UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
INFORMATION SHEET FOR STUDY PARTICIPANTS
Reading Level: 8.0
Study Title: Evaluation Models to Assess Patient Perspectives on Opt-out HIV testing in Clinical Settings
This is an evaluation about the effect that expanded HIV screening activities have on patient attitudes toward acceptance of routine HIV screening. The interviewers for the evaluation, from the University of California, San Francisco (UCSF), will explain this study to you.
Evaluation activities include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the project staff.
You are being asked to take part in this study because you have been offered routine HIV screening during your visit to a healthcare facility today.
Why is this study being done?
The purpose of this study is to assess the effect that expanded routine HIV screening has on acceptance of HIV testing among patients seen in sites implementing enhanced screening programs. The Centers for Disease Control and Prevention (CDC) pays for the conduct of this study.
How many people will take part in this study?
About 450 people will take part in this study.
What will happen if I take part in this study?
If you agree, the following procedures will occur:
The interviewer will help you use a laptop computer to complete the survey. The survey will include a series of questions related to your experiences with HIV testing and HIV risk behavior (drug use and sex).
Surveys will take approximately 20 minutes to complete.
You will be paid $10 at the end of the interview.
Study location: All these procedures will be done at this clinic.
How long will I be in the study?
Participation in the study will take a total of about 20 minutes.
Can I stop being in the study?
Yes. You can decide to stop at any time. Just tell the interviewer or staff person right away if you wish to stop being in the study.
Also, the interviewer may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the study?
You may feel uncomfortable or even upset while answering questions on the survey and because you have just learned the results of your HIV test, but you are free to decline to answer any questions you do not wish to answer or to leave at any time.
For more information about risks and side effects, ask one of the study staff members.
Are there benefits to taking part in the study?
There will be no direct benefits to participants in this study. However, participation in the project provides participants with the opportunity to express their perceptions regarding routine HIV screening, how it is being implemented, and how to improve it.
What other choices do I have if I do not take part in this study?
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Will information about me be kept private?
We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law.
Organizations that may look at and/or copy your records for quality assurance and data analysis include:
The Centers for Disease Control and Prevention (CDC)
The University of California San Francisco’s Institutional Review Board
What are the costs of taking part in this study?
The only cost of taking part in this study is your time.
You will not be charged for any of the study treatments or procedures.
Will I be paid for taking part in this study?
In return for your time, effort and travel expenses, you will be paid $10 for taking part in this study. You will be paid in cash immediately.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Who can answer my questions about the study?
You can talk to the interviewer or to the study director below about any questions or concerns you have about this study. Contact the study director, Dr. Janet Myers at (415) 597-8168. Collect calls will be accepted at this number.
If you have any questions, comments, or concerns about taking part in this study, first talk to the study director (above). If for any reason you do not wish to do this, or you still have concerns after doing so, you may contact the office of UCSF's Institutional Review Board (a group of people who review the project to protect your rights).
You can reach the Institutional Review Board office at 415-476-1814, 8 am to 5 pm, Monday through Friday. Or you may write to: UCSF Institutional Review Board, Box 0962, University of California, San Francisco (UCSF), San Francisco, CA 94143.
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You have been given a copy of this information form to keep.
PARTICIPATION IN THIS EVALUATION IS VOLUNTARY. You have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which you are otherwise entitled.
| File Type | application/msword |
| File Title | Appendix C: Patient Information and Consent Form |
| Author | elu5 |
| Last Modified By | vbs6 |
| File Modified | 2009-01-26 |
| File Created | 2008-05-20 |