Innovative HIV Counseling Study Results Published Today; Largest MSM Behavioral Intervention Enrolled 4,295 Participants

7/1/2004

From: Beryl Koblin, 212-570-3105, or Rich Murphy, 212-570-3101 or 917-439-7127, both of the New York Blood Center

NEW YORK, July 1 -- Project ACHIEVE of the New York Blood Center, part of the HIV Prevention Trials Network supported by the National Institutes of Health, announced today the publication of results from its Explore study -- the largest ever behavioral intervention trial for HIV prevention among men who have sex with men (MSM). The article, published in this week's issue of The Lancet, reports that while there were fewer new HIV infections in the intervention group compared with the control group (115 infections in the intervention group versus 144 infections in the control group, respectively), this difference was not statistically significant and was not at the level of benefit targeted by the research team. However, men receiving the intervention reported a statistically significant 20.5 percent decrease in high-risk behavior over the course of the study.

MSM accounted for 44 percent of all new HIV and AIDS diagnoses in the United States in 2002. The Explore study enrolled 4,295 uninfected MSM at high risk for HIV infection in six major U.S. cities, including 737 in New York City. The study achieved a retention rate of 87 percent overall (85 percent in the intervention arm and 89 percent in the control arm) over 4 years.

Explore participants in the intervention group were tested for HIV infection and were asked about recent sexual behaviors, alcohol and drug use and depression during 10 intensive one-on-one counseling modules in the initial 4 to 6 months of the study. These 10 sessions were followed by client-centered maintenance sessions at 3-month intervals throughout the 3 to 4 years of follow-up. Participants in the control group received standard voluntary counseling and testing every six months. Declines in sexual risk were seen in both arms of the study. The full effect of the intervention may have been muted, say the investigators, because participants in both arms received considerable attention over the course of the study to maintain involvement and retention. The quality of the HIV counseling and testing given to the control arm participants may have been better than the quality that is typically given in anonymous testing and counseling services. These study elements may have led all participants to lessen their behavioral risk, say the investigators.

Site PI Dr. Beryl Koblin said that "Although the intervention was not highly effective in reducing HIV infection, the decrease in high-risk behaviors and the lower number of new HIV infections in the intensive counseling group suggest a possible modest benefit over the standard twice-a-year counseling. It was good to see that both groups of men in the study experienced a reduction in risk behaviors over time. The data warrant further exploration."

Furthermore, Dr. Koblin, added, "While the Explore intervention should not be implemented on a wide-scale basis as is, we are conducting further analyses of the data to generate hypotheses that can help us develop more highly efficacious behavioral interventions."

You can access additional information on this study through the following website address: http://www.explorestudy.org. For more information about Project Achieve visit http://www.projectachieve.org or contact Dr. Beryl Koblin at bkoblin@nybloodcenter.org

Explore study co-chairs are Margaret Chesney, Ph.D., Beryl Koblin, Ph.D., and Thomas J. Coates, Ph.D. Principal investigators included Connie Celum, M.D., (Seattle), Susan Buchbinder, M.D. and Grant Colfax, M.D. (San Francisco), Kenneth Mayer, M.D. (Boston), David McKirnan, Ph.D. (Chicago), Frank Judson, M.D. (Denver), Beryl Koblin, Ph.D (New York).

This work was conducted by the HIV Network for Prevention Trials (HIVNET) and HIV Prevention Trials Network (HPTN) and sponsored by the U.S. National Institute of Allergy and Infectious Diseases, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Child Health and Human Development, the National Institute on Drug Abuse, the National Institute of Mental Health, and the Office of AIDS Research of the National Institutes of Health, Dept of Health and Human Services.