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Introduction: Due to a lack of robust population denominators, Australia is unable to accurately monitor changes in the HIV epidemic for some populations. The ratio of HIV transmission relative to the number of people with HIV (an incidence prevalence ratio, or IPR) can measure such changes. The IPR is measured against an IPR benchmark derived from post‐HIV acquisition life expectancy, to indicate whether an HIV epidemic is shrinking or growing. Using IPRs and Australia‐specific IPR benchmarks, this study aims to describe the Australian HIV epidemic among three groups: men with HIV attributed to male‐to‐male sex, women with HIV and people with HIV attributed to injection drug use. Methods: Using mathematical modelling derived from HIV notifications, cohort and administrative data, IPRs were generated for each of the three groups. These IPRs were compared with IPR benchmarks derived from post‐HIV acquisition mortality estimates using abridged life tables for men, women and people who inject drugs. The IPR benchmark for men was applied to people with HIV attributed to male‐to‐male sex. Trends in the IPR over time were described for each reported population from 2015 to 2022. Results: Overall, the IPR fell by 80%, from 0.040 (range: 0.034−0.045) in 2015 to 0.008 (range: 0.003−0.013) in 2022 and fell below the benchmark (0.022) in 2020. Among people with HIV attributed to male‐to‐male sex, the IPR fell by 85%, from 0.041 (range: 0.034−0.047) in 2015 to 0.006 (range: 0.003−0.024) in 2022 and fell below the benchmark (0.022) in 2020. Among women with HIV, the IPR fell by 56%, from 0.032 (range: 0.026−0.039) in 2015 to 0.014 (range: 0.003−0.029) in 2022 and fell below the benchmark (0.022) in 2019. Among people with HIV attributed to injection drug use, the IPR fell by 61%, from 0.036 (range: 0.022−0.047) in 2015 to 0.014 (range: 0.002−0.057) in 2022 and fell below the benchmark (0.028) in 2019. Conclusions: Australian IPRs in all populations examined have dropped below the level required to sustain the HIV epidemic at current levels. By applying this method in other contexts, the changing scale of HIV epidemics may be better described for populations lacking robust population denominators. [ABSTRACT FROM AUTHOR]

Introduction: HIV pre‐exposure prophylaxis (PrEP) has been recommended and partly subsidized in Québec, Canada, since 2013. We evaluated the population‐level impact of PrEP on HIV transmission among men who have sex with men (MSM) in Montréal, Québec's largest city, over 2013–2021. Methods: We used an agent‐based mathematical model of sexual HIV transmission to estimate the fraction of HIV acquisitions averted by PrEP compared to a counterfactual scenario without PrEP. The model was calibrated to local MSM survey, surveillance, and cohort data and accounted for COVID‐19 pandemic impacts on sexual activity, HIV prevention, and care. PrEP was modelled from 2013 onwards, assuming 86% individual‐level effectiveness. The PrEP eligibility criteria were: any anal sex unprotected by condoms (past 6 months) and either multiple partnerships (past 6 months) or multiple uses of post‐exposure prophylaxis (lifetime). To assess potential optimization strategies, we modelled hypothetical scenarios prioritizing PrEP to MSM with high sexual activity (≥11 anal sex partners annually) or aged ⩽45 years, increasing coverage to levels achieved in Vancouver, Canada (where PrEP is free‐of‐charge), and improving retention. Results: Over 2013–2021, the estimated annual HIV incidence decreased from 0.4 (90% credible interval [CrI]: 0.3–0.6) to 0.2 (90% CrI: 0.1–0.2) per 100 person‐years. PrEP coverage among HIV‐negative MSM remained low until 2015 (<1%). Afterwards, coverage increased to a maximum of 10% of all HIV‐negative MSM, or about 16% of the 62% PrEP‐eligible HIV‐negative MSM in 2020. Over 2015–2021, PrEP averted an estimated 20% (90% CrI: 11%–30%) of cumulative HIV acquisitions. The hypothetical scenarios modelled showed that, at the same coverage level, prioritizing PrEP to high sexual activity MSM could have averted 30% (90% CrI: 19%–42%) of HIV acquisitions from 2015‐2021. Even larger impacts could have resulted from higher coverage. Under the provincial eligibility criteria, reaching 10% coverage among HIV‐negative MSM in 2015 and 30% in 2019, like attained in Vancouver, could have averted up to 63% (90% CrI: 54%–70%) of HIV acquisitions from 2015 to 2021. Conclusions: PrEP reduced population‐level HIV transmission among Montréal MSM. However, our study suggests missed prevention opportunities and adds support for public policies that reduce PrEP barriers, financial or otherwise, to MSM at risk of HIV acquisition. [ABSTRACT FROM AUTHOR]

Introduction: Pre‐exposure prophylaxis (PrEP) delivery based on user needs can enhance PrEP access and impact. We examined whether telehealth for daily oral PrEP delivery could change the indicators of care related to prophylactic use in five Brazilian public HIV clinics (testing centres, outpatient clinics and infectious disease hospitals). Methods: Between July 2019 and December 2020, clients on PrEP for at least 6 months could transition to telehealth or stay with in‐person follow‐up. Clients were clinically monitored until June 2021. A desktop or mobile application was developed, comprising three asynchronous consultations and one annual in‐person consultation visit. Predictors influencing telehealth preference and care outcomes were examined. The analysis encompassed intent‐to‐treat (first choice) and adjustments for sexual practices, schooling, age, duration of PrEP use and PrEP status during the choice period. Results: Of 470 users, 52% chose telehealth, with the adjusted odds ratio (aOR) increasing over time for PrEP use (aOR for 25–months of use: 4.90; 95% CI: 1.32–18.25), having discontinued PrEP at the time of the choice (aOR: 2.91; 95% CI: 1.40–6.06) and having health insurance (aOR: 1.91; 95% CI: 1.24–2.94) and decreasing for those who reported higher‐risk behaviour (aOR for unprotected anal sex: 0.51; 95% CI: 0.29–0.88). After an average follow‐up period of 1.6 years (95% CI: 1.5–1.7), the risk of discontinuing PrEP (not having the medication for more than 90 days) was 34% lower with telehealth (adjusted hazard ratio: 0.66; 95% CI: 0.45–0.97). When adjusted by mixed linear regression, no differences in adherence (measured by mean medication possession rate) were found between in‐person and telehealth (p = 0.486) or at pre‐ and post‐telehealth follow‐ups (p = 0.245). Sexually transmitted infections increased between the pre‐follow‐up and post‐follow‐up choices and were not associated with in‐person or telehealth (p = 0.528). No HIV infections were observed. Conclusions: Our findings indicate that telehealth for PrEP delivery can enhance service rationalization and reinforce the prevention cascade. This approach reduces prophylaxis interruptions and is mainly preferred by individuals with lower demands for healthcare services. [ABSTRACT FROM AUTHOR]

Introduction: In 2016, South Africa (SA) initiated a national programme to scale‐up pre‐exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost‐effectiveness of this programme, including future scale‐up scenarios and the potential detrimental impact of the COVID‐19 pandemic. Methods: A compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self‐reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down‐adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0–70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2–87.6% efficacy). FSWs can transition between adherence levels, with lower loss‐to‐follow‐up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40–0.85; TAPS data). The model was calibrated to monthly data on the national scale‐up of PrEP among FSWs over 2016–2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016–2020) and the future impact (2021–2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost‐effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016–2040) of the current PrEP provision. Results: Calibrated to national data, model projections suggest that 2.1% of HIV‐negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35–0.57%) of HIV infections among FSWs over 2016–2020 or 605 (444–840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99–23.29). PrEP is cost‐saving, with $1.42 (1.03–1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572–9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7–11.6%) and impact increases 4.3 times with 24,114 (15,308–38,107) infections averted by 2040. Conclusions: Our findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services. [ABSTRACT FROM AUTHOR]

Introduction: HIV pre‐exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID‐19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID‐19 pandemic. Methods: Since 2017, the Partners Scale‐Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May–Aug 2020) and again after some decline in COVID‐19 rates (Nov–Jan 2021). We analysed data using inductive memo‐writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). Results: We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n = 20) and Western (n = 20) Kenya. About half (n = 19) were female, with a median age of 32 (IQR: 29–34) and 2.3 years of experience delivering PrEP (IQR: 2–3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple‐month PrEP refills, intensifying phone‐based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical‐room PrEP dispensing, pre‐packing PrEP and task‐shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. Conclusions: COVID‐19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post‐pandemic. [ABSTRACT FROM AUTHOR]

Introduction: HIV pre‐exposure prophylaxis (PrEP) has been government subsidized in Australia since April 2018 and while uptake is high among men who have sex with men, rates of discontinuation are also high. The aims of this study were to examine the impact of discontinuation on overall PrEP usage, the proportion of PrEP users who discontinue and the predictors of discontinuation. Methods: We used linked de‐identified dispensing records of all government subsidized PrEP in Australia between April 2018 and September 2021: a whole‐of‐population data set. Defining discontinuation as 180 days or more without PrEP after the final dispensed supply, we calculated the number of people who discontinued at each 6‐month interval during the study period, the proportion who had discontinued 2 years after the first supply and, using Cox regression, predictors of discontinuation. Results: Of 49,164 people dispensed PrEP (98.5% male, median age 34 years), 40.3% (19,815) had discontinued by September 2021. Within 2 years of their first supply, 11,150 (37.7%) of 29,549 PrEP users had discontinued, including 10.0% after a single dispensed supply. Large variations were observed, particularly according to prescriber characteristics: discontinuation was higher among people prescribed PrEP by low caseload (≤10 patients) prescribers (61.2%) than by high caseload (>100 patients) prescribers (31.1%, p<0.001), and by prescribers practising in areas with low estimated prevalence (<1.0%) of gay men (64.1%) than high (>5%) prevalence (36.7%, p<0.001). Women and younger people were more likely to discontinue, while patients receiving a higher level of government subsidy were less likely. The independent predictors of discontinuation with the greatest effect size were female sex (adjusted hazards ratio [aHR] 2.99, p<0.001), low estimated gay prevalence of prescriber location (aHR 1.98, p<0.001) and low prescriber PrEP caseload (aHR 1.79, p<0.001). Conclusions: There are high rates of PrEP discontinuation in Australia and some populations are at increased risk of discontinuation. Strategies are needed to support persistence on PrEP and the re‐starting of PrEP during periods of risk. [ABSTRACT FROM AUTHOR]

Introduction: Antiretroviral‐based pre‐exposure prophylaxis (PrEP) is today an established, effective and safe method of HIV prevention used in multiple countries worldwide by a broad range of populations at risk of HIV infection. Biomedical innovations are critical in supporting the primary prevention of HIV; however, their potential can only be maximized if end‐user challenges are recognized, described and used to develop next‐generation models. Discussion: First‐generation PrEP, a daily oral pill, is highly efficacious, discreet and affords users the ability to commence and conclude treatment rapidly. However, consistent daily adherence and persistence is challenging, especially among younger populations, due in part to side effects, the risk of stock‐outs and a lack of pill storage options. Second‐generation PrEP, longer acting agents that require less frequent dosing, could overcome such challenges. Agents that have shown efficacy in clinical trials include a monthly vaginal ring and PrEP injectables to be administered every 8 weeks, while products in development include 6 monthly injectables, oral therapy that uses monthly rather than daily pills, implants and the potential for long‐acting passive immunization. Conclusions: Second‐generation PrEP agents will have the potential to offer improved adherence and less frequent reminders once they have undergone further development and the delivery systems that will best support them have been established. In order to pursue global UNAIDS targets of reducing new HIV infections to fewer than 500,000 annually by 2025, and to ensure that all people have access to prevention options that meet their specific prevention needs, both early and next‐generation PrEP options are needed. [ABSTRACT FROM AUTHOR]

Introduction: Evidence indicates HIV oral pre‐exposure prophylaxis (PrEP) is highly efficacious and effective. Substantial early discontinuation rates are reported by many programs, which may be misconstrued as program failure. However, PrEP use may be non‐continuous and still effective, since HIV risk fluctuates. Real‐world PrEP use phenomena, like restarting and cyclical use, and the temporal characteristics of these use patterns are not well described. The objective of our study was to characterize and identify predictors of use patterns observed in large PrEP scale‐up programs in Africa. Methods: We analysed demographic and clinical data routinely collected during client visits between 2017 and 2019 in three Jhpiego‐supported programs in Kenya, Lesotho and Tanzania. We characterized duration on/off PrEP and, using ordinal regression, modelled the likelihood of spending additional time off and identified factors associated with increasing cycle number. The Andersen‐Gill model was used to identify predictors of time to PrEP discontinuation. To analyse factors associated with a client's first return following initiation, we used a two‐step Heckman probit. Results: Among 47,532 clients initiating PrEP, approximately half returned for follow‐up. With each increase in cycle number, time off PrEP between use cycles decreased. The Heckman first‐step model showed an increased probability of returning versus not by older age groups and among key and vulnerable population groups versus the general population; in the second‐step model older age groups and key and vulnerable populations were less likely in Kenya, but more likely in Lesotho, to return on‐time (refill) versus delayed (restarting). Conclusions: PrEP users frequently cycle on and off PrEP. Early discontinuation and delays in obtaining additional prescriptions were common, with broad predictive variability noted. Time off PrEP decreased with cycle number in all countries, suggesting normalization of use with experience. More nuanced measures of use are needed than exist for HIV treatment if effective use of PrEP is to be meaningfully measured. Providers should be equipped with measures and counselling messages that recognize non‐continuous and cyclical use patterns so that clients are supported to align fluctuating risk and use, and can readily restart PrEP after stopping, in effect empowering them further to make their own prevention choices. [ABSTRACT FROM AUTHOR]

Introduction: Randomized trials of new agents for HIV pre‐exposure prophylaxis (PrEP) compare against emtricitabine and tenofovir disoproxil fumarate (F/TDF), without a placebo group. We used the well‐characterized adherence‐efficacy relationship for F/TDF to back‐calculate the (non‐PrEP) counterfactual background HIV incidence (bHIV) in a randomized trial of a novel PrEP agent and estimate comparative efficacy (to counterfactual bHIV). Methods: The DISCOVER trial (ClinicalTrials.gov: NCT02842086) randomized 5387 men who have sex with men (MSM) and transgender women who have sex with men and demonstrated non‐inferiority of emtricitabine and tenofovir alafenamide (F/TAF) to F/TDF (HIV incidence rate ratio [IRR] 0·47, 95% CI: 0·19 to 1.15). Tenofovir diphosphate (TFV‐DP) levels in dried blood spots (DBS) were assessed for all diagnosed with HIV and in a random 10% of the cohort. We used a Bayesian model with a diffuse prior distribution, derived from established data relating tenofovir diphosphate levels to HIV prevention efficacy. This prior, combined with the F/TDF seroconversion rate and tenofovir diphosphate levels in DISCOVER, yielded Bayesian inferences on the counterfactual bHIV. Results: There were six versus 11 postbaseline HIV infections (0.14 vs. 0.25/100 person‐years [PY]) on F/TAF and F/TDF respectively. Of the 11 on F/TDF, 10 had low, none had medium and one had high tenofovir diphosphate levels; among HIV‐negative controls, 5% of the person‐time years had low, 9% had medium and 86% had high TFV‐DP levels. A non‐informative prior distribution for counterfactual bHIV, combined with the prior for TFV‐DP level‐efficacy relationship, yielded a posterior counterfactual bHIV of 3·4 infections/100 PY (0.80 Bayesian credible interval [CrI] 1·9 to 5·9), which suggests a median HIV efficacy of 96% (0.95 CrI [88% to 99%]) for F/TAF and 93% (0.95 CrI [87% to 96%]) for F/TDF compared to bHIV. Conclusions: Based on the established connection of drug concentrations to PrEP prevention efficacy, a Bayesian framework can be used to estimate a synthetic non‐PrEP control group in randomized, active‐controlled PrEP trials that include a F/TDF‐comparator group. [ABSTRACT FROM AUTHOR]

Introduction: Given the synergistic relationship between HIV and sexually transmitted infections (STI), the integration of services has the potential to reduce the incidence of both HIV and STIs. We explored the extent to which STI testing has been offered within HIV pre‐exposure prophylaxis (PrEP) programmes worldwide. Methods: We conducted a systematic review of PrEP programmes implementing STI testing services in nine databases. We approached PrEP implementers for additional unpublished data and implementation details. Descriptive statistics were used to present the characteristics of STI testing within PrEP programmes. Content analysis of the input from PrEP implementers was conducted to summarize the barriers to and facilitators of STI testing. Results: Of 9,161 citations, 91 studies conducted in 32 countries were included: 69% from high‐income countries (HICs) and 64% from programmes targeting men who have sex with men (MSM) and transgender women (TGW) only. The majority of programmes (70%, 64/91) conducted STI testing before the initiation of PrEP. The most common STIs tested were gonorrhoea (86%, 78/91), chlamydia (84%, 76/91) and syphilis (84%, 76/91). The majority provided STI testing at three‐month intervals (70%, 53/76, for syphilis; 70% 53/78, for chlamydia; 68%, 53/78, for gonorrhoea). Relative to low‐ and middle‐income countries (LMICs), a higher proportion of PrEP programmes in HICs offered testing for gonorrhoea (92% vs. 71%, p < 0.05), chlamydia (92% vs. 64%, p < 0.01), syphilis (87% vs. 75%, p < 0.05), hepatitis A (18% vs. 4%, p < 0.05) and hepatitis C (43% vs. 21%, p < 0.05); offered testing for a higher number of STIs (mean 3.75 vs. 3.04, p < 0.05); and offered triple (throat, genital/urine and anorectal) anatomical site screening (54% vs. 18%, p < 0.001). Common implementation challenges included costs, access to STI diagnostics, programme logistics of integrating STI testing into PrEP delivery models and lack of capacity building for staff involved in PrEP provision. Conclusions: Significant gaps and challenges remain in the provision of STI testing services within HIV PrEP programmes. We recommend more active integration of STI testing and management into PrEP programmes, supported by standardized practice guidelines, staff capacity building training and adequate funding. This could lead to improved sexual health and HIV outcomes in key populations. [ABSTRACT FROM AUTHOR]

Introduction: The human immunodeficiency virus 1 (HIV‐1) pandemic is characterized by numerous distinct sub‐epidemics (clusters) that continually fuel local transmission. The aims of this study were to identify active growing clusters, to understand which factors most influence the transmission dynamics, how these vary between different subtypes and how this information might contribute to effective public health responses. Methods: We used HIV‐1 genomic sequence data linked to demographic factors that accounted for approximately 70% of all new HIV‐1 notifications in New South Wales (NSW). We assessed differences in transmission cluster dynamics between subtype B and circulating recombinant form 01_AE (CRF01_AE). Separate phylogenetic trees were estimated using 2919 subtype B and 473 CRF01_AE sequences sampled between 2004 and 2018 in combination with global sequence data and NSW‐specific clades were classified as clusters, pairs or singletons. Significant differences in demographics between subtypes were assessed with Chi‐Square statistics. Results: We identified 104 subtype B and 11 CRF01_AE growing clusters containing a maximum of 29 and 11 sequences for subtype B and CRF01_AE respectively. We observed a > 2‐fold increase in the number of NSW‐specific CRF01_AE clades over time. Subtype B clusters were associated with individuals reporting men who have sex with men (MSM) as their transmission risk factor, being born in Australia, and being diagnosed during the early stage of infection (p < 0.01). CRF01_AE infections clusters were associated with infections among individuals diagnosed during the early stage of infection (p < 0.05) and CRF01_AE singletons were more likely to be from infections among individuals reporting heterosexual transmission (p < 0.05). We found six subtype B clusters with an above‐average growth rate (>1.5 sequences / 6‐months) and which consisted of a majority of infections among MSM. We also found four active growing CRF01_AE clusters containing only infections among MSM. Finally, we found 47 subtype B and seven CRF01_AE clusters that contained a large gap in time (>1 year) between infections and may be indicative of intermediate transmissions via undiagnosed individuals. Conclusions: The large number of active and growing clusters among MSM are the driving force of the ongoing epidemic in NSW for subtype B and CRF01_AE. [ABSTRACT FROM AUTHOR]

