Dr. Patricia Kissinger is the person in charge of this project. She is a Professor at Tulane University School of Public Health and Tropical Medicine and the Co-Principal Investigator for this study. She may be called at any time if you have any questions about this research project.

Phone: XXX-XXXX Beeper: XXX-XXXX (24 hour)

Partner notification is when a health care worker talks to you about your sex partners or tells you that one of your sex partners has human immunodeficiency virus (HIV, the virus that causes AIDS) or syphilis (a sexually transmitted disease). The purpose of this research project is to learn if risky behaviors or partnerships (relationships) change after partner notification, and to compare changes after partner notification for HIV with partner notification for syphilis.

It is important that you understand that participation in this study is completely voluntary, and that you may decide not to participate or to withdraw from the study without losing any of the benefits to which you are otherwise entitled.

You are eligible to participate in this study if you:

You are not eligible to participate in this study if you:

People who have HIV and people who are told that they are the sex partner of an HIV-positive person will be asked to be in this study. For comparison, people with syphilis and their sex partners will also be asked to be in this study. A total of 1260 subjects will be enrolled in this study.

Partner notification takes place if you are found to have HIV or syphilis. Partner notification is performed by the Delgado Clinic Disease Intervention Specialists (DIS), who will ask you if you are interested in participating in this study. If you sign this consent form and you agree to participate in this study, you will start in the study one to two weeks after partner notification. This will be the first study visit. There will be one other study visit 3 months after partner notification. This visit will be planned ahead of time, and will take place at your house if that is what you would like. You may also schedule the visit at the clinic or some other place. At each of the visits, you will be asked questions in a face-to-face interview that takes about 45 minutes. The questions will ask about risks for getting HIV and about changes in relationships. This interview includes questions about different types of sex and condom use, drug use, and problems with relationships.

A small group of subjects in this study will be asked to have an additional interview. This interview will ask you to talk about your feelings in a free-form fashion, rather than answering specific questions. Some things you might be asked to talk about might be partner notification, HIV or syphilis infection, relationships, and other things about how you feel. If you are asked to participate in this visit, your conversation will be taped by the interviewer to be sure that all that you say is understood. After the conversation has been transcribed (typed from the tape), the tape will be destroyed.

You may receive no benefit of participating in this study. However, knowledge gained from this study may benefit society at large.

One risk that may happen is that talking about sex and/or drug behaviors may be uncomfortable or embarrassing or upsetting to you. If at any time you do not wish to answer questions, you may tell the interviewer and the question will not be asked. If you need advice about finding a social worker or other help, you will be told where to go.

Another risk is confidentiality (privacy). To be sure that what you tell us is used only for research and that it is kept confidential to the extent allowed by law, it will be kept in locked file cabinets. It will be kept on computers that require special passwords to be turned on. All names will be taken off forms before they are sent to the agency paying for the study.

The alternative to participation is not to participate.

If you are not able to give informed consent or you act violently towards study staff, you will be removed from the study.

You may refuse to be in this study or may stop being in this study at any time without losing your health care benefits now or in the future. You may also refuse to answer any questions for any reason. If new things are learned during this project that may have an effect on your interest in being in this study, you will be given that information.

The results of this study will be given to the agency paying for the study, but names will not be given. The results of the study may also be published in scientific journals. But, the privacy of subjects will be protected at all times and your name will not be used in any way. New cases of HIV will be reported to the state since this is required by law.

The records related to this study will be available to the funding agency and study staff.

I understand that the Administrators of the Tulane Educational Fund, doing business as Tulane University Medical Center, does not provide any form of compensation for injuries or illnesses arising from my participation in this research protocol, including, but not limited to free medical care other than as described in this consent form, if any, payment of lost wages, or compensation for pain or suffering.

I understand that complete information concerning the non-availability of compensation and the availability of treatment can be obtained from the Office of Assistant General Counsel, Tulane University Medical School, 1430 Tulane Avenue, New Orleans, LA 70112, 504-588-5031. Additionally, that office is available to answer questions about subjects’ rights.

This study has been discussed with me and all my questions have been answered to my satisfaction. I know that any more questions about the study can be asked of the person listed on page 1 of this consent form (Patricia Kissinger). I have read and understand the information stated above and I sign this consent form willingly. I have received a copy of this consent form.

I am unable to read, but this consent form has been read and explained to me by (name of reader). I understand the information stated above and I willingly sign this consent form.