This process was repeated until no subgroup could be identified in which the incidence exceeded 1.5 per 100 PY. With each step,
PY and number of HIV seroconversions were summed across the included factors, and a combined HIV incidence was calculated. As the HIM study was designed as a vaccine preparedness study, a large number (53) of questions on participants’ attitudes towards HIV vaccine trials were asked annually from 2001 onwards. In contrast, only one question on how likely they would be to participate in a trial to test the effectiveness of a rectal microbicide ABT199 (‘very unlikely’, ‘unlikely’, ‘likely’, ‘very likely’ or ‘don’t know’) and one question on how likely they would be to participate in a trial to test the effectiveness of antiretroviral drugs (ARVs) in preventing HIV infection (‘very unlikely’, ‘unlikely’, ‘likely’, ‘very likely’ or ‘don’t know’) were asked annually, from 2006 onwards. The participants’ response to willingness questions in the final year was included in order to capture their most recent views on participation in trials. Willingness to participate find more in rectal microbicide trials and trials using ARVs to prevent HIV infection was analysed by logistic regression, comparing participants in the high incidence subgroup with the rest of
the HIM cohort. Although many questions concerning HIV vaccines were asked in the HIM study, there was no specific question on willingness to participate in HIV vaccine trials. For this reason, factor analysis was used to develop a scale to represent willingness to participate in HIV vaccine trials.
This was based upon previously published factor analysis of HIV vaccine attitudes in Sydney [36,37]. The three items included in the willingness to participate in HIV vaccine trials scale were: ‘I would participate in an HIV vaccine trial even MG-132 clinical trial if I thought the vaccine might not work’, ‘I want to take part in HIV vaccine trials because I think it will benefit me personally’ and ‘Gay men have nothing to lose by participating in an HIV vaccine trial’. To confirm the suitability of the scale for use in the HIM study, the three questions were entered into an exploratory factor analysis, and a reliability coefficient (Cronbach α-value) was calculated for all participants who responded to the questions. As with the questions on willingness to participate in rectal microbicide trials and trials using ARVs to prevent HIV infection, the participants’ last response was included in order to capture their most recent views on participation in trials. Mean scale scores for ‘high-incidence’ subgroups were compared with the mean scale scores for the remainder of the cohort, using the t-test statistic. Where the response was ‘Don’t know’, the value for the mean of the response to the question was used. A total of 1427 participants were enrolled in the HIM study between June 2001 and December 2004. The median age at enrolment was 35 years, with age ranging from 18 to 75 years.