9. Counselling

Consensus:

High-quality risk reduction counselling must be offered to all participants in an HIV vaccine efficacy trial, and should be provided independently of the investigator. Counselling capability should be part of the initial capacity-building process prior to a trial being conducted.

Discussion:

Independent monitoring of the quality of the counselling should be considered.

There should be standardization of counselling in some way. It must also be specific to cultural diversity and social norms. A country such as Uganda has extensive experience with this, but many others do not. They may need such international guidelines as standard formats, questionnaires, and training.