English
DeutschFrançais
English
DeutschFrançais

The EXPrESSIVE study

Can a new monthly pill protect against HIV as effectively and safely as the daily PrEP pill?

What is PrEP?
HIV pre-exposure prophylaxis (PrEP) refers to medications that protect against HIV infection. So far, there is one medication approved in Switzerland for HIV prevention, which—when taken daily—reduces the risk of HIV infection by more than 90%.

What is the aim of the EXPrESSIVE study?
This study is investigating a new antiviral medication that remains active in the body for a longer period and therefore only needs to be taken once a month. We are comparing the effectiveness and any potential side effects of this new medication with the already approved PrEP.

Has the new medication ever been tested in humans?
Yes, the new medication has already been tested in humans in previous studies. In this study, it will be given to a larger group of people to examine its effectiveness as well as any rare side effects.

Am I eligible?
You may be eligible to participate if you are at least 18 years old and the following applies:

  • You are not diagnosed with HIV.
  • You are a cisgender man¹, a transgender woman², a transgender man³, or have a non-binary gender identity⁴.
  • You have had receptive anal sex without a condom in the past year (except sex within a committed relationship).

Additional eligibility criteria and possible risks will be discussed with you by the study team.
How will this study be conducted?
Before you are enrolled in the study
First, we will have a conversation in which we explain the study and answer all your questions. You will receive written information about the study and a consent form.

During the study
You will be randomly assigned to one of two groups and will then receive:

  • the study drug (taken monthly) + daily placebo tablets

or

  • the approved PrEP medication (taken daily) + monthly placebo tablets.

During the study, neither you nor the study team will know which treatment you are receiving. However, this information can be revealed in a medical emergency.

The study will last up to 30 months (about 2.5 years). During this time, monthly follow-up visits will take place. At these visits, we will conduct laboratory tests (urine, throat and rectal swabs, blood), physical examinations, and interviews.

After the study ends, there will be a follow-up phase of 42 days.

What happens if I want to leave the study?
You can decide at any time, for any reason, to stop taking the study medication or to withdraw from the study, even before it ends. Signing the consent form is voluntary and does not constitute a contract.

Are there any costs associated with participating in the study
All study medications and study-related tests/examinations will be provided free of charge.

Will I receive compensation for participating in the study?
Travel expenses incurred by you within Switzerland in connection with the study will be reimbursed up to a specified maximum amount. We will inform you of the maximum amount during the initial consultation.

If you would like further information, particularly about the possible risks and benefits of participation, please contact us.

Interested in participating in the study? Register here without obligation:

It is also possible to participate at the two university hospitals in Bern and Basel. If you would like to join at one of these centers, please contact:

Basel University Hospital : Marcel.Stoeckle@usb.ch

Bern University Hospital : studien.infektiologie@insel.ch

All your data will be treated confidentially. Please note that your data will be recorded if you establish contact with CPZH or one of the other centers. If you are not interested in participating in the study, your data will be deleted immediately.

There may be no direct medical benefit for you. However, the knowledge gained from this study could help other people in the future.

1 you were assigned male at birth and identify as male
2 you were assigned male at birth and identify as a woman
3 you were assigned female at birth and identify as a man
4 You were assigned a gender at birth but do not identify exclusively as male or female