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Introduction: Despite a number of HIV prevention strategies, the number of new HIV infections remains high. In Australia, over three-quarters of new HIV diagnoses are in gay and bisexual men (GBM). Pre-exposure prophylaxis (PrEP) has been shown to be effective at preventing new HIV infections in several PRELUDE randomised trials. The study aims to evaluate the implementation of PrEP in healthcare settings in New South Wales (NSW), Australia, among a sample of high-risk adults. Methods and analysis: is an ongoing PRELUDE open-label, single-arm demonstration project, conducted in public and private clinics across NSW, Australia. Enrolment began in November 2014. The study is designed for 300 high-risk participants--mainly GBM and heterosexual women. Participants receive daily oral PrEP, composed of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), for up to 2.5 years. Quarterly study visits include testing for HIV and sexually transmitted infections (STIs), assessment of ongoing eligibility and side effects, and self-reported adherence. Following each study visit, online behavioural surveys are administered to collect information on medication adherence, risk behaviours and attitudes. Blood samples will be collected in a subset of patients 1, 6 and 12 months after PrEP initiation to measure FTC/TDF concentrations. Analyses using longitudinal regression models will focus on feasibility, adherence, safety, tolerability and effects of PrEP on behaviour. This study will inform PrEP policy and guide the implementation of PrEP in Australia in people at high risk of HIV. Ethics and dissemination: The study will be conducted in accordance with the Declaration of Helsinki. All patients will provide written informed consent prior to participation in the study. Publications relating to each of the primary end points will be gradually released after 12 months of follow-up is complete. [ABSTRACT FROM AUTHOR]

Setting: Bacteriological confirmation of TB diagnosis remains a key operational challenge in Papua New Guinea. Sandaun Provincial Hospital (SPH) is the main TB diagnostic and treatment centre of West Sepik Province., Objective: To evaluate TB caseload, patient characteristics, and quality of diagnosis at SPH between 2016 and 2021., Design: A retrospective descriptive study using TB treatment, laboratory, and presumptive TB registers to collect data on all TB patients. We used multivariable logistic regression to determine factors associated with bacteriological confirmation., Results: Of 1,305 TB patients registered, 25% were children (<15 years) and 30% had extrapulmonary TB. The quality of sputum was associated with a positive smear microscopy result ( P = 0.002). The proportion bacteriologically confirmed was low (37.3%), being higher in young adults 15-44 years (50.6%, 377/745) than in children <15 years (6.3%, 20/319) or older adults ≥45 years (37.6%, 68/181). Bacteriological confirmation was less likely in people travelling ≥3 hours to a health facility (adjusted OR 0.58, 95% CI 0.34-0.97) and extrapulmonary TB (aOR 0.01, 95% CI 0.00-0.03) but more likely for retreatment cases (aOR 1.59, 95% CI 1.00-2.51)., Conclusion: Diagnostic services in West Sepik Province need strengthening to achieve a higher proportion of bacteriological confirmation in new pulmonary and extrapulmonary TB cases of all ages and improve access for the rural population., Competing Interests: Conflicts of interest: none declared., (© 2024 The Authors.)

Setting: Madang Province is located on the northern coast of Papua New Guinea (PNG), a critical mixing point between the populous highlands and more remote regions. Madang Province faces challenges with limited capacity to diagnose and treat TB., Objective: To describe the TB caseload and investigate factors associated with known unfavourable treatment outcomes., Design: This is a retrospective cohort study using routinely collected TB programmatic data for treatments commenced 1 January 2019 to 31 December 2021. Using multivariable logistic regression, factors associated with known unfavourable treatment outcomes-death, failure after treatment, and loss to follow-up (LTFU)-were evaluated., Results: Of the 4,668 registered and treated, 3,755 had an evaluated outcome, and 33% had unfavourable outcomes, most commonly LTFU (23%). Unfavourable treatment outcomes were significantly associated with HIV-untested (aOR 2.82 compared to HIV-negative; 95% CI 2.39-3.33), having drug-resistant TB (aOR 3.26 compared to drug-susceptible TB, 95% CI 1.18-9.00), and travel time to the health facility 1-<3 hours by foot (aOR 3.53 compared to <1 hour by foot; 95% CI 1.04-12.06)., Conclusion: High LTFU from TB treatment was associated with factors that indicate barriers to access to care and treatment completion. Decentralisation and strengthening of TB services for improved person-centred care and treatment support are urgently required in Madang Province., Competing Interests: Conflicts of interest: none declared., (© 2024 The Authors.)

