DOI: /hiv British HIV Association HIV Medicine (2016), 17, SHORT COMMUNICATION

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1 DOI: /hiv SHORT COMMUNICATION Predictors of interest in taking pre-exposure prophylaxis among men who have sex with men who used a rapid HIV-testing site in Montreal (Actuel sur Rue) B Lebouché, 1,2 K Engler, 2 N Machouf, 3 D Lessard 1 and R Thomas 3 1 Family Medicine, McGill University, Montreal, QC, Canada, 2 Chronic Viral Illness Service, Research Institute of the McGill University Health Centre, Montreal, QC, Canada and 3 Clinique médicale l Actuel, Montreal, QC, Canada Objectives The effective use of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy depends on its uptake by individuals at high risk of infection. Few Canadian data are available on interest in PrEP among men who have sex with men (MSM). This study aimed to identify predictors of interest in PrEP among MSM clients of a rapid HIV-testing site in Montreal s gay village (Actuel sur Rue). Methods Data were collected using a self-administered and a community agent-administered questionnaire. Among men reporting at least one male sexual partner and visiting the site between July 2012 and November 2013, we aimed to identify sociodemographic, sexual and temporal predictors of interest in taking effective PrEP with logistic regression analyses (univariate and multivariable). Results Over half (55%; n = 653) of the sample of 1179 MSM were interested in PrEP. Among the 14 variables considered in the univariate analyses, only (younger) age, (greater) number of sexual partners (in the past 3 months), being part of a serodiscordant couple (in the past 12 months), ever combining sex with drugs and temporal events were associated with interest in PrEP at P < 0.20 and were included in the multivariable analyses. In the multivariable model, only being part of a serodiscordant couple [adjusted odds ratio (aor) 2.56; 95% confidence interval (CI) ], having > 10 partners (aor 1.73; 95% CI ) and responding after the publication of Quebec s interim PrEP guidelines (aor 1.82; 95% CI ) proved significant. Conclusions In this assessment of predictors of PrEP interest among Canadian MSM, partnering issues and the arrival of PrEP guidelines in Quebec (10 July 2013) were most closely linked to PrEP interest. Keywords: acceptability, Canada, checkpoint, HIV prevention, men who have sex with men, pre-exposure prophylaxis. Accepted 18 May 2015 Introduction In the Canadian province of Quebec, HIV infection is concentrated in the city of Montreal and among men who have sex with men (MSM) [1], in accordance with the high incidence of HIV infection in the urban gay and bisexual Correspondence: Dr. Bertrand Lebouché, Chronic Viral Illness Service, Local D , McGill University Health Centre, Glen site, 1001 Décarie Boulevard, Montreal, QC, H4A 3J1, Canada. Tel: ; fax: ; bertrand.lebouche@mcgill.ca male population in other parts of the Western world. The incidence of HIV infection in Quebec MSM has been stable for years, highlighting the need for novel prevention strategies. One biomedical strategy receiving much attention is pre-exposure prophylaxis (PrEP), the use antiretroviral therapy (ART) to prevent HIV acquisition in individuals at high risk of infection. In the Iniciativa Profilaxis Pre- Exposición (iprex) clinical trial, PrEP use by MSM and transgendered women was associated with a 44% reduction in HIV incidence; however, when ART was detected in 152

2 Predictors of interest in PrEP among Montreal MSM 153 participants blood, suggesting good adherence, efficacy increased to 92% [2]. An iprex substudy further suggests that blood concentrations equivalent to 7 doses per week will provide near-perfect (99%) protection from infection [3]. Despite the great potential of PrEP, it is the subject of international debate. Adherence to PrEP in real-life contexts, absent the intensive support often available under trial conditions, is of great concern. For example, in a recent open-label cohort study in MSM, protective blood drug levels (4 to 7 tablets per week) were detected on only 33% of study visits among participants on PrEP [4]. Furthermore, the recommended medical follow-up of those receiving it is resource-intensive and the public/private financial cost of ART is considerable [5]. Questions thus remain about whether PrEP will have a meaningful impact on transmission risk and whether it is worth investing the funding and medical resources, not to mention questions about potential repercussions for the users