A randomised controlled trial to study the transmission of SARS-CoV-2 and other respiratory viruses during indoor clubbing events (ANRS0066s ITOC study).

BACKGROUND: In the context of the circulation of the SARS-CoV-2 B.1.617.2 (Delta) variant, vaccination re-authorised mass indoor gatherings. The "Indoor Transmission of COVID-19" (ITOC) trial (ClinicalTrials.gov, NCT05311865) aimed to assess the risk of transmission of SARS-CoV-2 and other respiratory viruses during an indoor clubbing event among participants fully-vaccinated against COVID-19. METHODS: ITOC, a randomised, controlled trial in the Paris region (France), enrolled healthy volunteers aged 18-49 years, fully-vaccinated against COVID-19, with no co-morbidities or symptoms, randomised 1:1 to be interventional group "attendees" or control "non-attendees". The intervention, a 7-hour indoor event in a nightclub at full capacity, with no masking, prior SARS-CoV-2 test result or social distancing required. The primary-outcome measure was the numbers of RT-PCR-determined SARS-CoV-2-positive subjects on self-collected saliva 7 days post-gathering in the per-protocol population. Secondary endpoints focused on 20 other respiratory viruses. RESULTS: Healthy participants (n = 1,216) randomised 2:1 by blocks up to 10, 815 attendees and 401 non-attendees, yielding 529 and 287 subjects, respectively, with day-7 saliva samples. One day-7 sample from each group was positive. Looking at all respiratory viruses together, the clubbing event was associated with an increased risk of infection of 1.59 [95% CI 1.04-2.61]. CONCLUSIONS: In the context of low Delta-VOC circulation, no evidence of SARS-CoV-2 transmission among asymptomatic and vaccinated participants was found, but the risk of other respiratory virus transmission was higher.

Comparative Effectiveness of Interventions to Improve the HIV Continuum of Care and HIV Preexposure Prophylaxis in Kenya: A Model-Based Analysis.

BACKGROUND: In Western Kenya up to one-quarter of the adult population was human immunodeficiency virus (HIV)-infected in 2012. The Ministry of Health, Médecins Sans Frontières, and partners implemented an HIV program that surpassed the 90-90-90 UNAIDS targets. In this generalized epidemic, we compared the effectiveness of preexposure prophylaxis (PrEP) with improving continuum of care. METHODS: We developed a dynamic microsimulation model to project HIV incidence and infections averted to 2030. We modeled 3 strategies compared to a 90-90-90 continuum of care base case: (1) scaling up the continuum of care to 95-95-95, (2) PrEP targeting young adults with 10% coverage, and (3) scaling up to 95-95-95 and PrEP combined. RESULTS: In the base case, by 2030 HIV incidence was 0.37/100 person-years. Improving continuum levels to 95-95-95 averted 21.5% of infections, PrEP averted 8.0%, and combining 95-95-95 and PrEP averted 31.8%. Sensitivity analysis showed that PrEP coverage had to exceed 20% to avert as many infections as reaching 95-95-95. CONCLUSIONS: In a generalized HIV epidemic with continuum of care levels at 90-90-90, improving the continuum to 95-95-95 is more effective than providing PrEP. Continued improvement in the continuum of care will have the greatest impact on decreasing new HIV infections.

Voluntary Community Human Immunodeficiency Virus Testing, Linkage, and Retention in Care Interventions in Kenya: Modeling the Clinical Impact and Cost-effectiveness.

Background: In southwest Kenya, the prevalence of human immunodeficiency virus (HIV) infection is about 25%. Médecins Sans Frontières has implemented a voluntary community testing (VCT) program, with linkage to care and retention interventions, to achieve the Joint United Nations Program on HIV and AIDS (UNAIDS) 90-90-90 targets by 2017. We assessed the effectiveness and cost-effectiveness of these interventions. Methods: We developed a time-discrete, dynamic microsimulation model to project HIV incidence over time in the adult population in Kenya. We modeled 4 strategies: VCT, VCT-plus-linkage to care, a retention intervention, and all 3 interventions combined. Effectiveness outcomes included HIV incidence, years of life saved (YLS), cost (2014 €), and cost-effectiveness. We performed sensitivity analyses on key model parameters. Results: With current care, the projected HIV incidence for 2032 was 1.51/100 person-years (PY); the retention and combined interventions decreased incidence to 1.03/100 PY and 0.75/100 PY, respectively. For 100000 individuals, the retention intervention had an incremental cost-effectiveness ratio (ICER) of €130/YLS compared with current care; the combined intervention incremental cost-effectiveness ratio was €370/YLS compared with the retention intervention. VCT and VCT-plus-linkage interventions cost more and saved fewer life-years than the retention and combined interventions. Baseline HIV prevalence had the greatest impact on the results. Conclusions: Interventions targeting VCT, linkage to care, and retention would decrease HIV incidence rate over 15 years in rural Kenya if planned targets are achieved. These interventions together would be more effective and cost-effective than targeting a single stage of the HIV care cascade.

Gender-specific differences in Adamantiades-Behçet's disease manifestations: an analysis of the German registry and meta-analysis of data from the literature.

OBJECTIVE: We investigated the effect of gender on the clinical Adamantiades-Behçet's disease (ABD) phenotype with data from the German ABD registry and a meta-analysis from a systematic literature review. METHODS: Using the German ABD registry data, we compared 36 clinical variables by gender (with women as the reference category) and investigated potential effect modification by HLA-B5 or ethnic background. The registry data were combined with those from a literature search to calculate pooled relative risks (RRs) for variables with data from ≥10 relevant datasets. RESULTS: The German ABD registry provided information for 747 subjects (58.1% males) and the systematic literature review identified another 52 datasets informing on 16 variables. Both analyses consistently revealed the association of male gender with ocular involvement (RR 1.28 and 1.34 from the ABD registry and meta-analysis, respectively), folliculitis (RR 1.30 and 1.26), papulopustular lesions (RR 1.23 and 1.25), vascular involvement (RR 2.31 and 2.27), superficial (RR 2.96 and 1.63) and deep venous thromboses (RR 2.56 and 2.16) and female gender with genital ulcers (RR 0.78 and 0.92) and joint involvement (RR 0.79 and 0.89). The ABD registry data additionally showed male gender associated with heart involvement (RR 10.60), whereas the meta-analyses revealed male gender associated with the pathergy test (RR 1.14) and female gender associated with erythema nodosum (RR 0.86). HLA-B5 and Turkish or German origin did not affect the observed associations. CONCLUSION: These analyses support gender-associated clinical variations in ABD and in particular a clinically meaningful risk of cardiovascular involvement for men.