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Abstract Background Besides the high prevalence of HIV and HCV infections, people who inject drugs (PWID) have a cumulative risk of acquiring skin and soft tissue infections (SSTI) from, among other things, social precariousness, homelessness/unstable housing, and unhygienic injecting practices. We propose to evaluate whether a two-component educational hand hygiene intervention which combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB, is effective in reducing injection-related abscesses in the PWID population. Specifically, we shall implement a nationwide, two-arm, multi-centre, cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of this intervention in PWID. Methods HAWA is a community-based participatory research study to be conducted in 22 harm reduction centres (HR) in France (not yet recruiting); the latter will be randomised into two clusters: centres providing standard HR services and the intervention (i.e., intervention group) and those providing standard HR services only (i.e., control group). After randomization, each cluster will include 220 PWID, with an inclusion period of 12 months and an individual follow-up period of 6 months. For each participant, we will collect data at M0, M3 and M6 from photos of injection sites on the participant’s body, a face-to-face injection-related SSTI questionnaire, and a CATI questionnaire. The primary outcome is the reduction in abscess prevalence between M0 and M6, which will be compared between the control and intervention arms, and measured from observed (photographs) and self-declared (SSTI questionnaire) data. We will also assess the cost-effectiveness of the intervention. Discussion The HAWA trial will be the first cluster randomized controlled trial to improve hand hygiene among PWID with a view to reducing SSTI. If effective and cost-effective, the intervention combined with the distribution of MONO-RUBs (or a similar cleaning product) may prove to be an important HR tool, helping to reduce the enormous burden of infection-related deaths and diseases in PWID. Trial Registration NCT06131788, received on 2 January 2024.

ABSTRACTVaccination coverage against hepatitis A virus (HAV), hepatitis B virus (HBV), and human papillomaviruses (HPV) is insufficient among men who have sex with men (MSM), partly because of their high prevalence of vaccine hesitancy (VH) specific to these vaccines. This study aimed to investigate determinants of specific VH in MSM, focusing on characteristics of their sexual activity, propensity to use prevention tools and medical care, disclosure of sexual orientation to health care professionals (HCPs), and perceived stigmatization. A cross-sectional electronic survey (February – August 2022) collected perceptions of HBV, HAV, and HPV, and of their respective vaccines among 3,730 French MSM and enabled the construction of a specific VH variable. Using agglomerative hierarchical cluster analysis, we constructed a typology of MSM sexual and prevention practices. We identified three MSM clusters (low- (C1, 24%), moderate- (C2, 41%), and high- (C3, 35%) “sexual activity/medical engagement”) that showed an increasing gradient in the use of medical prevention with regular medical care and exposure to high-risk sexual practices. A multiple ordinal logistic regression showed that overall specific VH was higher in the C1 cluster and in men who had not informed their physician of their sexual orientation. This typology could usefully help to adapt vaccination communication strategies for MSM prevention program according to patients’ profiles. HCPs should be encouraged and trained to ask men about their sexual practices and to provide appropriate vaccination recommendations nonjudgmentally.

Abstract Background 3-methylmethcathinone (3-MMC) has been available on the European drug market for several years, but an increase in its availability seems to have occurred around 2020, associated with reports of harm and death. We aimed to analyze the composition of the supposed 3-MMC samples purchased and its concordance with the assumed composition of the drug. Methods A prospective multicenter (n = 6) study was conducted between February 2021 and September 2021 in Auvergne-Rhone-Alpes, France. The inclusion criteria were: 3-MMC users over 18 years of age in contact with a community-based organization (CBO) called AIDES. Consumption was evaluated with an anonymized questionnaire and samples of 3-MMC powder were analyzed with a combination of qualitative (GC–MS) and quantitative methods (UPLC-MS/MS), to compare the assumed and real compositions of the products purchased. Results We studied 45 samples provided by 33 users. The study population was predominantly male (91%), with a median age of 40 years, most were university graduates and regular users of 3-MMC. Intravenous drug use was reported by 15.2% of the population. Most of the users bought their 3-MMC online via the Clear Web. Drug testing was requested by 86% of the users, highlighting the need for this type of harm reduction strategy. The purity of the 3-MMC powder samples tested ranged from 21 to 98%. Other NPS drugs, such as 4-CEC (4-chloroethcathinone), 4-MMC, and 2-fluorodeschloroketamine (2-FDCK), supplied as methoxphenidine (MXP), were also detected. Conclusion This prospective study shows that 3-MMC purity and dose vary considerably. It also describes the characteristics of 3-MMC users and their expectations of a drug-checking program. Our data suggest that drug-checking services may be useful in this population. Health associations and laboratories should work together to help increase access to such programs.

