Participant-informed consent for human immunodeficiency virus (HIV) testing

Protocol no:______

Protocol title:______

Participant no: ______

Name of investigator: ______

Dear Participant

As part of the above research study, you are being asked to undergo a human immunodeficiency virus (HIV) test to test if you are positive for HIV. Before agreeing to participate in this research study, it is important that you read and understand the following explanation of HIV testing. You may not participate in the study if you decide that you do not want to have the HIV test performed. However, the result of this test will not only determine whether or not you are suitable to continue with the research study, but could also have an important influence on your health and lifestyle.

All associated costs of the HIV test, as well as the pre- and first post-test counseling, will be paid for by the sponsor.

Purpose

This test is performed to exclude any participants who are HIV-positive because these participants are more likely to have abnormal laboratory tests and side-effects because of their HIV infection. This may interfere with assessment of the study medication, which would make accurate analysis of the information that is gathered during the study impossible. In addition, the taking of new and experimental medication could pose additional risks to your health if you are suffering from an underlying disease of which the study doctors are unaware.

HIV infection is a serious medical condition that leads to acquired immune deficiency syndrome (AIDS). HIV is spread by sexual contact with an HIV-infected partner, exposure to infected blood, e.g. from sharing needles during injection drug use, and can also be spread from an HIV-infected mother to a child during pregnancy, delivery or through breastfeeding. Persons who may be at high risk of infection include people who have unprotected sex with an HIV-infected partner, men who have sex with other men, drug injection users and their sexual partners, persons who received blood transfusions between 1978 and 1985, as well as those who have had unprotected sex with multiple partners.

Procedure

You will receive counseling both before and after you have taken the test.

The HIV test will be carried out on a sample of your blood. The test can detect antibodies made by your immune system when HIV is present. The HIV/AIDS antibody test is used to determine if you have been infected with HIV. An HIV test is extremely accurate if performed three months after exposure to HIV.

A negative test means that it is extremely unlikely that you are infected with HIV. If you had a recent exposure (less than three months ago), an HIV test will need to be repeated to confirm that you are not in the “window” period of HIV infection, before the antibodies are present.

A confirmed HIV-positive test means that it is very likely that you have been infected with HIV. This test does not determine how advanced the illness is and is it not a test for AIDS. Medical care and additional testing will be needed to help plan treatment. If your test is positive, you may not continue as a participant in the study. You will be referred to a specialist clinic for further testing and counseling. The clinic is required to provide counseling and treatment that conforms to the national standard of care for HIV prevention and treatment.

If you test HIV-positive, you will not have any recourse to the sponsor or study site for compensation or treatment.

Advantages and disadvantages of human immunodeficiency virus testing

Advantages of HIV testing include:

·  Making yourself available to health care and counselling for HIV which has many benefits.

·  Preventing the transmission of HIV to your sexual partners.

·  Informing your partner so that he or she can also prevent the spread of HIV.

·  Avoiding blood donations.

·  Preventing mother-to-child HIV transmission.

Disadvantages of HIV testing include:

·  Emotional stress, depression and despair.

·  Stigmatisation.

·  Discrimination.

·  Rejection by family, friends, sexual partners and/or spouse.

The advantages and disadvantages should be carefully considered before signing the consent form.

Risks

Possible side-effects from drawing blood include feeling faint, inflammation of the vein, pain, bruising or bleeding at the site of puncture.

Confidentiality

Your HIV testing information and test results cannot be released to anyone without your written consent. General consent to health care and information release does not cover HIV-related information. If you are found to be HIV infected, you are personally not required to tell anyone about this diagnosis. However, it is very important to notify your sexual partners and those who might have been exposed to your blood.

Consent statement

Initial Block

1.  I hereby agree to have blood drawn in order to undergo the described HIV tests to determine my suitability for participation in a clinical study. I understand that until all pre-dose checks have been carried out and reviewed by the study doctor before the first dosing day, participation in the study is not guaranteed.
2.  I confirm that I have read and understood the above information leaflet, and that I have been informed by the study personnel about the nature, conduct, and potential benefits and risks of HIV testing, and have had the opportunity to ask questions.
3.  I do not consider myself to be in a high-risk group for contracting HIV and have no reason to believe that I have been previously exposed.
4.  I understand that I will be informed of the results of the test in confidence, and that should the result be positive, I will be advised about further counselling and care.
5.  I understand that should I be tested, and if I am found to be HIV-positive during the screening period, I cannot hold the sponsor of the study liable for my treatment or care.
6.  I will receive a signed copy of the Patient information leaflet and consent form for HIV testing.

______

Printed name of participant

______

Participant signature

______

Date

______

Printed name of person conducting consent (other than the investigator)

______

Signature of person conducting consent (other than the investigator)

______

Date

______

Printed name of investigator

______

Signature of investigator

______

Date

I hereby verify that verbal consent was obtained from the above participant. The participant has been informed about the risks and the benefits of the research, understands such risks and benefits, and is able to give consent to participate, without coercion, undue influence or inappropriate incentives.

______

Printed name of witness*

______

Signature of witness*

______

Date

*: Where applicable, see main Participant informed consent template for an explanation

Page 2 of 5

Version:

Date: