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.

Uncertainty and agency in COVID-19 hotel quarantine in Australia.

Mandatory 14-day hotel COVID-19 quarantine was introduced for international arrivals into Australia in late March 2020, with no precedent and little time to prepare. This public health initiative was a key factor in Australia's relatively low COVID-19 burden in the first 18 months of the pandemic. We conducted an empirical bioethics study exploring the experience of people who had quarantined in hotels in Australia. We used in depth interviews to develop an understanding of context and normative analysis to consider whether the way the program is conducted is ethically justifiable. 58 people participated; they had been in hotel quarantine in different parts of Australia in the period March 2020-January 2021. Participants faced considerable uncertainty while in quarantine and many experienced this as burdensome. Some uncertainty resulted from not being given information about key aspects of quarantine, some from rules that changed frequently or were otherwise inconsistent, some from being physically isolated. Lack of information and uncertainty contributed to diminished agency. Communication efforts made by individual hotels was well received. Earlier ethics literature about quarantine does not take into account the context our participants described, where the hotel and supervision arrangements were central to the experience. We argue that more suitable arrangements must be made if quarantine is to be an ongoing proposition.

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.

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.

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).

Increase in Depression and Anxiety Among Australian Gay and Bisexual Men During COVID-19 Restrictions: Findings from a Prospective Online Cohort Study.

We examined depression and anxiety prior to and during COVID-19 restrictions in Australian gay and bisexual men (GBM). In an online cohort, a COVID-19-focused survey was conducted in April 2020. During 2019 and in April 2020, 664 GBM completed the Patient Health Questionnaire (PHQ-9, measuring depression) and Generalized Anxiety Disorder Assessment (GAD-7, measuring anxiety). Increased depression and anxiety were defined as a ≥ 5 point increase on the respective scales. Mean PHQ-9 and GAD-7 scores increased between 2019 and 2020 (PHQ-9: from 5.11 in 2019 to 6.55 in 2020; GAD-7: from 3.80 in 2019 to 4.95 in 2020). The proportion of participants with moderate-severe depression (PHQ-9 ≥ 10) increased from 18.8% (n = 125) to 25.5% (n = 169), while the proportion of participants with moderate-severe anxiety (GAD-7 ≥ 10) increased from 12.7% (n = 84) to 17.3% (n = 115). Almost one-quarter of participants (n = 158, 23.8%) had increased depression; in these men, mean PHQ-9 increased from 2.49 in 2019 to 11.65 in 2020 (p < 0.001). One-in-five (20.6%) participants (n = 137) had increased anxiety; among these men, mean GAD-7 increased from 2.05 in 2019 to 10.22 in 2020 (p < 0.001). Increases were associated with concerns about job security, reduction in social and sexual connections and opportunities, and being personally concerned about COVID-19 itself. COVID-19 appeared to have a sudden and pronounced impact on depression and anxiety in Australian GBM, with a significant minority showing sharp increases. Ongoing monitoring is required to determine longer-term impacts and GBM need access to appropriate and sensitive supports both during and after the COVID-19 pandemic.

Qualitative Findings on the Impact of COVID-19 Restrictions on Australian Gay and Bisexual Men: Community Belonging and Mental Well-being.

COVID-19 may threaten the already poor mental health outcomes of Australian gay and bisexual men and cut ties to important social/sexual networks and community. Qualitative research into the experiences of gay and bisexual men during COVID-19 regulations is currently sparse. We report on 489 responses to a qualitative free-text question asking Australian gay and bisexual men about the impacts of COVID-19 during April 2020. Issues pertinent to gay and bisexual men include lost ties to gay and bisexual social/sexual communities, spaces, and activities, which can reduce a sense of belonging to important sexual identity spaces, as well as significant mental well-being vulnerabilities. Reminiscing the collective response to HIV/AIDS, findings reinforce the value of gay and bisexual community organizations, spaces, and networks as supports for gay and bisexual men and emphasize the need for delivering mental health services.

The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants.

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.

Substantial Decline in Use of HIV Preexposure Prophylaxis Following Introduction of COVID-19 Physical Distancing Restrictions in Australia: Results From a Prospective Observational Study of Gay and Bisexual Men.

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.

Physical Distancing Due to COVID-19 Disrupts Sexual Behaviors Among Gay and Bisexual Men in Australia: Implications for Trends in HIV and Other Sexually Transmissible Infections.

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.

Considerations for stakeholder engagement and COVID-19 related clinical trials' conduct in sub-Saharan Africa.

The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID-19-related clinical trials in sub-Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial-related physical, psychological, financial, and/or social harms; trial accrual, follow-up, exit trial closure and results dissemination; and post-trial access to trial products or procedures. The norms, values, and practices of collectivist societies in Sub-Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil-society organizations, members of community advisory boards and ethics committees, young persons, COVID-19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID-19 related clinical trials. Adapting ethics guidelines to the socio-cultural context of the region can facilitate achieving the aim of stakeholder engagement.