12. Post-Exposure Prophylaxis (PEP)

Consensus:

Post-exposure prophylaxis should be offered to trial participants to the degree that it has become the standard practice in the host country.

Discussion:

Participants need to be informed about what actions may be taken during the study with respect to post-exposure prophylaxis, regardless of whether or not it is provided without charge.

A major question is who would bear the cost. If the government is funding PEP for the public, then it would be provided through the same mechanism for study participants. If the government is not funding PEP, then they would be left to cover the cost privately.

Those who receive PEP might still be followed in a trial and provide valuable data.

Providing PEP to study participants that is not available to the general population may be an inappropriate inducement to volunteer in the trial.