The impact of outbreak response immunization (ORI) can be estimated by comparing observed outcomes to modelled counterfactual scenarios without ORI, but the most appropriate metrics depend on stakeholder needs and data availability. This study developed a framework for using mathematical models to assess the impact of ORI for vaccine-preventable diseases. Framework development involved (1) the assessment of impact metrics based on stakeholder interviews and literature reviews determining data availability and capacity to capture as model outcomes; (2) mapping investment in ORI elements to model parameters to define scenarios; (3) developing a system for engaging stakeholders and formulating model questions, performing analyses, and interpreting results; and (4) example applications for different settings and pathogens. The metrics identified as most useful were health impacts, economic impacts, and the risk of severe outbreaks. Scenario categories included investment in the response scale, response speed, and vaccine targeting. The framework defines four phases: (1) problem framing and data sourcing (identification of stakeholder needs, metrics, and scenarios); (2) model choice; (3) model implementation; and (4) interpretation and communication. The use of the framework is demonstrated by application to two outbreaks, measles in Papua New Guinea and Ebola in the Democratic Republic of the Congo. The framework is a systematic way to engage with stakeholders and ensure that an analysis is fit for purpose, makes the best use of available data, and uses suitable modelling methodology.

Routine vaccines are critical to child health. The COVID-19 pandemic significantly impacted essential health services, particularly in low-and middle-income countries (LMICs). We reviewed literature to determine the impact of COVID-19 on service delivery and uptake of routine childhood immunisation in LMICs. We reviewed papers published between March 2020 and June 2022 using a scoping review framework, and assessed each paper across the World Health Organisation health system strengthening framework. Our search identified 3,471 publications; 58 studies were included. One-quarter of studies showed routine childhood immunisation coverage declined (10% to 38%) between 2019 to 2021. Declines in the number of vaccine doses administered (25% to 51%), timeliness (6.2% to 34%), and the availability of fixed and outreach services were also reported. Strategies proposed to improve coverage included catch-up activities, strengthening supply chain and outreach services. Re-focusing efforts on increasing coverage is critical to improve child health and reduce the likelihood of disease outbreaks., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Dalton et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Most human immunodeficiency virus (HIV) seroconversions in people who have initiated preexposure prophylaxis (PrEP) occur in the context of insufficient adherence. We describe participants who seroconverted after being dispensed PrEP in a large PrEP implementation study in Australia., Methods: Expanded PrEP Implementation in Communities in New South Wales was an implementation study of daily oral PrEP in individuals aged ≥18 years at high risk for acquiring HIV. HIV seroconversions were defined as a positive HIV test by either antigen, antibody, or detectable HIV viral load after enrollment. Insufficient adherence, measured by dispensing logs or participant self-report, was defined as <4 PrEP doses per week., Results: A total of 9596 participants were enrolled and dispensed PrEP between 1 March 2016 and 30 April 2018; 30 were diagnosed with HIV by 31 March 2019. The median (interquartile range [IQR]) age was 31 (25-38) years, all identified as male, 29 (97%) identified as gay or homosexual, and 20 (69%) lived in a postcode with a low concentration of gay male residents. The median (IQR) days from first PrEP dispensing to diagnosis was 409 (347-656). There was no evidence that participants who seroconverted had been sufficiently adherent to PrEP. Nineteen (63%) participants who seroconverted were diagnosed with chlamydia, gonorrhoea, syphilis, or new hepatitis C infection. One participant had resistance to emtricitabine (M184V mutation) at diagnosis., Conclusions: Participants who seroconverted were insufficiently adherent to PrEP despite being at high risk for acquiring HIV. Understanding the reasons for poor PrEP adherence in individuals who subsequently acquire HIV is critical to improving PrEP effectiveness., Competing Interests: Potential conflicts of interest. N. J. D. has received research support through the Gilead Australia Fellowship for an unrelated project (paid to institution). A. C. has received research funding from Gilead Sciences, MSD, and ViiV Healthcare (paid to institution); consulting fees, lecture and travel sponsorships from Gilead Sciences, MSD. and ViiV Healthcare (paid to author); and has served on advisory boards for Gilead Sciences, MSD. and ViiV Healthcare (paid to author). I. Z. has received previous research support from Gilead Sciences for research unrelated to the current work and is a member of the Australian Nation PrEP Guideline Writing Group. P. R. has received research funding from Gilead Sciences, and honoraria for speaking from Gilead Sciences, MSD, and ViiV. B. B. reports grants from Gilead Sciences (Unrestricted research grant, 2021-22) and ViiV Healthcare (Unrestricted research grant, 2022-23), honorarium from Gilead Sciences (speakers fee, 2020), and support from ViiV Healthcare (Travel to Melbourne for meeting, 2022). A. E. G. reports royalties or licenses from ViiV, implementation research on injectable PrEP (paid to institution), support from ViiV for attending a meeting on injectable treatment (2022) and is a member of the Governing council of the International AIDS society. R. G. is an investigator on a project that receives funding from Gilead (unrelated to this project). J. H. is an executive member for the board at NSW Gender Centre inc. S. J. M. reports support from Gilead to attend local education evenings (does not include national or international meetings; unpaid participation, local restaurant dinner and talk). B. Y. reports support from Mylan Pty Ltd (travelled to Canberra, Australian Capital Territory to present EPIC-NSW study at a clinical care meeting at Canberra Hospital on 28 August 2019). