The objective observation of less cautious attitudes among gay men beginning in the late 1990s has gradually led public health bodies and organizations to promote new intervention and prevention strategies. These changes are inextricably linked to the development of research projects on measuring changes in behavior and assessing new tools for reducing risks. The French National Agency for Research on AIDS, ANRS, plays a key role in prevention research in terms of survey funding and consultation, as demonstrated by the Ipergay pre-exposure prophylaxis (PrEP) trial in which seronegative gay men with at-risk practices were offered an antiretroviral drug to avoid contamination. Performed between 2012 and 2016, the Ipergay trial reflects a broader interest on the part of players in the fight against AIDS in “treatment as prevention” approaches. Numerous sociological issues are at stake in PrEP,1 but our purpose here is to examine the way in which this trial targets particular subjects.
The AIDS literature established very early on how representations of sexuality, and in particular of male homosexual sexuality, on the part of academics and laypeople alike, contributed to shaping preventive approaches by centering around gender or race relations and by contrasting “good” versus “bad” sexual subjects6,16 (chap. 6). By addressing gay men who take risks, but without aiming primarily to reform their behavior, Ipergay occupies a particular place in this saga, a fact that explains in part the controversy surrounding the trial. Rather than highlighting the exemplary nature of gay men who protect themselves, the trial sheds light on the fragility of those who fail to do so, as well as the need to adapt prevention policies to their situation. Although this image aims to identify the profile of homosexuals who take risks, it gives rise to the singular figure of an individual concurrently incapable of protecting himself yet capable of following a complex treatment plan and of rationalizing his sexuality, and thus likely to be receptive to new prevention strategies: the fallible man.
The concept of the fallible man has a dual Aristotelian and Christian tradition that sheds light on its contemporary usages (on the persistence of philosophical schemas in contemporary conceptualizations, we were inspired by Boltanski2). In the first case, that of weakness and will, the main question is the place of rationality in practical reasoning, that is, identifying situations in which people who know what is good for them nonetheless choose to make the wrong choices14 (chap. 1). The second case concerns the question of evil, whereby man, as an individual who has an idea of totality and of the infinite but whose existence is governed by contingency, is always free to do evil.15 Although the aim of both the Aristotelian and Christian approaches is to identify a poor choice without reducing it to ignorance, the first connects fallibility to the limits of experience, whereas the second turns fallibility into a capacity, that of affirming evil. By considering the fallible man as a figure, our objective is not to assess that figure's descriptive or normative relevance but to show how it informs, in its various guises, prevention policies for male homosexuals.
This article is based on materials from participation, as sociologists, in the Ipergay trial: interviews with people involved in the trial [participants, promoters, employees of AIDES, or the Agence nationale de recherche sur le sida et les hépatites virales (ANRS)], participation in meetings, collection of documentation and communication materials produced as part of the campaign, monitoring discussions in community areas, and interviews with trial participants.
A CONTROVERSIAL AND JUSTIFIED TRIAL: BACKGROUND, IMPLEMENTATION, AND PROTOCOL
Launched in France in February 2012, Ipergay (Intervention Préventive de l'Exposition aux Risques avec et pour les Gays, or preventive intervention on risk exposure with and for gay men) was a randomized PrEP trial in which seronegative gay men with at-risk sexual practices were invited, on a voluntary basis, to follow an antiretroviral treatment (Truvada) to limit the risks of contamination. Ipergay followed on from a US study, I-PrEX, that demonstrated the efficacy of daily doses of PrEP but also revealed numerous difficulties in observing the treatment regimen, resulting in less effective protection. For reasons of efficacy, as well as cost, the Ipergay trial tested on-demand (or intermittent) PrEP, in which the treatment was not continuous but had to be taken several hours before or after an at-risk sexual encounter. The on-demand approach was envisaged as a possible response to problems in observing the treatment regimen because the drug was taken only during periods of sexual activity. To ensure scientific legitimacy, Ipergay was a double-blind placebo-controlled trial. All the participants were monitored in terms of sexual health [sexually transmitted infection (STI) testing and advice], but the treatment was administered to only half of the participants (selected by random drawing), and neither the participants nor the investigators knew which product was being taken. The trial was thus grounded in evidence-based medicine, wherein the efficacy of a drug is verified by means of standardized tests ahead of marketing authorization.11
In its operationalization, the Ipergay study is the result of a collaboration between biomedical research players, social science researchers, and representatives of the AIDES association. The trial is structured around a scientific committee, an advisory committee, and an independent committee, the latter being solely empowered to lift the double-blind to ensure the number of infection in both arms.
