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International audience; Combination HIV prevention covers a range of biomedical, behavioral, and socio-structural interventions. Despite the growing availability of pre-exposure prophylaxis (PrEP), it is not always accessible in European Centre for Disease Prevention and Control reporting countries and may not meet the needs of all at-risk populations. Based on the Flash! PrEP in Europe data, multiple correspondence analysis and hierarchical clustering were used to identify patterns in HIV prevention strategies among 9980 men who have sex with men (MSM). PrEP interest was evaluated among four identified clusters: (A) "high condom use, sometimes Treatment as Prevention (TasP)"; (B) "mix of methods, infrequent condom use"; (C) "high condom use, tendency to choose partners based on serological status" and (D) "moderate use of condoms mixed with other prevention strategies". Clusters B and D had higher PrEP interest. These results suggest that MSM use a range of behavioral and biomedical risk reduction strategies that are often combined. On-demand PrEP may meet the needs of MSM who infrequently use condoms and other prevention methods.

International audience; Background: Some people do not benefit from oral administration of opioid agonist treatment, and an intravenous (IV) formulation may be more suitable. Our objective was to evaluate the willingness of people who regularly inject sublingual buprenorphine to receive IV buprenorphine as a prescribed treatment, and to examine related correlates. Methods: We performed a secondary analysis of data from the cross-sectional study PrebupIV, conducted in France in 2015 among 557 people who inject opioids. The study comprised questionnaires completed either face to face or online and community-based workshops. We only included participants who reported buprenorphine as their main injected drug (n = 209). Willingness to receive IV buprenorphine treatment was measured on a scale from 0 to 10. Ordinal logistic regression identified correlates of willingness. Artworks and testimonies from participants in the workshops were also used to illustrate correlates of willingness. Results: Among the 209 participants, the mean score (SD) for willingness to receive IV buprenorphine was 8.0 (2.8). Multivariate analysis showed that participants who reported using non-prescribed buprenorphine (AOR = 4.82, p = 0.019), a higher daily dosage of buprenorphine (AOR (for 1 mg) = 1.05, p = 0.043), and a higher number of complications due to injection (AOR = 2.28, p = 0.037), were more willing to receive IV buprenorphine treatment. Conclusions: Willingness to initiate IV buprenorphine treatment was high among people who regularly inject sublingual buprenorphine. A prescribed IV formulation could attract and retain more people into care and reduce harms associated with the injection of buprenorphine tablets.

Despite increased availability of pre-exposure prophylaxis (PrEP), PrEP uptake has remained low. To promote uptake, factors related to PrEP interest among relevant target populations warrant investigation. The aim of this study was to provide an analysis of PrEP interest among men who have sex with men (MSM) in the Netherlands, while taking study recruitment strategies into account. We recruited 154 MSM from an LGBT research panel (AmsterdamPinkPanel) and 272 MSM from convenience sampling. Both samples were part of the Flash! PrEP in Europe Survey and were compared on their PrEP interest, usage intentions, and sexual behavior. We conducted logistic regression analyses to discover variables associated with PrEP interest and intentions. Participants from the AmsterdamPinkPanel were less likely to use PrEP, had less knowledge of PrEP, and were less interested in PrEP than participants from convenience sampling. Significant covariates of PrEP interest were being single, more prior PrEP knowledge, sexual risk behaviors, such as not having used a condom during last sex and having ever used drugs in a sexual context, and not participating in the AmsterdamPinkPanel. Adding the recruitment strategy to the regression increased explained variance on top of predictors already described in the literature. Increased sexual risk behavior is related to increased PrEP interest and it helps to identify PrEP target groups. Recruitment strategies have a substantial impact on findings regarding PrEP interest and usage intentions. This study emphasizes the importance of using multiple strategies for recruiting participants to obtain a more comprehensive view of MSM’s attitudes toward PrEP. Electronic supplementary material The online version of this article (10.1007/s10508-019-01620-x) contains supplementary material, which is available to authorized users.

Purpose People who inject drugs (PWID) face multiple health problems, including infectious diseases and drug overdoses. Applying syndemic and risk environment frameworks, this paper aims to examine the co-occurrence and clustering of drug-related harms and their association with incarceration experience with or without in-prison drug injection. Design/methodology/approach The authors used data from a cross-sectional survey conducted in 2015 among 557 active opioid injectors. Self-reported data were collected through face-to-face or online questionnaires. They distinguished three harm categories, namely, viral infections, bacterial infections and overdoses, and built an index variable by summing the number of harm categories experienced, yielding a score from 0 to 3. Association between incarceration experience and co-occurrence of harms was modelled using a multinomial logistic regression. Findings Of the 557 participants, 30% reported lifetime experience of drug-related viral infection, 46% bacterial infection and 22% drug overdose. Multinomial logistic models showed that those who injected drugs during incarceration were more likely to report two (aOR = 2.35, 95% CI: 1.03–5.36) and three (aOR = 9.72, 95% CI: 3.23–29.22) harm categories than those who had never been incarcerated. They were also more likely to report three harm categories than formerly incarcerated respondents who did not inject drugs in prison (aOR = 5.14, 95% CI: 1.71–15.48). Originality/value This study provides insights of the syndemic nature of drug-related harms and highlights that drug injection during incarceration is associated with co-occurring harms. Public health interventions and policy changes are needed to limit the deleterious impact of prison on PWID.

