11. Counselling

Consensus:

Risk behaviour counselling, condoms, and syringes, where appropriate, must be provided to participants in a preventive HIV vaccine efficacy trial. The nature of this counselling should be described in the study protocol. Counsellors must be adequately trained to provide the service as described in the protocol.

Discussion:

Counselling must be individual, intensive and comprehensive. Counsellors should be trained and experienced. It was agreed that the counselling ‘standard’ of the host may not be adequate for the trial situation.

Where there is scientific evidence for the effectiveness of counselling, this should be applied. International standards or guidelines for counselling should also be considered when available.

Controversy:

There was extensive discussion about the degree to which the preventive behaviour counselling should be independent of the investigators. Some felt that counselling should be the responsibility of agencies or bodies completely separate from the investigative authority, whereas others felt that counselling need only be independent of the individual investigators. It was suggested that counselling be contracted to independent agencies.