The study was made the focus of discussion within the HIV/AIDS and LGBT community. First through a community consultation conducted by the TRT5 in 2009 and 2010, then through numerous forums and public debate spaces. Throughout the duration of the test, tensions were high around its design. The question of the placebo arm has been debated since the first discussions on Ipergay: is it ethical to put HIV-negative individuals at risk of infection? Discussions have gained all the more intensity with the first results of the I-Prex study, which demonstrates the effectiveness of Truvada in prevention. The central argument of the study designers is the opportunity to evaluate a new so-called intermittent approach to PrEP. On the ethical level, the trial will be validated by the Protection Committee for Persons, although this provision has not quelled the debates. The disagreements over the design of the trial are partly at the origin of the divisions within the associative committee in 2012.
The hostility to the study persisted thereafter, around 2 main axes. First of all, activists from the association The Warning condemned the continuation of the trial with a placebo arm. They demanded rapid access to PrEP, arguing that Ipergay slow down the approval of Truvada as prevention strategy. Second, the study is criticized for its biomedical and pharmaceutical dimension. Hervé Latapie, essayist, activist, and manager of a gay establishment in the Marais District of Paris is the main spokesman for this critical stance. He regularly publishes texts deploring the general orientation of prevention toward biomedical tools, but also the influence of the pharmaceutical industry, conceived as a profit-driven lobby, in these developments. Although outside the scope of the fight against AIDS, his position has enjoyed resonance.
PrEP and Treatment as Prevention
On November 29, 2014, the ANRS announced that the trial “demonstrates the efficacy of preventive treatment” and discontinued the placebo component. This decision was made after completion of the UK study, PROUD, on October 16, 2014, the independent trial committee having deemed PrEP to be “highly protective” and recommending that a continuous PrEP be administered to all participants. Similarly, further to a request from the ANRS after the discontinuation of PROUD, the independent Ipergay committee recommended, after halting the blind trial, that the active molecule be administered to all trial participants.
The results justifying this decision were presented at the annual CROI Conference on Retroviruses and Opportunistic Infections in February 2015. On-demand PrEP “demonstrated an 86% efficacy rate” with a confidence interval of 40%–99%, owing to the low number of infected individuals (figures not available on the trial web site). In concrete terms, 16 participants were infected, 14 having taken the placebo and 2 Truvada.13 The 2 cases of contamination can be attributed to a problem of observance; the participants concerned did not follow the treatment correctly. The recruitment of participants was halted in spring 2015, and Ipergay became an observational cohort focused on the uses of PrEP as part of a combined prevention approach, its effects on the body, and observance.
Ipergay was performed against a backdrop of worldwide promotion of treatment as prevention, an approach popularized in 2008 by a group of Swiss physicians and researchers who established a link between viral load and transmission risk based on observational data on serodiscordant heterosexual couples.17 The Swiss Statement generated a number of skeptical reactions among researchers, activists and public health authorities. The reliability of the evidence put forward by the Swiss physicians and researchers was a source of debate, as was its possible transposition to homosexual relations. The preventive effects of antiretroviral drugs have interested researchers for many years, and numerous trials were performed in the late 2000s, including Caprisa in South Africa on heterosexual women (2007–2010), Iprex in Peru, Brazil, Ecuador, South Africa, and Thailand on men having had sex with men (2007–2010), and the HPTN052 trial on serodiscordant couples (2005–2010).
PrEP as Risk-Anticipation Strategy
Regarding PrEP, the already extensive trial-based literature examines the effects of the approach on individuals' previous prevention strategies—and in particular, the risk of “disinhibition” (with PrEP encouraging unsafe sexual relations). It also explored the conditions for correct observance, vital to the efficacy of treatment, and the groups to which it is relevant (Should migrants and women be considered as populations concerned by PrEP?). A number of studies have also addressed the social acceptability of PrEP among the groups concerned, as well as among prescribing physicians. In summer 2012, the United States approved PrEP as a complementary prevention strategy for several target populations. In the wake of this measure, the World Health Organization recommended that cohorts be setup to provide information on the social acceptability and medium-term effects of PrEP on sexual behavior and the dynamics of new infections. In the United States and several Latin American countries, the Iprex OLE study picked up where the Iprex study left off, all participants knowingly taking PrEP. Numerous studies were initiated elsewhere, and PrEP became available in Canada, France, Kenya, and Norway by the end of 2016.
