Marion Mora

Expanding access to non-medicalized community-based rapid testing to men who have sex with men: an urgent HIV prevention intervention (the ANRS-DRAG study).

Background Little is known about the public health benefits of community-based, non-medicalized rapid HIV testing offers (CBOffer) specifically targeting men who have sex with men (MSM), compared with the standard medicalized HIV testing offer (SMOffer) in France. This study aimed to verify whether such a CBOffer, implemented in voluntary counselling and testing centres, could improve access to less recently HIV-tested MSM who present a risk behaviour profile similar to or higher than MSM tested with the SMOffer. Method This multisite study enrolled MSM attending voluntary counselling and testing centres’ during opening hours in the SMOffer. CBOffer enrolees voluntarily came to the centres outside of opening hours, following a communication campaign in gay venues. A self-administered questionnaire was used to investigate HIV testing history and sexual behaviours including inconsistent condom use and risk reduction behaviours (in particular, a score of “intentional avoidance” for various at-risk situations was calculated). A mixed logistic regression identified factors associated with access to the CBOffer. Results Among the 330 participants, 64% attended the CBOffer. Percentages of inconsistent condom use in both offers were similar (51% CBOffer, 50% SMOffer). In multivariate analyses, those attending the CBOffer had only one or no test in the previous two years, had a lower intentional avoidance score, and met more casual partners in saunas and backrooms than SMOffer enrolees. Conclusion This specific rapid CBOffer attracted MSM less recently HIV-tested, who presented similar inconsistent condom use rates to SMOffer enrolees but who exposed themselves more to HIV-associated risks. Increasing entry points for HIV testing using community and non-medicalized tests is a priority to reach MSM who are still excluded.

Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)

Objective Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC. Methods In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively. Results In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively). Conclusions Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence. Trial registration Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511

Uptake of PrEP and condom and sexual risk behavior among MSM during the ANRS IPERGAY trial

ABSTRACT The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM.

Association between elevated coffee consumption and daily chocolate intake with normal liver enzymes in HIV-HCV infected individuals: Results from the ANRS CO13 HEPAVIH cohort study

BACKGROUND & AIMS We used longitudinal data from the ANRS CO13 HEPAVIH cohort study of HIV-HCV co-infected individuals to investigate whether polyphenol rich food intake through coffee and/or daily chocolate consumption could play a role in reducing liver enzymes levels. METHODS Longitudinal data collection included self-administered questionnaires and medical data (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) liver enzymes). Two analyses were performed to assess the association between coffee (≥3 cups a day) and daily chocolate intake and abnormal values of AST and ALT (AST or ALT >2.5 × upper normal limit (UNL)) (N=990) over time, after adjustment for known correlates. Logistic regression models based on generalized estimating equations were used to take into account the correlations between repeated measures and estimate adjusted odds ratio. RESULTS After adjustment, patients reporting elevated coffee consumption and daily chocolate intake were less likely to present abnormal ALT (OR=0.65; p=0.04 and OR=0.57; p=0.04, for coffee and chocolate respectively), while only patients reporting elevated coffee consumption were less likely to have abnormal AST values (p=0.05). Nevertheless, the combined indicator of coffee and chocolate intake was most significantly associated with approximately 40% reduced risk of abnormal liver enzymes (p=0.003 for AST; p=0.002 for ALT). CONCLUSIONS Elevated coffee consumption and daily chocolate intake appear to be associated with reduced levels of liver enzymes in HIV-HCV co-infected patients. Further experimental and observational research is needed to better understand the role that polyphenol intake or supplementation can play on liver disease and liver injury.

Predictors of non-prescribed opioid use after one year of methadone treatment: An attributable-risk approach (ANRS-Methaville trial)

