The study clinic will provide you with a participant information sheet and consent form for the study which details all of the study requirements, procedures, risks and benefits. You will be given time to review and discuss the form before deciding whether or not to participate in PRELUDE.
First, a study doctor will make sure you are a good candidate for PrEP. You will be asked about ten questions to see if you are at increased risk of getting HIV from sex.
If you are considered at risk, you will be tested for hepatitis B, and sexually transmitted infections (STIs), including HIV, chlamydia, gonorrhoea and syphilis.
Your health and blood will be checked to make sure you are not at increased risk of possible side effects from TRUVADA, such as kidney or liver problems. You will also have a medical examination and will be asked about your medical history.
If you are a woman who can get pregnant, you will have a pregnancy test before starting PrEP and while taking it, so that you and your doctor can make an informed decision together about whether you start and continue taking PrEP.
You will be asked to complete a self-administered on-line survey in a location of your choice (e.g. at home) on attitudes, behaviour and lifestyle.
Taking PrEP and study visits
If you meet all study criteria, you will be given a prescription for 30 days of TRUVADA, which you will be asked to take every day. Your doctor will provide you with information to help you remember to take TRUVADA every day. You will also receive condoms, and counselling on condom use and safe sex.
For this study, you will be asked to take PrEP daily for at least 30 days. You may continue to take PrEP every day for up to 30 months total.
After you start the study, you will attend a follow-up visit at the clinic one month after you start taking PrEP, and then every three months after you start taking PrEP, for up to 30 months. At each of these visits, you will have an HIV test, and at some of these visits you will be tested for other sexually transmitted infections (STIs). You will also receive standard-of-care medical care at each follow-up visit, and will be asked to take a self-administered online survey.