Researching For Answers Baystate’s New Spermicide Study Could Contribute To Lower HIV Rates Globally

The search has begun for a better birth control method that could also reduce HIV transmission rates worldwide.

 

And a portion of the exhaustive, global research process is currently taking place locally in Western Mass.

A new spermicide study and trial funded by the National Institutes of Health (NIH) is underway at Baystate Medical Center, which was recently named one of several testing sites across the country recruiting sexually active women to test the effectiveness of the spermicide, in terms of preventing pregnancy.

The second half of the trial, testing its effectiveness in preventing the transmission of HIV, is currently being conducted in several African countries, where HIV and AIDS rates are the highest in the world.

Julie Feinland, a faculty midwife at Baystate’s Wesson Women and Infants Center and director of the study, said the spermicide is similar to nonoxynol-9, the most common spermicide in the world, used in condoms and other contraceptives.

New Recruits

N-9’s major drawback, however, is that not only does it not guard against HIV, it has actually been shown to increase transmission rates. This new spermicidal gel, C31G, as it is currently dubbed, has shown promise in decreasing the risk of HIV transmission, Feinland said, and is currently the subject of clinical trials that will likely run for the next two to three years.

The aspect of the global study being conducted in the U.S. is not focusing on the gel’s relation to preventing HIV, but rather gathering data on its percentage of failure rate in preventing pregnancy, as well as any side effects that would deter women from using the product, such as urinary tract infections, vaginitis, or general irritation.

“Baystate is one of 12 sites across the country involved in the network,” she explained, adding that the hospital recently began recruiting women to take part in the study. “These women get a full, annual gynecological exam, including a pap smear and STD testing, and their spermicide is provided free of charge.”

The control group in the study will not receive a traditional placebo, but instead will be provided N-9 as a birth control method, in order to compare the effects and the side effects of each method.

Feinland said the ideal candidate for the study is one who is sexualy active, in a monogamous relationship, and the type of woman who, if the product is released onto the market, could potentially use and benefit from C31G.

“We’re looking to form a good cross-section of women, and to do that we have to talk to a lot of people,” she said. “We don’t want any women in the study who, if a pregnancy occurred, would be unhappy or not in a position to handle that.”

Spermicides used alone are not generally among the most effective birth control methods currently available to women, Feinland explained, and therefore studies of compounds such as C31G are often hard to recruit for.

“It’s not a new pill or a patch that we already know will work well,” so it can be difficult and time-consuming to find women who are in a place in their lives that could accommodate a pregnancy if one occurred,” she said.

However, Feinland said enrollment thus far has been steady, and many women who fit the study’s criteria but lack health insurance are taking advantage of the benefit of free check-ups and spermicide.

“Plus, they’re contributing to science, and I like to think that that factors in for some of them,” she said.

Global Impact

And despite the focus of the U.S. leg of the study on birth control efficacy rather than HIV prevention, that aspect of the study is not lost on Feinland or her fellow researchers. Dr. Ronald Burkman, chair of the obstetrics and gynecology department at Baystate Medical Center, has been involved in a number of contraceptive studies since the early seventies, and said the C31G study differs from many because of the major focus on global health.

“There is an enormous public health implication associated with this study,” he said. “About 40 million women worldwide have HIV, and it is most commonly transmitted through sex.

“The fact that the spermicide kills the HIV virus is the most important aspect of the study and also the only reason the NIH would spend money on it,” Burkman continued. “The market for spermicide is not huge, but the impact on public health certainly is.”

As a teaching and research hospital, as well as the Western Mass. campus for Tufts University School of Medicine, Burkman said Baystate has been involved with other birth control studies in the past, including that of a low-dose birth control pill and a contraceptive patch. He added that he hopes the hospital’s involvement in the C31G study will call further attention to its research capabilities.

“We were sought out specifically because of our expertise,” he said. “We’ve been involved in some important studies in the past, but we’ve been involved quietly. I hope this study helps our research abilities become less of a well-kept secret; it’s studies like these that attract the best and the brightest students and physicians, keep the academic juices flowing, and keep us on the cutting edge of developing medicine.”

Study Halls

Feinland agreed, saying that although she enjoys her clinical work as a midwife, she is eager to put her masters degree in public health to good use.

“I love the clinical aspect of my job,” she said, “but I am looking forward to making a contribution to new, important knowledge.”