The battle against HIV/AIDS has shifted dramatically in the past decade, as our understanding of the virus and how to combat it has increased. The introduction of Pre-Exposure Prophylaxis (PrEP), a daily pill commonly known as Truvada, has been an incredible game changer for HIV prevention. Currently, condom use and PrEP are the most proven effective methods for protection against HIV infection.
“Using Truvada for PrEP has been revolutionary for HIV prevention, but, unfortunately, it’s not a one size fits all solution,” said Ryan Tappin, Clinical Manager, Biomedical Research at The Fenway Institute. “The more choices for PrEP that patients and providers have, the more accessible PrEP becomes. For new versions of PrEP to be available, research showing these medications are safe and effective is critical. And, to complete this research, we are looking for volunteers eager to be a part of the next generation of PrEP.”
There is still much work to do to ensure that everyone has access to safe and effective HIV prevention methods – and you can help make that happen. The Fenway Institute is currently enrolling participants for the following groundbreaking PrEP studies:
The AMP Study: AMP, which stands for Antibody Mediated Prevention, is a method of administering a specific antibody that works against HIV. Our bodies naturally make antibodies that the immune system uses to fight infections. This study’s aim is to determine if these anti-HIV antibodies, which are created in a laboratory, can be used to prevent HIV infection. Participants will randomly be assigned to receive one of two different doses of the antibody or a placebo. These antibodies are administered through an IV about once every 8 weeks. Participants may also be on Truvada during this study, which can be provided at no cost. The study will last about 26 months. Eligible participants are between the ages of 18 and 50 and are men who sleep with men (MSM) or transgender people who sleep with men.
DISCOVER: The DISCOVER study is looking at a new drug combination for PrEP compared to the widely used Truvada. This new drug, which contains emtricitabine and tenofovir alafenamide, will be tested to see if it’s just as effective as Truvada and how the drug side effects may differ. F/TAF is already approved for treating HIV in the United States. Participants will be asked to take two pills once daily, one containing either Truvada or F/TAF and one containing a placebo. After initial start-up visits, study visits will occur about once every 12 weeks, which is similar to how often current guidelines for PrEP recommends users see their healthcare provider. The commitment for this study is about three years. Eligible participants are MSM or transgender women who sleep with men and are 18+.
Injectable PrEP: This study’s goal is to test an injectable drug, cabotegravir, compared to Truvada as PrEP. Participants will be asked to take one pill daily and receive an injection about every eight weeks. Either the pills or the injection will contain a study medication and the other will be a placebo. Towards the end of the study, all participants will be asked to take Truvada throughout follow-up. The goal of this study is to find out how well cabotegravir compares to Truvada as a version of PrEP and what side effects may occur. Participants are closely followed, with visits two or three times per month, and the study will run for about three years. Eligible participants are MSM or transgender women who sleep with men and are 18+.
Please note that all studies are voluntary and participants will be compensated for their time. Study participants may end their involvement at any time; however, our researchers often ask to follow participants for a few months after stopping any study medications to ensure their safety. In addition, every study provides participants with routine HIV and STI testing. For more information on these studies and how to get involved in lifesaving HIV research, please call 617.927.6450.