Informed, but uncertain: managing transmission risk and isolation in the 2022 mpox outbreak among gay and bisexual men in Australia.

In 2022, a global outbreak of mpox (formerly 'monkeypox') emerged in non-endemic countries, including Australia, predominantly affecting gay, bisexual and other men who have sex with men. Public health advice on transmission and isolation emerged rapidly from different sources, sometimes conflicting and producing uncertainty. Using the concept of 'counterpublic health', which acknowledges the incorporation of official science and experiences of affected communities into embodied practice, this paper investigates how people affected by mpox in Australia managed risk of transmission and navigated self-isolation. In-depth interviews were conducted with 16 people: 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay and bisexual men living in Australia. Participants thought critically about public health advice, often finding it restrictive and unresponsive to the needs of people with mpox. Participants' decisions about reducing mpox risk and isolating often drew on experiences with other infections (i.e. HIV; COVID-19) and were made collaboratively with the people closest to them (e.g. partners, friends, family) to sustain relationships. Future public health responses to infectious disease outbreaks would benefit from identifying more opportunities to formalise and embed mechanisms to obtain feedback from affected communities so as to inform responses.

Mpox Illness Narratives: Stigmatising Care and Recovery During and After an Emergency Outbreak.

In May 2022, a global outbreak of mpox (formerly monkeypox virus) affected thousands of mainly gay and bisexual men. Mpox is usually a time-limited illness that can involve fever, pain, and skin lesions, but may require hospitalisation. There is scant research into the firsthand experiences of people affected by mpox, including experiences of symptoms, healthcare, and recovery. This study considers the different illness narratives of people who experienced mpox in Australia in 2022. In-depth interviews and 6-month follow-up interviews were conducted with 16 people, including 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay or bisexual men living in Australia. Participants' accounts described minor to severe periods of sickness, negative and stigmatising experiences engaging with healthcare, and some participants experienced long-term effects on their sexual well-being and complications from mpox. The emergency outbreak context meant that mpox was highly distressing, making it difficult to manage and producing varying forms of disruption to everyday life. Mpox was narrated as disruptive in different ways: as a minor interruption to holiday plans, a prolonged period of poor health, or a biographically disruptive event prompting a re-evaluation of sexual values and health. This analysis demonstrates that an unfamiliar emergent disease outbreak related to sexual practices and sociality can reconfigure personal life and sexual well-being, suggesting a need to focus on providing quality patient care in outbreaks of mpox and other infectious diseases.

The experience of abortion for Cook Islands women: exploring the socio-cultural dimensions of abortion safety.

Abortion is significantly restricted by law in most Pacific Island countries, impacting the rights, health and autonomy of people who experience pregnancy. We undertook qualitative research between February and August 2022 on Rarotonga, Cook Islands, where abortion is illegal under most circumstances. We conducted interviews with women who had accessed or tried to access abortion services; people who had supported women to access abortion services; health workers; and advocates to understand their experiences regarding abortion. We conducted focus groups to explore broader social perceptions and experiences of sexual and reproductive health and rights, including abortion. Participants described their abortion decisions and methods, and their negotiation of the personal context of their sexual behaviours, pregnancies, and abortions relative to their socio-cultural context and values. As defined by the World Health Organization, safe abortion relates to the methods and equipment used and the skills of the abortion provider. We argue for an expansion of this definition to consider inclusion of reference to individuals' 'abortion safety nets' as the sum of their access to financial, political, health care and socio-cultural resources. These safety nets are shaped by discourses related to abortion and socio-cultural support and values, impacting physical, emotional, psychological, social and spiritual health.

Factors Associated with Transgender and Gender Diverse People's Experience of Sexual Coercion, and Help-Seeking and Wellbeing Among Victims/Survivors: Results of the First Australian Trans and Gender Diverse Sexual Health Survey.

