Gay men were the first Americans to contract HIV in the early 1980's, and from there rumors developed and spread for years that it was a disease of and from gay men. While those myths have been dispelled in recent years, now men who sleep with men being given a chance to help find a vaccine for HIV through Vanderbilt University's HIV Vaccine Program.

For the past 21 years, scientists in Vanderbilt University's HIV Vaccine Program have been working toward stopping the spread of the global disease. Led by Kyle Rybczyk, FNP, RN, program coordinator, they are a part of an international network known as the HIV Vaccine Trials Network and their latest study, which opened late last month, is turning its focus to men who have sex with men (MSM) - a demographic that is disproportionately affected by the disease.

“The gay male demographic was the hardest hit in the very beginning," Rybczyk said. "It’s interesting that there is now an opportunity for men who aren’t infected with HIV to make an impact.” 
 

The 411 on HIV
  • AIDS has been diagnosed for more than half a million MSM. Over 300,000 MSM with AIDS have died since the beginning of the epidemic.
  • MSM made up more than two thirds (68%) of all men living with HIV in 2005, even though only about 5% to 7% of men in the United States reported having sex with other men.
  • In a 2005 study of 5 large US cities, 46% of African American MSM were HIV-positive.

Source: Centers for Disease Control & Prevention cdc.gov

The study, called HVTN 505, is being conducted  nationwide and will track 1,350 men for up to five years. Vanderbilt was the first site to enroll a participant in the study and must enroll a total of 100 MSM  in the next few months.

“Part of the excitement for this study—for any field of research, really—is to get the first subject enrolled, because that really starts the momentum for all the sites, and Vanderbilt was the first site to get someone enrolled in the study, which surprised our entire network,” Rybsyck said. “We need lots of men to call in, this is not a small project for us, or for the network. It’s one of the biggest things we’ve done, which adds both excitement and challenge.”

The study requires little on the part of each participant. The first step is an education session to learn how the study works.
 
Rybczyk said a common question asked is whether or not it is possible to get HIV from the vaccine. The answer is 'no.' 

“There’s no chance of getting infected from the vaccine," Rybczyk said. "In blood tests, we can absolutely tell the difference between whether you become HIV -infected or whether you have antibodies from the vaccine." 

The initial appointment includes no commitment, no forms to be signed or blood drawn. The study policy precludes a potential participant from being educated and having their screening the same day.

“All potential participants go home and have to think about the commitment and what it means," Rybczyk said. "We don’t want anyone to enroll because they feel pressure. We’re not out to just fill the numbers, we’re out to better the world. So, it’s a very non-threatening, easy, one-on-one session to go over information about the trial."

After deciding to enroll, candidates are screened to ensure they meet the requirements for the study. If approved, they share their medical history and undergo a physical exam before receiving their first vaccination. From there, regular appointments are scheduled for blood draws and questionnaires, very similar to doctor’s appointments.

 

Read our Q&A with trial participant Justin Waldner below.


The HVTN 505 study requires most visits - about 12 to 15 - in the first twelve months.  Afterwards, there is a long-term period of follow-up to gain data, with visits scheduled in three-month intervals for up to five years.

Rbyszyck said interested participants shouldn’t be swayed by the long-term commitment. Patient data can easily be transferred to another research cite, if the patient move to another cite city and would receive an NIAID card that provides direct access to the National Institutes of Health (NIH).
 
“We and the NIH have become very adept over the years at setting up tests for past participants who’ve moved to locations where there aren’t study sites who need to be HIV-tested,” Rybczyk said. “We don’t leave them hanging. We take care of our volunteers.”

Rybczyk said this isn't expected to be the study that stops the spread of HIV, but he said it is a vital step in reaching that goal.

“It’s a very exciting study, but we’re very frank about this - It won’t be the study that makes us say, ‘Yes! We’ve found it. We can now end HIV,’" Rybczyk said. “It is a step in the process, but it is the first major study that we’ve done solely in men who have sex with men, and we look forward to the data we can learn in that population." 
 

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