As with any randomized trial, Ipergay had an assessment objective4 (chap. 2) that made it possible to identify the specific features of the trial relative to previous ones. On-demand PrEP was the first to be assessed. The IPrEX trial conducted on 2499 homosexual men in the United States, the results of which were published in 2010, proved that the trial achieved a certain level of efficacy in terms of prevention (44% reduction in HIV infection for Truvada relative to the placebo), but that efficacy was conditional on treatment observance.8 The study was based on continuous treatment (daily doses). Efficacy was lower than expected, and the profile of the participants (young, with high alcohol consumption, some of them being paid for sex, and making little use of postexposure treatment) raised doubts about whether the study could be extrapolated to other populations.
Although other continuous treatment trials were under way when the trial began, this strategy was considered as “not particularly feasible” given the cost and the constraints of continuous treatment (tolerance and observance issues). According to the trial protocol, the emphasis was more on proposing “a practical and easy-to-follow prophylaxis plan” based on the sexual activity of the subjects rather than on their sexual orientation or social characteristics. In practice, the participants were required to take one Truvada pill 24 hours before sexual intercourse (and at the latest, 2 hours before), followed by one pill every 24 hours during the period of sexual activity, and, finally, one pill 24 hours after sexual activity. Under the terms of its protocol, the trial was also designed to assess the feasibility of PrEP with a “well-informed European population,” and thus the sociobehavioral specificities of populations in their attitudes to risk and to AIDS.
Looking beyond its objective of assessing PrEP, Ipergay fosters the use of other means of protection. PrEP is accompanied by the promotion of “combined prevention”: acknowledging the existence of at-risk behavior is not a motive for abandoning behavioral prevention methods to the benefit of biomedical prevention, but rather for reinforcing them. The discourse of the members of the Ipergay scientific committee repeatedly stipulates that the aim is to extend the range of prevention tools. This aspect is linked to the existence of a placebo as well as to a certain idea of prevention for gay men. Ipergay, then, aims not only to provide antiretrovirals but also to ensure medical care for participants. They are up-to-date in their vaccinations, receive counseling and advice, and attend regular medical appointments and focus groups that provide opportunities to talk about their experience with other volunteers. “Motivational interviews” are also offered in the 1st and 12th months to encourage the individuals to maintain a high level of protection. Consequently, engagement in the trial is not without return benefit. The idea is not for participants to assert themselves as good prevention subjects but rather to talk about their motivations. Objectivation is accompanied by incentives for participants to express themselves so as to gain a finer understanding of the individuals who feel the issue is relevant to them, and is an aspect of the injunction of expression characteristic of contemporary medical power.12 Through this combined prevention system, AIDES also seeks to foster and objectivize preventive counseling and support.
THE MORAL OF THE TRIAL
The trial inclusion criteria combined medical, demographic, and behavioral aspects. In terms of behavior, the trial targeted men (or transgender individuals) older than 18 years with a “high risk of HIV contamination” (ie, having had anal sex at least twice in the past 6 months without a condom). The subjects were recruited by a member of the AIDES organization and by other organizations at gay socialization and sexual encounter venues as well as on dating web sites. In a certain respect, the objective of Ipergay—as its name (When read aloud in French, the word “Ipergay” is homonymous with “hyper-gay.”) suggests, although this was never mentioned by the people who devised the name—was to deepen understanding on “very gay” gays, notably highly social individuals with extensive sexual relations.
The Making of a Targeted Communication
The communication campaign at the start of the trial thus showed pictures of men with relatively varied profiles saying “I'm Ipergay. And you?” Commenting on this initial recruitment campaign, the first communication officer (a 32-year-old journalist responsible for communication in 2011 and 2012) talked about the tension present in the recruitment process. The aim was to identify, within the male homosexual population, a specific fringe likely to be receptive to the trial but difficult to delineate.
“Among the general gay population, we had to find those most likely to be in need, aware of being in need, and who then would agree to take part in a trial. So there was a real skimming process. We gradually realized that we weren't reaching enough people, which is why recruitment was very slow at the start. I think it speeded up afterwards. Because we had to refine our strategies…[…] This was the second phase of communication, with a graphic artist. The first phase was with a photographer, with 4 profiles of different boys.
Now it's “I'm Ipergay. How about you?”
