study, contact the onsite study coordinator, NAME, by phone (NUMBER) or email (EMAIL ADDRESS).

who to contact with questions

The investigator in charge of this study at RTI International is Dr. Jennifer Uhrig. You may call Dr. Uhrig toll-free at 1-866-784-1958, extension 2-3311. You can call Dr. Uhrig if you have any problems or questions related to this study.

If you have any questions about your rights as a research subject, you may ask RTI's Office of Research Protection at 1-866-214-2043 (a toll-free number).

STATEMENT OF CONSENT FOR THE INTERVENTION STUDY

Signing the line below indicates that we have described the study procedures to you, asked you to take part, and given you the chance to ask questions. You do not give up any rights by signing this consent form. We can give you an unsigned copy of this form if you would like.

Do you have any questions?

By putting my signature on the line below, I am agreeing to take part in the intervention study.

_______ _____________________________________

Date Signature of Individual

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