Abstract Background Hepatitis C virus (HCV) infection prevalence is particularly high in people who inject drugs (PWID), a population that faces many barriers to HCV testing and care. A better understanding of the determinants of access to HCV testing is needed to improve their engagement in the HCV care cascade. We used data from a cross-sectional survey of people who inject drugs, mainly opioids, to identify factors associated with recent HCV testing. Methods Self-reported data on HCV antibody testing were analyzed for 550 of the 557 PWID enrolled in PrebupIV, a French cross-sectional community-based survey which assessed PWID acceptability of injectable buprenorphine as a treatment. Factors associated with recent (i.e., in the previous six months) HCV antibody testing were identified performing multivariable logistic regression. Results Among the study sample, 79% were men and 31% reported recent HCV antibody testing. Multivariable analysis found that PWID who did not disclose their injection practices to anyone (aOR [95% CI] 0.31 [0.12,0.82], p = 0.018), older PWID (aOR [95% CI] 0.97 [0.95,1.00], p = 0.030) and employed respondents (aOR [95% CI] 0.58 [0.37,0.92], p = 0.019) were all less likely to report recent HCV testing. No association was found between opioid agonist therapy and HCV testing. Conclusions Our findings suggest that non-disclosure of injection practices, employment and age were all barriers to HCV antibody testing. Preventing stigma around injection practices, developing the HCV testing offer in primary care and addiction care services, and training healthcare providers in HCV care management could improve HCV testing and therefore, the HCV care cascade in PWID.

IntroductionGiven the high infection rate of sexually transmitted infections (STI) among migrant women sex workers (WSWs), it is necessary to understand how to improve prevention, information and care for this vulnerable population. Community health workers (CHWs), by linking community to health services, are positioned to improve health outcomes in migrant communities. This article aims to describe a pilot innovative intervention performed by CHWs to improve sexual health in migrant WSWs.MethodsThis one-year intervention study used a respondent-driven sampling (RDS) to recruit a representative cohort of migrant WSWs in Marseille, France. Four CHWs were recruited from different communities and participated in all stages of the research. They performed individual and group interventions of prevention, support in care and empowerment. Data on participant characteristics, type of intervention and adherence to the intervention were reported via questionnaires given to participants. Simultaneously, semi-structured interviews and informal interviews of migrant WSW, CHWs and care providers were carried out.ResultsA total of 132 migrant WSWs were included in the cohort. Very few of them knew about PrEP (12%) or already used HIV post-exposure treatment (9%). Migrant WSWs were often victims of rape or racism, 15 and 21%, respectively. In two-thirds of cases the level of health literacy was low. Participants suffered from a combination of vulnerability factors: difficulties with access to social rights, food or housing. Only 13% reported having benefited from medical follow-up or assistance by an NGO in the 3 months prior to the program. By 3 months, more than one third of the participants had been tested for HIV (35%) and 63% knew about PrEP. A total retention rate of 70% was reported in the cohort after 6 months.ConclusionCHWs enabled to improve care access for migrant WSWs by improving the collaboration between care and social actors at a local level. Through these “bring-back-to” interventions for this hard-to-reach population, CHWs enabled an optimization of the care pathway. Our results also highlight the importance of a population-based approach for individual and group support of empowerment interventions in order to strengthen their capacity for action.

