LifeLube did a little Q&A
with Project PrEPare Director,
Keith Green -
LifeLube - What is PrEP?
Keith - PrEP stands for Pre-Exposure Prophylaxis. The concept of PrEP for HIV is similar to the use of pre-exposure prophylaxis protocols used for other diseases, such as malaria and rabies. PrEP for HIV involves the use of certain medications routinely prescribed for the treatment of HIV/AIDS to study whether they can prevent infection with the virus in HIV-negative people who take them prior to exposure. There are several thousand people currently involved in PrEP studies around the world, which demonstrates global support that PrEP may have some protective effect against HIV.
Tell us about this new Chicago PrEP study. In a nutshell, who is being recruited, and what will participants be asked to do?
This new Chicago PrEP study, called Project PrEPare, is a multisite study through the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). We are looking to recruit approximately 100 young men who have sex with men (YMSM). Recruitment activities will take place through Stroger Hospital of Cook County, the CORE Center, and Howard Brown Health Center.
Once it has been determined that a potential participant meets all eligibility requirements, he will participate in a 2-day HIV prevention workshop designed to help YMSM understand their risks and take action towards behavioral change. Each participant will then be randomized into one of the three arms of our study: once-daily Truvada as PrEP, placebo, or no pill at all. They will also be provided with condoms and lube, and encouraged to use them should they choose to engage in sexual activity. From there, the young men will be closely monitored for six months by our research team of experienced healthcare providers, which will include monthly study visits at either of our site. Safer sex counseling and condoms will also be provided at each visit.
What kind of protections are in place for participants?
The initial 2-day HIV prevention workshop is an important protective measure. More than anything, we want our participants to understand the risks associated with unprotected sexual activity and to be able to make behavioral changes wherever possible. The workshop is designed to educate them and to stimulate such change. It has been approved by the U.S. Centers for Disease Control and Prevention (CDC) as an effective HIV prevention intervention.
During monthly study visits, participants will also be tested for HIV to ensure that they have not become infected with the virus over the past 30 days. In the event that a participant does seroconvert, we will be able to connect him to care in a timely fashion. This is important because it could help to reduce the likelihood of him developing any type of antiretroviral resistance from having been on an HIV medication such as PrEP (if he was actually in the study arm where participants received Truvada). Though this type of resistance has not been seen in any of the larger studies, we’re doing everything that we can to ensure that it doesn’t happen to the young men in our study. In addition, participants will also be screened for other sexually transmissible infections, and other blood tests will be performed in order to detect and/or monitor any potential side effects of the medication.
Our research team will check-in with participants every two weeks between study visits, in order to address anything that may come up before their next scheduled study visit. Participants will also have the cell phone number of at least one team member, to be used in the event of an emergency (related to this study or otherwise). We really want our participants to understand that we are here to support them, not just as it relates to what’s going on in their sex lives. That kind of support is often lacking in other areas of their lives, which can certainly make them more vulnerable to risky situations. We want them to know that we are available to them as resources to be tapped into.
What things has the trial been designed to answer?
This study is designed to explore whether or not YMSM will be willing to even take part in a study involving PrEP. We want to learn if it is possible to do this kind of study with a large group of young men and what are the potential barriers. Some of the questions we want to answer are: what makes young men want to join and stay on the study, what makes them follow the study procedures, and will being on the drugs make them act riskier because they feel they are protected. However, our study is not designed to test whether or not these drugs actually work to prevent infection with HIV for those who are exposed to the virus.
Why is this research important? Why should we care?
Aside from the very important questions that it is intended to answer, this research is important because it is designed to give voice to young peoples’ thoughts and challenges around this innovative HIV prevention concept. PrEP is coming down the pipeline, whether we like it or not. But we really don’t have any information about how young people, the population who could benefit most from it here in the U.S., will respond to it. The average age of participants in the larger studies is 32. Here in Chicago, people much younger than that are becoming infected with HIV at alarming rates. Recent surveillance data suggests that the HIV prevalence rate among YMSM ages 18-24 in Chicago is 13.6 percent overall, and an astounding 24.6 percent among African American YMSM. If PrEP for HIV is indeed proven to be efficacious, we need to know how young people feel about it. We need to know if they will be interested in the concept, and the challenges they will face to accessing it and adhering to a regimen.
If we care about our young people at all, then we should certainly care about this research.
How can I volunteer for the trial?
You can volunteer for our trial by contacting Keith at 312-864-8003 or at firstname.lastname@example.org. You can also get more information at www.projectpreparechicago.org.
Thanks Keith! Keep us posted on how the reial goes - and best of luck from your friends at LifeLube!