Enhancing sexual health and empowerment among migrant women sex workers: a community health worker-led intervention in Marseille, France.

Introduction: Given 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. Methods: This 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. Results: A 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. Conclusion: CHWs 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.

Advantages and limits of remote consultations for HIV pre-exposure prophylaxis health pathway: ePrEP qualitative study.

OBJECTIVE: Because of a high rate of HIV diagnosis and restricted medical access in the Centre-Val de Loire region in France , remote consultations (RC) with a community-based approach has been implemented to promote access to healthcare. Our study aimed to determine whether RC could improve access to pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of the healthcare pathway associated with PrEP. MATERIALS AND METHODS: A qualitative approach involving semi-structured interviews with 17 MSM and 3 physicians from specialized sexual health centres was performed, with a mean duration of interview over one hour. The research focused on the health pathway associated with PrEP, from initial awareness to ongoing prescription and follow-up. RESULTS: Transitioning PrEP consultations to RC is feasible, but concerns about a potential decline in care quality compared to traditional sexual health centres follow-ups were noted. Both MSM and physicians recognized that RC could complement face-to-face approaches, especially in terms of organizational benefits. In rural areas, access to specialists through RC was seen as a partial solution, though it could be hindered by barriers in accessing laboratory testing and pharmacy services, like fear of stigmatization. More generally, distrust of medication and the difficulty of discussing sexuality with a GP were highlighted, which could limit the uptake of PrEP without access to specialists. CONCLUSIONS: The initiation and uptake of PrEP among MSM are more effectively influenced by initiatives that provide information, reassurance, and facilitate initial procedures, rather than solely through RC. A strategy combining digital and community-based approaches, along with medical expertise, is recommended to increase PrEP utilization among MSM.

Questioning the "Ease" in disease: Was living with HIV a burden or boost during the first wave of Covid-19 in France? A qualitative study (COVIDHIV).

INTRODUCTION: Clinical 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. METHOD: People 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. RESULTS: We 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. CONCLUSION: Living 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.

When awareness is not a barrier to PrEP uptake among men who have sex with men who are eligible for PrEP in France.

Despite PrEP being available and free of charge in France, a gap remains between the estimated number of men who have sex with men (MSM) with high-risk exposure to HIV and the number of MSM PrEP users. The objective of this study is to identify factors associated with non-intention to use PrEP among PrEP-eligible and PrEP-aware MSM in France, "non-intenders".European MSM Internet Survey (EMIS)-2017 was a cross-sectional survey conducted among MSM concerning their HIV prevention needs. Logistic regression models were used to identify factors associated with "non-intenders".Compared to PrEP users, factors associated with non-intention to use PrEP were: age (aOR[95%CI] = 3.80[2.21;6.53]); not being vaccinated against hepatitis B (2.20[1.45;3.34]); self-efficacy (1.84[1.29;2.60]); lower knowledge about on-demand PrEP (11.48[7.37;17.87]) and daily PrEP (2.58[1.27;5.25]); not having a PrEP discussion at a hospital (12.39[8.90;17.27]) or at a community service/drop-in (4.93[3.48;6.97]); living in a department with few PrEP access points (1.70[1.10;2.63]).On-demand PrEP may meet the prevention needs of "non-intenders" who have lower HIV risk perception. Increasing communication from health providers and community health workers to all MSM is needed.

Gradient of vaccine hesitancy among French men having sex with men: An electronic cross-sectional survey in 2022.

In 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.

[Unsafe practices fostering cutaneous abscesses in people who inject substances : Results from the ANRS-OUTSIDER study]. / Des pratiques à risque favorisant la survenue d'abcès cutanés chez les personnes qui injectent des substances : résultats de l'étude ANRS-OUTSIDER.

INTRODUCTION: Cutaneous abscesses are a common complication of intravenous substance use. Although these skin and soft tissue infections represent one of the main causes of emergency room visits and hospitalizations in people who inject drugs (PWID), data on their prevalence and causes are scarce. The present study was part of the larger ANRS-OUTSIDER project and aimed to study the factors associated with skin abscesses in PWID, focusing in particular on the different stages of injection. METHOD: Analyses were based on data of the 164 persons who regularly injected psychoactive substances participating in the French ANRS-OUTSIDER project. A face-to-face questionnaire collected data on sociodemographics, substance use, injection practices, and experience of skin abscesses in the previous six months. Factors associated with skin abscesses were studied using a logistic regression model. RESULTS: Of the 140 participants for whom abscess data were recorded at inclusion, 35% reported having a skin abscess in the previous six months. Factors associated with skin abscesses were: benefiting from universal health coverage (PUMA/CMU/AME) (Odd ratio (OR) = 0.28, confidence interval (CI) à 95%=0.08-0.99), finding the vein to inject by touch (OR=3.44, 95% CI=1.41-8.43) and licking the needle before injection (OR=5.16, 95% CI=1.10-24.30). CONCLUSION: Our results highlight that skin abscesses were very frequent among the complications observed in our sample of French PWID, and that certain injection practices fostered their occurrence. These data will provide stakeholders with useful information to improve prevention and harm reduction messages for PWID.

