The study will enroll about 3800 cisgender men and transgender people who have sex with cisgender men and/or transgender people at clinics located in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States. To join this study, participants must be healthy, HIV-negative, and between 18 and 60 years old. These participants must be willing to have medical check-ups and regular HIV counseling and testing. There are also other criteria that must be met for a person to be eligible to join the study. If you have chosen to use HIV pre-exposure prophylaxis (PrEP), you are not eligible for this study, as PrEP, when taken correctly, is a highly effective HIV prevention method. If you are interested in accessing PrEP, we can help link you to services.
We will answer any questions you have to make sure you understand what is involved in participating in this study.
The study is expected to begin enrolling participants in the fourth quarter of 2019 throughout 2020 and is taking place at multiple clinics in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States.
Participants who receive study vaccines could have a reactive result or “test positive” on some types of HIV tests that are commonly used. If a participant gets an HIV study vaccine, their body may make antibodies to HIV. Standard HIV tests like the Rapid HIV test (fingerprick test) measure HIV antibodies as a sign of HIV infection. Because of this, participants who receive the study vaccines in Mosaico could have a reactive HIV test result even if they are not infected with HIV. This is called vaccine-induced sero-positivity (VISP), or you may see this called a vaccine-induced seroreactive (VISR) test result. No health problems are associated with VISP. However, if someone believes you are infected with HIV, you could face discrimination and/or other problems. For example, you could have problems obtaining medical or dental care, employment, insurance, a visa for traveling, or entry into the military. You might not be allowed to donate blood or other organs.
People with VISP need specific HIV tests to see if a reactive test result is due to VISP or a true HIV infection. Research clinics participating in this study have access to these specific tests that look for the virus itself, instead of looking for antibodies.