Yes, so it's a classic recruitment campaign playing on the “How about you?” aspect. We went for “I'm Ipergay. How about you?’ so as not to highlight the PrEP aspect. We needed to emphasize the Ipergay trial, which was general, including PrEP.”
“I'm Ipergay. How about you?” thus functions as an outline description of a target population, but above all as a way of generating a question and recognition. Promoting Ipergay as a “general” prevention trial generated tensions between the assessment objective of PrEP, uncertainty about its reception by gays, and the need to disseminate the information throughout the gay population, including among individuals not concerned by the trial or potentially opposed to it. In 2014, a new recruitment campaign also played on this method by asking individuals to “become Ipergay.”
Gender relations are as important here as questions of sexuality. The campaigns shifted between 2 aspects. On the one hand, they used signs of deviant homosexuality, representing so-called hard practices such as chains, harnesses, tattoos and sports gear, reminiscent of the pornographic visuals of specialized magazines, and the various “trips” distinguishing sexual subcultures in part of the gay population (Fig. 1). On the other hand, and sometimes in the same image, the campaigns depicted a relatively “straight” homosexuality3 and thus a masculine relationship to risk in which risk-taking is not necessarily avoided but sometimes championed (Fig. 2). A virile audience was targeted in both cases. The logo was changed during the trial from pink to the more consensual colors of the rainbow (Figs. 1 and 2).
How to Talk to Fallible Men
The trial also targeted “people with a high risk of contamination (the expression was used in the summer 2013 newsletter sent to doctors by the trial coordination team).”The 2013 poster stating that “HIV affects 200 times more gays than heterosexuals” was not a simple epidemiological reminder. It broke with the usual cautious approach of prevention campaigns that, for fear of stigmatizing populations, fail to highlight differences in prevalence in such a forthright manner. Yet, Ipergay's communication did not distinguish between responsible individuals and others. It did not necessarily target individuals who intentionally take risks—as in the worrying (but also doubtless reassuring) figure that haunted debates over bareback activity and which embodied the intentionality of risk.7 In the prevention campaigns, this figure is depicted once, in the highly specific context of the campaign for the BBackzone web site addressing individuals self-identifying as barebackers. This campaign highlighted the “love” in “sex without condoms,” although the information text began by stressing the importance of combined prevention (Fig. 3). Prevention, then, is compatible with a “total acceptance of practices,” an expression used several times in the campaigns.
However, this approach was only a minor aspect of the trial communication. The studies funded by the ANRS showed that barebacking was a category with blurred borders and which failed to properly describe a small part of the population.10 Instead, the campaign targeted those who are powerless to protect themselves consistently, those who do not reject prevention, but for whom it is problematic. A web banner showed a puzzled young man along with the words, “How do you protect yourself from HIV?” (Fig. 4). A 2013 poster asked whether readers had “a problem with condoms.” The first page of a leaflet for recruiting volunteers showed a man looking the viewer straight in the eye along with the question, “Want to stop worrying after each sexual encounter?” Taking prevention difficulties head-on and mobilizing affective responses was central to the campaign, the aim being to raise, and perhaps above all bring to the surface, existing questions in the target group. Thus, a flyer in the form of a miniquiz with 6 questions on sexuality was not simply an ingenious way of making contact. Asked about the campaign in an interview, the second communication officer (a 35-year-old advertising man responsible for trial communication from March 2013 onward) said that the objective was to depict “doubt”:
“With this campaign, we showed people asking questions about the trial rather than trial participants. People who sometimes have doubts about their sexuality and practices; and our answer to those doubts is the Ipergay trial. So it was more about our target than our participants.
Was it aimed at all gay men, or just some?
The criterion for inclusion in the trial was being seronegative and having had unprotected anal sex with at least 2 partners in the past 12 months. Aside from that, it was fairly open (Figs. 3, 4).
Just as PrEP was kept in the background in the initial campaigns, risk-taking did not feature in the communication, although it was the focus of the trial. This strategy was not aimed at concealing the real objectives of the trial but at building the moral situation underpinning its promotion. The refusal to affirm universal moral principles, the attention paid to the singularity of cases and situations, to the knowledge of individuals, and to the affective aspect of human life, likens the participants targeted by the Ipergay communication campaigns to the Aristotelian figure of the weakness of will, a figure that seeks to account for situations in which an individual makes the wrong choice, not through ignorance but knowingly. As pointed out by Nussbaum in her commentary on Aristotle, the reasoning of an individual guided by pleasure can be coherent: “And yet he is evasive. He does not fully confront or acknowledge the situation to himself, or allow himself to see vividly its implications for his life and the lives of others, and to have the responses that are appropriate to that vision. His interest in short-term pleasure causes him to insulate himself from these responses and from the knowledge they help to constitute”14 (p. 125–126).
