AEGiS-15IAC: Challenges and approach to conducting HIV vaccine trial in the community.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Challenges and approach to conducting HIV vaccine trial in the community.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. A10275)

pitisuttithum PP
university, bangkok, Thailand

ISSUES: Good Clinical Practice, highest standard of treatment and care and ethics in conducting clinical trials, are major concerns especially when a trial is conducted in developing countries. To meet these requirements, there are many challenges in various stages as the trial goes along which include development of clinical sites, standard operating procedures, an process for informed consent, and continuing education of personnel. The subsequent concern is how to maintain the quality of work and morale of staff throughout a multi-year trial

DESCRIPTION: The phase III trial with ALVAC-HIV priming & AIDSVAX® B/E boosting was launched in September 2003 under the leadership of the Ministry of Public Health. The trial will enroll 16,000 HIV-negative volunteers in the communities of the Eastern Seaboard of Thailand. Given the magnitude of the trial, 400 staff were trained to conduct the trial, focused on various activities and divided into recruitment team, screening team, vaccination team (includes clinical research coordinators, research assistants, counselors and doctors), follow-up team and supervision team. Extensive training and supervision were done to insure the standard of the trial. The informed consent process includes watching video, booklet education, group and individual discussion.

LESSONS LEARNED: Capacity building, both physical and human, is required and needs strong commitment, knowledge, positive attitudes and innovation from both staff and communities. To provide the highest standard of care attainable by host country requires strong commitment from policy makers. The informed consent process, built on experience from multiple earlier trials, functions very well in these young Thai adults.

RECOMMENDATIONS: Community engagement, recruitment and enrollment must continue, while concurrent efforts focus on continued education of staff, maintenance of morale and retention of volunteers.

Keywords: AEGIS, AIDS Vaccines, Residence Characteristics, Behavior, Acquired Immunodeficiency Syndrome, Clinical Trials, HIV Infections, Clinical Trials, Phase III, HIV, Developing Countries, Informed Consent, Research, HIV Envelope Protein gp120, Demography, Attitude, Research Subjects, Thailand, AIDSVAX, Adult, Humans, Ethics, immunology

040711
A10275