Purpose: Our study examined factors associated with transgender and gender diverse ("trans") people's experience of sexual coercion, as well as the factors associated with help-seeking and wellbeing among victims/survivors. Methods: We analyzed cross-sectional data from the first Australian Trans and Gender Diverse Sexual Health Survey, conducted in 2018. Logistic regressions were undertaken to identify factors associated with sexual coercion, help-seeking, and wellbeing. Results: Of the sample of 1448 participants, 53.4% had been sexually coerced, which was associated with older age, Aboriginal or Torres Strait Islander descent, nonbinary gender, being presumed female gender at birth, currently living publicly some or all the time as their affirmed gender, having regular sex, and use of drugs to enhance or alter sexual experiences. Protective factors included having a higher income and access to gender affirming care. Help-seeking was reported among 49.5% of victims/survivors and was associated with having more trans friends. Wellbeing among victims/survivors was associated with being older, residing in regional/remote areas, having higher levels of education and annual income, being presumed female gender at birth, having stronger satisfaction with one's sex life, and good health care access. Wellbeing was not associated with help-seeking. Conclusion: Sexual coercion was prevalent among participants, but help-seeking behavior was low. Protective factors identified underscore the importance of socioeconomic supports, access to health and gender affirming care, and peers. Accessible peer-led and culturally safe preventive and trauma-focused supports should also be considered for trans people who experience sexual coercion.

The impact of blood donation deferral strategies on the eligibility of men who have sex with men and other sexual risk behavior in Australia.

BACKGROUND: In Australia, a man cannot donate blood if he has had sex with another man within the past 3 months. However, this policy has been criticized as being discriminatory as it does not consider lower risk subgroups, and led to calls for modifications to the policy that more accurately distinguish risk among gay, bisexual, and other men who have sex with men (GBM). STUDY DESIGN AND METHODS: We used data from a nationally representative survey to estimate the proportion of GBM aged 18-74 years old who would be eligible to donate under current criteria and other scenarios. RESULTS: Among the 5178 survey participants, 155 (3.0%) were classified as GBM based on survey responses, Among the GBM, 40.2% (95% CI 28.0%-53.7%) were eligible to donate based on current criteria, and 21.0% (95% CI 14.5%-29.5%) were ineligible due to the 3 months deferral alone. Eligibility among GBM, all men, and the population increased as criteria were removed. Under the new Australian plasma donation criteria, 73.6% (95% CI 64.4%-81.1%) of GBM, 68.4% (95% CI 65.5%-71.2%) of all men, and 60.8% (95% CI 58.8%-62.8%) of the full population were estimated to be eligible. Only 16.1% (95% CI 8.6%-28.1%) of GBM knew that the male-to-male sex deferral period is 3 months. DISCUSSION: Changing the deferral criteria and sexual risk evaluation would lead to a higher proportion of GBM being eligible to donate blood. Knowledge of the current GBM deferral period is very low. Improved education about the current criteria and any future changes are required to improve blood donation rates.

What's trust got to do with research: why not accountability?

This paper explores the intricate dynamics of trust, power, and vulnerability in the relationship between researchers and study participants/communities in the field of bioethics. The power and knowledge imbalances between researchers and participants create a structural vulnerability for the latter. While trust-building is important between researchers and study participants/communities, the consenting process can be challenging, often burdening participants with power abrogation. Trust can be breached. The paper highlights the contractual nature of the research relationship and argues that trust alone cannot prevent exploitation as power imbalances and vulnerabilities persist. To protect participants, bioethics guidance documents promote accountability and ethical compliance. These documents uphold fairness in the researcher-participant relationship and safeguard the interests of socially vulnerable participants. The paper also highlights the role of shared decision-making and inclusive deliberation with diverse stakeholders and recommends that efforts should be made by researchers to clarify roles and responsibilities, while research regulatory agents should transform the research-participant relationship into a legal-based contract governed by accountability principles. While trust remains important, alternative mechanisms may be needed to ensure ethical research practices and protect the interests of participants and communities. Striking a balance between trust and accountability is crucial in this regard.

Prevalence of blood donation eligibility in Australia: A population survey.

BACKGROUND: Reliable estimates of the population proportion eligible to donate blood are needed by blood collection agencies to model the likely impact of changes in eligibility criteria and inform targeted population-level education, recruitment, and retention strategies. In Australia, the sole estimate was calculated 10+ years ago. With several subsequent changes to the eligibility criteria, an updated estimate is required. STUDY DESIGN AND METHODS: We conducted a cross-sectional national population survey to estimate eligibility for blood donation. Respondents were aged 18+ and resident in Australia. Results were weighted to obtain a representative sample of the population. RESULTS: Estimated population prevalence of blood donation eligibility for those aged 18-74 was 57.3% (95% CI 55.3-59.3). The remaining 42.7% (95% CI 40.7-44.7) were either temporarily (25.3%, 95% CI 23.5-27.2) or permanently ineligible (17.4%, 95% CI 16.1-18.9). Of those eligible at the time of the survey, that is, with the UK geographic deferral for variant Creutzfeldt-Jakob disease included, (52.9%, 95% CI 50.8-54.9), 14.2% (95% CI 12.3-16.3) reported donating blood within the previous 2 years. Eligibility was higher among men (62.6%, 95% CI 59.6-65.6) than women (52.8%, 95% CI 50.1-55.6). The most common exclusion factor was iron deficiency/anemia within the last 6 months; 3.8% (95% CI 3.2-4.6) of the sample were ineligible due to this factor alone. DISCUSSION: We estimate that approximately 10.5 million people (57.3% of 18-74-year-olds) are eligible to donate blood in Australia. Only 14.2% of those eligible at the time of survey reported donating blood within the previous 2 years, indicating a large untapped pool of potentially eligible blood donors.