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The use of preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has raised concerns of increased sexual risk behaviors. These behaviors may be associated with increased incidence of sexually acquired hepatitis C virus (HCV) among gay and bisexual men., Methods: The Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) study was a cohort study of daily coformulated tenofovir disoproxil fumarate and emtricitabine for HIV prevention. We recruited 9596 people at high risk of HIV acquisition from 31 clinics across New South Wales and the Australia Capital Territory in Australia. We report prior exposure to HCV and incidence in this cohort between 2016 and 2019., Results: At least 1 HCV test result was available for 8658 (90.2%) participants. These individuals had a median age of 34 years (interquartile range, 28-43), most of whom were male (8530, 98.5%), identified as gay (7944, 91.8%), and were born in Australia (51.8%). Prior exposure to HCV was detected among 81 participants at baseline (0.9%; 95% confidence interval [CI]: .71.2). Twenty of 8577 participants were diagnosed with incident infection (rate 0.2/100 person-years [95% CI: .1-.3/100 person-years]). They were significantly older (median age 41 years vs 34 years, P = .044), and more likely to report methamphetamine use at baseline (incidence rate ratio, 2.7 [95% CI: 1.00-7.2]) than those without incident infection., Conclusions: In this population of PrEP users, HCV prior exposure and incidence were low. With high levels of HCV and HIV testing and treatment, the dual goals of HIV and HCV elimination could be achieved in this population. Clinical Trials Registration: number NCT02870790., Competing Interests: Potential conflicts of interest. A. G. receives grant funding from Viiv for study of injectable preexposure prophylaxis and Seqirus for genital warts surveillance; membership of global forum on adult HPV from MSD; member of Governing Council 2020 from International AIDS Society; and in kind support for a trial of a gonorrhea vaccine (Bexsero vaccine) from GSK. B. B. receives unrestricted grant funding from ViiV and Gilead Sciences for studies unrelated to the submitted work, 2021–2022; travel honorarium in 2019 from Gilead Sciences; honorarium in 2020 from Gilead Sciences and honorarium in 2021 from Virology Education; and Board Director of HIV communication organization in NSW Australia from ACON Health. G. M, receives grant funding from Gilead Sciences and AbbVie and reports payment or honoraria from Janssen. N. D. received research support paid to her institution (UNSW Sydney) through a Gilead Australia Fellowship for an unrelated project. P. R. receives from funding from Gilead Sciences and personal speaker fees from Gilead Sciences and AbbVie. D. J. T. has received payment for providing expert reports for the NSW justice system on the significance of STIs in cases of suspected child sexual abuse. He has not received payment for expert testimony relevant to any aspect of this manuscript on PrEP more generally. D. A. B. reports trial funding from Viiv Healthcare and MSD; participation on an Advisory Board for Gilead Sciences and AbbVie; and a leadership or fiduciary role as an advisor to Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM). No other investigators reported any other relevant funding or conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Event-driven pre-exposure prophylaxis (ED-PrEP), when taken according to the "2-1-1" dosing method, is highly effective at preventing HIV acquisition for gay, bisexual, and other men who have sex with men (GBM). Any missed doses when using ED-PrEP drastically reduce its effectiveness, so it is vital that people using this method know how to take it correctly. This study investigated Australian GBM's awareness of ED-PrEP and their knowledge of how to take it correctly., Method: We conducted a survey of 1471 PrEP-experienced GBM in Australia, between October 2019 and March 2020. The survey assessed awareness and knowledge of the 3 components of the "2-1-1" ED-PrEP dosing regimen (number of pills for loading dose, timing of loading dose, and number of days after sex to take PrEP pills) among GBM. Characteristics associated with ED-PrEP awareness and correct knowledge of how to take ED-PrEP were assessed with multivariate logistic regression., Results: Two-thirds (n = 1004, 68.4%) had heard of ED-PrEP, of whom only one-eighth (n = 125, 12.5%) knew the correct details of the "2-1-1" ED-PrEP method; one-third (n = 339, 33.8%) did not know any of the 3 key components. Awareness of ED-PrEP and correct knowledge was associated with greater belief in PrEP efficacy, university education, and intention to take a nondaily PrEP regimen in the next 6 months., Conclusions: Although ED-PrEP awareness was considerable, most participants did not know how to use ED-PrEP correctly. Further work is needed to increase awareness and knowledge of ED-PrEP among GBM., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