International audience; BackgroundThere are few data available regarding the use of on-demand pre-exposure prophylaxis (PrEP) for HIV prevention. We aimed to assess PrEP effectiveness, adherence, and safety in adults using daily or on-demand PrEP.MethodsWe conducted a prospective observational cohort study (ANRS PREVENIR) at 26 sites in the Paris region, France. We enrolled HIV-negative adults (aged ≥18 years) at high risk of HIV infection who were starting or continuing PrEP. PrEP was prescribed as a fixed-dose combination of tenofovir disoproxil and emtricitabine (245 mg and 200 mg, respectively, per pill). PrEP could be prescribed as a daily regimen with one pill per day or, in men who have sex with men (MSM) or in transgender women who have sex with men, as an on-demand regimen following the IPERGAY dosing recommendation. At enrolment and every 3 months thereafter, participants were tested for HIV and provided information regarding the PrEP dosing regimen used. Adherence to PrEP was assessed by self-report and by tenofovir diphosphate concentrations in dried blood spots. The primary outcome of HIV-1 incidence was assessed using Poisson regression among participants who started PrEP. This study is registered with ClinicalTrials.gov, NCT03113123, and EudraCT, 2016A0157744.FindingsBetween May 3, 2017, and May 2, 2019, 3082 people were assessed for eligibility and 3065 participants were enrolled. 3056 (99·7%) of 3065 participants reported using PrEP and were included in the analyses. The median age was 36 years (IQR 29–43), 1344 (44·0%) of 3056 participants were PrEP-naive, and 3016 (98·7%) were MSM. At enrolment, 1540 (50·5%) of 3049 participants opted for daily PrEP dosing and 1509 (49·5%) opted for on-demand PrEP dosing; these proportions remained stable during follow-up. Median follow-up was 22·1 months (IQR 15·9–29·7) and incidence of study discontinuation was 17·6 participants (95% CI 16·5–18·7) per 100 person-years. At the data cutoff on Sept 30, 2020, there had been six HIV-1 seroconversions (three participants using daily PrEP and three using on-demand PrEP; all were MSM) over 5623 person-years. Overall HIV-1 incidence was 1·1 cases (95% CI 0·4–2·3) per 1000 person-years, and did not differ between participants using daily PrEP and those using on-demand PrEP (incidence rate ratio 1·00, 95% CI 0·13–7·49; p=0·99). Four participants (two using daily PrEP and two using on-demand PrEP) discontinued PrEP due to treatment-related adverse events (nausea [n=2], vomiting and diarrhoea [n=1], and lumbar pain [n=1]).InterpretationIn this study, which enrolled mainly MSM, HIV-1 incidence on PrEP was low and did not differ between participants using daily PrEP and those using on-demand PrEP. On-demand PrEP therefore represents a valid alternative to daily PrEP for MSM, providing greater choice in HIV prevention.FundingANRS/Maladies Infectieuses Emergentes, Gilead Sciences, SIDACTION, and Région Ile de France.TranslationFor the French translation of the abstract see Supplementary Materials section.; ANRS/Maladies Infectieuses Emergentes, Gilead Sciences, SIDACTION, and Région Ile de France.

International audience; Objective The aim of this study was to evaluate people living with HIV (PLWH) and HIV specialist prescribers' perception of discussing antiretroviral therapy (ART) price in PLWH's care and the acceptability of choosing or switching to various types of less expensive ARTs. Design Cross-sectional surveys (one in a convenience sample of PLWH and one in a voluntary response sample of HIV specialist prescribers). Setting and participants The surveys were conducted among PLHW attending an HIV clinic in the North of Paris (cohort of 4922 PLWH in 2016), and HIV specialists working in French HIV clinics (210 across 12 districts/28), between January and June 2016. Method Self-administered questionnaires were constructed using data collected during focus groups with PLWH and prescribers. Pretests were carried out to select the questions and items. Descriptive analyses of the 129 complete questionnaires of PLWH and 79 of prescribers are presented. Results Among PLWH, 128/129 were on ART and 54% (69/128) gave a fair estimation of the price of their current regimen. Among prescribers, 24% (19/79) thought that their patients knew this price. Taking into account the price of ART was not perceived as a negative step in the history of French response to HIV epidemic for 53% (68/129) of PLWH and 82% (65/79) of prescribers. Seventy-seven PLWH (60%) would agree to switch to less expensive antiretroviral regimens (as effective and with similar adverse events) if pills were bigger; 42 (33%) if there were more daily doses, and 37 (29%) if there were more pills per dose; prescribers were more circumspect. Conclusion A high proportion of PLWH gave a fair estimate of their ART price and this seemed unexpected by HIV specialists. Consideration of drug prices when choosing ART was perceived as conceivable by PLWH and prescribers if effectiveness and tolerance were also considered.

International audience; Background: The effectiveness of collaborative approaches in health interventions is underlined in the literature. Given the serious challenges to adequately managing the HCV epidemic in people who inject drugs (PWID), and the need to improve existing harm reduction (HR) interventions in this population, it seems important to investigate how collaboration between stakeholders is ensured in action research interventions. The present study aimed to explore interactions between outreach workers and research officers collaborating in the implementation of an action research project for PWID entitled OUTSIDER. Methods: Using three focus groups, we studied the views of 24 outreach workers involved in the implementation and evaluation of a harm reduction educational intervention to help PWID inject more safely in off-site settings. Results: The analysis of participants' discourses highlighted the mixed perceptions they had about OUTSIDER. Several limitations to collaboration emerged. Epistemological (theoretical vs. practical knowledge), methodological (science vs. intervention), axiological (standardised vs. adapted approach), and material (mobilised vs. available resources) issues all placed a burden on the outreach worker-research officer relationship. Outreach workers' acceptance of the project's intervention dimension but rejection of its scientific dimension highlights a lack of contractualisation between the stakeholders involved, and a more general problematisation of the role of outreach workers in implementing action research in HR. How collaboration was perceived and practised by outreach workers participating in OUTSIDER can be considered a reflection of the current challenges to implementing action research in HR. Conclusion: This study of the interaction between the research and implementation dimensions of an action research project explored the tensions between different intervention stakeholders that must work together. Equitable participation and integration of the expertise, practices, and knowledge of all stakeholders involved is essential for successful action research. Given current HCV epidemiological challenges, new forms of cooperation are needed when developing healthcare services and when strengthening collaborative approaches.

