P14-11. Educating community medical providers about HIV vaccine induced seropositivity

Background

Experimental HIV vaccines can elicit antibodies to HIV proteins expressed by the vaccine, leading to a positive HIV serologic test result without infection. Vaccine induced seropositivity (VISP) can cause social harms for trial participants and potentially threatens study validity by unblinding participants and staff. Trial participants are educated to avoid HIV testing outside the trial site until trial completion or disappearance of VISP, whichever occurs later. In 2006, the U.S. Centers for Disease Control and Prevention released guidelines recommending that HIV testing be performed as part of routine medical care without specific written consent, raising concern that trial participant education alone might be insufficient to avoid inadvertent HIV testing of trial participants in the community.

Methods

The Seattle HIV Vaccine Trials Unit (HVTU), in collaboration with the HIV Vaccine Trials Network, conducted a pilot project designed to educate medical and HIV test providers in the Seattle area about VISP. We gathered local data about vaccine study participation, sought input from local HIV care providers and test counselors, public health officials, and community based organizations, and developed a VISP educational program.

Results

Since 1990, >1144 persons in the Seattle area have enrolled in HIV vaccine trials, of whom 900 (79%) received active vaccine. Of 786 vaccine recipients completing trials between 1990–2008, 253 (32%) developed VISP, lasting months to >10 years after vaccine receipt. Highlights from community input included the importance of making sure that VISP education is not misconstrued as anti-HIV testing, continued participant education, and desire for brief written materials for clinicians. From June 1, 2008–May 8, 2009, 43 VISP educational presentations were conducted, written materials developed, and VISP education slides adapted into required Washington state training courses reaching >400 HIV service providers.

Conclusion

The Seattle HVTU was able to successfully incorporate VISP education into community education regarding HIV vaccine research.