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Purpose: The MAKASI intervention aimed to empower Sub-Saharan African immigrants living in precarious situations in the Paris metropolitan area. Because there are factors specifically related to immigration that may increase the risk for common mental disorders, the present study aimed to examine participants' levels of depression and loneliness and analyze the effect of the intervention on depression and loneliness. Methods: The MAKASI study was designed as a stepped wedge cluster randomized trial. Study participants were recruited through an outreach program led by a nongovernmental organization and randomly assigned to two clusters, with an intervention delay of 3 months between them. Participants were assessed for 6 months after inclusion and the effect of the intervention on depression and loneliness was assessed using generalized linear mixed models. The study was conducted from 2018 to 2021 and took in consideration whether being interviewed during one of the Covid-19 confinement had an effect on the results. Results: Between 2018 and 2021 a total of 821 subjects participated in the Makasi study. High levels of depression and loneliness were found in the study population. We found no effect of the intervention on depression [95% CI 0.77 to 2.40]. Similarly, no effect of the intervention was found on loneliness [95% CI 0.87 to 2.54]. Conclusions: The intervention tested did not appear to improve the level of depression and loneliness among participants. However, the high prevalence of mental and emotional problems in the study population suggests a public health crisis among immigrants in the greater Paris area. Clinical Trial Registration Number: Trial registration Clinicaltrials.gov, NCT04468724 (July 13, 2020). [ABSTRACT FROM AUTHOR]

Background: A pilot HIV testing programme, Au Labo sans Ordo (ALSO; "to the laboratory without prescription") was implemented in two French Fast-Track Cities Initiative areas from 07/2019 to 12/2020. ALSO aimed to remove barriers to HIV testing by providing free testing with widespread access through all laboratories, extended opening hours, and no prescription requirements. Objectives: Assessing the ALSO programme in terms of testing activity, user characteristics, and costs, compared to other HIV testing offers. Methods: Laboratories and STI clinics reported the monthly numbers of tests performed and positive tests. Two short surveys were carried out 12 months apart in people who sought HIV testing. In each offer, the mean costs of HIV testing have been estimated according to negative or positive results using a microcosting approach. Results: During the study period, 214/264 laboratories reported performing 38,941 ALSO tests that accounted for 7.2% of laboratory HIV testing activity. Positivity rates of ALSO and prescribed tests were similar (2.2/1000) but lower than that in STI clinics (6.0/1000). Heterosexual men, and individuals with multiple sexual partners, poor health insurance and few visits to GPs were more likely to use the ALSO offer than tests upon prescription. Compared to ALSO, STI clinic users were younger, more exposed to HIV and with a less favourable socio-economic situation. ALSO had low costs: €13 for a negative test, €163 for a positive test and €5,388 to identify an HIV-positive person (versus €9,068 in STI clinics and €20,126 with prescribed tests). Conclusion: ALSO has attracted users less likely to visit STI clinics or to seek a prescribed test, particularly heterosexual men. Activities, user profiles and costs suggested the complementarity of the HIV testing offers and the relevance of making them coexist. French health authorities have decided to maintain and expand this programme to complement existing HIV testing offers. [ABSTRACT FROM AUTHOR]

Background Aspirational targets to end AIDS by 2030 include having 95% of people with human immunodeficiency virus (HIV; PWH) diagnosed, 95% treated, and 95% with controlled viral load (VL). Our objective was to describe, using a large French prospective cohort, the median transition times through the cascade of care between 2009 and 2019. Methods We analyzed patients whose first HIV diagnosis was made between 1 January 2009 and 31 December 2019. Using the Kaplan–Meier method, we estimated the time to linkage to care (from HIV diagnosis to first biological assessment), to treatment (date of first antiretroviral therapy [ART] prescription), and to controlled VL (first value <200 copies/mL). Analyses were disaggregated by time periods and patients' characteristics. Censoring date was 31 December 2021. Results Among the 16 864 patients linked to care since 2009, the median [Q1; Q3] time from HIV diagnosis to controlled VL decreased from 254 [127–745] to 73 [48–132] days in 2009–2011 and 2018–2019, respectively. Transition times from linkage to care to first ART decreased from 67 [17; 414] in 2009–2011 to 13 [5; 26] days in 2018–2019, and from ART to controlled VL from 83 [35; 130] in 2009–2011 to 38 [28; 90] days in 2018–2019. Differences were observed depending on patients' characteristics. Conclusions We describe drastic reductions in transition time through the cascade of care, allowing reduction in the transmission period following each new infection. Delayed diagnosis remains the main obstacle to ending AIDS in the next decade. [ABSTRACT FROM AUTHOR]