Introduction: PrEP is a powerful HIV prevention tool, and locally relevant eligibility criteria are necessary to optimize the prevention impact of PrEP. We assessed performance of existing national and international PrEP eligibility criteria to predict future HIV seroconversion among MSM in Beijing, China. Methods: Participants were MSM aged ≥18 years who enrolled in a cohort study between July 2009 and March 2016. Participants completed HIV testing, syphilis testing, and a questionnaire on recent sexual health behaviours at each follow‐up visit and were followed until HIV seroconversion or dropout. We assessed PrEP eligibility at the most recent follow‐up visit prior to the final study visit. Participants were classified as indicated for PrEP (or not) based on criteria from guidelines from Europe, Korea, South Africa, Taiwan, the United Kingdom, United States and the World Health Organization. To compare guideline performance, we calculated sensitivity, specificity, Youden's Index (YI), Matthew's Correlation Coefficient (MCC), F1 scores and diagnostic odds ratios. For each guideline, performance measures were compared to random allocation of PrEP by randomly selecting a proportion of participants equal to the proportion indicated. Results: There were 287 (17∙3%) incident HIV seroconversions among 1663 MSM. The number of men indicated for PrEP from different guidelines ranged from 556 (33∙4%) to 1569 (94∙2%). Compared to random allocation, sensitivity of algorithms to predict seroconversion ranged from slightly worse (−4∙7%) to 30∙2% better than random. However, in absolute terms, none of the sensitivity values increased by more than 11% when compared to random allocation. For all guidelines, specificity was not meaningfully better than random allocation. No guidelines had high binary classification performance measures. Conclusions: The performance of international indication guidelines in this sample was only slightly better than random allocation. Using such guidelines to screen out MSM self‐identifying as interested in PrEP could lead to misallocation of resources and to good candidates for PrEP being denied access. For settings in which international guidelines perform poorly, alternative indication approaches should be considered. [ABSTRACT FROM AUTHOR]

Introduction: Men who have sex with men (MSM) and transgender women (TGW) are at increased risk for acquiring HIV, but there are limited HIV incidence data for these key populations in Africa. Understanding HIV prevalence and incidence provides important context for designing HIV prevention strategies, including pre‐exposure prophylaxis (PrEP) programmes. We describe HIV prevalence, awareness of HIV infection, HIV incidence and associated factors for a cohort of MSM and TGW in Cape Town and Port Elizabeth, South Africa. Methods: From 2015 to 2016, MSM and TGW in Cape Town and Port Elizabeth were enrolled and prospectively followed for 12 months, receiving a comprehensive package of HIV prevention services. HIV testing was conducted at baseline and at follow‐up visits (targeted for three, six and twelve months). All HIV‐negative PrEP‐eligible participants were offered PrEP enrolment during the first four months of study participation. We determined HIV prevalence among participants at baseline, and incidence by repeat screening of initially HIV‐negative participants with HIV tests at three, six and twelve months. Results: Among 292 participants enrolled, HIV prevalence was high (43%; 95% CI: 38 to 49) and awareness of HIV status was low (50%). The 167 HIV‐negative participants who were followed prospectively for 144.7 person‐years; nine incident HIV infections were documented. Overall annual incidence was 6.2% (CI: 2.8 to 11.8) and did not differ by city. Annual HIV incidence was significantly higher for younger (18 to 19 years) MSM and TGW (MSM: 21.8% (CI: 1.2 to 100); TGW: 31.0 (CI: 3.7, 111.2)). About half of participants started PrEP during the study; the annual incidence of HIV among 82 (49%) PrEP starters was 3.6% (CI: 0.4, 13.1) and among those who did not start PrEP was 7.8% (CI: 3.1, 16.1). Conclusions: HIV incidence was high among MSM and TGW in the context of receiving a comprehensive package of prevention interventions and offering of PrEP. PrEP uptake was high; the observed incidence of HIV in those who started PrEP was about half the incidence of HIV in those who did not. Future implementation‐oriented studies should focus on decisions to start and continue PrEP for those at highest risk, including young MSM. [ABSTRACT FROM AUTHOR]

Introduction: The clinical relevance of low‐level viraemia (LLV) and virological outcomes among children living with HIV (CLHIV) remains controversial. This study aimed to determine the impact of LLV on virological failure (VF) among Asian CLHIV on first‐line combination antiretroviral therapy (cART). Methods: CLHIV aged <18 years, who were on first‐line cART for ≥12 months, and had virological suppression (two consecutive plasma viral load [pVL] <50 copies/mL) were included. Those who started treatment with mono/dual antiretroviral therapy, had a history of treatment interruption >14 days, or received treatment and care at sites with a pVL lower limit of detection >50 copies/mL were excluded. LLV was defined as a pVL 50 to 1000 copies/mL, and VF as a single pVL >1000 copies/mL. Baseline was the time of the second pVL < 50 copies/mL. Cox proportional hazards models were performed to assess the association between LLV and VF. Results: From January 2008 to September 2016, 508 CLHIV (55% female) were eligible for the study. At baseline, the median age was 9.6 (IQR: 7.0 to 12.3) years, cART duration was 1.4 (IQR: 1.3 to 1.8) years, 97% of CLHIV were on non‐nucleoside reverse transcriptase inhibitor‐based regimens, and the median CD4 was 25% (IQR: 20% to 30%). Over a median follow‐up time of 6.0 (IQR: 3.1 to 8.9) years from baseline, 86 CLHIV (17%) had ever experienced LLV, of whom 32 (37%) had multiple LLV episodes. Female sex, living in Malaysia (compared to Cambodia), having family members other than biological parents/grandparents as a primary caregiver, and baseline CD4 < 25% increased risk of LLV. Overall, 115 children (23%) developed VF, corresponding to a rate of 4.0 (95%CI: 3.4 to 4.9) per 100 person‐years of follow‐up (PYFU). VF was greater among children who had ever experienced LLV compared with those who maintained virological suppression throughout the study period (8.9 vs. 3.3 per 100 PYFU; p < 0.001). In multivariable analyses, ever experiencing LLV was associated with increased risk of subsequent VF (adjusted hazard ratio: 3.01; 95%CI: 1.97 to 4.60). Conclusions: LLV increased the risk of subsequent VF among Asian CLHIV who had previously been suppressed on first‐line cART. Adherence interventions and additional targeted pVL monitoring may be warranted among children with LLV to facilitate early detection of VF. [ABSTRACT FROM AUTHOR]

