Methodological Challenges in HIV Prevention Trials

Type: Consensus Study
Topics: Biomedical and Health Research, Diseases, Global Health, Public Health
Board: Board on Global Health

Activity Description

The Institute of Medicine (IOM) convened a committee to examine methodological challenges in HIV prevention trials. The committee prepared 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 undertook a study with the following tasks:

1. The committee reviewed 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 made 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 also considered the ethical issues directly related to methodological issues under study, such as those that might arise during interim monitoring of trials.

This study did 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.

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