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.

Acceptability of sexual history questions in a gender-neutral risk assessment for blood donation.

BACKGROUND: Currently in Australia, men are deferred from donating blood if they have had sex with another man within the past 3 months. However, a proposed gender-neutral assessment (GNA) process will ask all donors questions about sex with new or multiple recent partners, with deferral based on responses to a question about anal sex. Understanding the acceptability of such questions among existing and potential blood donors is paramount for successful implementation of GNA. STUDY DESIGN AND METHODS: We used data from a nationally representative survey to estimate the levels of comfort with the proposed GNA questions among the Australian population and subgroups, defined by self-reported ethnicity and religion. Respondents were aged over 18 and living in Australia. Results were weighted to represent the population. RESULTS: Most of the 5178 respondents described themselves as comfortable with answering questions about new partners (73.1%) or anal sex (64.0%) to donate blood. However, 2.2% and 4.5% indicated that questions about new sex partners and anal sex, respectively, would stop them from donating, and 4.4% and 7.7% respectively, said they were "completely uncomfortable." By religion, the least comfortable were Muslim or Eastern Orthodox respondents, and by country of birth, the least comfortable were those born in the Middle East, followed by those born in Southern Europe and Asia. DISCUSSION: GNA appears to be broadly acceptable in the Australian context, but our findings suggest that key GNA questions are less acceptable in some population subgroups, indicating a need for targeted campaigns that consider cultural sensitivities.

Notification rates for syphilis in women of reproductive age and congenital syphilis in Australia, 2011-2021: a retrospective cohort analysis of national notifications data.

OBJECTIVES: To estimate notification rates for infectious syphilis in women of reproductive age and congenital syphilis in Australia. STUDY DESIGN: Retrospective cohort study; analysis of national infectious syphilis and enhanced congenital syphilis surveillance data. SETTING, PARTICIPANTS: Women aged 15-44 years diagnosed with infectious syphilis, and babies with congenital syphilis, Australia, 2011-2021. MAIN OUTCOME MEASURES: Numbers and rates of infectious syphilis notifications, by Indigenous status and age group; numbers and rates of congenital syphilis, by Indigenous status of the infant; antenatal care history for mothers of infants born with congenital syphilis. RESULTS: During 2011-2021, 5011 cases of infectious syphilis in women aged 15-44 years were notified. The notification rate for Aboriginal and Torres Strait Islander women rose from 56 (95% confidence interval [CI], 45-65) cases per 100 000 in 2011 to 227 (95% CI, 206-248) cases per 100 000 population in 2021; for non-Indigenous women, it rose from 1.1 (95% CI, 0.8-1.4) to 9.2 (95% CI, 8.4-10.1) cases per 100 000 population. The notification rate was higher for Aboriginal and Torres Strait Islander women than for non-Indigenous women (incidence rate ratio [IRR], 23.1; 95% CI, 19.7-27.1), lower for 15-24- (IRR, 0.7; 95% CI, 0.6-0.9) and 35-44-year-old women (IRR, 0.6; 95% CI, 0.5-0.7) than for 25-34-year-old women, and higher in remote regions than in major cities (IRR, 2.7; 95% CI, 2.2-3.8). During 2011-2021, 74 cases of congenital syphilis were notified, the annual number increasing from six in 2011 to a peak of 17 in 2020; the rate was consistently higher among Aboriginal and Torres Strait Islander infants than among non-Indigenous infants (2021: 38.3 v 2.1 per 100 000 live births). The mothers of 32 infants with congenital syphilis (43%) had not received antenatal care. CONCLUSIONS: The number of infectious syphilis notifications for women of reproductive age increased in Australia during 2011-2021, as did the number of cases of congenital syphilis. To avert congenital syphilis, antenatal screening of pregnant women, followed by prompt treatment for infectious syphilis when diagnosed, needs to be improved.

Clinical and Public Health Implications of Human T-Lymphotropic Virus Type 1 Infection.