BACKGROUND The effectiveness of methadone as an opioid maintenance treatment (OMT) for opioid dependence has been widely demonstrated. However many patients continue to use other opioids while on methadone treatment. Studies assessing avoidable cases of continued non-prescribed opioid use during methadone treatment are sparse. METHODS At 12 months of treatment (M12), 158 subjects had available data on opioid use, measured using the Opiate Treatment Index. We identified variables associated with non-prescribed opioid use at M12, using a univariate logistic regression and two multivariate models, one incorporating only pre-treatment variables, the second adding the in-treatment variables. We also calculated attributable fractions for risk factors. RESULTS At M12, 32.3% of the patients had used non-prescribed opioids during the previous month. A good patient-physician relationship was the most influential factor associated with not using non-prescribed opioids after one year. Living with a heroin user after one year of treatment, using cocaine during treatment and hazardous alcohol consumption at enrolment were all associated with an increased risk of non-prescribed opioid use at M12. Analysis of attributable fractions indicated that living with a heroin user at M12 accounted for 21% of patients reporting non-prescribed opioid use at M12, while the lack of a good relationship with the physician accounted for 26%. CONCLUSIONS The attributable risk approach suggests that continued non-prescribed opioid use by a considerable proportion of individuals could potentially be reduced by improving patient-physician relationships, enhancing care for co-dependent patients and encouraging patients to modify their social network.

Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial

BackgroundIn France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT), in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU) but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA) or a hospital setting) and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment.Methods/DesignThe ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks) in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147), the other in CSAPA (n = 48). The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA.DiscussionThe ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the New Drug Application (NDA) of methadone and make methadone induction by trained primary care physicians possible.The trial is registered with the French Agency of Pharmaceutical Products (AFSSAPS) under the number 2008-A0277-48, the European Union Drug Regulating Authorities Clinical Trials.Number Eudract 2008-001338-28, the ClinicalTrials.gov Identifier: NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511.

Empowering HIV testing as a prevention tool: Targeting interventions for high-risk men who have sex with men

Abstract In France, HIV testing can be easily performed in free and anonymous voluntary counselling testing (VCT) centres. The recent national study among French men who have sex with men (MSM) showed that 73% of those already tested for HIV had been tested in the previous two years. Nothing is known about the risk behaviours of MSM attending VCT centres. This study aimed to characterize sexual risk behaviours of MSM tested for HIV in such centres and identify factors associated with inconsistent condom use (ICU). A cross-sectional study was conducted from March to December 2009 in four VCT centres where a self-administered questionnaire was proposed to all MSM about to have a HIV test. ICU was defined as reporting non-systematic condom use during anal intercourse with casual male partners. Among the 287 MSM who fully completed their questionnaire, 44% reported ICU in the previous six months. Among those who had been already tested, 63% had had their test in the previous two years. Factors independently associated with ICU included: never avoiding one-night stands, not having been recently HIV tested, experiencing difficulty in using condoms when with a HIV negative partner or when under the influence of drugs or alcohol and finally, reporting to have had a large number of casual male partners in the previous six months. The rate of recently tested MSM was high in our study. Nevertheless, this rate was lower than that found in the last national study. Furthermore those not recently tested were significantly more likely to report high risk behaviours. We therefore recommend that further efforts be made to adapt the offer of both HIV testing and counselling to meet the specific needs of hard-to-reach MSM. Accordingly, an additional community-based offer of HIV testing to reach most-at-risk MSM is forthcoming in France.

Increased Uptake of HCV Testing through a Community-Based Educational Intervention in Difficult-to-Reach People Who Inject Drugs: Results from the ANRS-AERLI Study

Aims The community-based AERLI intervention provided training and education to people who inject drugs (PWID) about HIV and HCV transmission risk reduction, with a focus on drug injecting practices, other injection-related complications, and access to HIV and HCV testing and care. We hypothesized that in such a population where HCV prevalence is very high and where few know their HCV serostatus, AERLI would lead to increased HCV testing. Methods The national multisite intervention study ANRS-AERLI consisted in assessing the impact of an injection-centered face-to-face educational session offered in volunteer harm reduction (HR) centers (“with intervention”) compared with standard HR centers (“without intervention”). The study included 271 PWID interviewed on three occasions: enrolment, 6 and 12 months. Participants in the intervention group received at least one face-to-face educational session during the first 6 months. Measurements The primary outcome of this analysis was reporting to have been tested for HCV during the previous 6 months. Statistical analyses used a two-step Heckman approach to account for bias arising from the non-randomized clustering design. This approach identified factors associated with HCV testing during the previous 6 months. Findings Of the 271 participants, 127 and 144 were enrolled in the control and intervention groups, respectively. Of the latter, 113 received at least one educational session. For the present analysis, we selected 114 and 88 participants eligible for HCV testing in the control and intervention groups, respectively. In the intervention group, 44% of participants reported having being tested for HCV during the previous 6 months at enrolment and 85% at 6 months or 12 months. In the control group, these percentages were 51% at enrolment and 78% at 12 months. Multivariable analyses showed that participants who received at least one educational session during follow-up were more likely to report HCV testing, compared with those who did not receive any intervention (95%[CI] = 4.13[1.03;16.60]). Conclusion The educational intervention AERLI had already shown efficiency in reducing HCV at-risk practices and associated cutaneous complications and also seems to have a positive impact in increasing HCV testing in PWID.