Background Inconsistent hand hygiene puts people who inject drugs (PWID) at high risk of infectious diseases, in particular skin and soft tissue infections. In healthcare settings, handwashing with alcohol-based hand rubs (ABRH) is recommended before aseptic procedures including intravenous injections. We aimed to evaluate the acceptability, safety and preliminary efficacy of an intervention combining ABHR provision and educational training for PWID. Methods A mixed-methods design was used including a pre-post quantitative study and a qualitative study. Participants were active PWID recruited in 4 harm reduction programmes of France and followed up for 6 weeks. After baseline assessment, participants received a face-to-face educational intervention. ABHR was then provided throughout the study period. Quantitative data were collected through questionnaires at baseline, and weeks 2 (W2) and 6 (W6) post-intervention. Qualitative data were collected through focus groups with participants who completed the 6-week study. Results Among the 59 participants included, 48 (81%) and 43 (73%) attended W2 and W6 visits, respectively. ABHR acceptability was high and adoption rates were 50% (W2) and 61% (W6). Only a minority of participants reported adverse skin reactions (ranging from 2 to 6%). Preliminary efficacy of the intervention was shown through increased hand hygiene frequency (multivariable linear mixed model: coef. W2 = 0.58, p = 0.002; coef. W6 = 0.61, p = 0.002) and fewer self-reported injecting-related infections (multivariable logistic mixed model: AOR W6 = 0.23, p = 0.021). Two focus groups were conducted with 10 participants and showed that young PWID and those living in unstable housing benefited most from the intervention. Conclusions ABHR for hand hygiene prior to injection are acceptable to and safe for PWID, particularly those living in unstable housing. The intervention’s educational component was crucial to ensure adoption of safe practices. We also provide preliminary evidence of the intervention’s efficacy through increased hand hygiene frequency and a reduced risk of infection. Supplementary Information The online version contains supplementary material available at 10.1186/s12879-021-05895-1.

International audience; Background: Harm reduction (HR) interventions are essential to reduce human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission in people who inject drugs (PWID). Preliminary testing of the Individually Tailored Support and Education for Safer Injection (ITSESI) evidence-based educational intervention for PWID was performed in France in 2011. We created the Eurosider project to implement and evaluate ITSESI at a wider European level, with a view to its future pan-European diffusion.Methods: We performed a mixed-methods study involving quantitative (a 6-month before-after study with PWID) and qualitative (focus groups with field workers) components. The study was conducted in 2018-2019 with 307 eligible PWID participating in four existing HR programmes in Bulgaria, Greece, Portugal, and Romania. ITSESI consists in trained field workers observing PWID injection practices and providing an educational exchange. For the present study, PWID participants were allocated to either the control group (i.e., they continued receiving only the current HR services) or the intervention group (i.e., current HR services plus ITSESI). We used the RE-AIM QuEST framework to assess the effectiveness of ITSESI and its acceptability by field workers. Effectiveness was defined as a reduction in both syringe sharing - the highest HIV/HCV transmission risk practice - and in cutaneous abscesses. We used a multivariable mixed logit model to analyse both effectiveness outcomes and to provide adjusted odds ratios (aOR) and 95% confidence intervals (CI). Field workers' acceptability of the intervention was described using a thematic analysis of the qualitative data.Results: Of the 307 PWID, 55% received ITSESI. Syringe sharing and cutaneous abscesses decreased during follow-up in the intervention group (from 25 to 16% and from 27 to 14%, respectively). Reductions were smaller in the control group (from 29 to 24% and from 23 to 18%, respectively). The multivariable analyses confirmed the effect of the intervention on both of these outcomes (aOR [95% CI]: 0.38 [0.17, 0.85]) and (aOR [95% CI]: 0.38 [0.16, 0.90], respectively). Our qualitative data on acceptability showed the feasibility of involving field workers as proactive research partners in making ITSESI more accessible and acceptable across Europe.Conclusions: We demonstrated both the effectiveness of ITSESI in reducing syringe sharing and cutaneous abscesses in four European countries, and a high level of intervention acceptability by field workers. Our findings provide important insights into how ITSESI can be adapted for pan-European implementation.

The World Health Organization recommends pre-exposure prophylaxis (PrEP) for all populations at substantial risk of HIV infection, including women. However, data regarding PrEP interest among women is lacking, particularly in Europe. Factors associated with interest in using PrEP were assessed among women respondents to the Flash! PrEP in Europe (FPIE) survey. This community-based cross-sectional study, conducted in 12 European countries, aimed to assess PrEP knowledge and interest. “High objective risk” (HOR) was assessed using established risk criteria following EACS and CDC guidelines. Factors associated with interest in using PrEP were assessed in univariable and multivariable logistic regression models. Among 678 women, 12.5% (n = 85) were considered at HOR, 46.8% (n = 317) indicated prior PrEP knowledge and 18.0% (n = 122) reported interest in using PrEP. Among women at HOR, 40.0% (n = 34) were interested in PrEP. Factors significantly associated with PrEP interest in the final multivariable model were: younger age (18–29 years) (aOR 1.91[95CI: 1.07; 3.41]), bad self-perceived financial status (1.84[1.09; 3.11]), migrant status (south to north) (2.87[1.05; 7.89]), single or dating relationship status (1.93[1.23; 3.03]), sexual abuse history (1.86[1.17; 2.97]), “rather high”/ “high” self-perceived HIV risk (3.21[1.32; 7.81]), and HOR (2.49[1.42; 4.35]). These results show that women at HOR and those who perceived themselves to be at high risk are interested in using PrEP. There is a critical need for targeted information and improved access to PrEP to increase uptake of this HIV prevention tool to meet PrEP interest among women, KJJ received a grant from Dutch AIDS Fonds (Grant P-11302)

