Who will enroll? Predicting participation in a phase II AIDS vaccine trial.
BACKGROUND
The problems of underenrollment and selective enrollment may undermine AIDS vaccine trials. If prospective study subjects' stated willingness to participate (WTP) in hypothetical vaccine trials predicts future enrollment, then measuring WTP before recruitment may enhance the enrollment in, and ethics of, such trials.


METHODS
We prospectively studied changes over an 18-month period in the stated WTP in, and knowledge of, a hypothetical AIDS vaccine trial among 610 Philadelphia residents at high risk for HIV infection. Of these people, 499 were subsequently recruited to participate in an actual, phase II AIDS vaccine trial. We used multivariable logistic regression and the area under the receiver-operating characteristic (ROC) curve to model predictors of actual enrollment.


RESULTS
Actual enrollment rates were 8.3%, 6.8%, 15.8%, and 29.0% among those who had initially said they were "definitely not," "probably not," "probably," and "definitely" willing to participate, respectively (p =.006). The area under the ROC curve was 0.65, indicating a modest ability of stated WTP to differentiate those who enroll from those who do not. Knowledge of basic vaccine trial concepts, though unrelated to enrollment, increased over an 18-month period with repeated education sessions (p <.0001), whereas stated WTP declined over this same period (p <.0001).


CONCLUSIONS
Although other factors not captured by stated WTP may also influence future enrollment, prospectively assessing stated WTP may augment the validity of the informed consent process, help prevent underenrollment, and clarify the population from which the study sample is drawn.
Halpern
S D
SD
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pensylvania 19104-6021, USA. shalpern@mail.med.upenn.edu
Metzger
D S
DS
Berlin
J A
JA
Ubel
P A
PA
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D005544:Forecasting; D007722:Health Knowledge, Attitudes, Practice; D006805:Human Experimentation; D006801:Humans; D009042:Motivation; D010342:Patient Acceptance of Health Care; D010358:Patient Participation / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012307:Risk Factors; D014481:United States; D014611:Vaccination
D016915:AIDS Vaccines