Evaluating the Efficacy and Safety of Long-Acting Lenacapavir for HIV PrEP

Trial Image

Study Overview

The primary objective of the PURPOSE2 study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of contracting human immunodeficiency virus (HIV).

The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase).

1) The Incidence Phase will include testing for HIV, which will provide us with an estimate of the HIV-1 incidence rate. Only those who participate and are found eligible in the Incidence Phase will be invited to participate in the Randomized Phase.

2) The Randomized Phase looks to evaluate the efficacy of lenacapavir for HIV-1 pre-exposure prophylaxis (PrEP) in cisgender men (CGM), transgender women (TGW), transgender men (TGM), and gender nonbinary people (GNB) ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. Only those who have successfully completed the Incidence Phase portion will be invited to screen for the Randomized Phase.

  • Study Identifier: 849273

Recruitment Status


Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Sign-up

Participate in medical studies to develop new diagnostic and clinical treatments and improve current standards of care.

Sign Up Now!

If you need assistance finding a non-cancer study or if you have any questions, please email psom-ocr@pobox.upenn.edu