IntroductionTransgender identity is poorly accepted in France, and data on living conditions and the daily difficulties transgender people encounter are scarce. This lack of data reinforces their invisibility in social life, contributes to their stigmatisation and probably increases the burden of HIV infection, especially for HIV-positive transgender people (TRHIV). The main objective of the community-based research study ANRS Trans&HIV is to identify personal and social situations of vulnerability in TRHIV, the obstacles they encounter in terms of access to and retention in medical care, and their gender affirmation and HIV care needs.Methods and analysisANRS Trans&HIV is a national, comprehensive, cross-sectional survey of all TRHIV currently being followed in HIV care units in France. TRHIV women are exclusively included in the quantitative component, and TRHIV men in the qualitative component. Data are collected by community-based interviewers and will be analysed to explore patient care pathways and living conditions in the TRHIV population with regard to gender affirmation and HIV. Data collection began in October 2020 and should be completed in December 2021. The statistical analyses techniques used will be adapted to each of the study’s objectives and to the type of data collected (cross-sectional (questionnaires) and retrospective (biographical trajectory)). The study’s results will provide a greater understanding of TRHIV health needs in order to suggest possible national recommendations for comprehensive HIV and gender affirmation medical care.Ethics and disseminationANRS Trans&HIV was approved by Inserm’s Ethical Evaluation Committee (no 20-694 on 12 May 2020) and is registered with the National Commission on Informatics and Liberty under number 2518030720. Potential participants are informed about the study through an information note provided by their attending HIV physician. All results published in peer-reviewed journals will be disseminated to the HIV transgender community, institutional stakeholders and healthcare providers.Trial registration numberNCT04849767.

International audience; Pre-Exposure Prophylaxis (PrEP) is changing the landscape of HIV prevention, and may bring changes in sexual behaviors. The double-blind phase (DBP) and open-label extension (OLE) study of the ANRS-IPERGAY trial allowed us to assess changes in sexual behavior of men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP. Generalized Estimating Equation (GEE) models found a significant decrease in the number of sexual partners (Coefficient [CI95%], p value; - 0.37[- 0.70 to - 0.04], p = 0.03) between the DBP and OLE as well as in the number of sexual relations (- 0.25 [- 0.49 to 0.00], 0.04). GEE estimates also showed that respondents' most recent sexual relation was less likely to have been with an unknown casual partner during the OLE than during the DBP (Odds Ratio [CI95%], p value: 0.75[0.62-0.92], 0.005). Furthermore, they showed an increase in the proportion of condomless anal sex in the OLE (1.32[1.04-1.67], 0.02), a decrease in the proportion of 'suboptimal PrEP adherence' over time (0.75[0.58-0.97], p = 0.03), a decrease in PrEP only use (0.73[0.55-0.96], 0.03) and in both PrEP and condom use over time (0.70[0.51-0.95], 0.02) and finally, a decrease in alcohol consumption between the DBP and OLE (0.74[0.61-0.90], 0.002). We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase. Our findings are consistent with results from previous PrEP trials.

International audience; Pre-exposure prophylaxis (PrEP) is fully reimbursed by the French health insurance system since 2016. However, uptake of PrEP is slower than expected and little is known about men who have sex with men (MSM) who are eligible for PrEP according to French guidelines, but not using it. This study aims to (1) assess and describe MSM that are eligible to PrEP but not using it, and (2) identify potential individual and structural barriers of PrEP uptake among eligible MSM who are aware and intend to take PrEP. Data from EMIS-2017, a cross-sectional internet survey among gay, bisexual, and other MSM, were used. Among 7965 respondents without diagnosed HIV, 9.2% were PrEP users. Among 7231 non-PrEP users, 35.2% were eligible to PrEP and 15.2% were eligible, aware and intended to take PrEP. Eligible MSM who are not using PrEP are mostly younger, students, less "out", living in small cities, using condoms more frequently but still with low self-efficacy regarding safe sex and more distant from preventive health care and information than PrEP users. Despite free PrEP availability in France, results suggest that PrEP is not fully accessible and that there is a need to increase PrEP demand and decentralize PrEP delivery.

International audience; Background: Cotton fever is a febrile syndrome occurring after intravenous drug injection. Although its clinical presentation is well described in the literature, data regarding prevention is lacking. We aimed to assess proportion and correlates of cotton fever experience among people who inject opioids. Methods: We performed a cross-sectional study using data from the community-based survey PrebupIV conducted in France in 2015 among 557 people who regularly injected opioids. Self-reported sociodemographic data, together with data on substance use, injecting practices and occurrence of cotton fever were all collected through face-to-face (n = 398) or online (n = 159) questionnaires. Factors associated with cotton fever experience were assessed using logistic regression model. Results: Over half of the participants (54%) reported cotton fever experience. In the multivariable logistic regression, crack cocaine injection (adjusted Odds Ratio (aOR) = 1.96, 95% Confidence Interval (CI) = 1.03-3.63), longer duration of opioid use (for 1 year of use: aOR = 1.05, 95%CI = 1.02-1.09), and filtering mainly with cotton filters (compared with membrane filters, aOR = 1.86, 95%CI = 1.24-2.78) were all associated with cotton fever experience. Conclusions: Our findings highlight that cotton fever is a frequent complication of injecting drug use. Avoiding the use and reuse of cotton balls to filter injected solutions, and promoting membrane filters use could reduce the risk of the condition occurring.

Background People who inject drugs face several health issues because of unsafe injecting practices. We aimed to evaluate changes in supervised drug-injecting practices following the implementation of a face-to-face educational intervention. Methods The national study ANRS-AERLI was conducted in 17 harm reduction (HR) facilities in France between 2011 and 2013. Eight offered the intervention and nine did not. We conducted a pre-post analysis focusing on injecting practices data, collected in the 8 HR facilities providing the intervention. The intervention consisted of providing face-to-face educational sessions including direct observation of injecting practices, counseling about safer injecting, and shared discussion. Injecting practices were collected following a checklist and classified as safe or unsafe. To assess changes in injecting practices, practices were compared before (at baseline) and after at least one educational session. Findings Mixed logistic models showed that the 78 participants included were more likely to improve in the following drug-use steps: setting up a clean preparation area (Adjusted Odds Ratio (AOR) = 3.4, 95% Confidence Interval (95% CI) = 1.6–7.6), hand washing (AOR = 7.2, 95% CI = 3.1–16.4), skin cleaning (AOR = 5.6, 95% CI = 2.5–12.1), choice of safe injection site (AOR = 6.5, 95% CI = 1.5–28.8) and post-injection bleeding management (AOR = 12.8, 95% CI = 5.5–29.9). Furthermore, participants were less likely to lick their needles before injecting (AOR = 8.1, 95% CI = 1.5–43.4) and to perform booting/flushing (AOR = 2.5, 95% CI = 1.2–5.3). Conclusions The AERLI intervention seems to be effective in increasing safe drug-injecting practices.