Introduction: In the Asia‐Pacific, pre‐exposure prophylaxis (PrEP) is a newly introduced public health intervention for minimizing HIV transmission, the coverage of which has remained limited. The best delivery models and strategies for broadening access of the vulnerable communities are not fully known. This review identified PrEP programmes reported in the Asia‐Pacific, which were classified by delivery models and assessed with a healthcare accessibility framework. Methods: We performed a literature search on PubMed and Ovid MEDLINE using relevant search terms, manual searched grey literature by visiting relevant websites, examined reference lists and contacted authors for clarification of included PrEP programmes reported through July 2019. A structured table was used for data extraction and summarizing findings in accordance with the five constructs of approachability, acceptability, availability, affordability and appropriateness grounded in the conceptual framework of Healthcare Accessibility. Results and discussion: This literature search yielded a total of 1308 publications; 119 full texts and abstracts were screened, and 24 publications were included in the review. We identified 11 programmes implemented in seven cities/countries in the Asia‐Pacific. A typology of four PrEP delivery models was delineated: (a) fee‐based public service model; (b) fee‐based community setting model; (c) free public service model; and (d) free community setting model. Overall, the free community setting model was most commonly adopted in the Asia‐Pacific, with the strength to boost the capacity of facility and human resources, which enhanced "approachability", "availability" and "acceptability." The free public service model was characterized by components designed in improving "approachability," "availability" and "appropriateness," with attention on equity in accessing PrEP. Among free‐based models, long‐term affordability both to the government and PrEP users would need to be maximized to increase accessibility. Alongside the need for raising awareness, supportive environments and ensuring timely access were means for enabling the development of a sustainable PrEP service. Conclusion: PrEP programmes could be classified by delivery models through the five constructs of healthcare accessibility. While the coverage of PrEP remains limited in the Asia‐Pacific, an evaluation of these models could benchmark best practices, which would in turn allow effective models to be designed. [ABSTRACT FROM AUTHOR]

Introduction: Men who have sex with men (MSM) and transgender women (TGW) are two key populations (KPs) in Thailand at high risk for HIV. Uptake and scale‐up of pre‐exposure prophylaxis (PrEP) among them has been slow. We used data from Princess PrEP, Thailand's largest KP‐led PrEP programme, to operationalize PrEP service cascades. We identified gaps and pointed out where additional data are needed to inform a larger HIV prevention cascade. Methods: Numbers of people tested for HIV, tested HIV negative, eligible for PrEP (defined as any of the following in the past three months: condomless sex with partners of unknown/uncertain HIV status or antiretroviral treatment or viral load status, multiple partners, engaging in sex work, sexually transmitted infections, injecting drugs, using amphetamine‐type stimulants, or repeated use of post‐exposure prophylaxis), offered PrEP and accepted PrEP during January to November 2019 were retrieved from Princess PrEP database to inform PrEP service cascades for MSM and TGW. Reasons for not accepting PrEP were documented. Results: Of 6287 MSM who received HIV testing in Princess PrEP, 92.3% were HIV negative and 70.2% of them were eligible for PrEP. PrEP was offered to 94.7% of those eligible and 48.0% of those offered accepted it. Among 900 TGW who had HIV testing, 95.3% tested HIV negative and 64.8% of them met PrEP eligibility criteria. Of these, 95.0% were offered PrEP and 43.9% of them accepted it. Among MSM and TGW who met PrEP eligibility criteria, no or low‐HIV‐risk perception was the most common reason provided (46.7% of 2007 MSM and 41.9% of 296 TGW) for not accepting PrEP. Conclusions: PrEP service cascades from the Princess PrEP programme identified no or low‐risk perception as key barrier to PrEP acceptance among MSM and TGW who met PrEP eligibility criteria. More implementation research studies are needed to explore PrEP motivation and access in larger communities outside of clinical services. This is to identify gaps and strategies to address them within motivation, access and effective use domains of the HIV prevention cascade. [ABSTRACT FROM AUTHOR]

Introduction: Pre‐exposure prophylaxis (PrEP) is highly effective, although PrEP adherence and persistence has been variable during real world implementation. Little is known about missed opportunities to enhance PrEP adherence among individuals who later HIV seroconverted after using PrEP. The goal of this analysis was to identify all HIV infections among individuals who had accessed PrEP in an integrated health system in San Francisco, and to identify potentially intervenable factors that could have prevented HIV infection through in‐depth interviews with people who HIV seroconverted after using PrEP. Methods: We identified individuals who initiated PrEP in an integrated safety‐net public health system and performed in‐depth chart review to determine person‐time on and after stopping PrEP over six years. We identified all PrEP seroconversions using the Centers for Disease Control and Prevention's Enhanced HIV/AIDS Reporting System and then calculated HIV incidence while using PrEP and during gaps in use. We then performed in‐depth interviews with those who seroconverted. Results: Overall, 986 initiated PrEP across the San Francisco Department of Public Health from July 2012 to November 2018. Data were gathered from 895 person‐years on PrEP and 953 after stopping PrEP. The HIV incidence was 7.5‐fold higher after stopping PrEP compared to while on PrEP (95% CI 1 to 336). Of the eight individuals who HIV seroconverted; only one was taking PrEP at the time of seroconversion but was using on‐demand PrEP inconsistently. All eight agreed to qualitative interviews. Major barriers to PrEP persistence included substance use, mental health and housing loss; difficulty accessing PrEP due to cost, insurance, and the cost and time of medical visits; difficulty weighing PrEP's benefit versus self‐perceived risk; and entering a primary partnership. The individual who developed HIV using on‐demand PrEP reported confusion about the dosing regimen and which sexual encounters required accompanying PrEP dosing. Conclusions: HIV incidence during gaps in PrEP use was nearly eight‐fold higher than while on PrEP in this large cohort in San Francisco. Many individuals who stop PrEP remain at risk of HIV, and participants reported that proactive outreach could potentially have prevented HIV infections. Individuals using non‐daily PrEP may require additional education and support in the United States. [ABSTRACT FROM AUTHOR]

Keywords: Latin America; HIV epidemic; migration; HIV; PrEP in Latin America; ART; HIV testing EN Latin America HIV epidemic migration HIV PrEP in Latin America ART HIV testing 1 4 4 04/01/20 20200301 NES 200301 According to Joint United Nations Programme on HIV/AIDS (UNAIDS) data, 1,900,000 adults and children were living with HIV in Latin America and the Caribbean in 2018 [1], where overall prevalence was 0.5%. Finally, the consequences of migration for the HIV epidemic in our region have rarely been considered in relation to the implementation of HIV prevention, treatment and care programmes. Latin America, HIV epidemic, migration, HIV, PrEP in Latin America, ART, HIV testing. [Extracted from the article]