The coronavirus disease pandemic has highlighted the utility of pathogen genomics as a key part of comprehensive public health response to emerging infectious diseases threats, however, the ability to generate, analyse, and respond to pathogen genomic data varies around the world. Papua New Guinea (PNG), which has limited in-country capacity for genomics, has experienced significant outbreaks of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with initial genomics data indicating a large proportion of cases were from lineages that are not well defined within the current nomenclature. Through a partnership between in-country public health agencies and academic organisations, industry, and a public health genomics reference laboratory in Australia a system for routine SARS-CoV-2 genomics from PNG was established. Here we aim to characterise and describe the genomics of PNG's second wave and examine the sudden expansion of a lineage that is not well defined but very prevalent in the Western Pacific region. We generated 1797 sequences from cases in PNG and performed phylogenetic and phylodynamic analyses to examine the outbreak and characterise the circulating lineages and clusters present. Our results reveal the rapid expansion of the B.1.466.2 and related lineages within PNG, from multiple introductions into the country. We also highlight the difficulties that unstable lineage assignment causes when using genomics to assist with rapid cluster definitions., (© The Author(s) 2022. Published by Oxford University Press.)

Background: While hematological symptoms are considered difficult to manage in a Pediatric Palliative Care setting, home may still represent a safe and convenient place for transfusions in patients with advanced malignancy or chronic conditions. This research focuses on the safety and feasibility of a home transfusion program., Methods: This is a case series of patients between 0 and 18 years diagnosed with advanced malignancy or incurable chronic conditions and eligible to Pediatric Palliative Care who received home platelet or packed red cell transfusions. For all patients, we recorded adverse events such as acute hemolytic reactions, allergic reactions, or any emergency condition requiring hospital admission, equipment failure, blood product transport or storage errors, errors in patient identification, and personnel safety issues. We explored parental satisfaction with a Likert-type questionnaire and short open questions., Results: We reviewed 101 transfusion procedures for six patients in Pediatric Palliative Care performed by the Regional Pediatric Palliative Care network between 2014 and 2020. We did not report any adverse effects. Families reported satisfaction and a sense of safety and positively evaluated the opportunity of having transfusion at home to minimize the disruption in everyday life. The cost analysis resulted in a consistent saving for the Regional Health System., Conclusion: This study supports the safety and feasibility of home transfusion in Pediatric Palliative Care., (Copyright © 2021 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Alternatives to daily dosing of HIV pre-exposure prophylaxis (PrEP) are continuing to emerge. From October 2019 to March 2020, we conducted an online survey of PrEP-experienced gay and bisexual men in Australia about interest in and preference for four different PrEP modalities: daily dosing, event-driven dosing, long-acting injectable (LAI)-PrEP and subdermal PrEP implants. Using data from 1477 participants, we measured interest and preference of different modalities using multivariate logistic regression. High proportions of participants were interested in LAI-PrEP (59.7%), daily PrEP (52.0%), PrEP implants (45.3%) and event-driven PrEP (42.8%). LAI-PrEP was the most frequently selected preference (30.5%), followed by PrEP implants (26.3%), daily PrEP (21.4%) and event-driven PrEP (21.2%). Higher interest and preference for non-daily PrEP modalities were associated with being concerned about side effects and perceived difficulties with daily adherence. As novel modalities emerge, attitudes to them should be considered in public health messaging to facilitate informed decision-making., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background Overseas-born people who are ineligible for government-subsidised health care experience barriers to accessing HIV pre-exposure prophylaxis (PrEP) in Australia. This study aimed to assess a program providing free PrEP to overseas-born adults at risk of acquiring HIV. Methods Medicare-Ineligible Expanded Implementation in Communities (MI-EPIC) was a single-arm, open-label trial of daily tenofovir disoproxil fumarate/emtricitabine as PrEP. Six clinics recruited Medicare-ineligible adults who met HIV risk criteria in New South Wales, Australia. We recorded data on HIV and sexually transmitted infection (STI) diagnoses, and PrEP dispensing from July 2019 to June 2020. PrEP adherence as a medication possession ratio (MPR) was calculated as pills dispensed divided by days. We administered an optional survey on behaviours and attitudes to PrEP and sexual health. Results The 221 participants (206 men; 93.2%) had a median age of 29years (IQR 26-34). Participants were mostly born in Asia (53.4%), Latin America or the Caribbean (25.3%), or Europe (10.9%). Adherence was high; 190 participants (86.0%) had an MPR of >60%. Of 121 survey participants, 42 (34.7%) completed the survey in a language other than English. Of participants who had not used PrEP in the 6months before enrolment (n=45, 37.2%), the most common reasons were cost (n=22, 48.9%), and lack of knowledge about accessing PrEP (n=20, 44.4%). Conclusions Medicare-ineligible people at risk of HIV demonstrate high adherence when given access to free PrEP and translated information. Increasing PrEP awareness and reducing barriers to accessing PrEP in this high-risk population should be priorities in HIV prevention.