Suicidal risk among patients enrolled in methadone maintenance treatment: HCV status and implications for suicide prevention (ANRS Methaville).

BACKGROUND Suicide is a critical issue among opioid users. The aim of this study was to assess the relationship between HCV status and suicidal risk in patients receiving methadone treatment. METHODS We used data from Methaville, a multicenter, pragmatic randomized trial designed to evaluate the feasibility of methadone induction in primary care compared with induction in specialized centers. Suicidal risk was assessed at enrollment and after one year of methadone treatment using the suicidality module in the MINI International Neuropsychiatric Interview. Socio-demographic characteristics, drug and alcohol consumption, behavioral and personality factors, history of drug use and health indicators were also assessed. RESULTS A total of 195 individuals were enrolled from January 2009 to December 2010. Suicidal risk assessment was available at month 0 (M0) and M12 for 159 (72%) and 118 (73%) individuals, respectively. Forty-four (28%) were at risk of suicide at M0 and 17 (14%) at M12 (p=0.004). One patient attempted suicide by overdose during the one-year follow-up. The following three factors were associated with suicidal risk: hepatitis C virus (HCV) positive status (OR [95%CI]=17.25 [1.14-161.07]; p=0.04), receiving food assistance (OR [95%CI]=0.05 [0.00-1.05]; p=0.05) and a higher number of health problems (OR [95%CI]=1.24 [1.08-1.44]; p=0.003). CONCLUSIONS Special attention should be given to HCV-positive patients through suicidal risk prevention strategies and routine suicide assessment as part of a comprehensive approach to prevention and care for opioid users. Our results represent a new and powerful argument for the expansion of access to HCV treatment to drug users with chronic infection.

Factors associated with HCV risk practices in methadone-maintained patients: the importance of considering the couple in prevention interventions

BackgroundOne important public health issue associated with opioid use today is the risk of hepatitis C (HCV) infection. Although methadone maintenance may help to decrease HCV-related risk practices, HCV risk behaviors persist and are strongly associated with specific substance use patterns, mental status and social context. The ANRS-Methaville study gave us the opportunity to better disentangle the different relationships between these various factors and HCV risk practices.MethodsThe ANRS-Methaville multisite randomized trial was designed to assess the feasibility of initiating methadone in primary care by comparing it with methadone initiation in specialized centers. This study recruited 195 participants initiating methadone maintenance and followed up for 12 months. Longitudinal data from this trial was used to acquire a greater understanding of HCV risk practices and their pattern of correlates in this population. We selected 176 patients who had data on HCV risk practices at M0 and M12, accounting for 312 visits. HCV risk practices were defined as follows: sharing needles or syringes, sharing drug paraphernalia, getting a tattoo or having a piercing in a non-professional context, sharing toiletry items. To identify factors associated with HCV risk practices, we performed a mixed logistic regression analysis.ResultsHCV risk practices were reported by 19% and 15% of participants at baseline and M12, respectively. After adjustment for age, cocaine use and alcohol dependence as well as suicidal risk, living in a couple with a non-drug user and in a couple with a drug user were both independent predictors of HCV risk practices (OR[CI95%] = 4.16 [1.42-12.12]; OR[CI95%] = 9.85 [3.13-31.06], respectively).ConclusionsIdentifying individuals at risk of HCV transmission during methadone treatment such as stimulant users, alcohol dependent individuals, and those at suicidal risk is necessary to optimize response to treatment. Innovative prevention approaches tailored to couples are also urgently needed and could decrease HCV-risk in this population.The trial is registered with the French Agency of Pharmaceutical Products (ANSM) under the number 2008-A0277-48, the European Union Drug Regulating Authorities Clinical Trials. Number Eudract 2008-001338-28, the ClinicalTrials.gov Identifier: NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511.