International audience; The ANRS-PREVENIR (2017-2020) prospective cohort study aims to reduce the number of new HIV infections in the "Ile-de-France" region in France, by enrolling individuals at high risk of HIV infection and proposing daily and on-demand pre-exposure prophylaxis (PrEP). The qualitative component of the ANRS-PREVENIR study aimed to investigate social and relational evolutions associated with PrEP use in men who have sex with men (MSM). In 2018, 12 focus groups with MSM (n = 68) were conducted by a social sciences researcher in Paris. A thematic analysis was performed. Results showed that stigma concerning PrEP use is a complex issue, with various kinds of stigmatization being practiced, sometimes even by the wider MSM population and PrEP users themselves. All types of stigma identified were expressed in forms of verbal abuse which made PrEP use taboo. Inside the wider MSM population a PrEP-user "community" was identified which shared a certain complicity in terms of values and a positive attitude towards PrEP. The emergence of new intragroup and intergroup social norms should be taken into account by policy makers to promote a more positive image of PrEP users.

International audience; Objective: This study aimed to identify situational and behavioral factors associated with condomless anal sex without on-demand PrEP in the open-label extension (OLE) study of the ANRS-IPERGAY trial.Methods: Univariable and multivariable modified Poisson regressions with a generalized estimating equation (GEE) were used. The attributable risk percentage for each explanatory variable and for condomless anal sex without PrEP was calculated.Results: In the OLE, 19% of anal intercourses were unprotected (i.e. no PrEP or condom). Of these, 85% were attributable to sexual intercourse with main partners and 47% with HIV-negative partners. The following factors were positively associated with condomless anal sex without PrEP: a depressive episode in the previous 12 months [aR (95% CI), P-value: 1.49 (1.02--2.17), 0.039], a higher number of sexual intercourses during the previous 4 weeks [1.01 [1.002--1.02], 0.014], and sexual intercourses under the influence of alcohol [1.45 (1.10--1.92), 0.008]. By contrast, condomless anal sex without PrEP was less frequent during sexual intercourses with known casual, unknown casual and multiple partners [0.20 (0.14--0.30)

The recent implementation of innovative biomedical preventive approaches to combat the continued high prevalence of HIV among certain populations, has refocused attention on the question of support in the management of treatment adherence. What distinguishes these approaches from classic research on similar themes is that the populations concerned are not HIV positive. The objective of this study was to assess participant and physician satisfaction with medical and community support provided in the ANRS-IPERGAY trial. As part of this trial, individual interviews were conducted with physicians and with HIV-negative participants involved in the trial. Collective interviews and focus groups were also conducted with the participants. A content thematic analysis was performed on the full two corpuses’ data, with the aim of investigating discourse themes regarding the support offered as part of the trial. The discourse analysis of the HIV-negative participants and physicians underlined their satisfaction with many aspects of the medical and community support provided during the trial. The results were interpreted with respect to new forms of patient education necessary for the implementation of the medicalized prevention., Face à une prévalence toujours élevée du VIH dans certaines populations, des moyens innovants de prévention biomédicale ont récemment été mis en place remettant ainsi au cœur du débat la question de l’accompagnement dans la gestion de l’adhésion au traitement. Ce qui distingue ces approches par rapport aux travaux classiques sur ces thématiques renvoie au fait que les populations concernées ne sont pas malades. L’objectif de cette étude est donc d’évaluer la satisfaction liée à l’accompagnement médical et communautaire mis en place dans l’essai ANRS-IPERGAY. Dans le cadre de cet essai, des entretiens individuels ont été conduit auprès des médecins de l’essai et des participants à la recherche. Des entretiens collectifs ainsi que des focus groups ont également été menés auprès des participants. Une analyse thématique de contenu a été réalisée sur les deux corpus avec pour objectif d’investiguer les discours relatifs à l’accompagnement proposé dans l’essai. L’analyse du discours des différents acteurs souligne les points forts de l’évaluation de l’accompagnement à la fois du point de vue des participants ainsi que des médecins. L’interprétation des résultats est faite en lien avec les nouvelles formes d’éducation du patient, nécessaire au déploiement de la prévention médicalisée.

International audience; AIMS:In France, a non-negligible proportion of opioid-dependent individuals inject morphine sulfate. Although it has not yet been officially approved as an opioid substitution treatment (OST), some physicians can prescribe its use for people in methadone or buprenorphine treatment failure. Longitudinal data from the ANRS-AERLI study, which evaluated an educational intervention for safer injection called AERLI, provided us the opportunity to better characterize the profile, risk practices and needs of people who inject morphine sulfate (MSI), through comparison with other injectors, and to identify correlates of HIV/HCV risk practices in this group.METHODS:The national multisite ANRS-AERLI study assessed the impact of AERLI offered in volunteer harm reduction (HR) centers ("with intervention") (n = 113) through comparison with standard HR centers ("without intervention") (n = 127). All participants were scheduled to be followed up for 12 months and have 3 telephone interviews: at baseline, 6 months and 12 months. We compared MSI (n = 79) with other opioid injectors (n = 161) and then used a mixed logistic model to identify factors associated with HIV/HCV risk practices among MSI.FINDINGS:Of the 240 eligible participants, 79 were regular MSI. They were less likely to use cocaine, crack or buprenorphine and to receive OST than other participants. Conversely, MSI were more likely to inject drugs more than three times a day and to report HIV/HCV risk practices. Among MSI, multivariate analysis showed that those receiving morphine sulfate as an OST were less likely to report such practices than other participants (aOR [95%CI] = 0.11 [0.02-0.61]).CONCLUSION:Our results show that while MSI use fewer stimulants, they have more HIV/HCV risk practices than other injectors. However, when MSI are prescribed morphine sulfate as a treatment, these practices tend to decrease. Our findings suggest the importance of increasing access to morphine sulfate as a new OST in France.