Background: HIV preexposure prophylaxis (PrEP) with fixed-dose tenofovir disoproxil fumarate (TDF) and emtricitabine has been associated with low rates of renal impairment in clinical trials. Large-scale PrEP implementation may result in higher rates, as the prevalence of associated risk factors may be higher than in trial populations., Methods: A posthoc analysis of EPIC-NSW, a large Australian multicentre PrEP implementation trial for patients at high risk of HIV infection. Participants were eligible for inclusion if they commenced PrEP between 1 March 2016 and 30 April 2018, and had renal function assessed at baseline and at least once more before the censor date. The primary outcome was new-onset renal impairment, defined as an estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m2., Results: A total of 6808 participants were eligible for inclusion. Almost all were male (99%), with a median age of 35 years [interquartile range (IQR): 28-44]. Approximately one-quarter (26%) had a baseline eGFR <90 ml/min per 1.73 m2. Over a median follow-up period of 1.2 years (IQR: 0.6-1.7), the rate of renal impairment was 5.8 episodes per 1000 person-years [95% confidence interval (CI): 4.0-7.8]. In multivariable Cox regression, there was a higher risk of renal impairment in participants aged ≥50 years [hazard ratio (HR) 14.7, 95% CI: 5.0-43.3, P < 0.001] and those with an eGFR <90 ml/min per 1.73 m2 (HR 28.9, 95% CI: 6.9-121.9) at baseline., Conclusion: In a large-scale implementation study, TDF-containing PrEP was associated with a low risk of renal impairment overall, whereas older patients and those with preexisting renal dysfunction were at substantially increased risk., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To examine patterns of long-term pre-exposure prophylaxis (PrEP) adherence and its association with HIV seroconversion in NSW, Australia., Design: Population-based HIV PrEP implementation study., Methods: Expanded PrEP Implementation in Communities in New South Wales was an open-label study of daily oral PrEP which recruited participants from March 2016 to April 2018. Adherence was measured using dispensing records. PrEP discontinuation was defined as an at least 120-day period without PrEP coverage. Long-term adherence patterns were identified using group-based trajectory modelling., Results: Participants dispensed at least once (n = 9586) were almost all male (98.5%), identified as gay (91.3%), with a median age of 34 years (range: 18-86). Of the 6460 (67.4%) participants who had at least 9 months of follow-up since first dispensing, 1942 (30.1%) discontinued. Among these, 292 (15.0%) restarted later. Four distinct groups were identified ['Steep decline' in adherence (15.8%), 'Steady decline' (11.6%), 'Good adherence' (37.4%), and 'Excellent adherence' (35.2%)]. Older (P < 0.001) and gay-identified (P < 0.001) participants were more likely to have higher adherence, so were those living in postcodes with a higher proportion of gay-identified male residents (P < 0.001). Conversely, those who at baseline reported recent crystal methamphetamine use and had a recent diagnosis of sexually transmitted infection (STI) had lower adherence (P < 0.001). Overall HIV incidence was 0.94 per 1000 person-years (95% confidence interval: 0.49-1.81; n = 9) and was highest in the 'steep decline' group (5.45 per 1000 person-years; P = 0.001)., Conclusion: : About 15% of participants stopped PrEP during study follow-up and were at increased risk of HIV infection. They were more likely to be younger and report a recent STI or methamphetamine use prior to PrEP initiation., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: We aimed to identify the barriers and enablers that Health Care Workers (HCWs) in Papua New Guinea experienced in swabbing for COVID-19., Methods: We conducted a cross-sectional multi-methods study: a qualitative scoping exercise and a telephone survey. The target population was COVID-19-trained HCWs from all provinces of Papua New Guinea. A descriptive analysis of survey responses was conducted alongside a rapid qualitative analysis of interviews and open-ended survey questions., Results: Four thematic areas were identified: human resources, logistics, HCW attitudes and community attitudes. The survey response rate was 70.3% (407/579). Commonly reported barriers to COVID-19 swabbing were insufficient staff trained (74.0%, n = 301), inadequate staffing in general (64.9%, n = 264), insufficient supply of personal protective equipment (60.9%, n = 248) and no cold chain to store swabs (57.5%, n = 234). Commonly reported enablers to swabbing were community awareness and risk communication (80.8%, n = 329), consistent and sufficient supplies of personal protective equipment (67.8%, n = 276), increased surge workforce (63.9%, n = 260) and having a fridge to store swabs (59.7%, n = 243)., Conclusions: A comprehensive community and HCW engagement strategy combined with innovations to improve the supply chain are needed to increase COVID-19 swabbing in Papua New Guinea to reach national testing targets. Investments in increasing numbers of frontline workforce, consistent supplies of PPE, swabs, transport medium, cold boxes and ability to make ice packs, in addtion to establishing regular tranport of specimens from the facility to the testing site will strengthen the supply chain. Innovations are needed to address these issues., (Copyright © 2021. Published by Elsevier Ltd.)

