The issue of Vaccine Induced Seropositivity or VISP is very real for our vaccine participants. About 10 to 20% of people who join our HIV vaccine studies report personal problems or discrimination because of joining an HIV vaccine study. Family or friends may worry, get upset or angry, or assume that you are infected with HIV or at high risk and treat you unfairly as a result. It’s more rare for a person to lose a job because the study took too much time away from work, or because their employer thought they had HIV. But there are issues with foreign travel, insurance, and US military service.
The protocol consents for our HIV vaccine trials address the potential social impact risks of study participation and all our CAB members participate in reviewing protocols, consents, and communications materials, including VISP-related materials. The protocols and other materials detail the potential risks including being denied medical or dental care, employment, insurance, a visa, or entry into the [US] military. Participants are told that if they do have a positive HIV antibody test caused by the study vaccine, they will not be able to donate blood or organs.
DAIDS has had procedures in place to help our study participants with VISP since before the first extramural HIV vaccine volunteer was ever vaccinated, and they continue to be in place today. We provide our study participants free HIV testing for as long they need it. (Some patients have tested positive for more than 20 years, and continue to obtain free confirmatory testing as needed.)
DAIDS also helps with immigration and visa issues as many countries ban travel of those who are HIV infected. Each country has its own policy and some are more reasonable than others. One issue that we have been unable to address successful is entry into the US military. We also work to make sure our participants can get insurance. Agreements were reached with insurers years ago and we have had to remind them of those agreements and provide documentation related to study participation/VISP. For all of these staff at DAIDS and at the HVTN have worked with a range of stakeholders, clinicians, labs, CABs, and global experts among others.
We also have a protocol (participation is voluntary) that follows folks with VISP to determine the duration of VISP and any changes over time and there is a VISP registry so that if a site should close there is a record of trial participation. Participants are aslso offered ID cards to authenticate their participation and there is a toll free number for them to call if any issues arise. This is all voluntary as some people may not want physical evidence that they were in the trial. NIAID/DAIDS also has several funded projects underway for rapid tests that would not be reliant on antibodies.
DAIDS, and the Global Vaccine Enterprise also organized a workshop with global stakeholders in 2013 to address these issues and figure out how they could best support study volunteers in the short and long-term.