Prevent and Judge
Ipergay thus pertains to individuals with a problematic relationship to risk and prevention because the quest for pleasure or the scenarios around their desires are incompatible with the use of a condom (eg, an erectile problem), because in their sexual scenario the use of a condom becomes secondary, or because they accept a certain risk margin. In any case, it is conflicts of values and practical reasoning rather than a lack of knowledge that lead them to weigh the need for prevention against their relationship to sexuality or the definition of acceptable risk. And thus, a moral dimension is added to behavioral characteristics, as reflected in the importance of powerlessness. The trial does not have to do with a subject who does what he likes, be it by using protection or otherwise. Engagement in the trial suggests that the volunteers want to change their behavior but have been unable to do so. In a certain sense, it exemplifies a moral situation in which the singularities of situations and differences in perceptions need to be taken into account. From this standpoint, giving fallible individuals tools is not simply about distributing antiretrovirals or disseminating knowledge on HIV and AIDS; it is about taking account of the singularities of the respective populations, factoring in their doubts and working with them to help them reduce their risks. Participation in the trial was not just about acquiring new tools to remain safe but also about changing perceptions of risks and sexuality.
The determination to avoid any form of judgment affirmed by the promoters of the trial does not exclude, whether toned-down or behind the scenes, the reaffirmation of a less fluid conception of sexual morality. During the trial, in response to the high number of STIs, the team encouraged participants to be vigilant, to look out for symptoms, and, finally, to use condoms. More indirectly, questions on the risk of disinhibition (PrEP supposedly encouraging trial participants to take more risks) reflect an idea of potentially unhindered and unlimited homosexual sexuality that could be channeled by social norms and public health care frameworks. These discourses can be related to the Christian idea of fallibility whereby “fragility is not merely the “locus,” the point of insertion of evil, nor even the “origin” of man's descent; it is the “capacity” for evil”15 (p. 162). If this image of male homosexuality is not made public, this is not simply because the association between homosexuality and sin would be incongruous in this context. What can prevention achieve against the capacity for evil? Weakness of will serves to articulate the awareness of risk-taking and the possibility of limiting that behavior, whereas the affirmation of the freedom to become seropositive leaves little room for prevention.
Ipergay's targeting of fallible men thus makes sense in the light of the “relapse” at the end of the 1990s. The framing of risk-taking gay men as fallible individuals is contrasted with those sometimes considered as “lost causes” who deliberately take risks and intend to keep doing so. The acknowledgement of weakness relative to risk on the part of certain gay men provides a basis for prevention that takes account of the inadequacy of behavioral prevention.
Our objective in detecting figures of moral philosophy in HIV and AIDS prevention policies is not to condemn their moralizing aspect. In a context where epidemiological data provide the basis for a certain realism relative to the epidemic, and in which the timeframes informing action and thought are extremely brief—thereby building an image of a gay population with swiftly changing tastes and behaviors—, and serious consideration of a moral dimension provides a means to establish connections between AIDS policies and ancient figures far removed from the epidemic. Nor was our objective to show that the Aristotelian approach is useful in understanding risk-taking (it is an open question. See D. Halperin who mobilizes Genet to understand homosexual at-risk behavior9). Instead, we sought to demonstrate that technological and epidemiological realism was not free of a moral dimension. The implementation of PrEP raises questions on whether, in the figure of the fallible man, it is an attention to weakness and singularities that prevails or the denunciation of “bad” homosexuals.
We would, however, like to underline the constraints under which the mobilization of such a figure takes place. These constraints amount to what Nicolas Dodier called “therapeutic modernity,” that is, the development of controlled and randomized trials, the distancing of paternalism, and the use of associations, ethics committees, and laypeople.5 However, they also have to justify prevention and offer a basis for action. The figure of the fallible man also expresses an uncertainty: does the at-risk behavior seen over the past 15 years result from a weakness that can be surmounted, an affirmation of risk or a lack of interest in risk-free sexuality? To answer that question, a better understanding must be formed in surveys with at-risk populations on attitudes toward risk, the dilemmas and doubts of individuals, and the feelings associated with their sexual practices.
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Keywords:Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
pre-exposure prophylaxis trial; communication strategies; HIV; gay men; France