Introduction: Pre-Exposure Prophylaxis (PrEP) is highly effective in reducing the risk for HIV infection among men who have sex with men (MSM) and may have an important impact in slowing down the HIV epidemic. Concerns remain however about low adherence, increased risk behaviour and reduced condom use when using PrEP. The aim of this study was to assess these factors prospectively among MSM using daily and event-driven PrEP in Belgium. Methods: An open-label prospective cohort study was conducted from October 2017 to May 2018 at the Institute of Tropical Medicine, in Antwerp, Belgium. At enrolment, MSM at high risk for HIV chose between daily or event-driven PrEP. They were allowed to switch regimens or stop taking PrEP at each of their tri-monthly visits. Data were collected on an electronic case report form, web-based diary and self-administered questionnaire. Screening for HIV and other Sexually Transmitted Infections (STIs) was also performed. Results: Two hundred MSM were followed up for a total duration of 318 person-years. At month 18, 75.4% of the participants were on daily and 24.6% were on event-driven PrEP. The mean proportion of covered sex acts by PrEP for the complete follow-up period was 91.5% for all participants, 96.5% for daily and 67.0% for event-driven PrEP use. The number of casual and anonymous sex partners was significantly higher for daily users, as compared with event-driven users, but did not change over time. In contrast, the mean proportion of condomless receptive anal intercourse with casual and anonymous partners increased significantly during follow-up, for both daily and event-driven use (p < 0.0001 for all 4 trends). No new HIV infection was diagnosed during follow-up. The incidence of bacterial STIs was 75.4 per 100 person-years (95% CI 63.8 to 89.1). We did not detect a significant change in N. gonorrhoeae/C. trachomatis incidence over time. The incidence of hepatitis C was 2.9 per 100 person-years. Conclusions: PrEP is an effective and well adopted HIV prevention tool for MSM in Belgium. Participants adapted daily and event-driven regimens to their own needs and were able to adapt their PrEP adherence to risk exposure. [ABSTRACT FROM AUTHOR]

The global paediatric HIV epidemic is shifting into a new phase as children on antiretroviral therapy (ART) move into adolescence and adulthood, and face new challenges of living with HIV. UNAIDS reports that 3.4 million children aged below 15 years and 2 million adolescents aged between 10 and 19 years have HIV. Although the vast majority of children were perinatally infected, older children are combined with behaviourally infected adolescents and youth in global reporting, making it difficult to keep track of their outcomes. Perinatally HIV-infected adolescents (PHIVA) are a highly unique patient sub-population, having been infected before development of their immune systems, been subject to suboptimal ART options and formulations, and now face transition from complete dependence on adult caregivers to becoming their own caregivers. As we are unable to track long-term complications and survival of PHIVA through national and global reporting systems, local and regional cohorts are the main sources for surveillance and research among PHIVA. This global review will utilize those data to highlight the epidemiology of PHIVA infection, treatment challenges and chronic disease risks. Unless mechanisms are created to count and separate out PHIVA outcomes, we will have few opportunities to characterize the negative consequences of life-long HIV infection in order to find ways to prevent them [ABSTRACT FROM AUTHOR]

Introduction: There are limited data on paediatric HIV care and treatment programmes in low-resource settings. Methods: A standardized survey was completed by International epidemiologic Databases to Evaluate AIDS paediatric cohort sites in the regions of Asia-Pacific (AP), Central Africa (CA), East Africa (EA), Southern Africa (SA) and West Africa (WA) to understand operational resource availability and paediatric management practices. Data were collected through January 2010 using a secure, web-based software program (REDCap). Results: A total of 64,552 children were under care at 63 clinics (AP, N=10; CA, N=4; EA, N=29; SA, N=10; WA, N=10). Most were in urban settings (N=41, 65%) and received funding from governments (N=51, 81%), PEPFAR (N=34, 54%), and/or the Global Fund (N=15, 24%). The majority were combined adult-paediatric clinics (N=36, 57%). Prevention of motherto- child transmission was integrated at 35 (56%) sites; 89% (N=56) had access to DNA PCR for infant diagnosis. African (N=40/ 53) but not Asian sites recommended exclusive breastfeeding up until 4-6 months. Regular laboratory monitoring included CD4 (N=60, 95%), and viral load (N=24, 38%). Although 42 (67%) sites had the ability to conduct acid-fast bacilli (AFB) smears, 23 (37%) sites could conduct AFB cultures and 18 (29%) sites could conduct tuberculosis drug susceptibility testing. Loss to follow-up was defined as >3 months of lost contact for 25 (40%) sites, >6 months for 27 sites (43%) and >12 months for 6 sites (10%). Telephone calls (N=52, 83%) and outreach worker home visits to trace children lost to follow-up (N=45, 71%) were common. Conclusions: In general, there was a high level of patient and laboratory monitoring within this multiregional paediatric cohort consortium that will facilitate detailed observational research studies. Practices will continue to be monitored as the WHO/ UNAIDS Treatment 2.0 framework is implemented [ABSTRACT FROM AUTHOR]

Introduction: Gonorrhoea and chlamydia cases have been rising among gay, bisexual and other men who have sex with men (MSM) over the last decade. The majority of cases are extragenital and occur at the oropharynx and anorectum. The aim of this narrative review was to review the risk factors and mode of transmission for gonorrhoea and chlamydia at the oropharynx and anorectum among MSM. Results and discussion: New evidence suggests that oropharyngeal gonorrhoea can be transmitted by kissing in addition to through the established route of condomless oral sex; and anorectal gonorrhoea can be acquired when saliva is used as a lubricant for anal sex and rimming in addition to the established route of condomless penile‐anal sex in MSM. In contrast, condomless penile‐anal sex remains the major route for chlamydia transmission. Conclusions: Substantial transmission of gonorrhoea may occur with practices other than the established routes of condomless oral and/or anal sex and hence condoms may not be effective in preventing gonorrhoea transmission to extragenital sites. In contrast, condoms are effective for chlamydia control because it is mainly transmitted through condomless penile‐anal sex. Novel interventions for gonorrhoea that reduce the risk of transmission at extragenital site are required. [ABSTRACT FROM AUTHOR]

Introduction: Questions remain whether HIV pre‐exposure prophylaxis (PrEP) can be translated into a successful public health intervention, leading to a decrease in population‐level HIV incidence. We use examples from HIV treatment and contraceptives to discuss expectations for PrEP uptake, adherence, and persistence and their combined impact on the epidemic. Discussion: Targets for PrEP uptake must be based on the local HIV epidemic and will depend on appropriate estimates of the key populations at risk for HIV. However, there is evidence that targets, once established, can successfully be met and that uptake may increase with awareness. Messaging around adherence should include that daily adherence is the goal (except for those MSM for whom event‐driven dosing is a good fit), but perfect adherence should not be a barrier. Ideally, clients persist on PrEP for as long as they are at risk for HIV. While PrEP will be most effective when coverage is focused on high‐risk populations, normalizing rather than stigmatizing PrEP will be highly beneficial. Conclusions: While many challenges to PrEP implementation exist, we focused on the three key steps of uptake, adherence and persistence as measurable processes that can lead to improved coverage and decreased HIV incidence. [ABSTRACT FROM AUTHOR]

The authors discuss the need for increased efforts to maximize the impact of HIV prevention technologies in sub-Saharan Africa. Topics include reduction of incident infections as key to sustainable HIV control, community perspectives on health and HIV and their health-seeking behaviour, and the success of reproductive health programmes promoting access to contraception in many settings.