Human T-lymphotropic virus type 1 (HTLV-1) is estimated to affect 5 to 10 million people globally and can cause severe and potentially fatal disease, including adult T-cell leukemia/lymphoma (ATL) and HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP). The burden of HTLV-1 infection appears to be geographically concentrated, with high prevalence in discrete regions and populations. While most high-income countries have introduced HTLV-1 screening of blood donations, few other public health measures have been implemented to prevent infection or its consequences. Recent advocacy from concerned researchers, clinicians, and community members has emphasized the potential for improved prevention and management of HTLV-1 infection. Despite all that has been learned in the 4 decades following the discovery of HTLV-1, gaps in knowledge across clinical and public health aspects persist, impeding optimal control and prevention, as well as the development of policies and guidelines. Awareness of HTLV-1 among health care providers, communities, and affected individuals remains limited, even in countries of endemicity. This review provides a comprehensive overview on HTLV-1 epidemiology and on clinical and public health and highlights key areas for further research and collaboration to advance the health of people with and at risk of HTLV-1 infection.

Elimination and eradication goals for communicable diseases: a systematic review.

Objective: To consolidate recent information on elimination and eradication goals for infectious diseases and clarify the definitions and associated terminology for different goals. Methods: We conducted a systematic search of the World Health Organization's Institutional Repository for Information Sharing (WHO IRIS) and a customized systematic Google advanced search for documents published between 2008 and 2022 on elimination or eradication strategies for infectious conditions authored by WHO or other leading health organizations. We extracted information on names of infectious conditions, the elimination and eradication goals and timelines, definitions of goals, non-standardized terminology, targets and assessment processes. Findings: We identified nine goals for 27 infectious conditions, ranging from disease control to eradication. In comparison with the hierarchy of disease control, as defined at the Dahlem Workshop in 1997, six goals related to disease control with varying levels of advancement, two related to elimination and one to eradication. Goals progressed along a disease-control continuum, such as end of disease epidemic to pre-elimination to elimination as a public health problem or threat. We identified the use of non-standardized terminology with certain goals, including virtual elimination, elimination of disease epidemics, public health threat and public health concern. Conclusion: As we approach the 2030 target date to achieve many of the goals related to disease control and for other infections to become candidates for elimination in the future, clarity of definitions and objectives is important for public health professionals and policy-makers to avoid misperceptions and miscommunication.

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.

Time trends in cancer incidence in Australian people living with HIV between 1982 and 2012.

OBJECTIVES: The aim of the study was to describe time trends in cancer incidence in people living with HIV (PLHIV) in Australia between 1982 and 2012. METHODS: A population-based prospective study was conducted using data linkage between the national HIV and cancer registries. Invasive cancers identified in PLHIV were grouped into AIDS-defining cancers (ADCs), infection-related non-ADCs (NADCs), and non-infection-related NADCs. Crude and age-standardized incidence rates of cancers were calculated and compared over five time periods: 1982-1995, 1996-1999, 2000-2004, 2005-2008 and 2009-2012, roughly reflecting advances in HIV antiretroviral therapy. Standardized incidence ratios (SIRs) compared with the Australian general population were calculated for each time period. Generalized linear models were developed to assess time trends in crude and age-standardized incidences. RESULTS: For ADCs, the crude and age-standardized incidences of Kaposi sarcoma and non-Hodgkin lymphoma substantially declined over time (P-trend < 0.001 for all) but SIRs remained significantly elevated. For infection-related NADCs, there were significant increases in the crude incidences of anal, liver and head and neck cancers. Age-standardized incidences increased for anal cancer (P-trend = 0.002) and liver cancer (P-trend < 0.001). SIRs were significantly elevated for anal cancer, liver cancer and Hodgkin lymphoma. For non-infection-related NADCs, the crude incidence of colorectal, lung and prostate cancers increased over time, but age-standardized incidences remained stable. CONCLUSIONS: Continuous improvements and high coverage of antiretroviral therapy have reduced the incidence of ADCs in PLHIV in Australia. Clinical monitoring of anal and liver cancers in people living with HIV should be performed, given the increasing incidence of these cancers.

