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The Institutional Review Boards of The Fenway Institute and Beth Israel Deaconess Medical Center approved the study procedures. All participants provided internet-based informed consent. As all data were analyzed anonymously, documentation of written informed consent was waived by these Institutional Review Boards.
Members of a large, multinational social networking site for MSM were invited to complete an anonymous online survey about PrEP knowledge, interest and experience before (September–October, 2010) and after (December–January, 2011) the release of iPrEx trial data. At the start of the computer interview, a general description of PrEP was provided to pre- and post-iPrEx groups. After this description, data were collected on PrEP awareness, interest, and experience. For the purpose of these analyses, iPrEx results were not provided, since the goal was to capture an unbiased assessment of community norms after public reporting of iPrEx. Pre-iPrEx, the survey contained 74 items and required approximately 15–20 minutes to complete. Post-iPrEx, 11 additional items (not included in the current analyses) were added to the end of the survey, extending the survey by approximately 4 minutes. Participants were eligible if they were biologically male at birth, at least 18 years of age, HIV-uninfected by self-report, and could read and understand English and use computers and the Internet. Pre-iPrEx, an email broadcast was sent to the most active United States members (n = 20 000) with an invitation to learn about the study: 13 284 received and opened the emails, 1 790 (13.5%) clicked through to the survey, 581 (32.5%) consented to complete a pre-screening questionnaire, 473 (81.4%) met eligibility criteria, and 398 (84.1%) consented to enroll in the study and have their data analyzed, representing a 22.2% response rate of those who clicked on the hyperlink for the study; 134 (33.7%) of participants abandoned the study before completion. Post-iPrEx, another email broadcast was sent with an invitation to learn about the study, and the number of members targeted was increased to include all U.S. members (excluding those with self-disclosed HIV infection) given modest enrollment rates from the pre-iPrEx phase: 93 972 members received and opened the emails, 16 715 (17.8%) clicked through to the survey, 6 267 (37.5%) consented to complete a pre-screening questionnaire, 5 399 (86.1%) met eligibility criteria, and 4 558 (84.4%) consented to enroll in the study and have their data analyzed, representing a 27.3% response rate; 1 584 (34.8%) of participants abandoned the study before completion. For participants who did not complete the full survey, data were analyzed for all questions that were answered. As such, the total number of respondents is given for each of the measures reported. Thirty-seven U.S. states and the District of Columbia were represented pre-iPrEx, and all 50 states and the District of Columbia were represented post-iPrEx.
Participants reported information on demographics and history of sexual partnerships [16].
To screen for alcoholism, the 4-item CAGE questionnaire was administered [17], [18], [19]. A score of ≥10 on the 10-item version of the Centers for Epidemiologic Studies Depression (CES-D) scale, a validated survey to assess for depressive symptoms, was considered a positive screen for depression [20].
Data were collected on prior sexually transmitted infections (STI) and high-risk sexual behaviors, including recreational substance use during sex and unprotected anal intercourse with multiple partners or partners who are reportedly HIV-infected or of unknown HIV serostatus.
Self-Perceived Risk of HIV Acquisition: Participants rated their risk on a scale of 1 (“Not risky at all”) to 10 (“Extremely risky”) based on their sexual behaviors in the prior 3 months [21], [22]. Participants were asked if they had visited a healthcare provider in the prior 12 months and whether they identified a primary care provider (PCP) [23].
To assess communication about HIV risk behaviors, participants were asked to indicate their level of comfort discussing same-sex behaviors with a PCP on a 5-point scale from 1 (“Extremely uncomfortable”) to 5 (“Extremely comfortable”); responses were dichotomized for analyses such that a rating of ≤3 was categorized as “Not comfortable” and ≥4 was “Comfortable” to provide a conservative estimate of comfort levels. Participants were also asked if they had discussed unprotected anal sex behaviors or ways to protect themselves against HIV infection with a PCP, based on a prior study focused on patient-provider communication among MSM [23].
Participants were asked about their awareness and experience with PEP based on questions employed in previous studies conducted at the Fenway Institute [7], [24].
PrEP Awareness, Interest, and Experience: Data were collected on PrEP awareness, interest, and experience using questions adapted from a prior study of PrEP attitudes among MSM [7]. OpenEpi (Atlanta, GA) [25] was used to perform t-tests and χ2 tests of independence, and SAS version 9.2 (Cary, NC) was used for descriptive statistics and logistic regression modeling. Tests were statistically significant at the P<0.05 level. Minimal non-independence of respondents contributing to pre- and post-iPrEx samples was presumed given the large difference in sample sizes. Because data were obtained using different recruitment methods for each sample, descriptive analyses were used instead of formal statistical testing to compare pre- and post-iPrEx results. The characteristics of participants who completed the survey pre- and post-iPrEx were stratified by awareness of PrEP. To determine the relationship between participant characteristics and outcomes of interest, bivariate logistic regression procedures were conducted. Variables significant at P<0.05 were included in three distinct multivariable models to determine factors that were independently associated with PrEP awareness, interest, and experience. Multicollinearity was assessed among independent variables. None of the independent variables were found to be intercorrelated at or above a threshold of 0.80 and all were retained in the final models. Regression procedures were conducted only on post-iPrEx data, as the substantially larger sample size was more likely to result in meaningful analyses.
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