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Capturing Participant Data for Mucosal Sample Interpretation:
A Guide for HIV Investigators

An expanded and updated resource for organizations and investigators engaged in clinical studies with a mucosal immunology component.

There is growing evidence that effective HIV prevention tools will need to act at mucosal sites, the virus’ primary portal of entry. The ability to compare immune responses across different HIV prevention modalities in samples taken from mucosa is critical as we continue to assess the potential of new prevention tools, including HIV vaccines.

Capturing Participant Data for Mucosal Sample Interpretation: A Guide for HIV Investigators is a resource to help identify key participant characteristics that can affect mucosal immunity and are therefore important factors to consider for proper interpretation and potential cross-trial comparison of mucosal immunology data.

The first edition of this guide was developed in 2014.

Because identifying factors that influence mucosal immune responses remains a very active field of research, the 2016 version of the Guide has been updated to retain its relevance. The Second Edition was developed under the leadership of Drs. Patricia D'Souza (NIAID-NIH), Mary Gross (FHCRC), Raul Gomez Roman, and Yegor Voronin (the Enterprise) and incorporates contributions by over 40 expert reviewers from more than 20 organizations engaged in HIV prevention research.

In this Second Edition, all sections have been updated to reflect the latest knowledge about mucosal immunity and generally expanded to include additional variables not considered in the first edition. The section on Reproductive History has been substantially reorganized to enable users to more logically query women’s reproductive history information. The Sexual History section now includes considerations about competent condom use and about the use of rectal and vaginal products or devices. New references have been added throughout, and a summary checklist was created to enable users to quickly review the sections they may need to consider in their study.

The Guide is meant to be used in conjunction with study specific procedures and policies, protocols, and clinical report forms and does not replace them. The Guide serves as a tool to supplement and enhance the quality of clinical research conducted with mucosal specimens.

 

Capturing Participant Data for Mucosal Sample Interpretation: A Guide for HIV Investigators

To order printed copies of the booklet version of the Guide (2nd Edition, 1st Printing), to provide feedback on the Guide, or to volunteer to review the next version of the Guide, email: timelytopics@vaccineenterprise.org

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