Framings of abortion in Pacific Island print media: qualitative analysis of articles, opinion pieces, and letters to the editor.

Abortion is significantly restricted by law in most Pacific Island countries, and this has profound implications for the lives and health of women from this region. There are limited data on how abortion is framed in the Pacific Islands: that is, interpreted, discussed, and made meaningful as an issue in public forums. How abortion is framed can have implications for how it is treated in public and political debate and policy, abortion stigmatisation, and inform advocacy strategies. We undertook a thematic analysis of 246 articles, opinion pieces, and letters to the editor that covered the topic of abortion in mainstream print media. We found three dominant framings. Abortion was often positioned in opposition to gender ideology and national identity, with gender and national identity constructed by many commentators according to socially conservative, Christian doctrine. Abortion was also constructed as the killing of the "unborn," with the fetus positioned as the key social subject. Alternatively, abortion was framed as often unsafe and a response to teenage pregnancy, with various solutions suggested in this context. Few commentators constructed women who experienced unwanted pregnancies and abortions as making decisions about their pregnancies in response to complex gendered and socio-economic conditions. Dominant framings of abortion as opposed to gender ideals, nationalism, and the killing of the "unborn" complicate simplified appeals to "choice" in advocacy efforts. Focusing on health and broader injustice experienced by women offer alternative framings.

Understanding the health care needs of transgender and gender diverse people engaging with rural Australian sexual health centres: a qualitative interview study.

BACKGROUND: Although there is a presumption that LGBTQ+ people living in rural Australia will have poorer health outcomes than those living in metropolitan areas, minimal research has focused specifically on the perspectives of transgender and gender diverse (henceforth referred to as 'trans') people living in these regions. The purpose of this study was to understand what health and wellbeing means to trans people in a regional or rural community and identify their health needs and experiences. METHODS: A total of 21 trans people were recruited through two regional sexual health centres (SHC) and interviewed between April and August 2021. Data were analysed via reflexive thematic analysis. This paper focuses on participants' accounts of health and wellbeing regarding gender affirmation, the experience of rural living, respectful holistic care, safety in rural communities, isolation, loneliness, and employment. RESULTS: The experience of living rurally can have both positive and negative impacts on the experiences of trans people. Participants reported experiences of stigma and discrimination, reduced employment opportunities and limited social interactions, which led to feelings of isolation and loneliness; however, they also reported high quality of care, particularly with the specific SHCs which supported this research. CONCLUSION: Living rurally can impact both positively and negatively on the health and wellbeing of trans peoples, and the experiences of living in this environment are diverse. Our findings challenge the perception that rural trans people experience only poor health outcomes and shows the difference that key health services such as SHCs can make in supporting trans health.

Identifying Patterns of Discontinuing and Recommencing Pre-exposure Prophylaxis in the Context of Sexual Behavior Among Gay and Bisexual Men in Australia.

We mapped gay and bisexual men's (GBM) patterns of using pre-exposure prophylaxis (PrEP) over time and explored sexual behavior as PrEP use changed. We conducted semi-structured interviews between June 2020 and February 2021 with 40 GBM living in Australia who had changed their PrEP use since initiating. There was considerable diversity in patterns of discontinuation, suspension, and recommencement of PrEP. Reasons for changing PrEP use mostly centered on accurate perceived changes to HIV risk. Twelve participants reported condomless anal intercourse with casual or fuckbuddy partners after discontinuing PrEP. These sex events were unanticipated, condoms were not a preferred option, and other risk reduction strategies were applied inconsistently. Service delivery and health promotion can support safer sex among GBM when PrEP use fluctuates by promoting event-driven PrEP and/or non-condom-based risk reduction methods during periods off daily PrEP, and guiding GBM to better recognize changing circumstances of risk and when to recommence PrEP.