IntroductionClinical research has focused on risk factors and treatment for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), particularly in people with a comorbidity including the human immunodeficiency virus (HIV), but little attention has been paid to the care pathway. This article aims to show how living with HIV may have been a biopsychosocial burden or boost in care pathways for Covid-19.MethodPeople living with HIV (PLHIV) from 9 clinical centers were invited to participate in this qualitative study. The sampling was purposive with a maximum variation in their sociodemographic profiles. Semi-structured interviews were conducted until data saturation, then coded for thematic analysis, using an inductive general approach.ResultsWe interviewed 34 PLHIV of which 20 had SARS-COV-2 once. They were 24 males, 26 born in France; median age: 55. Twenty had a CD4 number above 500, and all were on antiretroviral therapy (ART). HIV appeared as a burden when Covid-19 symptoms reminded HIV seroconversion, fear of contamination, and triggered questions about ART effectiveness. HIV was not considered relevant when diagnosing Covid-19, caused fear of disclosure when participants sought SARS-COV-2 testing, and its care in hospitals was disrupted by the pandemic. ART-pill fatigue caused avoidance for Covid-19 treatment. As a boost, living with HIV led participants to observe symptoms, to get advice from healthcare professionals, and screening access through them. Some participants could accept the result of screening or a clinical diagnosis out of resilience. Some could consider ART or another drug prescribed by their HIV specialist help them to recover from Covid-19.ConclusionLiving with HIV could function as a burden and/or a boost in the care pathways for Covid-19, according to patients' relationship to their HIV history, comorbidities and representation of ART. Covid-19 in PLHIV needs further qualitative study to gain a more comprehensive assessment of the pandemic's consequences on their lives and coping strategies.

ABSTRACTIn developed countries, vaccinations against hepatitis B (HBV), hepatitis A (HAV), and human papillomavirus (HPV) are often recommended to men who have sex with men (MSM) because of the risky sexual practices in which some engage. Vaccine coverage against these diseases is not optimal in France, probably due in part to vaccine hesitancy (VH). The overall aim of this survey among MSM was to estimate the prevalence of different grades of VH for these vaccines as well as of general VH (toward any vaccine). The specific objectives were to study the sociodemographic correlates of MSM specific and general VH and its association with vaccine uptake. A cross-sectional electronic survey (February–August 2022) collected information from 3,730 French MSM about their perceptions of HBV, HAV, and HPV and their related vaccines, to construct “specific VH” variables. Information about their past vaccination behaviors for any vaccine was used to construct a “general VH” variable, based on the World Health Organization definition. Almost 90% of MSM showed moderate or high specific VH for HBV, HAV, and/or HPV, and 54% general VH. A higher education level and comfortable financial situation were associated with lower grades of specific and general VH. Younger age was associated with less frequent specific VH and more frequent general VH. Specific VH, versus general, was more strongly associated with frequent self-reported non-vaccination against these three disease. Addressing their concerns about vaccines, improving their knowledge of vaccine-preventable sexually transmitted infections, and motivating them to get vaccinated are public health priorities.

BackgroundThe World Health Organization recommends pre-exposure prophylaxis (PrEP) for all populations at substantial risk of HIV infection. However, at-risk women very rarely use PrEP in France—this represents a critical issue among migrant women sex workers (MWSWs). Previous studies on PrEP use among women sex workers or migrants focused on individual or social determinants of motivation. However, operational studies in real-word settings using a holistic population approach to maximize PrEP adherence among MWSWs are lacking. ObjectiveFASSETS (ie, “Favoriser l’Accès à la Santé Sexuelle des Travailleuses du Sexe”; English: “facilitate the access to Sexual Health in women sex workers”) is a participative, multilevel, mixed methods study aiming to improve global knowledge of and access to sexual health care and PrEP among MWSWs through targeted empowerment strategies. MethodsThis study comprises several phases: (1) phase 1: an initial qualitative study combining semistructured interviews, informal interviews, and participative observations will be performed among MWSWs, local community nongovernmental organizations, and institutions providing sexual reproductive health services to identify the determinants of PrEP access among MWSWs and for respondent-driven sampling (RDS); (2) phase 2: the size of the hidden MWSW population is estimated in Marseille through capture-recapture (the RDS survey will serve as “recapture”); (3) phase 3: a longitudinal cohort will be formed through RDS to represent the MWSW population with a goal of 150 inclusions—this cohort will be followed up for 12 months, and sequential questionnaires exploring medical history; knowledge of sexual health, HIV, and sexually transmitted infections; migration route; and current living conditions will be administered at inclusion (month 0) and months 3, 6, and 12 to measure the following interventional phase’s outcomes; and (4) phase 4: an interventional study with community empowerment actions about sexual health and PrEP will be conducted with community health workers; standardized questionnaires and semistructured interviews, observations, and focus groups will highlight MWSWs’ experiences with empowerment resources, concerns about sexual health, and especially PrEP use or uptake, and we will evaluate whether and how community-adapted empowerment actions conducted by community health workers are effective in increasing access to sexual health, prevention and screening of sexually transmitted infections, and PrEP knowledge and access among MWSWs. ResultsRecruitment commenced on March 1, 2022. We estimate the follow-up period to end on September 30, 2023. ConclusionsThis multiphase study will provide robust evidence about the magnitude of the MWSW population in Marseille (the second largest town in France) and their current conditions of living, access to and knowledge of sexual health, and PrEP access. Using a mixed methods analysis, we will investigate whether individual and collective community health empowerment approaches can facilitate access to PrEP and its initiation, use, and adherence in this vulnerable population. International Registered Report Identifier (IRRID)DERR1-10.2196/42844