Introduction: Recommendations on the optimal frequency of plasma viral load (pVL) monitoring in children living with HIV (CLWH) who are stable on combination antiretroviral therapy (cART) are inconsistent. This study aimed to determine the impact of annual versus semi‐annual pVL monitoring on treatment outcomes in Asian CLWH. Methods: Data on children with perinatally acquired HIV aged <18 years on first‐line, non‐nucleoside reverse transcriptase inhibitor‐based cART with viral suppression (two consecutive pVL <400 copies/mL over a six‐month period) were included from a regional cohort study; those exposed to prior mono‐ or dual antiretroviral treatment were excluded. Frequency of pVL monitoring was determined at the site‐level based on the median rate of pVL measurement: annual 0.75 to 1.5, and semi‐annual >1.5 tests/patient/year. Treatment failure was defined as virologic failure (two consecutive pVL >1000 copies/mL), change of antiretroviral drug class, or death. Baseline was the date of the second consecutive pVL <400 copies/mL. Competing risk regression models were used to identify predictors of treatment failure. Results: During January 2008 to March 2015, there were 1220 eligible children from 10 sites that performed at least annual pVL monitoring, 1042 (85%) and 178 (15%) were from sites performing annual (n = 6) and semi‐annual pVL monitoring (n = 4) respectively. Pre‐cART, 675 children (55%) had World Health Organization clinical stage 3 or 4, the median nadir CD4 percentage was 9%, and the median pVL was 5.2 log10 copies/mL. At baseline, the median age was 9.2 years, 64% were on nevirapine‐based regimens, the median cART duration was 1.6 years, and the median CD4 percentage was 26%. Over the follow‐up period, 258 (25%) CLWH with annual and 40 (23%) with semi‐annual pVL monitoring developed treatment failure, corresponding to incidence rates of 5.4 (95% CI: 4.8 to 6.1) and 4.3 (95% CI: 3.1 to 5.8) per 100 patient‐years of follow‐up respectively (p = 0.27). In multivariable analyses, the frequency of pVL monitoring was not associated with treatment failure (adjusted hazard ratio: 1.12; 95% CI: 0.80 to 1.59). Conclusions: Annual compared to semi‐annual pVL monitoring was not associated with an increased risk of treatment failure in our cohort of virally suppressed children with perinatally acquired HIV on first‐line NNRTI‐based cART. [ABSTRACT FROM AUTHOR]

Introduction: Discontinuations of HIV preexposure prophylaxis (PrEP) by at‐risk individuals could decrease the effectiveness of PrEP. Our objective was to characterize patterns of, reasons for, and clinical outcomes associated with PrEP discontinuations in primary care. Methods: We conducted medical chart reviews for patients prescribed PrEP during 2011 to 2014 at a Boston community health centre specializing in healthcare for sexual and gender minorities. Patients were followed through 2015. We characterized patients' sociodemographics, relationship status, behavioural health conditions, patterns of and reasons for PrEP discontinuations, and HIV seroconversions. Cox proportional hazards models were used to assess patient factors associated with PrEP discontinuations. Results: Of the 663 patients prescribed PrEP, the median age was 33 years, 96% were men who have sex with men (MSM) and 73% were non‐Hispanic white; 40% were in committed relationships and 15% had HIV‐infected partners. Patients either used PrEP continuously (60%), had 1 or more discontinuations (36%), or did not initiate PrEP (4%). Discontinuations were most often due to a decrease in HIV risk perception (33%), non‐adherence to care plans (16%), or insurance barriers (12%). Of the 7 (1.1%) PrEP patients diagnosed with HIV, 1 was HIV‐infected at baseline, 2 seroconverted while using PrEP, and 4 seroconverted after discontinuations. In a multivariable model adjusted for race/ethnicity, relationship status, substance use disorders, and insurance status, those who were less than 30 years old (aHR 2.0, 95% CI 1.4 to 2.9 for ages 18 to 24, aHR 2.2, 95% CI 1.6 to 3.1 for ages 25 to 29, vs. ages 30 to 39 years), who identified as transgender women (aHR 2.0, 95% CI 1.2 to 3.4, vs. cisgender men), and who had mental health disorders (aHR 1.2, 95% CI 1.1 to 1.4 for each additional disorder) were more likely to have discontinuations. Conclusions: Discontinuations of PrEP use among this American sample of predominately MSM were common, particularly among patients who were younger, identified as transgender women, or had behavioural health issues. As HIV seroconversions occurred after discontinuations of PrEP, strategies to prevent inappropriate discontinuations are needed. [ABSTRACT FROM AUTHOR]

Introduction: We assessed mortality and losses to follow‐up (LTFU) during adolescence in routine care settings in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. Methods: Cohorts in the Asia‐Pacific, the Caribbean, Central, and South America, and sub‐Saharan Africa (Central, East, Southern, West) contributed data, and included adolescents living with HIV (ALHIV) enrolled from January 2003 and aged 10 to 19 years (period of adolescence) while under care up to database closure (June 2016). Follow‐up started at age 10 years or the first clinic visit, whichever was later. Entering care at <15 years was a proxy for perinatal infection, while entering care ≥15 years represented infection acquired during adolescence. Competing risk regression was used to assess associations with death and LTFU among those ever receiving triple‐drug antiretroviral therapy (triple‐ART). Results: Of the 61,242 ALHIV from 270 clinics in 34 countries included in the analysis, 69% (n = 42,138) entered care <15 years of age (53% female), and 31% (n = 19,104) entered care ≥15 years (81% female). During adolescence, 3.9% died, 30% were LTFU and 8.1% were transferred. For those with infection acquired perinatally versus during adolescence, the four‐year cumulative incidences of mortality were 3.9% versus 5.4% and of LTFU were 26% versus 69% respectively (both p < 0.001). Overall, there were higher hazards of death for females (adjusted sub‐hazard ratio (asHR) 1.19, 95% confidence interval (CI) 1.07 to 1.33), and those starting treatment at ≥5 years of age (highest asHR for age ≥15: 8.72, 95% CI 5.85 to 13.02), and in care in mostly urban (asHR 1.40, 95% CI 1.13 to 1.75) and mostly rural settings (asHR 1.39, 95% CI 1.03 to 1.87) compared to urban settings. Overall, higher hazards of LTFU were observed among females (asHR 1.12, 95% CI 1.07 to 1.17), and those starting treatment at age ≥5 years (highest asHR for age ≥15: 11.11, 95% CI 9.86 to 12.53), in care at district hospitals (asHR 1.27, 95% CI 1.18 to 1.37) or in rural settings (asHR 1.21, 95% CI 1.13 to 1.29), and starting triple‐ART after 2006 (highest asHR for 2011 to 2016 1.84, 95% CI 1.71 to 1.99). Conclusions: Both mortality and LTFU were worse among those entering care at ≥15 years. ALHIV should be evaluated apart from younger children and adults to identify population‐specific reasons for death and LTFU. [ABSTRACT FROM AUTHOR]