Reasons for not Using HIV Pre-Exposure Prophylaxis (PrEP) among Gay and Bisexual Men in Australia: Mixed-Methods Analyses from a National, Online, Observational Study.

Although approximately 31,000 Australian gay and bisexual men (GBM) are eligible for HIV pre-exposure prophylaxis (PrEP), only 18,500 people currently use it, indicating a need to investigate why GBM do not use it. This article uses data from a national, online, observational study. It adopts a mixed-methods analysis to responses to survey questions asking about reasons Australian GBM were not using PrEP in 2018, according to their level of HIV risk as delineated by the Australian PrEP prescribing guidelines at the time. Participants responded to check-box questions and had the option to respond to a qualitative free-text question. Results showed that just over one-fifth of men were at higher risk of HIV acquisition. Compared to lower-risk men, higher-risk men were more likely to indicate PrEP was too expensive and more likely to cite embarrassment asking for it. Reasons for not using PrEP included a lack of personal relevance, poor accessibility or knowledge, concerns about PrEP's inability to protect against STIs, potential side effects, and a preference for condoms. We conclude that health promotion more effectively targeting GBM who may benefit the most from PrEP may be valuable.

How to have sex in a pandemic: the development of strategies to prevent COVID-19 transmission in sexual encounters among gay and bisexual men in Australia.

Although many studies reported on decreases in sexual partner numbers among gay and bisexual-identifying men in the early period of the COVID-19 pandemic, few studies have explored COVID-19 risk-reduction strategies. Drawing on free-text responses in an online survey (from April to July 2020), we describe the ways in which men sought to minimise the risk of COVID-19 in sexual encounters. Partner selection was an important strategy, in particular, restricting sex to men they already knew. Accounts also indicate how participants assessed risk from potential sex partners based on symptoms, residential location, recent travel, work role, and number of other sexual contacts. Less common were in situ practices, such as avoiding kissing. Participants' responses provide insight into creative community-based responses in the early months of the pandemic, some of which have resonances with early responses to HIV. Findings are discussed in relation to the concepts of 'lay epidemiology' and 'counterpublic health'. In particular, we examine how risks and health are experienced and valued in relation to local knowledges, meanings, and practices; and how practices emerge in response to dominant public health discourses that produce an idealised public based on (hetero)normative assumptions.

Illegal abortion and reproductive injustice in the Pacific Islands: A qualitative analysis of court data.

The Oceania region is home to some of the world's most restrictive abortion laws, and there is evidence of Pacific Island women's reproductive oppression across several aspects of their reproductive lives, including in relation to contraceptive decision-making, birthing, and fertility. In this paper we analyse documents from court cases in the Pacific Islands regarding the illegal procurement of abortion. We undertook inductive thematic analysis of documents from eighteen illegal abortion court cases from Pacific Island countries. Using the lens of reproductive justice, we discuss the methods of abortion, the reported context of these abortions, and the ways in which these women and abortion were constructed in judges' summing up, judgements, or sentencing. Our analysis of these cases reveals layers of sexual and reproductive oppression experienced by these women that are related to colonialism, women's socioeconomic disadvantage, gendered violence, limited reproductive control, and the punitive consequences related to not performing gender appropriately.

Relationship Between Sexual Behaviors with Non-committed Relationship Partners and COVID-19 Restrictions and Notification Rates: Results from a Longitudinal Study of Gay and Bisexual Men in Australia.

Introduction: COVID-19 related lockdowns have impacted the sexual activity of gay and bisexual men (GBM). We investigated trends in sexual behaviors and the COVID-19 context in which they occurred (COVID-notification rates and jurisdictional restrictions) to understand changes in the duration and severity of periods of lockdown on the sexual behavior of Australian GBM. Methods: In an online, prospective observational study of 831 GBM from May 2020 to May 2021, we investigated associations between changes in sexual behavior among Australian GBM, lockdowns, and COVID-19 notification rates through weekly surveys from May 2020 to May 2021. Results: The mean age was 45.71 years (SD: 13.93). Most identified as gay (89.0%) and 10.2% were living with HIV. There was an overall increase in the mean weekly number of non-committed relationship partners (0.53-0.90, p < 0.001). The state of Victoria experienced a significant extended COVID-19 outbreak, accompanied by severe lockdown restrictions. In response, Victorian men's partner numbers shifted three times, while elsewhere there was an overall gradually increasing trend. Conclusions: Less severe outbreaks with shorter lockdown periods, involving fewer and geographically contained, COVID-19 notifications were accompanied by non-significant changes in sex with non-relationship partners than more severe outbreaks over extended periods and larger geographical areas. Supplementary Information: The online version contains supplementary material available at 10.1007/s13178-022-00733-8.