Effectiveness of a Community Empowerment Intervention to Improve Access to Pre-exposure Prophylaxis in Migrant Women Sex Workers: Protocol for a Mixed Methods Implementation Study.

BACKGROUND: The 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. OBJECTIVE: FASSETS (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. METHODS: This 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. RESULTS: Recruitment commenced on March 1, 2022. We estimate the follow-up period to end on September 30, 2023. CONCLUSIONS: This 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.

NPAideS: a drug-checking study among 3-methylmethcathinone (3-MMC) users.

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.

Non-disclosure of drug injection practices as a barrier to HCV testing: results from the PrebupIV community-based research study.

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.

Loss of fatty acid binding protein 3 ameliorates lipopolysaccharide-induced inflammation and endothelial dysfunction.

Circulating fatty acid-binding protein 3 (FABP3) is an effective biomarker of myocardial injury and peripheral artery disease (PAD). The endothelium, which forms the inner most layer of every blood vessel, is exposed to higher levels of FABP3 in PAD or following myocardial injury, but the pathophysiological role of endothelial FABP3, the effect of FABP3 exposure on endothelial cells, and related mechanisms are unknown. Here, we aimed to evaluate the pathophysiological role of endothelial FABP3 and related mechanisms in vitro. Our molecular and functional in vitro analyses show that (1) FABP3 is basally expressed in endothelial cells; (2) inflammatory stress in the form of lipopolysaccharide (LPS) upregulated endothelial FABP3 expression; (3) loss of endogenous FABP3 protected endothelial cells against LPS-induced endothelial dysfunction; however, exogenous FABP3 exposure exacerbated LPS-induced inflammation; (4) loss of endogenous FABP3 protected against LPS-induced endothelial dysfunction by promoting cell survival and anti-inflammatory and pro-angiogenic signaling pathways. Together, these findings suggest that gain-of endothelial FABP3 exacerbates, whereas loss-of endothelial FABP3 inhibits LPS-induced endothelial dysfunction by promoting cell survival and anti-inflammatory and pro-angiogenic signaling. We propose that an increased circulating FABP3 in myocardial injury or PAD patients may be detrimental to endothelial function, and therefore, therapies aimed at inhibiting FABP3 may improve endothelial function in diseased states.

Rapid multi-attribute characterization of intact bispecific antibodies by a microfluidic chip-based integrated icIEF-MS technology.

Rapid, direct identification and quantitation of protein charge variants, and assessment of critical quality attributes with high sensitivity are important drivers required to accelerate the development of biotherapeutics. We describe the use of an enhanced microfluidic chip-based integrated imaged capillary isoelectric focusing-mass spectrometry (icIEF-MS) technology to assess multiple quality attributes of intact antibodies in a single run. Results demonstrate comprehensive detection of multiple charge variants of an aglycosylated knob-into-hole bispecific antibody. Upfront, on-chip separation by icIEF coupled to MS provides the orthogonal separation required to resolve and identify acidic posttranslational modifications including difficult-to-detect deamidation and glycation events at the intact protein level. In addition, on-chip UV detection enables pI determination and relative quantitation of charge isoforms. Six charge variant peaks were resolved by icIEF, mobilized toward the on-chip electrospray tip and directly identified by in-line icIEF-MS using a connected quadrupole time-of-flight mass spectrometer. In addition to acidic charge variants, basic variants were identified as C-terminal lysine, N-terminal cyclization, proline amidation, and the combination of modifications (not typically identified by other intact methods), including lysine and one or two hexose additions. Nonspecific chain cleavages were also resolved, along with their acidic charge variants, demonstrating highly sensitive and comprehensive intact antibody multi-attribute characterization within a 15-min run time.

Étude qualitative de l'acceptabilité de la téléconsultation pour le traitement préventif du VIH.

