The Global Campaign for Microbicides (GCM) has just released the first extensive survey mapping the Standards of Care provided in microbicide clinical trials.

Over the years there has been considerable public debate regarding the level of health care and prevention services provided to participants in HIV prevention trials. Although this subject (commonly referred to as the “standards of care” in clinical trials) has been the subject of ethics deliberations in international fora, these discussions have not, historically been informed by an accurate picture of either the daily realities of trial participants or the real-life challenges inherent in implementing trials.

In 2005, the Global Campaign and allied groups posed the following question with the release of a document entitled Consensus Points on Access to Treatment and Standards of Care in Microbicides Trials: “To what extent do conditions on the ground conform to the aspirations of advocates or to the various ethics guidance documents that inform the field?”

To help address this question GCM undertook a systematic mapping exercise of the standards of care provided to participants enrolled in late-stage microbicide trials, as well as one trial evaluating the diaphragm for HIV prevention.

The resulting report, Mapping the Standards of Care at Microbicide Clinical Trial Sites, not only captures the on-the-ground realities and challenges of conducting large-scale HIV prevention trials, but provides insights on how best to inform the design and implementation of future trials as the field moves forward. The report, which details the findings of the exercise and the 28 consensus and author recommendations, is now available for download from the Global Campaign for Microbicides’ website.

Mapping the Standards of Care at Microbicide Clinical Trial Sites
Full Report
Executive Summary

For more information about the standards of care mapping or to receive a printed copy of the report, please contact Katie West Slevin.