health (i.e. long-term effects and risk compensation). Intermittent rather than daily dosing of PrEP, as examined in the France-Canada Intervention Préventive de l Exposition aux Risques avec et pour les hommes Gays (IPERGAY) trial among HIV-negative MSM, may help to improve adherence and cost-effectiveness. Encouragingly, this study s early efficacy results, showing an 86% relative reduction of HIV incidence in the PrEP arm, prompted the closing of the randomization phase of the study so that on demand PrEP could also be offered to the placebo arm [6]. While experts in Quebec are divided regarding PrEP, in 2013, interim guidelines for HIV clinicians were released by the provincial department of health and social services [7] and no other Canadian province has yet followed suit. Quebec guidelines state that continuous, daily PrEP can be used, exceptionally, in MSM who have unprotected anal sex with partners of unknown or HIV-positive status as well as in individuals who have an HIV-positive partner whose viral load is detectable. Unlike the situation for emtricitabine/ tenofovir disoproxil fumarate (Truvada, Gilead Sciences, Inc., Foster City, CA, USA) in the USA, no specific antiretroviral drug combination has been approved for PrEP in Canada. Instead, ART can be used off-label for this purpose and evidence indicates that PrEP is being prescribed in Canada [8]. Indeed, some Montreal MSM have accessed it through clinic pilot projects [9]. Also unique to Quebec is the fact that it is the only Canadian province in which off-label Truvada for PrEP can be covered through public or private drug plans. Nevertheless, realizing the preventive potential of PrEP depends, in part, on its uptake by high-risk MSM, and this appears limited, given US prescription rates [10] and North American providers practices regarding PrEP [11]. Conversely, little is known about Canadian MSM s interest in PrEP and its predictors. Interest in taking PrEP among MSM varies widely in published research and may depend, in part, on the population considered, and how interest is assessed. Reported levels of interest can range from 23.3% [12] to 82.6% [13], while it typically reaches levels of 50% or higher [14]. Research repeatedly finds associations between interest and sociodemographics (e.g. age, income and education) and sexual risk practices (e.g. unprotected anal sex), but findings are mixed and no consistent predictors have emerged [14,15]. In Canada, a study among men who took a rapid HIV test at a popular Toronto clinic reported that 33.3% of MSM were definitely willing to use a safe and effective PrEP, with willingness independently associated with having multiple partners in their global sample [16]. The main objectives of this exploratory study were to contribute to the assessment of interest in PrEP among Canadian MSM and to identify sociodemographic and sexual predictors of this interest. We also analysed PrEP interest in relation to specific events that could arguably affect it, namely, the publication of Quebec s interim PrEP guidelines (on 10 July 2013) and the Supreme Court of Canada s decision on HIV disclosure (on 5 October 2012). Methods Participants were recruited from Actuel sur Rue, a rapid HIV-testing and linkage-to-care pilot project (or Checkpoint [17]) initiated in Montreal s gay village in July Sociodemographic and sexual health-related information was collected from clients using an electronic tablet via two questionnaires: one was self-administered and the other was administered by a community agent. Research ethics approval was obtained from an independent research ethics board (Veritas, Montreal). Clients signed a consent form prior to receiving services and received no compensation for providing study data. For this paper, male clients visiting the site from July 2012 to November 2013, who provided data on the study s dependent variable and reported at least one male sexual partner, were included in the analyses. Interest in PrEP was assessed using the following question: If findings proved that PrEP was effective in protecting you against HIV infection, would you take it? Response choices were: (1) yes; (2) no; (3) I do not know enough about PrEP. This variable was re-coded for analysis to be dichotomous (yes vs. no/undecided). Clients were also asked if they had ever heard of PrEP (yes or no). Sociodemographic variables examined in relation to interest in PrEP were age; living situation; self-defined sexual orientation; highest level of completed education; and annual income.

