The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results.
According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.
Institute of Medicine. 2008. Methodological Challenges in Biomedical HIV Prevention Trials. Washington, DC: The National Academies Press. https://doi.org/10.17226/12056.
|1 The Status and Challenges of Biomedical HIV Prevention Trials||37-68|
|2 Basic Design Features: Size, Duration, and Type of Trials, and Choice of Control Group||69-87|
|3 Design Considerations: Risk-Reduction Counseling||88-103|
|4 Design Considerations: Pregnancy||104-118|
|5 Design Considerations: Adherence||119-147|
|6 Design Considerations: Recruitment and Retention||148-159|
|7 Site Preparedness||160-174|
|8 Estimating HIV Incidence||175-185|
|9 Interim Monitoring and Analysis of Results||186-203|
|10 Alternative Designs||204-224|
|Appendix A: Public Committee Meeting Agendas||225-233|
|Appendix B: Acronyms||234-235|
|Appendix C: Supporting Materials for Chapter 2||236-244|
|Appendix D: Methods for Analyzing Adherence||245-249|
|Appendix E: Committee Biographies||250-258|
The Chapter Skim search tool presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter. You may select key terms to highlight them within pages of each chapter.
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, pleaseclick here to view more information.