COVID-19 Testing in a Weekly Cohort Study of Gay and Bisexual Men: The Impact of Health-Seeking Behaviors and Social Connection.

Gay, bisexual, and other men who have sex with men (GBM) have developed community norms for regular HIV/STI testing. We investigated factors associated with self-reported COVID-19 testing in response to reported COVID-19 cases and public health restrictions. Participants responded to weekly cohort surveys between 10th May 2021 and 27th September 2021. We used the Andersen-Gill extensions to the Cox proportional hazards model for multivariable survival data to predict factors influencing COVID-19 testing. Mean age of the 942 study participants was 45.6 years (SD: 13.9). In multivariable analysis, GBM were more likely to report testing during periods of high COVID-19 caseload in their state of residence; if they were younger; university educated; close contact of someone with COVID-19; or reported coping with COVID-19 poorly. COVID-19 testing was higher among men who: were more socially engaged with other GBM; had a higher proportion of friends willing to vaccinate against COVID-19; and were willing to contact sexual partners for contact tracing. Social connection with other gay men was associated with COVID-19 testing, similar to what has been observed throughout the HIV epidemic, making community networks a potential focus for the promotion of COVID-19 safe practices.

Switching to Non-daily Pre-exposure Prophylaxis Among Gay and Bisexual Men in Australia: Implications for Improving Knowledge, Safety, and Uptake.

Introduction: Preexposure prophylaxis (PrEP) dosing options such as event-driven PrEP hold promise to increase PrEP uptake among gay, bisexual, and queer men (GBQM), but their impacts have not yet been realized and uptake by GBQM suitable for PrEP remains slow in countries where it is only considered an alternative option to daily PrEP. Methods: We conducted semi-structured interviews between June 2020 and February 2021 with 40 GBQM in Australia to understand PrEP dosing behaviors, knowledge, and preferences. Results: All participants commenced PrEP daily; 35% had ever switched to non-daily PrEP, mostly taking it event-driven. GBQM who preferred non-daily PrEP had infrequent or predictable sex, were concerned about cost given infrequency of sex, and/or wanted to minimize unnecessary drug exposure. Accurate knowledge of event-driven PrEP was poor. However, reflecting concepts underpinning critical pedagogy, having accurate knowledge was supported by access to consistent messaging across clinical, social, community, and public settings. Several participants who switched to event-driven PrEP had condomless sex events in which they were unable to adhere to pills due to unanticipated sex. Conclusions and Policy Implications: Implementation of comprehensive and consistent education about correct dosing for event-driven PrEP across multiple settings is needed to ensure increased uptake and safe use. GBQM require messaging about non-condom based HIV prevention strategies when they cannot access daily or event-driven PrEP.

Prescribing as affective clinical practice: Transformations in sexual health consultations through HIV pre-exposure prophylaxis.

New medicines can transform routines and priorities in clinical practice, but how do clinicians think and feel about these changes, and how does it affect their work? In Australia, the HIV prevention regimen pre-exposure prophylaxis (PrEP) has been rapidly rolled out, transforming the sexual cultures and practices of users, but less attention has been given to the ways PrEP has reconfigured clinical practice. This paper draws on 28 qualitative semi-structured interviews conducted between 2019 and 2020 with PrEP-providing doctors and nurses in Australia to consider how they have affectively engaged with PrEP and put it into practice. Through a reflexive thematic analysis, we explore how clinicians adapted to PrEP, how the field of HIV prevention has been transformed, and how these developments have changed how clinicians approach patients. While the introduction of PrEP was initially received with uncertainty and shock, clinicians described PrEP as enjoyable to prescribe, and better aligned with the moral duties of sexual health consultations than existing HIV prevention strategies like condoms. Through approaching clinical work as an 'affective practice', we argue for attending not only to how new interventions change expectations and practices, but also how these changes are felt and valued by clinicians.

Experiences of risk in Australian hotel quarantine: a qualitative study.

