African American Participation in HIV Preventive Clinical Trial – A Preliminary Examination of Willingness to Participate in HIV Vaccine Clinical Trials and the Impact of HIV Vaccine and Other Clinical Trial Knowledge on Willingness

Background: 
In the District of Columbia (DC) 1 out of 50 is living with AIDS and has rates of 179.2 per 100,000.  Further, African Americans account for 75% of all reported AIDS cases in the District. 

Given these high rates, DC is an ideal location to assess willingness to participate and knowledge of HIV preventive vaccine clinical trials.

Objectives: 
To assess willingness to participate in HIV preventive vaccine clinical trials, the level of knowledge of clinical trials in this community, and its impact on individual willingness to participate in HIV preventive vaccine trials.

Methods: 
African Americans in DC were recruited to complete an ACASI survey on HIV vaccine clinical trials.  Participants were presented a knowledge assessment (general clinical trials, HIV trials and Tuskegee Syphilis study) and a “step-wise” mock consent process of an HIV vaccine clinical trial. 

Willingness to participate was assessed on a four point scale.  An ordinal logistic regression was conducted to determine the impact of demographics and knowledge on willingness to participate.

Results: 
Of the 395 enrolled:
69% responded to 80% of the general clinical trial instrument correctly;
25% responded to 80% of the HIV clinical trial instrument correctly;
and 46% had heard of the Tuskegee Syphilis study. 

Only 29% of this group answered 6 or more of the remaining 7 items correctly about Tuskegee. 

Between 33-47% of all respondents indicated that they were “not at all” willing to participate in a HIV vaccine trial and 3-5% indicating that they were “definitely” willing to participate. 

An ordinal regression analysis found that an individuals HIV risk status (high risk; 95% CI: 1.30-5.65) and knowing someone with AIDS (95% CI: 1.04-3.22) increasing likelihood of participation in such studies. (x2=27.6, p<.0001).

Conclusions: 
Knowledge is relatively low and in need of improvement in this community if decisions regarding participation are to come from an informed framework.  Preliminary data appear to indicate that high risk individuals and persons knowing someone with AIDS are more willing to participate in these types of clinical trials and that recruiting efforts should include such individuals in their outreach efforts or recruitment plans.