Introduction : In France, the incidence of HIV infections remains at 6,000 infections a year. Pre-Exposure Prophylaxis (PrEP) could reduce this number. Despite available reimbursement since 2016 to exposed populations, the recipients remain mostly men who have sex with men (MSM) living in large cities. In Center-Val de Loire, where newly HIV diagnoses and difficulties of access to care are tremendous, community tele-support and dedicated teleconsultations have been launched to promote access, particularly in rural areas. This study aimed to identify the interests and limits of these teleconsultations for PreP users.Purpose of research : E-PrEP qualitative study conducted by semi-structured interviews with MSM PrEP users allowing the thematic analysis of eight interviews lasting an average of one hour, conducted with MSM taking at least one teleconsultation.Results : The teleconsultation met user expectations with good acceptability. It integrated naturally into the associated preventive care pathway where applicable. The description of a more impersonal face-to–face exchange is balanced by establishing a trusting relationship. Teleconsultation has sometimes eased talking about sexuality. An enhanced confidentiality could represent a specific motif to choose teleconsultation. Access to the specialist seems to be an asset compared to a GP follow-up hardly chosen for this type of consultation. Fears of lack of discretion or judgmental behavior from these unspecialized healthcare professionals were pronounced..Conclusions : The deployment of teleconsultations can be encouraged to facilitate access to PrEP with vigilance on the associated health path.

Challenges and Strategies for a Thorough Characterization of Antibody Acidic Charge Variants.

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.

Endothelial cell-specific loss of eNOS differentially affects endothelial function.

The endothelium maintains and regulates vascular homeostasis mainly by balancing interplay between vasorelaxation and vasoconstriction via regulating Nitric Oxide (NO) availability. Endothelial nitric oxide synthase (eNOS) is one of three NOS isoforms that catalyses the synthesis of NO to regulate endothelial function. However, eNOS's role in the regulation of endothelial function, such as cell proliferation and migration remain unclear. To gain a better understanding, we genetically knocked down eNOS in cultured endothelial cells using sieNOS and evaluated cell proliferation, migration and also tube forming potential in vitro. To our surprise, loss of eNOS significantly induced endothelial cell proliferation, which was associated with significant downregulation of both cell cycle inhibitor p21 and cell proliferation antigen Ki-67. Knockdown of eNOS induced cell migration but inhibited formation of tube-like structures in vitro. Mechanistically, loss of eNOS was associated with activation of MAPK/ERK and inhibition of PI3-K/AKT signaling pathway. On the contrary, pharmacologic inhibition of eNOS by inhibitors L-NAME or L-NMMA, inhibited cell proliferation. Genetic and pharmacologic inhibition of eNOS, both promoted endothelial cell migration but inhibited tube-forming potential. Our findings confirm that eNOS regulate endothelial function by inversely controlling endothelial cell proliferation and migration, and by directly regulating its tube-forming potential. Differential results obtained following pharmacologic versus genetic inhibition of eNOS indicates a more complex mechanism behind eNOS regulation and activity in endothelial cells, warranting further investigation.

Transcriptomics of angiotensin II-induced long noncoding and coding RNAs in endothelial cells.

OBJECTIVE: Angiotensin II (Ang II)-induced endothelial dysfunction plays an important role in the pathogenesis of cardiovascular diseases such as systemic hypertension, cardiac hypertrophy and atherosclerosis. Recently, long noncoding RNAs (lncRNAs) have been shown to play an essential role in the pathobiology of cardiovascular diseases; however, the effect of Ang II on lncRNAs and coding RNAs expression in endothelial cells has not been evaluated. Accordingly, we sought to evaluate the expression profiles of lncRNAs and coding RNAs in endothelial cells following treatment with Ang II. METHODS: Human umbilical vein endothelial cells (HUVECs) were cultured and treated with Ang II (10-6 mol/l) for 24 h. The cells were then profiled for the expression of lncRNAs and mRNAs using the Arraystar Human lncRNA Expression Microarray V3.0. RESULTS: In HUVECs following Ang II treatment, from a total of 30 584 lncRNA targets screened, 25 targets were significantly upregulated, while 69 were downregulated. In the same HUVECs samples, from 26 106 mRNA targets screened, 28 targets were significantly upregulated and 67 were downregulated. Of the differentially expressed lncRNAs, RP11-354P11.2 and RP11-360F5.1 were the most upregulated (11-fold) and downregulated (three-fold) lncRNAs, respectively. Assigning the differentially regulated genes into functional groups using bioinformatics reveals numerous genes involved in the nucleotide excision repair and ECM-receptor interaction. CONCLUSION: This is the first study to profile the Ang II-induced differentially expressed lncRNAs and mRNAs in human endothelial cells. Our results reveal novel targets and substantially extend the list of potential candidate genes involved in Ang II-induced endothelial dysfunction and cardiovascular diseases.

