The Institute of Medicine (IOM) will convene a committee to examine methodological challenges in HIV prevention trials. The committee will prepare a report to improve the methodology, design, and conduct of HIV prevention trials, focusing on microbicide and pre-exposure prophylaxis (PrEP) trials, in order to increase their likelihood of success and to enable donors to optimally invest resources. The committee will undertake a study with the following tasks:

1. The committee will review select Phase II and III HIV prevention trials in order to provide an assessment of best practices for site preparedness and estimation of incidence.

2. The committee will make recommendations regarding methodological best practices for microbicide and PrEP efficacy trials. Issues to be addressed include but are not limited to: loss of study power through lower-than-expected incidence and high pregnancy rates; other design considerations such as choice of endpoints and control groups; methods for monitoring the interim results of trials (including adjustments to trial size/duration); pooling of data from trials testing the same product; methods for improving adherence to study regimens and the quality of self-reported behavioral data; and optimizing retention of trial participants. The committee will also consider the ethical issues directly related to methodological issues under study, such as those that might arise during interim monitoring of trials.

This study will not address broader ethical issues such as adequacy of informed consent, compensation for trial-related adverse events, access to HIV treatment for seroconverters, and best practices for engaging community members.

This project is sponsored by the Bill and Melinda Gates Foundation. The approximate start date for the project is October 15, 2006.  A report will be issued in January 2008.

You can provide feedback to the committee members and staff concerning this project through the National Academies Current Project System.

Please note that any comments that you submit to the committee through this website or otherwise, including your name and identifying information, will not be kept confidential and will be included in a Public Access File. The National Academies shall be authorized to use any such comments or submissions in accordance with the National Academies' Terms of Use Statement.

If you would like to receive updates about committee proceedings, please join our listserv by clicking on Subscribe to the HIV Prevention Trials Listserv.

For more information, please contact Rachel Passman at rpassman@nas.edu.