3 154 B Lebouché et al. The sexual variables considered were currently having a primary partner; the number of sexual partners in the past 3 months; the location of sex; having unprotected anal intercourse with a partner of HIV-positive or unknown status in the past 3 months; being part of a serodiscordant couple within the past 12 months; current use of drugs during sex (e.g. poppers, cocaine, ecstasy or crystal meth); hard sexual practices in the past 12 months (i.e. fisting and/or sadomasochism); and ever having unprotected sex in a group sex context. The temporal events considered were the Supreme Court of Canada decision on HIV disclosure and the release of Quebec s interim PrEP guidelines. Data analysis, performed with the software SPSS 17.0 (IBM Corporation, Armonk, NY, USA), began for descriptive purposes with χ 2 analyses for categorical variables and a one-way analysis of variance (ANOVA) for age. Subsequently, variables were submitted to univariate logistic regression analysis and those found to be significant at P < 0.20 were included in a multivariable logistic regression. For descriptive purposes, temporal events are presented as dichotomous variables in the χ 2 analyses but combined into a three-level variable for logistic regression analyses, given their high level of correlation: (1) the reference category: before the Supreme Court decision (up to 4 October 2012); (2) from the Court decision to before the interim Quebec guidelines (5 October 2012 to 9 July 2013); and (3) release of the Quebec guidelines (10 July 2013 and later). Results Data were available for 1765 individuals. Among these, 1414 provided information on the dependent variable, 1287 of whom were men. Finally, 1179 of these men reported ever having a male sexual partner and were included in the analyses. While only 30.0% had heard of PrEP, over half of the MSM sample (55.4%; n = 653) were interested in PrEP, with the remaining 44.6% responding either that they would not take it (13.4%) or that they did not know enough about it (undecided) (31.2%). ANOVA showed that interest in PrEP differed by age; interested MSM were significantly younger than those who were not interested or undecided [for those responding Yes, the mean age was 37.1 years; standard deviation (SD) 11.9 years; for those responding No or who were undecided, the mean age was 38.7 years; SD 13.1 years; F(1, 1133) = 4.91; P = 0.027]. Other participant characteristics and the χ 2 test results are presented in Table 1. None of the other sociodemographic variables considered were significant at P 0.05 in these analyses, indicating no difference in interest in PrEP according to sexual orientation, living situation, education or income. However, MSM who reported being part of a serodiscordant couple in the past 12 months compared to those who did not (73% vs. 53%; P < 0.001) and MSM who had ever used drugs before or during sex relative to those who had not (62% vs. 55%; P = 0.050) were significantly more interested in PrEP. No difference was found in these analyses in interest in PrEP according to the number of partners, having a primary partner, the location of sex, having unprotected anal intercourse with a partner of HIV-positive or unknown status, engaging in hard sexual practices, and ever engaging in unprotected sex during group sex. Table 2 presents the results of the univariate and multivariable logistic regression analyses and thus the final model of factors independently associated with interest in PrEP in our sample. Variables found to be significant at P < 0.20 in the univariate logistic regression analyses were age, number of partners, being part of a serodiscordant couple, ever combining drugs with sex and temporal events. Greater odds of interest in PrEP were found in younger MSM [odds ratio (OR) 0.99; 95% confidence interval (CI) ; P = 0.027], those with more than four partners relative to those with four or fewer (five to 10 partners: OR 1.31; 95% CI ; P = 0.082; more than 10 partners: OR 1.39; 95% CI ; P = 0.052), those reporting