La recherche communautaire en temps de pandémie : retour sur l'étude multi-pays EPIC.

In 2020, the COVID-19 health crisis affected all regions of the world, not sparing people already vulnerable to other viral epidemics such as HIV or HCV and/or those in precarious or socially marginalized situations. This is particularly the case for drug users or sex workers.Coalition PLUS, a network of associations fighting against HIV and viral hepatitis which defends and promotes the community-based approach, and its partners, have set up a multi-country community-based research project aimed at documenting the impact of the health crisis on the fight against HIV and viral hepatitis (key populations and community workers/activists), as well as the community responses put in place (EPIC survey).The objective of this paper is to reflect on the implementation of this community-based research study during the COVID-19 health crisis, and in particular the unforeseen difficulties to which the community-based research process had to confront and adapt. The goal is to draw lessons on what worked (and what did not work) in order to capitalize on community-based research practices during this pandemic and subsequently, facilitate the implementation of new research projects in similar contexts.

Global intercompany assessment of ICIEF platform comparability for the characterization of therapeutic proteins.

An international team spanning 19 sites across 18 biopharmaceutical and in vitro diagnostics companies in the United States, Europe, and China, along with one regulatory agency, was formed to compare the precision and robustness of imaged CIEF (ICIEF) for the charge heterogeneity analysis of the National Institute of Standards and Technology (NIST) mAb and a rhPD-L1-Fc fusion protein on the iCE3 and the Maurice instruments. This information has been requested to help companies better understand how these instruments compare and how to transition ICIEF methods from iCE3 to the Maurice instrument. The different laboratories performed ICIEF on the NIST mAb and rhPD-L1-Fc with both the iCE3 and Maurice using analytical methods specifically developed for each of the molecules. After processing the electropherograms, statistical evaluation of the data was performed to determine consistencies within and between laboratory and outlying information. The apparent isoelectric point (pI) data generated, based on two-point calibration, for the main isoform of the NIST mAb showed high precision between laboratories, with RSD values of less than 0.3% on both instruments. The SDs for the NIST mAb and the rhPD-L1-Fc charged variants percent peak area values for both instruments are less than 1.02% across different laboratories. These results validate the appropriate use of both the iCE3 and Maurice for ICIEF in the biopharmaceutical industry in support of process development and regulatory submissions of biotherapeutic molecules. Further, the data comparability between the iCE3 and Maurice illustrates that the Maurice platform is a next-generation replacement for the iCE3 that provides comparable data.

Impact of the early 2020 COVID-19 crisis and lockdown on PrEP use among men who have sex with men (MSM) in France.

OBJECTIVE: To describe changes in pre-exposure prophylaxis (PrEP) use during and following the COVID-19 lockdown in France (March-May 2020) and identify the factors associated with PrEP discontinuation among men who have sex with men (MSM) after the lockdown. METHODS: Data from the, an anonymous, cross-sectional internet survey among MSM in July 2020, were analysed. Among respondents who were using PrEP prior to the lockdown, a binary logistic regression model was used to compare participants who were still taking PrEP (current PrEP users) with those who were not taking PrEP at the time of the survey (former PrEP users). RESULTS: Among 8345 respondents, 946 were PrEP users before the lockdown, of whom 58.8% (n=556) reported stopping PrEP during the lockdown and 15.4% (n=146) were not using PrEP at the time of the survey. Among the 556 who stopped PrEP during lockdown, 86.5% (n=481) reported no sexual activity; 76.8% (n=427) restarted PrEP after lockdown. Former PrEP users were more likely to be younger, not living with a stable male sexual partner, report moderate anxiety, report increased psychoactive drug use during the lockdown, and report not having tested for HIV or STI since the end of the lockdown because they did not know where to go, preferred to wait or for another reason. Reporting fewer male sexual partners in the last 6 months was also significantly associated with being a former PrEP user. CONCLUSIONS: MSM adapted PrEP use to their sexual activity during and after the French lockdown. After the lockdown, discontinued PrEP occurred more often among MSM who had fewer sexual partners and had mental health vulnerabilities. These factors could also be predictive of PrEP discontinuation in a more general context. PrEP users should be informed on how to safely stop/start PrEP and on the use of other prevention tools to reduce potential risk exposure during PrEP discontinuation.