(HIVNET Protocol 015, "EXPLORE") WHAT DO WE HOPE TO LEARN FROM THIS STUDY? We want to measure the effect of a behavioral intervention on the spread of HIV and other sexually transmitted diseases. The behavioral intervention will consist of a series of ten one-on-one counseling sessions over three months, followed by quarterly "booster" sessions, that focus on changing risk behavior. The behavioral intervention will be compared to twice-a-year risk reduction counseling that usually accompanies HIV counseling and testing (standard counseling). WHO IS PARTICIPATING IN THE STUDY? Three thousand nine hundred and thirty men who have sex with men who are HIV negative and who report engaging in anal sex within the past 12 months. WHAT HIVNET SITES ARE INVOLVED IN THE STUDY?
HOW IS THE STUDY BEING CONDUCTED? The behavioral intervention counseling uses a client-centered approach to changing attitudes, beliefs, and behaviors that increase the risk of getting HIV. It targets condom use and breakage, alcohol and drug use, and changes in specific sexual practices, and is based on past research on counseling and behavior change in men who have sex with men. Standard risk reduction counseling will consist of a pre-HIV test, post-test, and risk reduction counseling session every six months. An equal number of participants will be randomly assigned to each group. The main goal of the study is to see if behavioral intervention is more effective than standard counseling in decreasing the number of HIV infections over a three-year period. Participants will also be tested for genital herpes infection and gonorrhea, to see if the behavioral intervention also helps keep people from developing these sexually transmitted diseases. The results of the study will be analyzed to determine if changes in specific risk behaviors can explain any differences in the number of HIV, gonorrhea, or genital herpes infections between the group who received the behavioral intervention and the group who received standard counseling. WHAT IS THE TIME LINE FOR THE STUDY? A small-scale pilot test of the intervention is nearing completion. The results of the pilot test showed that a large portion of participants completed the intervention sessions. The full study will include a six-month enrollment and intervention period, followed by a three year follow-up period. Start-up of the full study is scheduled for Winter, 1999.
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