being part of a serodiscordant couple (OR 2.43; 95% CI ; P = 0.001), and those who had ever combined sex and drugs (OR 1.32; 95% CI ; P = 0.086). Odds of interest were also greater after the Supreme Court decision (OR 1.36; 95% CI ; P = 0.044) and following the release of Quebec s interim PrEP guidelines (OR 1.65; 95% CI ; P = 0.003). In the adjusted model, only being in a serodiscordant couple in the past 12 months, the number of sexual partners in the past 3 months and temporal events were significantly associated with interest in PrEP. MSM who reported being part of a serodiscordant couple were two and a half times more likely to be interested in PrEP than those who did not [adjusted odds ratio (aor) 2.56; 95% CI ; P = 0.001], while MSM with more than 10 partners, relative to those with fewer than five, were 73% more likely to be interested in PrEP (aor 1.73; 95% CI ; P = 0.006). Finally, odds of interest were 82% greater (P = 0.003) after the release of Quebec s PrEP guidelines as compared with the period before 5 October Discussion This study examined predictors of interest in PrEP among Montreal MSM clients of a rapid HIV-testing facility. It found that, while a minority were aware of PrEP (30%), the majority were interested in it (55%), with an addi-

4 Predictors of interest in PrEP among Montreal MSM 155 Table 1 χ 2 analyses of interest in pre-exposure prophylaxis (PrEP) by sociodemographic, sexual, and temporal event variables in men who have sex with men (MSM) users of a rapid HIV-testing site in Montreal (Canada) (n = 1179) Interest in PrEP n (%) Yes No/undecided n (%) n (%) P-value Sexual orientation Homosexual 989 (84) 553 (56) 436 (44) Heterosexual 58 (5) 32 (55) 26 (45) Bisexual 132 (11) 68 (52) 64 (49) Living situation Alone 562 (48) 305 (54) 257 (46) With a sexual partner 248 (21) 135 (54) 113 (46) With other people 365 (31) 211 (58) 154 (42) Education High school or less 255 (22) 150 (59) 105 (41) College/university undergraduate 492 (42) 262 (53) 230 (47) Graduate degree 425 (36) 238 (56) 187 (44) Annual income < $ 301 (27) 158 (53) 143 (48) $ 471 (43) 269 (57) 202 (43) $ 334 (30) 186 (56) 148 (44) Primary partner Yes 550 (47) 306 (56) 244 (44) No 624 (53) 344 (55) 280 (45) Number of sexual partners (past 3 months) 0 4 partners 732 (64) 389 (53) 343 (47) partners 226 (20) 135 (60) 91 (40) >10 partners 178 (16) 109 (61) 69 (39) Place of sex Home/hotel/car 660 (59) 379 (57) 281 (43) Sauna/club/massage parlour 405 (36) 217 (54) 188 (46) Other public space 53 (5) 30 (57) 23 (43) UAS, HIV-positive or unknown status partner (past 3 months) Yes 417 (41) 238 (57) 179 (43) No 598 (59) 327 (55) 271 (45) Serodiscordant couple (past 12 months) Yes 75 (8) 55 (73) 20 (27) < 0.001* No 862 (92) 458 (53) 404 (47) Ever combined drugs and sex Yes 206 (23) 127 (62) 79 (38) 0.050* No 705 (77) 387 (55) 318 (45) Hard sexual practices (fisting and/or sadomasochism; past 12 months) Yes 96 (18) 61 (64) 35 (37) No 426 (82) 257 (60) 169 (40) Unprotected sex during group sex Yes 108 (20) 67 (62) 41 (38) No 436 (80) 262 (60) 174 (40) Supreme Court of Canada decision on HIV disclosure Before 5 October (21) 120 (48) 129 (52) 0.010* 5 October 2012 and later 929 (79) 533 (57) 396 (43) Release of Quebec s interim PrEP guidelines Before 10 July (74) 464 (54) 402 (46) 0.033* 10 July 2013 and later 312 (26) 189 (61) 123 (39) *Significant at P UAS, unprotected anal sex. tional 31% requiring more information before taking a position. This PrEP interest level in MSM falls within the range typically found in other research [14]. Interest and awareness of PrEP were higher in our sample than among MSM who took a rapid test at the Hassle Free clinic in Toronto (33% interest; 14% awareness) [16]. However, the Toronto study collected data prior to the publication of iprex trial results [2]. Media and scientific attention devoted to PrEP has since increased, which could explain these findings. Alternately, they could be related to factors specific to Quebec such as its drug coverage policy and interim PrEP guidelines.