International audience; Before January 2016, Pre-Exposure Prophylaxis (PrEP), a new biomedical HIV-prevention tool, was only available in France via ANRS-Ipergay clinical study but informal use was reported outside this setting. PrEPage qualitative study reports profiles and experiences of participants who used PrEP outside of a biomedical trial before this prevention method was authorized. Between March 2015 and February 2016, a cross-section of twenty-four informal PrEP users, mostly MSM, was recruited to complete in-depth semi-structured interviews. While ANRS-Ipergay was still ongoing (2012-2016), participants described their initiation to PrEP, the way they used it and the difficulties they faced to acquire antiretroviral drugs in an environment where PrEP was still not widely known and often criticized . Through the testimonies, different user profiles and motivation toward informal PrEP use emerged: (a) participants who have increasing difficulties using condoms, (b) "opportunists" who tried PrEP without the intention of using it regularly and (c) participants with a risk aversion who sought additional protection against HIV. Participants chose to use PrEP and/or their usual prevention strategies depending on available supplies, type of partners and individual attitudes toward risk. The feeling of living a safer sex life helped participants to outweigh the fear of possible toxicity and drug resistance. Participants' needs and expectations about PrEP implementation in France were also presented.

Aims In France, a non-negligible proportion of opioid-dependent individuals inject morphine sulfate. Although it has not yet been officially approved as an opioid substitution treatment (OST), some physicians can prescribe its use for people in methadone or buprenorphine treatment failure. Longitudinal data from the ANRS-AERLI study, which evaluated an educational intervention for safer injection called AERLI, provided us the opportunity to better characterize the profile, risk practices and needs of people who inject morphine sulfate (MSI), through comparison with other injectors, and to identify correlates of HIV/HCV risk practices in this group. Methods The national multisite ANRS-AERLI study assessed the impact of AERLI offered in volunteer harm reduction (HR) centers (“with intervention”) (n = 113) through comparison with standard HR centers (“without intervention”) (n = 127). All participants were scheduled to be followed up for 12 months and have 3 telephone interviews: at baseline, 6 months and 12 months. We compared MSI (n = 79) with other opioid injectors (n = 161) and then used a mixed logistic model to identify factors associated with HIV/HCV risk practices among MSI. Findings Of the 240 eligible participants, 79 were regular MSI. They were less likely to use cocaine, crack or buprenorphine and to receive OST than other participants. Conversely, MSI were more likely to inject drugs more than three times a day and to report HIV/HCV risk practices. Among MSI, multivariate analysis showed that those receiving morphine sulfate as an OST were less likely to report such practices than other participants (aOR [95%CI] = 0.11 [0.02-0.61]). Conclusion Our results show that while MSI use fewer stimulants, they have more HIV/HCV risk practices than other injectors. However, when MSI are prescribed morphine sulfate as a treatment, these practices tend to decrease. Our findings suggest the importance of increasing access to morphine sulfate as a new OST in France.

International audience; BACKGROUND: Regular consumption of opioids exposes individuals to several side effects. One of these is a loss of libido, which has a negative impact on quality of life. We used a cross-sectional community-based survey of people who inject opioids to study factors associated with loss of libido, and more particularly the impact of the type of opioid injected.METHODS: This secondary study was conducted throughout France in 2015 and involved 514 people who inject opioids. Self-reported sociodemographic characteristics, drug consumption, injection-related data and loss of libido were collected using a brief questionnaire administered either through face-to-face interviews or online. Two different models were used to identify factors associated with loss of libido: simple logistic regression and a two-step Heckman model.RESULTS: Forty-three percent of the participants reported a loss of libido. The first model showed that filling in the questionnaire online (OR[95%CI] = 2.55[1.64;3.96]; p

International audience; The ANRS-IPERGAY trial consisted in providing sexual activity-based antiretroviral prophylaxis for HIV prevention (PrEP) with a package of prevention tools (counselling, condoms, HIV and sexually transmitted infections' screening) to highly exposed HIV-negative men who have sex with men (MSM). Few data exist concerning the patient-physician relationship in the particular context of PrEP, where physicians discuss sexual behaviours with MSM who are not classic patients, in that consultation is for prevention purposes, not for illness. This study took place during the open-label extension of ANRS-IPERGAY trial when all participants received PrEP. In this qualitative study, we examined how physicians perceived their relationship with participants in the ANRS-IPERGAY trial. Of all 30 physicians involved in the trial who were contacted by email to participate in an interview about their opinions and perceptions of ANRS-IPERGAY 18 volunteered to participate in the current sub-study. We performed a vertical analysis for each interview to identify the extract in each physician's discourse concerning their relationship with MSM participants, and conducted a horizontal analysis to construct the thematic tree and subsequently investigate differences and similitudes between themes. An analysis of all physicians' discourses showed that the participant-physician relationship during the trial could be described through 4 themes: (i) personal experience of the relationship, (ii) trust and non-judgement, (iii) positive relational climate and (iv) influence of physician's characteristics (age, gender, etc.) on relationship. We found that the particular context of PrEP led some physicians to adopt a patient-as-partner approach during consultations rather than a paternalist or hierarchical approach. Indeed, the close follow-up provided by the trial and the active role of patients in their own prevention care trajectory, are more compatible with the patient-as-partner approach. The prescription of PrEP may lead to an evolution in patient-physician relationships and may even modify the professional identity of physicians.