BACKGROUND: In response to the threat of COVID-19 infection, Australia mandated a 14 day quarantine period in a designated facility for all travellers returning from overseas from late March 2020. These facilities were usually hotels, or hotel-like serviced apartments, and also included a repurposed former mining village in the Northern Territory. This paper aimed to investigate the experiences of risk of people quarantined in designated supervised facilities in Australia, which has not been systematically explored before. METHODS: In this qualitative study semi-structured interviews were conducted with 58 participants quarantined between March 2020 and January 2021. Participants were returned Australian citizens and residents who were required to undergo mandatory supervised quarantine for COVID-19. Interviews were conducted using video teleconferencing (via Zoom), transcribed and coded, then analysed thematically. RESULTS: While participants generally supported the concept of quarantine to protect the Australian public, they were critical of elements of it where they felt exposed to risk (COVID-related or not). They also described instances where infection control within the system seemed inadequate. For some, particularly those quarantined with small children, they reported that the facilities were inadequate or inappropriate for health and wellbeing. Using thematic analysis, three major themes were identified that related to problems in the existing system: perception of being subjected to high risk through lax standards of COVID protection in the quarantine process; risks to the community identified in quarantine; and risk in non-hotel managed quarantine facilities. CONCLUSIONS: There are systemic issues with infection control in hotel quarantine, which can be further undermined by individual non-compliance. Risks to safety for those in quarantine can be reduced, both in terms of infection control within hotel quarantine and, in the case of the Northern Territory facility, timely in-person medical care as needed for non-COVID conditions. Systems of infection control need ongoing review to ensure that people entering quarantine are protected from known risks of infection at every stage. Medical services in quarantine facilities should be examined to ensure timely and appropriate non-COVID medical services are available.

Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

INTRODUCTION: The International AIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethical management of clinical trials involving people living with HIV (PLWH) during the SARS-CoV-2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART). DISCUSSION: There is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS-CoV-2 pandemic. How to do this safely and justly remains a critical debate. The SARS-CoV-2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS-CoV-2 prevention and treatment strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more contagious and potentially pathogenic SARS-CoV-2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS-CoV-2 prevention and treatment strategies will be available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research. CONCLUSIONS: It can be assumed for the foreseeable future that SARS-CoV-2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop.

Effectiveness evaluation of digital contact tracing for COVID-19 in New South Wales, Australia.

BACKGROUND: Digital proximity tracing apps were rolled out early in the COVID-19 pandemic in many countries to complement conventional contact tracing. Empirical evidence about their benefits for pandemic response remains scarce. We evaluated the effectiveness and usefulness of COVIDSafe, Australia's national smartphone-based proximity tracing app for COVID-19. METHODS: In this prospective study, done in New South Wales (NSW), Australia, we included all individuals in the state who were older than 12 years with confirmed, locally acquired SARS-CoV-2 infection between May 4 and Nov 4, 2020. We used data from the NSW Notifiable Conditions Information Management System, the national COVIDSafe database, and information from case interviews, including information on app usage, the number of app-suggested contacts, and the number of app-suggested contacts determined by public health staff to be actual close contacts. We calculated the positive predictive value and sensitivity of COVIDSafe, its additional contact yield, and the number of averted public exposure events. Semi-structured interviews with public health staff were done to assess the app's perceived usefulness. FINDINGS: There were 619 confirmed COVID-19 cases with more than 25 300 close contacts identified by conventional contact tracing during the study period. COVIDSafe was used by 137 (22%) cases and detected 205 contacts, 79 (39%) of whom met the close contact definition. Its positive predictive value was therefore 39%. 35 (15%) of the 236 close contacts who could have been expected to have been using the app during the study period were identified by the app, making its estimated sensitivity 15%. 79 (0·3%) of the estimated 25 300 contacts in NSW were app-suggested and met the close contact definition. The app detected 17 (<0·1%) additional close contacts who were not identified by conventional contact tracing. COVIDSafe generated a substantial additional perceived workload for public health staff and was not considered useful. INTERPRETATION: The low uptake of the app among cases probably led to a reduced sensitivity estimate in our study, given that only contacts who were using the app could be detected. COVIDSafe was not sufficiently effective to make a meaningful contribution to the COVID-19 response in Australia's most populous state over a 6 month period. We provide an empirical evaluation of this digital contact tracing app that questions the potential benefits of digital contact tracing apps to the public health response to COVID-19. Effectiveness evaluations should be integrated into future implementations of proximity contact tracing systems to justify their investment. FUNDING: New South Wales Ministry of Health (Australia); National Health and Medical Research Council (Australia).