Bay Windows - July 22, 2004
Ethan Jacobs, ejacobs@baywindows.com.

Explore

For Benjamin Perkins, 39, the decision to commit four years of his life to taking part in Explore, a study on HIV prevention methods, was about much more than just a stipend.

"My interest was really, it was sort of based on the community piece, on doing something for the community," said Perkins. He also had a personal stake in the research: His childhood friend died from complications from AIDS, and one of his ex-partners was HIV positive.

Perkins wasn't alone. From January 1999 through the study's end last July, more than 700 Boston-area gay men and other men who have sex with men (MSM) volunteered as research subjects in Explore, providing researchers with reams of data about prevention messages and HIV transmission that the study's principal investigators hope will lead to more effective efforts to stop the spread of the virus. Boston's Fenway Community Health Center partnered with researchers in five other cities - New York, Chicago, Denver, San Francisco, and Seattle - to compare prevention messages among more than 4000 sexually active MSM.

Researchers split the volunteers into two groups. One group received ten intensive counseling sessions at the start of the study about a wide variety of topics related to HIV infection, including sexual negotiation, alcohol and drug use, Internet hookups, and knowledge of a partner's HIV status. After those ten sessions volunteers met with counselors every three months for "maintenance sessions" to continue discussions about risk factors. The control group received standard counseling sessions and HIV testing every six months. Researchers hoped to see whether after four years the intensive counseling sessions had decreased the likelihood that volunteers would contract HIV.

Perkins was one of the volunteers who received the ten counseling sessions, or modules. Although currently living in Washington, D.C., Perkins was a graduate student in Boston during the time of the study, which he discovered after seeing an advertisement posted on a school bulletin board. He said that while the counseling sessions were time consuming, his schedule as a grad student enabled him to make time to participate.

At his first session Perkins and his counselor drew a circle that they labeled the "universe of risk." The counselor had Perkins list sexual practices and behaviors inside the circle that he considered risky, and he listed activities outside the circle that he considered less risky.

"For me that kind of set the tone for the entire four years," said Perkins. "I was always, I always sort of had in mind the universe of risk."

That initial session was followed by modules on drugs, alcohol, the Internet, and sexual risk-taking, among others.

Like the vast majority of participants in both groups, Perkins tested negative at the end of four years, and while the study showed that the intensive counseling had only a modest benefit in terms of reducing HIV infection, Perkins said he felt that the discussions of risk factors would be helpful to many gay men.

"I think often with gay men we can be quite good about talking about sex, but having a discussion about risk and safety is another proposition," said Perkins. "... I felt good about the process of becoming more self-reflective about sexual behavior."

Dr. Kenneth Mayer, the principle investigator working on the study at Fenway, said that while the number of infected participants in each group was too close to be statistically significant (115 people were infected in the intensive counseling group, compared with 144 people in the control group) there was a greater decrease in risky behavior among the volunteers who received intensive counseling. He said the study suggests "a high likelihood of a modest benefit" to the ten counseling sessions.

The counseling sessions were particularly effective in the first few months after the study began, said Mayer, and researchers hope to use the data to find ways to maintain that level of effectiveness in the long term.

FOTO

Community Research Initiative of New England (CRI), a Boston-based nonprofit that conducts clinical research on HIV/AIDS-related topics, recently presented the results of another study taking place in Boston. CRI's Director of Research Dr. Calvin Cohen presented the results of its Five days On, Two days Off (FOTO) study July 12 at the 15th International AIDS Conference in Bangkok, and while the study is still in progress, the results thus far suggest that some HIV positive people might be able to break away from the standard daily drug regimens.

Cohen said the study, which has been going on for more than a year, is very small-scale, involving only about 30 volunteers. The goal of the study is to see whether HIV positive people can maintain undetectable levels of HIV by taking their medications daily during the workweek and then going off meds on the weekends.

"Some people have trouble taking the meds every day, every day, every day for the rest of their lives," said Cohen. He noted that an earlier study by the National Institutes of Health found that people were able to keep their virus levels under control by alternating between one week on meds and one week off, but Cohen worries that a week-on, week-off schedule might be confusing over the long term. He believes the FOTO schedule is much more intuitive.

Mike, a study participant who asked that his real name not be used, said that the FOTO schedule for taking meds has kept his virus levels undetectable, and as long as it continues working he sees himself maintaining the schedule.

"I could foresee me doing this even after the study is complete," said the 29-year-old Cambridge resident. He said he has noticed no change in his health since switching from the daily schedule to the FOTO schedule.

Mike said he found out about the study soon after testing positive for HIV, while searching the Internet for research studies seeking volunteers in the Boston area.

"I felt like I wanted to be part of the research process on a larger scale," he said.

Since his current drug regimen was already working, Mike said he had no interest in volunteering to test experimental drugs. The FOTO study seemed more appealing, but he said it still took several months of convincing from researchers that the study was relatively safe.

"Basically just because of the nature of the studies I had some reservations about interrupting my treatment," said Mike. Yet so far he and most other participants have done well on the FOTO schedule.

Cohen said that the one group of patients for whom the results haven't been entirely positive are those taking protease inhibitors. Within that group, two out of the nine had detectable HIV levels after 24 weeks on the FOTO schedule. Cohen said there are other types of protease inhibitors that stay in the system longer than those used by participants, and he hopes to test whether those drugs are more effective on the FOTO schedule.

Mike said the new drug schedule has not intruded in his daily life, and it allows him to be more social on the weekends.

Cohen said another benefit of the schedule is that it cuts down on the cost of taking medications by almost 30 percent. He also said the reduced schedule may reduce some of the long-term side effects of HIV meds. But Cohen cautioned that the schedule was only appropriate for people whose virus levels were already under control, and he said more research needs to be done before health care providers can recommend the schedule to their patients.

"We certainly don't think that the experience of [the small group of participants] over a year is enough to change people's practice," said Cohen.

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