While HIV pre-exposure prophylaxis (PrEP) is highly effective, it has arguably disrupted norms of 'safe sex' that for many years were synonymous with condom use. This qualitative study explored the culture of PrEP adoption and evolving concepts of 'safe sex' in Sydney, Australia, during a period of rapidly escalating access from 2015-2018, drawing on interviews with sexually active gay men (n = 31) and interviews and focus groups with key stakeholders (n = 10). Data were analysed thematically. Our results explored the decreasing centrality of condoms in risk reduction and new patterns of sexual negotiation. With regards to stigma, we found that there was arguably more stigma related to not taking PrEP than to taking PrEP in this sample. We also found that participants remained highly engaged with promoting the wellbeing of their communities through activities as seemingly disparate as regular STI testing, promotion of PrEP in their social circles, and contribution to research. This study has important implications for health promotion. It demonstrates how constructing PrEP as a rigid new standard to which gay men 'should' adhere can alienate some men and potentially create community divisions. Instead, we recommend promoting choice from a range of HIV prevention options that have both high efficacy and high acceptability., Competing Interests: The authors have declared that no competing interests exist

Background: Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP., Methods: Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790., Findings: Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13-2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46-3·44)., Interpretation: HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk., Funding: New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences., Competing Interests: Declaration of interests AEG received a grant from the NSW Ministry of Health and the ACT Health Directorate, and non-financial support from Gilead Sciences, enabling the conduct of the reported study. AEG also receives personal fees from Viiv Healthcare and a grant from Seqirus Australia, outside the submitted work. AC reports grants, personal fees, and non-financial support from Gilead Sciences, grants and personal fees from ViiV Healthcare, and grants and personal fees from MSD, outside the submitted work. BY reports travel and accommodation support from Mylan Australia to present at the HIV Clinical Care meeting in the ACT in 2019, unrelated to the submitted work. BRB reports personal fees from Gilead Sciences, outside the submitted work. CTMS reports support from Gilead Sciences to attend a workshop and accommodation. DAB reports grants from ViiV Healthcare, Gilead Sciences, and MSD, during the conduct of the study. MB reports grants from NSW State Government during the conduct of the study; grants and personal fees from Gilead Sciences, ViiV Healthcare, and AbbVie, personal fees from Janssen, and grants from MSD and GSK, outside the submitted work. NJD reports grants from Gilead Sciences unrelated to the submitted work. PR reports institutional research funding and speaking honoraria received from Gilead Sciences unrelated to this manuscript. SM reports grants from ACT Health Directorate and ACT Government, during the conduct of the study. All other authors report no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Preexposure prophylaxis (PrEP) prevents HIV infection but relies on good adherence at times of risk, termed "prevention-effective adherence." Most studies assess adherence without reference to sexual behaviur, making it challenging to determine if poor adherence coincides with HIV risk., Setting: We examined data from a behavioral substudy of a large-scale PrEP implementation trial in New South Wales, Australia., Methods: Trial participants completed optional brief quarterly surveys, reporting the number of pills taken and sexual behavior with male partners for each day of the "last full week" before each survey. Condomless sex (CLS) was defined as "higher risk" for HIV when with HIV-positive men with detectable/unknown viral loads or unknown HIV status men. Adequate PrEP protection was defined as ≥4 pills for participants assigned male sex at birth and ≥6 pills for participants assigned female sex at birth (including transgender men)., Results: Of 9596 participants dispensed PrEP, 4401 completed baseline and ≥1 follow-up survey. Participants reported on 12,399 "last full weeks": 7485 weeks (60.4%) involved CLS and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS. There were 103 weeks in which participants did not have adequate PrEP protection and had