: Introduction: Daily pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on‐demand PrEP with TDF/FTC in HIV‐1 uninfected men. Methods: We used data from the randomized double‐blind placebo‐controlled ANRS‐IPERGAY trial and its open‐label extension conducted between February 2012 and June 2016 among HIV‐uninfected MSM starting on‐demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study. Results: During the blind phase, with a median follow‐up of 9.4 months, the mean decline slope of eGFR from baseline was −0.88 and −1.53 mL/min/1.73 m[sup.2] per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m[sup.2] per year (p = 0.27). Including both phases, 389 participants started on‐demand TDF/FTC with a median follow‐up of 19.2 months and a mean decline of eGFR from baseline of −1.14 mL/min/1.73 m[sup.2] per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m[sup.2] (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose‐response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of −0.88 mL/min/1.73 m[sup.2] between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: −0.98 mL/min/1.73 m[sup.2], >10 to ≤40ng/mL: −1.28 mL/min/1.73 m[sup.2], >40 ng/mL: −1.82 mL/min/1.73 m[sup.2], p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m[sup.2] during the OLE phase. No case of Fanconi syndrome was reported. Conclusions: The renal safety of on‐demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety., Introduction Pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) – emtricitabine (FTC) raises a lot of expectations to hamper HIV epidemic due to its high effectiveness to prevent HIV acquisition [...]

: Introduction: The universal test‐and‐treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa. Methods: The TasP cluster‐randomized trial (2012 to 2016) implemented six‐monthly repeat home‐based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level. Results: 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited. Conclusions: PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART‐initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90‐90‐90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context‐specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH‐27‐0512‐3974 (South African National Clinical Trials Register)., Introduction Antiretroviral treatment (ART), when taken early has several benefits, both in terms of morbidity and mortality and in terms of reduction in HIV sexual transmission. Mathematical modelling work suggested [...]

Introduction: We aimed to quantify and identify associated factors of linkage to HIV care following home-based HIV counseling and testing (HBHCT) in the ongoing ANRS 12249 treatment-as-prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa. Methods: Individuals [greater than or equal to] 16 years were offered HBHCT; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm. Results: Overall, 1323 HIV-positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n =488) linked to care 42%, p Conclusions: Fewer than 40% of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care. Keywords: HIV/AIDS; home-based HIV counselling and testing; linkage to care; universal test and treat; South Africa., Introduction Initiating antiretroviral treatment (ART) as early as possible after acquiring HIV infection results in better health outcomes, reducing HIV-related morbidity or mortality [1, 2]. Further, decreasing viral load with [...]

Introduction: People living with HIV (PLHIV) on antiretroviral therapy (ART), with sustained undetectable viral load (sUVL) and no history of sexually transmitted infections for at least six months, are considered to have a low risk of HIV transmission (LRT). We aimed to characterize, in a representative sample of French PLHIV, the sexual behaviour of LRT PLHIV compared with non- LRT PLHIV. Methods: The cross-sectional ANRS-VESPA2 survey was conducted on adult PLHIV attending French hospitals in 2011. The LRT PLHIV group included participants with sUVL and no sexually transmitted infection for at least 12 months. Socio- behavioural and medical data were collected. Chi-square tests helped compare sexual risk indicators between LRT and non-LRT PLHIV. The survey's retrospective nature allowed us to perform complementary category-based analyses of LRT PLHIV according to whether they had sUVL for at least 18, 24 or 36 months in three socio-epidemiological groups: men who have sex with men (MSM), other men and women. Results: Analysis included 2638 PLHIV diagnosed > 12 months with available viral load data. The proportion of LRT PLHIV varied from 58% ([greater than or equal to] 12 months sUVL) to 38% ([greater than or equal to] 36 months sUVL). Irrespective of sUVL duration, we found the following: 1) LRT men (MSM and other men) were more likely to report having no sexual partner than their non-LRT counterparts. Among men having sexual partners in the previous 12 months, no significant difference was seen between LRT and non-LRT men in the number of sexual partners. LRT women were less likely to report having more than one sexual partner than non-LRT women; 2) LRT MSM were more likely to report being in sexually inactive couples than their non-LRT counterparts; 3) among sexually active participants, no difference was observed between LRT and non-LRT PLHIV concerning condom use with their serodiscordant steady partner or with their most recent casual sexual partners. Conclusions: LRT PLHIV with sUVL [greater than or equal to] 12 months did not report more sexual risk behaviours than their non-LRT counterparts. Because the same result was obtained for those having a sUVL [greater than or equal to] 36 months, the hypothesis of increased sexual risk behaviour over time in PLHIV meeting non-transmission biomedical criteria is not supported. Keywords: HIV; successful ART; biomedical risk of HIV transmission; sexual risk behaviour., Introduction Antiretroviral therapies (ART) are now part of combination HIV prevention strategies, as their efficacy in decreasing blood plasma viral load (VL) has led to a dramatic reduction in HIV-1 [...]