5 156 B Lebouché et al. Table 2 Logistic regression analyses of interest in pre-exposure prophylaxis (PrEP) according to sociodemographic, sexual and temporal event variables in men who have sex with men (MSM) users of a rapid HIV-testing site in Montreal, Canada (n = 1179) Univariate (unadjusted) model OR (95% CI) Multivariable (adjusted) model aor (95% CI) Sexual orientation Homosexual 1 Heterosexual 0.97 ( ) Bisexual 0.84 ( ) Age 0.99 ( ) 0.99 ( ) Living situation Alone 1 With a partner 1.00 ( ) With other people 1.16 ( ) Education High school or less 1 College/university undergraduate degree 0.80 ( ) Graduate degree 0.89 ( ) Annual income (CAD) < $ $ 1.21 ( ) $ 1.14 ( ) Primary partner No 1 Yes 1.02 ( ) Number of partners (past 3 months) 0 4 partners partners 1.31 ( ) 1.26 ( ) >10 partners 1.39 ( ) 1.73 ( ) Place of sex Home/hotel/car 1 Sauna/club/massage parlour 0.86 ( ) Other public space 0.97 ( ) UAS, HIV-positive or unknown status partner (past 3 months) Yes 1 No 1.10 ( ) Serodiscordant couple (past 12 months) No 1 1 Yes 2.43 ( ) 2.56 ( ) Ever combined drugs and sex No 1 1 Yes 1.32 ( ) 1.21 ( ) Hard sexual practices (fisting and/or sadomasochism; past 12 months) Yes 1 ( ) No 1.15 Unprotected sex during group sex Yes 1 No 1.09 ( ) Temporal events Up to 4 October 2012 (prior to Supreme Court decision) October 2012 to 9 July ( ) 1.38 ( ) 10 July 2013 and later (as of release of PrEP guidelines) 1.65 ( ) 1.82 ( ) In bold: variables in the univariate analyses found to be significant at P < Underlined: variables in the multivariable analyses found to be significant at P aor, adjusted odds ratio (for variables found to be significant at P < 0.20 in the univariate logistic regression analyses); CAD, Canadian dollars; CI, confidence interval; OR, odds ratio; UAS, unprotected anal sex. In the multiple logistic regression analyses, among the individual-level variables considered, only reporting being part of a serodiscordant couple and having more than 10 partners were independently associated with interest in PrEP. Interestingly, in the Toronto study s multivariable analyses, only having more partners remained significant [16]. Heightened interest in PrEP among HIV-negative members of serodiscordant MSM couples has been documented by other investigators [e.g. 13]. These findings tentatively suggest that partnering issues may be important

6 Predictors of interest in PrEP among Montreal MSM 157 predictors of PrEP interest. As proposed by Golub [18], the subjective experience of risk-taking may vary by relational context. A sense of risk could be greater when part of a serodiscordant relationship (perhaps depending on the HIV-positive partner s viral load and adherence to his antiretroviral therapy) or when having multiple partners in rapid succession, considering, for example, that HIV prevalence is estimated at 12.5% in Montreal MSM, with 23.2% unaware of their status [19]. In these relational contexts, motivation could be greater for taking PrEP, which may represent a means of quelling fears and anxiety, allowing for increased intimacy and/or pleasure [20] or other side benefits of PrEP. As to the temporal events considered, the multivariable analyses revealed significantly greater odds of interest after the release of Quebec s interim PrEP guidelines, which may have increased the visibility of PrEP in the media and in sexual health services. While the result is intriguing, the cross-sectional nature of this study eliminates any possibility of causal attribution. In our sample, many would be eligible for PrEP in Quebec: 41% on the basis of unprotected anal sex with a partner of unknown or HIV-positive status and up to 8% on the basis of being part of a serodiscordant couple. Over half (57%) of the first group and almost three-quarters (73%) of the latter were interested in taking PrEP, suggesting that its uptake could be quite extensive. However, this study s limitations give rise to certain caveats. The MSM recruited may not be representative of the broader MSM populations in Montreal or Quebec and, like other measures of interest in PrEP, ours was rather simple. A more complex measure that incorporates such aspects as dosage, efficacy and side effects, as in Holt et al. [12], may reveal lower interest levels. This study, nevertheless, adds to the limited Canadian data on interest in PrEP among MSM and to understanding its predictors. More remains to be learned about what might motivate PrEP use among MSM. The relational or partnering dimension of PrEP seems to be an area warranting further investigation in this regard, as well as in the effort to identify appropriate candidates for PrEP and to provide support to its users. Finally, longitudinal analyses could help clarify the impact on interest of relevant temporal events. Acknowledgements Actuel sur Rue was made possible with funding provided by Clinique médicale l Actuel. References 1 Institut national de la santé publique du Québec, Programme de surveillance de l infection par le virus de l immunodéficience humaine (VIH) au Québec. 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