higher risk CLS: 4.1% of higher-risk CLS weeks (n = 103/2521), 1.4% of all CLS weeks (n = 103/7485), and 0.8% of all observed weeks (n = 103/12,399)., Conclusions: In a large PrEP trial, prevention-effective adherence to PrEP was very high at 99%. Our findings illustrate the importance of measuring pill-taking and sexual behavior in the same period so that prevention-effective adherence can be better estimated., Competing Interests: The authors have no conflict of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: In response to the novel coronavirus disease (COVID-19) pandemic, Australia introduced public health and physical distancing restrictions in late March 2020. We investigated the impact of these restrictions on HIV preexposure prophylaxis (PrEP) use among Australian gay and bisexual men (GBM)., Methods: Participants in an ongoing online cohort study previously reported PrEP use from 2014 to 2019. In April 2020, 847 HIV-negative and untested participants completed questionnaires assessing changes in PrEP use as a result of COVID-19 public health measures. Binary logistic multiple regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) to compare changes in PrEP use behaviors., Results: Among 847 men, mean age was 44.1 years (SD: 12.7). PrEP use rose from 4.9% in 2015 to 47.2% in 2020. Among those, 41.8% (n = 167) discontinued PrEP use during COVID-19 restrictions. Discontinuing PrEP during COVID-19 restrictions was independently associated with being less likely to have recently tested for HIV (aOR: 0.17; 95% CI: 0.09 to 0.34; P < 0.001) and less likely to report sex with casual partners (aOR: 0.28; 95% CI: 0.14 to 0.54; P < 0.001)., Conclusions: By April 2020, following the introduction of COVID-19 restrictions, GBM dramatically reduced PrEP use, coinciding with a reduction in sexual activity. Longer-term impacts of COVID-19 restrictions on sexual behaviors among GBM need to be monitored because they may foreshadow fluctuations in prevention coverage and risk of HIV infection. Our findings indicate a potential need for clear, targeted information about resumption of PrEP and on-demand optimal dosing regimens in response to ongoing changes in restrictions.

Importance: There have been concerns that HIV preexposure prophylaxis (PrEP) may be associated with increases in sexually transmitted infections (STIs) because of subsequent reductions in condom use and/or increases in sexual partners., Objective: To determine trends in STI test positivity among high-risk men who have sex with men (MSM) before and after the start of HIV PrEP., Design, Setting, and Participants: A before-after analysis was conducted using a subcohort of a single-group PrEP implementation study cohort in New South Wales, Australia (Expanded PreEP Implementation in Communities in New South Wales [EPIC-NSW]), from up to 1 year before enrollment if after January 1, 2015, and up to 2 years after enrollment and before December 31, 2018. STI testing data were extracted from a network of 54 sexual health clinics and 6 primary health care clinics Australia-wide, using software to deidentify, encrypt, and anonymously link participants between clinics. A cohort of MSM dispensed PrEP for the first time during the study, with 2 or more STI tests in the prior year and who tested during follow-up, were included from the EPIC-NSW cohort of HIV-negative participants with high-risk sexual behavior. Data analysis was performed from June to December 2019., Exposures: Participants were dispensed coformulated tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP., Main Outcomes and Measures: The main outcome was STI, measured using test positivity, defined as the proportion of participants testing positive for an STI at least once per quarter of follow-up. Outcomes were calculated for Chlamydia trachomatis and Neisseria gonorrhoea by site of infection (anorectal, pharyngeal, urethral, or any) and for syphilis., Results: Of the EPIC-NSW cohort of 9709 MSM, 2404 were included in the before-after analysis. The mean (SD) age of the participants was 36 (10.4) years, and 1192 (50%) were Australia-born. STI positivity was 52% in the year after PrEP (23.3% per quarter; 95% CI, 22.5%-24.2% per quarter) with no significant trend (mean rate ratio [RR] increase of 1.01 per quarter [95% CI, 0.99-1.02]; P = .29), compared with 50% positivity in the year prior to PrEP (20.0% per quarter [95% CI, 19.04%-20.95% per quarter]; RR for overall STI positivity, 1.17 [95% CI, 1.10-1.24]; P < .001), with an increase in quarterly STI positivity (mean RR of 1.08 per quarter, or an 8% increase per quarter [95% CI, 1.05-1.11]; P < .001; RR, 0.93 [95% CI, 0.90-0.96]; P < .001). Findings were similar when stratified by specific STIs and anatomical site., Conclusions and Relevance: STI rates were high but stable among high-risk MSM while taking PrEP, compared with a high but increasing trend in STI positivity before commencing PrEP. These findings suggest the importance of considering trends in STIs when describing how PrEP use may be associated with STI incidence.

