Starting from scratch: program development and lessons learned from HIV vaccine trial counseling in Thailand.

Counseling for participants in preventive HIV vaccine trials has been an area of continuing concern because of the need to address possible behavioral side effects (e.g., increased risk behavior because trial participants believe they may have received an active, effective vaccine) and social harms (e.g., discrimination in health care or employment because of vaccine-induced seropositivity on commercial HIV tests). Yet, the data on behavioral effects and social harms are limited and rather little detail has been provided regarding the counseling provided in current or past trials. This paper summarizes conceptual, cultural, and practical considerations in the development of a counseling program for HIV vaccine trials and provides examples from work done in the context of Phase I/II vaccine trials in Thailand.