Determinants of enrollment in a preventive HIV vaccine trial

Objective: To compare hypothetical and actual willingness to enroll in a preventive HIV vaccine trial and identify factors affecting enrollment. Methods: Participants previously enrolled in an HIV vaccine preparedness study (VPS) in 8 US cities were invited to be screened for a phase 2 HIV vaccine trial. Demographic and risk characteristics of those enrolling, ineligible, and refusing enrollment were compared using the x(2) or Fisher exact test. Multivariable logistic models were used to identify independent predictors of refusal. Results: Of 2531 high-risk HIV-uninfected former VPS participants contacted for the vaccine trial, 13% enrolled, 34% were ineligible, and 53% refused enrollment. Only 20% of those stating hypothetical willingness during the VPS actually enrolled in this vaccine trial. In multivariate analysis, refusal was higher among African Americans and lower in persons >40 years of age, those attending college, and those with greater than or equal to5 partners in the prior 6 months. All racial ethnic groups cited concerns about vaccine-induced seropositivity; African Americans also cited mistrust of government and safety concerns as barriers to enrollment. Conclusions: Steps can be taken to minimize potential social harms and to mobilize diverse communities to enroll in trials. Statements of hypothetical willingness to participate in future trials may overestimate true enrollment.