Introduction: In March 2020, Australian state and federal governments introduced physical distancing measures alongside widespread testing to combat COVID-19. These measures may decrease people's sexual contacts and thus reduce the transmission of HIV and other sexually transmissible infections (STIs). We investigated the impact of physical distancing measures due to COVID-19 on the sexual behavior of gay and bisexual men in Australia., Methods: Between April 4, 2020, and April 29, 2020, 940 participants in an ongoing cohort study responded to questions to measure changes in sexual behaviors during the COVID-19 pandemic. Men reported the date they become concerned about COVID-19 and whether they engaged in sexual behavior with regular or casual partners or "fuckbuddies" in the 6 months before becoming concerned about COVID-19 (hereafter referred to as "before COVID-19"), and following the date, they become concerned about COVID-19 (hereafter referred to as "since COVID-19"). Before and since COVID-19 was based on individual participants' own perceived date of becoming concerned about COVID-19., Results: The mean age of was 39.9 years (SD: 13.4). Most participants (88.3%) reported sex with other men during the 6 months before COVID-19. Of the 587 men (62.4%) who reported sex with casual partners before COVID-19, 93 (15.8%) continued to do so in the period since COVID-19, representing a relative reduction of 84.2%., Conclusion: Gay and bisexual men in Australia have dramatically reduced their sexual contacts with other men since COVID-19. These behavioral changes will likely result in short-term reductions in new HIV and STI diagnoses. If sexual health screenings are undertaken before resuming sexual activity, this could present a novel opportunity to interrupt chains of HIV and STI transmission.

Use of crystal methamphetamine (crystal) among gay and bisexual men (GBM) has been associated with condomless anal intercourse with casual partners (CLAIC) and HIV infection. Pre-exposure prophylaxis (PrEP) and undetectable viral load (UVL) are important biomedical HIV prevention strategies. We investigate the relationship between crystal use and HIV sexual risk behaviours in the context of PrEP and UVL. In 2018, 1367 GBM provided details about crystal use and HIV prevention strategies. Binary logistic regression was used to estimate associations between crystal use and behaviour. Recent crystal use was independently associated with greater social engagement with gay men and having more sexual partners. Crystal use was also independently associated with use of PrEP and UVL among GBM who engaged in CLAIC. Although GBM who used crystal were more likely to have engaged in CLAIC, they were also more likely to use biomedical HIV prevention which mitigates against the risks of HIV infection.

Background: Many gay and bisexual men (GBM) experience HIV anxiety, particularly around condomless anal intercourse. HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy that may reduce HIV anxiety among GBM., Methods: The Following Lives Undergoing Change (Flux) Study is a national, online, open-prospective observational study of licit and illicit drug use among GBM in Australia. In 2018, participants responded to newly included items regarding anxiety about HIV transmission. Stratifying GBM as high or low risk as determined by the Australian PrEP Guidelines, we assess whether PrEP use is associated with lower levels of HIV anxiety. Multivariate logistic regression was used to compare factors associated with PrEP use among GBM at high risk (PrEP-eligible) and low risk (PrEP-ineligible) of HIV infection. Results are reported as adjusted odds ratios and corresponding 95% confidence intervals., Results: Among 1547 men, the mean age was 37.1 years (SD 13.1). Men aged 25 years or younger had higher HIV anxiety scores than older men. Among PrEP-eligible men, men who use PrEP reported lower levels of HIV anxiety (adjusted odds ratio = 0.92; 95% confidence interval = 0.87 to 0.99; P < 0.001). No differences were observed on HIV anxiety among PrEP-ineligible men., Conclusions: Among PrEP-eligible men, PrEP use was independently associated with lower levels of HIV anxiety. In addition to avoiding HIV infection, PrEP use may help reduce anxiety among men at risk of HIV. This feature of PrEP could be promoted as part of demand creation initiatives to increase PrEP uptake.