Front Matter -- Reviewers -- Contents -- Summary -- Introduction -- 1 The Status and Challenges of Biomedical HIV Prevention Trials -- 2 Basic Design Features: Size, Duration, and Type of Trials, and Choice of Control Group -- 3 Design Considerations: Risk-Reduction Counseling -- 4 Design Considerations: Pregnancy -- 5 Design Considerations: Adherence -- 6 Design Considerations: Recruitment and Retention -- 7 Site Preparedness -- 8 Estimating HIV Incidence -- 9 Interim Monitoring and Analysis of Results -- 10 Alternative Designs -- Appendixes -- Appendix A: Public Committee Meeting Agendas -- Appendix B: Acronyms -- Appendix C: Supporting Materials for Chapter 2 -- Appendix D: Methods for Analyzing Adherence -- Appendix E: Committee Biographies.