Ar. Sheon et al., Preventing discrimination against volunteers in prophylactic HIV vaccine trials: Lessons from a phase II trial, J ACQ IMM D, 19(5), 1998, pp. 519-526
Context: Preventive HIV vaccines can temporarily cause uninfected individua
ls to have positive results on HIV testing. As preparations are underway to
mount larger efficacy trials, the social risks of trial participation shou
ld be studied.
Objective: To describe frequency of HIV testing and discrimination among pa
rticipants in a preventive phase II HIV vaccine trial.
Participants: 266 vaccine trial volunteers were eligible; 247 participated
in a confidential survey.
Results: 63 volunteers (26% of respondents) reported 185 HIV tests during t
he prior 12 to 24 months; most tests were for other research studies, healt
h care, insurance, incarceration, or employment. Only 5 volunteers reported
having positive HIV test results. Volunteers reported 99 adverse social in
cidents or problems, 53 of which were related to the trial. The most common
type of event occurred when volunteers disclosed their trial participation
and were mistakenly presumed to be infected with HIV. Few reported difficu
lty obtaining insurance, job loss, and inadvertent disclosure of their part
icipation in the trial.
Conclusion: In this vaccine trial, few serious social harms were reported.
Those who conduct HIV tests for insurance, employment, health care, or othe
r reasons should be made aware that HIV vaccines can cause false-positive H
IV test results. Those planning future trials must continue to provide need
ed support to volunteers. Social harms should be monitored with the same vi
gilance accorded to physical harms.