P15-21. Investigating the utility and relevance of the good participatory practice guidelines for biomedical HIV prevention trials

Background

The ''Good Participatory Practice Guidelines for biomedical HIV prevention trials'' were published by UNAIDS and AVAC in November, 2007. Since publication of the guidelines, AVAC, together with 12 partner organizations, gathered data about their utilization, as well as stakeholder views of their appropriateness and usefulness.

Methods

Between June 2008 and May 2009, AVAC collaborated with biomedical HIV prevention stakeholders from multiple countries on activities that raised awareness of and generated feedback on the guidelines. Diverse audiences targeted by these consultations included: trial site staff and volunteers, CABs, IRB members, NGO representatives, sex workers, PLWHA, IDUs, and other community members. Collaborating partners oriented stakeholders to the GPP guidelines and conducted interviews, focus group discussions and consultations to gather data on stakeholders' views of the guidelines, and recommendations for implementation and revisions, if necessary. Data were gathered by each partner and AVAC compiled the results.

Results

Data from 21 countries indicated support of the guidelines as well as recommendations for their implementation and improvement. While stakeholders said the guidelines are comprehensive and should be implemented across trial sites, the language and format of the guidelines could be improved for better understanding and utilization by trial sites and community members alike.

Conclusion

There was widespread agreement that the GPP guidelines are vital as there was no previous normative agency guidance document to guide trial site sponsors and implementers on community engagement. Stakeholders included in the consultations recommend that trial sites be required to follow the GPP guidelines, much like with Good Clinical Practice. UNAIDS should formally notify trial sponsors, implementers and governments about the current version of the guidelines through its country offices. While the current version of the guidelines is being rolled out globally, AVAC and UNAIDS should convene a committee to revise the guidelines to make the document more useful.