1 | INTRODUCTION Australia is at the forefront of successful control of human immunodeficiency virus type 1 (HIV-1) transmission due to rapid and comprehensive public health responses from the beginning [...], Introduction: The human immunodeficiency virus 1 (HIV-1) pandemic is characterized by numerous distinct sub-epidemics (clusters) that continually fuel local transmission. The aims of this study were to identify active growing clusters, to understand which factors most influence the transmission dynamics, how these vary between different subtypes and how this information might contribute to effective public health responses. Methods: We used HIV-1 genomic sequence data linked to demographic factors that accounted for approximately 70% of all new HIV-1 notifications in New South Wales (NSW). We assessed differences in transmission cluster dynamics between subtype B and circulating recombinant form 01AE (CRF01AE). Separate phylogenetic trees were estimated using 2919 subtype B and 473 CRF01AE sequences sampled between 2004 and 2018 in combination with global sequence data and NSW-specific clades were classified as clusters, pairs or singletons. Significant differences in demographics between subtypes were assessed with Chi-Square statistics. Results: We identified 104 subtype B and 11 CRF01AE growing clusters containing a maximum of 29 and 11 sequences for subtype B and CRF01AE respectively. We observed a > 2-fold increase in the number of NSW-specific CRF01AE clades over time. Subtype B clusters were associated with individuals reporting men who have sex with men (MSM) as their transmission risk factor, being born in Australia, and being diagnosed during the early stage of infection (p < 0.01). CRF01AE infections clusters were associated with infections among individuals diagnosed during the early stage of infection (p < 0.05) and CRF01AE singletons were more likely to be from infections among individuals reporting heterosexual transmission (p < 0.05). We found six subtype B clusters with an above-average growth rate (>1.5 sequences / 6-months) and which consisted of a majority of infections among MSM. We also found four active growing CRF01AE clusters containing only infections among MSM. Finally, we found 47 subtype B and seven CRF01AE clusters that contained a large gap in time (>1 year) between infections and may be indicative of intermediate transmissions via undiagnosed individuals. Conclusions: The large number of active and growing clusters among MSM are the driving force of the ongoing epidemic in NSW for subtype B and CRF01AE. Keywords: HIV1; transmission cluster; subtype B and CRF01AE; demographic differences; early infections; public health

1 | INTRODUCTION Pre-exposure prophylaxis (PrEP), with tenofovir disoproxil/emtricitabine, has been proven to be highly effective in preventing HIV infections in men who have sex with men (MSM) and other [...], Introduction: Until September 2019, pre-exposure prophylaxis (PrEP) with tenofovir disoproxil/emtricitabine for HIV prevention was not covered by health insurance plans in Germany, and was only available through private prescriptions with self-pay or through informal non-prescription sources. The objective of this study was to investigate the proportion of informal PrEP use among PrEP users and to identify factors of public health relevance that might be associated with informal PrEP use. Methods: We conducted a cross-sectional study recruiting PrEP users independent of their PrEP source. Clients from anonymous community testing checkpoints, users of three dating apps for men who have sex with men residing in Germany and users of a PrEP community website, were recruited to complete a short anonymous online survey. Participants were recruited between 24 July and 3 September 2018. The results were analysed using univariable and multivariable logistic regressions. Results: We recruited 2005 participants currently using PrEP. The median age was 38 years, and 80.3% of the participants identified themselves as male (missing: 19.1%). Overall, 71.6% obtained PrEP through medical services with a private prescription or a clinical trial, and 17.4% obtained PrEP through informal sources (missing: 11.0%). The most common informal sources were ordering online from another country (8.8%), travel abroad (3.6%), and friends (2.5%). Factors associated with informa PrEP use were on demand/intermittent dosing (adjusted OR: 3.5, 95% CI 2.5 to 5.0) and not receiving medical tests during PrEP use (adjusted OR: 3.2, 95% CI 2.0 to 5.2). In addition, informal PrEP users who did not take PrEP daily had a strongly increased risk of starting PrEP without prior medical tests (adjusted stratum-specific OR = 31.7, 95% CI 4.6 to 219.5). Conclusions: Informal PrEP use was associated with a higher risk of not getting tested before and during PrEP use, which could lead to HIV infections resistant to tenofovir and emtricitabine if people with undiagnosed HIV use PrEP. Health insurance plans that cover PrEP and the accompanying routine tests could ensure adequate medical supervision of PrEP users and reduce barriers to PrEP use. Our findings strongly support the implementation of PrEP programmes in countries with similar patterns of informal PrEP use. Keywords: PrEP; men who have sex with men; testing; informal PrEP; non-daily use; affordability

Introduction UNAIDS estimates that 3.4 million children under the age of 15 years are currently living with HIV infection; 91% of these children reside in sub-Saharan Africa [1]. HIV infection [...], Introduction: There are limited data on paediatric HIV care and treatment programmes in low-resource settings. Methods: A standardized survey was completed by International epidemiologic Databases to Evaluate AIDS paediatric cohort sites in the regions of Asia-Pacific (AP), Central Africa (CA), East Africa (EA), Southern Africa (SA) and West Africa (WA) to understand operational resource availability and paediatric management practices. Data were collected through January 2010 using a secure, web-based software program (REDCap). Results: A total of 64,552 children were under care at 63 clinics (AP, N = 10; CA, N = 4; EA, N = 29; SA, N = 10; WA, N = 10). Most were in urban settings (N = 41, 65%) and received funding from governments (N = 51, 81%), PEPFAR (N = 34, 54%), and/or the Global Fund (N = 15, 24%). The majority were combined adult-paediatric clinics (N = 36, 57%). Prevention of mother-to-child transmission was integrated at 35 (56%) sites; 89% (N = 56) had access to DNA PCR for infant diagnosis. African (N = 40/53) but not Asian sites recommended exclusive breastfeeding up until 4-6 months. Regular laboratory monitoring included CD4 (N = 60, 95%), and viral load (N = 24, 38%). Although 42 (67%) sites had the ability to conduct acid-fast bacilli (AFB) smears, 23 (37%) sites could conduct AFB cultures and 18 (29%) sites could conduct tuberculosis drug susceptibility testing. Loss to follow-up was defined as >3 months of lost contact for 25 (40%) sites, >6 months for 27 sites (43%) and >12 months for 6 sites (10%). Telephone calls (N = 52, 83%) and outreach worker home visits to trace children lost to follow-up (N = 45, 71%) were common. Conclusions: In general, there was a high level of patient and laboratory monitoring within this multiregional paediatric cohort consortium that will facilitate detailed observational research studies. Practices will continue to be monitored as the WHO/UNAIDS Treatment 2.0 framework is implemented. Keywords: paediatric HIV; cohort; observational; Africa; Asia.