Background/aims In line with Self-determination Theory, individuals who feel they are able to adopt new behaviors autonomously, and who perceive their social environment as supportive of their autonomy and confident in their competencies, are more likely to engage in sustainable behavioral change over time. We aimed to study the impact of an educational intervention, which has already shown its effectiveness in reducing transmission-risk behaviors and injection-related complications among drug users (Roux et al., 2016), on three psychosocial factors (PSF) involved in initiating and maintaining new health behaviors over time, as follows: A) self-regulation of behaviors (autonomous vs. controlled regulation); B) perceived competence in adopting new behaviors (a feeling of being able or unable to adopt new behaviors) and C) perceived autonomy support (social environment perceived by drug users as supportive of autonomy vs. controlling). Methods This non-random clustered intervention study was conducted in 9 intervention groups (programs offering the intervention) and 8 control groups (programs not offering it). Each participant was followed up through a phone interview at enrolment, at 6 months and 12 months. Of the 271 participants, 113 received at least one educational session in the first six months. We used the “Health-Care Self-Determination Theory Questionnaire” to assess the impact of this intervention on the development of self-regulation, perceived competence and perceived autonomy support. Results Participants exposed to the intervention at least once were associated with a higher level of perceived competence and perceived autonomy support at M12. However, the intervention did not impact self-regulation (either autonomous or controlled). In addition, the study revealed that other factors, such as gender, age, drug use patterns and participants' healthcare pathways, also have an impact on these PSF. Conclusions This educational intervention significantly increases patients' perceived competence but has no impact on the factors specifically involved in maintaining new behaviors over time. This study also highlights the existence of user profiles whose socio-demographic characteristics, use patterns and care pathways can influence these FPS involved in motivation to change and maintain new health behaviors over time.

International audience; Objectives: We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial, which showed the efficacy of on-demand preexposure prophy-laxis (PrEP) with tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) in preventing HIV infection among high-risk MSM. Design and methods: The economic evaluation was prospective. Counseling, drugs (TDF-FTC at s500.88 for 30 tablets), tests, visits, and hospital admissions were valued based on in-trial use. The cost of on-demand PrEP/HIV infection averted was compared with the yearly and lifetime costs of HIV infection in France in a cost and benefits analysis. Results: The yearly number of participants needed to treat to prevent one HIV infection was 17.6 (95% confidence interval ¼ 10.7-49.9). The annual cost of counseling was s690/participant. The total 1-year costs of PrEP were s4271/participant, of which s3129 (73%) were drug costs corresponding to 15 tablets of TDF-FTC/month. The yearly cost of on-demand PrEP to avoid one infection was s75 258. Using TDF-FTC generic (s179.9/30 tablets) reduced the 1-year costs of on-demand PrEP to s2271/ participant and s39 970/infection averted, respectively. Using TDF-FTC at international market discounted prices (s60/30 tablets) reduced the costs to s1517/participant and the cost to s26 787/infection averted, comparable with the yearly treatment cost of HIV infection in France. On-demand PrEP was found to be cost saving in France if the duration of exposure was less than 7.5 years at current drug price and 13 years at generic price. Conclusion: On-demand PrEP in high-risk MSM with TDF-FTC can be considered cost saving. Other benefits include the treatments of other diseases and reductions in secondary infections.

International audience; BACKGROUND:People who inject drugs face several health issues because of unsafe injecting practices. We aimed to evaluate changes in supervised drug-injecting practices following the implementation of a face-to-face educational intervention.METHODS:The national study ANRS-AERLI was conducted in 17 harm reduction (HR) facilities in France between 2011 and 2013. Eight offered the intervention and nine did not. We conducted a pre-post analysis focusing on injecting practices data, collected in the 8 HR facilities providing the intervention. The intervention consisted of providing face-to-face educational sessions including direct observation of injecting practices, counseling about safer injecting, and shared discussion. Injecting practices were collected following a checklist and classified as safe or unsafe. To assess changes in injecting practices, practices were compared before (at baseline) and after at least one educational session.FINDINGS:Mixed logistic models showed that the 78 participants included were more likely to improve in the following drug-use steps: setting up a clean preparation area (Adjusted Odds Ratio (AOR) = 3.4, 95% Confidence Interval (95% CI) = 1.6-7.6), hand washing (AOR = 7.2, 95% CI = 3.1-16.4), skin cleaning (AOR = 5.6, 95% CI = 2.5-12.1), choice of safe injection site (AOR = 6.5, 95% CI = 1.5-28.8) and post-injection bleeding management (AOR = 12.8, 95% CI = 5.5-29.9). Furthermore, participants were less likely to lick their needles before injecting (AOR = 8.1, 95% CI = 1.5-43.4) and to perform booting/flushing (AOR = 2.5, 95% CI = 1.2-5.3).CONCLUSIONS:The AERLI intervention seems to be effective in increasing safe drug-injecting practices.

International audience; BACKGROUND: Regular consumption of opioids exposes individuals to several side effects. One of these is a loss of libido, which has a negative impact on quality of life. We used a cross-sectional community-based survey of people who inject opioids to study factors associated with loss of libido, and more particularly the impact of the type of opioid injected.METHODS: This secondary study was conducted throughout France in 2015 and involved 514 people who inject opioids. Self-reported sociodemographic characteristics, drug consumption, injection-related data and loss of libido were collected using a brief questionnaire administered either through face-to-face interviews or online. Two different models were used to identify factors associated with loss of libido: simple logistic regression and a two-step Heckman model.RESULTS: Forty-three percent of the participants reported a loss of libido. The first model showed that filling in the questionnaire online (OR[95%CI] = 2.55[1.64;3.96]; p