Abstract 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.

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.

Heterogeneity of therapeutic Monoclonal antibody (mAb) drugs are due to protein variants generated during the manufacturing process. These protein variants can be critical quality attributes (CQAs) depending on their potential impact on drug safety and/or efficacy. To identify CQAs and ensure the drug product qualities, a thorough characterization is required but challenging due to the complex structure of biotherapeutics. Past characterization studies for basic and acidic variants revealed that full characterizations were limited to the basic charge variants, while the quantitative measurements of acidic variants left gaps. Consequently, the characterization and quantitation of acidic variants are more challenging. A case study of a therapeutic mAb1 accounted for two-thirds of the enriched acidic variants in the initial characterization study. This led to additional investigations, closing the quantification gaps of mAb1 acidic variants. This work demonstrates that a well-designed study with the right choices of analytical methods can play a key role in characterization studies. Thus, the updated strategies for more complete antibody charge variant characterization are recommended.

Abstract Mutations in the tumor suppressor gene BRCA2 (BReast CAncer susceptibility gene 2) predispose carriers to breast, ovarian, and other cancers. In response to DNA damage, BRCA2 participates in homology‐directed DNA damage repair to maintain genome stability. Genome‐wide association studies have identified an association between BRCA2 single nucleotide polymorphisms and plasma‐lipid levels and lipid deregulation in humans. To date, DNA damage, apoptosis, and lipid deregulation are recognized as central pathways for endothelial dysfunction and atherosclerosis; however, the role of BRCA2 in endothelial dysfunction remains to be elucidated. To determine the role of BRCA2 in endothelial dysfunction, BRCA2 was silenced in human umbilical vein endothelial cells (ECs) and assessed for markers of DNA damage, apoptosis, and endothelial function following oxidized low‐density lipoprotein (oxLDL) treatment. OxLDL was found to induce significant reactive oxygen species (ROS) production in BRCA2‐silenced ECs. This increase in ROS production was associated with exacerbated DNA damage evidenced by increased expression and activation of DNA double‐stranded break (DSB) marker γH2AX and reduced RAD51‐foci formation—an essential regulator of DSB repair. Increased DSBs were associated with enhanced expression and activation of pro‐apoptotic p53 and significant apoptosis in oxLDL‐treated BRCA2‐silenced ECs. Loss of BRCA2 in ECs was further associated with oxLDL‐induced impaired tube‐forming potential and eNOS expression. Collectively, the data reveals, for the first time, a novel role of BRCA2 as a regulator of EC survival and function in the setting of oxLDL treatment in vitro. Additionally, the data provide important clues regarding the potential susceptibility of BRCA2 mutation carriers to endothelial dysfunction, atherosclerosis, and other cardiovascular diseases.

Drawing on interviews with fourteen women patients experiencing sexual difficulties and having consulted a sexologist, this article analyzes the role of coupledom in their experience. Specifically, the data reveal that relationship issues are the underlying causes for their sexology consultations and that they interrupt their sexuality through the lens of coupledom, as do to many of their peers. However, analyzing their explanations for their decisions to see a sexologist, the article shows that these women mobilize two registers drawing on two distinct perspectives about sexuality to justify themselves. First, they usually use a register of “necessity.” They resort to sexology in direct response to the perceived threat that their relationship will end because of a lack of sex, which either goes against an egalitarian ideal they have of sexuality in a relationship, or because they think it may lead to infidelity. Then, usually later in the interview, they use a register of “intention.” They talk of their choice as a project in their relationships, which is part of a larger strategy of constructing and managing their couples.