International audience; In the ANRS IPERGAY pre-exposure prophylaxis (PrEP) trial, a single dose of tenofovir disoproxil fumarate and emtricitabine was taken orally 2-24 h before sexual intercourse. A sub-study was conducted to assess the pharmacokinetics of tenofovir and emtricitabine in blood, saliva and rectal tissue following this initial oral intake. Methods: Plasma, PBMC, saliva and rectal tissue sampling was performed over 24 h in 12 seronegative men before enrolment in the ANRS IPERGAY trial, following a single dose of 600 mg tenofovir disoproxil fumarate/400 mg emtricitabine. Ex vivo HIV infectibility of rectal biopsies was also assessed. Results: The median plasma T max of tenofovir (median C max : 401 mg/L) and emtricitabine (median C max : 2868 mg/L) was obtained 1 h (range: 0.5-4) and 2 h (range: 1-4) after dosing, respectively. The median C 24 of tenofovir and emtricitabine was 40 and 63 mg/L, respectively. The median PBMC tenofovir diphosphate and emtricitabine triphosphate levels were 12.2 and 16.7 fmol/10 6 cells and 2800 and 2000 fmol/10 6 cells at 2 and 24 h after dosing, respectively. Saliva/plasma AUC 0-24 ratios were 2% and 17% for tenofovir and emtricitabine, respectively. Emtricitabine was detected in rectal tissue 30 min after dosing, whereas tenofovir was only detectable at 24 h. Ex vivo HIV infectibility assays of rectal biopsies showed partial protection after dosing (P,0.07). Discussion: A single high dose of oral tenofovir disoproxil fumarate/emtricitabine provides rapid and high blood levels of tenofovir and emtricitabine, with rapid diffusion of emtricitabine in saliva and rectal tissue.

A new approach to simulate interface damage in brittle matrix composites Alexia Este 1, Bernard Toson 1, Jacqueline Saliba 2, Jean-Christophe Mindeguia 2, Stephane Morel 2, Eric Martin 3 1 CEA-CESTA, F-33114 Le Barp, France 2 Universite de Bordeaux, UMR 5295, Institut de Mecanique et d’Ingenierie - Bordeaux (I2M), Dept. Genie Civil et Environnemental (GCE), F-33000 Bordeaux, France 3 Laboratoire des Composites Thermo-Structuraux, CNRS UMR 5801, Universite Bordeaux, F-33600 Pessac, France alexia.este@cea.fr Keywords: damage, crack deflection, fiber/matrix interface, brittle matrix composites. Abstract: Under mechanical loading, brittle matrix composites develop various damage processes which include cracking of matrix and fiber/matrix interface [1]. Cohesive zone models are widely used to model interface damage [2]. The aim of this paper is to propose an alternate approach based on a damage model associated to a diffuse meshing method. In this study, the deflection of a matrix crack at the fiber/matrix interface in a single fiber composite is simulated using CZM and the results are compared with those obtained with the new approach. The damage model requires the relation between stress and strain vectors on planes of various directions which are superposed to obtain the macroscopic strain-stress relation [3]. The damage model used was developed and implemented by S. Fichant and C. La Borderie [4,5] in the finite element modelling software Cast3M [6]. With this model, a diffuse meshing method [7] is used which consists in projecting material properties on the shape functions of a finite element mesh. At each Gauss point, the properties of the fiber, matrix or interface are assigned based on the integration point position. This meshing method allows the user to override the geometry of heterogeneities and therefore to use a regular mesh. The simulation of a tensile test (in the fiber direction) on a brittle single fiber composite is performed by using the damage model and shows a good agreement with the reference one obtained from CZM. On this basis, it is shown that the damage model is able to reproduce complex phenomenon as periodic matrix crack deflections at the fiber/matrix interface. References: 1. Evans, Zok, Davis. 1991. The role of interfaces in fiber-reinforced brittle matrix composites. Composites Science and Technology, Vol. 42, Issues 1-3: 3-24. 2. Alfano, Crisfield. 2001. Finite element interface models for the delamination analysis of laminated composites: mechanical and computational issues. International Journal for Numerical Methods in Engineering. Vol. 50, Issue 7: 1701-1736. 3. Bazant, Ozbolt. 1990. Nonlocal Microplane Model for Fracture, Damage and Size Effect in Structures. Journal of Engineering Mechanics, Vol. 116, No. 11: 2485-2505. 4. Fichant, Pijaudier-Cabot, La Borderie. 1997. Continuum damage modelling: approximation of crack induced anisotropy. Mechanics Research Communications, Vol. 24, No. 2: 109-114. 5. Fichant, La Borderie, Pijaudier-Cabot. 1999. Isotropic and anisotropic descriptions of damage in concrete structures. Mechanics of Cohesive-Frictional Materials, Vol. 4: 339-359. 6. CEA, Cast3M, http://www-cast3m.cea.fr/. 7. Daoud, Maurel, La Borderie. 2013. 2D mesoscopic modelling of bar-concrete bond. Engineering Structures, Vol. 49: 696-706.

International audience; Introduction: In the context of emerging combined prevention of HIV in France, post-exposure prophylaxis (PEP) appears to be poorly known and underutilized. This study was designed to investigate the representations and perceived barriers to PEP use and PEP follow-up. Methods: A qualitative, semi-directed interview-based exploratory study was conducted in the Rhone-Alpes region (2015) among individuals who had used PEP during the previous 12 months (n=11), individuals in whom PEP was indicated, but was not administered (n = 9), and healthcare professionals involved in PEP management (n = 9). Data were submitted to textual analysis (Iramuteq) and thematic/categorical analysis (Nvivo). Results: Data analysis indicated that the barriers to PEP access and follow-up were delayed management, a feeling of being judged, treatment adherence difficulties, inconsistent mastery of the protocol and heterogeneous professional practices. In contrast, the quality of the doctor-patient relationship and the presence of support (partner, association, doctor) appeared to be facilitating factors. The participants proposed more diverse access to PEP and training of healthcare providers. Conclusion: Two challenges were identified to improve the place of PEP in combined prevention: (1) improvement of healthcare professionals' knowledge, practices and attitudes; and (2) revision of the guidelines concerning first-line prescription, the conditions for access to PEP, and sexual health support.