Modelling response strategies for controlling gonorrhoea outbreaks in men who have sex with men in Australia.

The ability to treat gonorrhoea with current first-line drugs is threatened by the global spread of extensively drug resistant (XDR) Neisseria gonorrhoeae (NG) strains. In Australia, urban transmission is high among men who have sex with men (MSM) and importation of an XDR NG strain in this population could result in an epidemic that would be difficult and costly to control. An individual-based, anatomical site-specific mathematical model of NG transmission among Australian MSM was developed and used to evaluate the potential for elimination of an imported NG strain under a range of case-based and population-based test-and-treat strategies. When initiated upon detection of the imported strain, these strategies enhance the probability of elimination and reduce the outbreak size compared with current practice (current testing levels and no contact tracing). The most effective strategies combine testing targeted at regular and casual partners with increased rates of population testing. However, even with the most effective strategies, outbreaks can persist for up to 2 years post-detection. Our simulations suggest that local elimination of imported NG strains can be achieved with high probability using combined case-based and population-based test-and-treat strategies. These strategies may be an effective means of preserving current treatments in the event of wider XDR NG emergence.

Population-level diagnosis and care cascade for chlamydia in Australia.

OBJECTIVES: Key strategies to control chlamydia include testing, treatment, partner management and re-testing. We developed a diagnosis and care cascade for chlamydia to highlight gaps in control strategies nationally and to inform efforts to optimise control programmes. METHODS: The Australian Chlamydia Cascade was organised into four steps: (1) annual number of new chlamydia infections (including re-infections); (2) annual number of chlamydia diagnoses; (3) annual number of diagnoses treated; (4) annual number of diagnoses followed by a re-test for chlamydia within 42-180 days of diagnosis. For 2016, we estimated the number of infections among young men and women aged 15-29 years in each of these steps using a combination of mathematical modelling, national notification data, sentinel surveillance data and previous research studies. RESULTS: Among young people in Australia, there were an estimated 248 580 (range, 240 690-256 470) new chlamydia infections in 2016 (96 470 in women; 152 100 in men) of which 70 164 were diagnosed (28.2% overall: women 43.4%, men 18.6%). Of the chlamydia infections diagnosed, 65 490 (range, 59 640-70 160) were treated (93.3% across all populations), but only 11 330 (range, 7660-16 285) diagnoses were followed by a re-test within 42-180 days (17.3% overall: women 20.6%, men 12.5%) of diagnosis. CONCLUSIONS: The greatest gaps in the Australian Chlamydia Cascade for young people were in the diagnosis and re-testing steps, with 72% of infections undiagnosed and 83% of those diagnosed not re-tested: both were especially low among men. Treatment rates were also lower than recommended by guidelines. Our cascade highlights the need for enhanced strategies to improve treatment and re-testing coverage such as short message service reminders, point-of-care and postal test kits.

Two Distinct Gonorrhea Trends and Risk Factors Among Women in Australia.

BACKGROUND: In recent years, gonorrhea notifications have increased in women in Australia and other countries. We measured trends over time and risk factors among Australian Aboriginal and Torres Strait Islander ("Aboriginal") and non-Aboriginal women. METHODS: We conducted a cross-sectional analysis of data from 41 sexual health clinics. Gonorrhea positivity at each patient's first visit (first-test positivity) during the period 2009 to 2016 was calculated. Univariate and multivariate analyses assessed risk factors for first-test positivity in Aboriginal and non-Aboriginal women. RESULTS: Gonorrhea positivity decreased among Aboriginal women (7.1% in 2009 to 5.2% in 2016, P < 0.001) and increased among non-Aboriginal women (0.6%-2.9%, P < 0.001). Among Aboriginal women, first-test positivity was independently associated with living in a regional or remote area (adjusted odds ratio [aOR], 4.29; 95% confidence interval [CI], 2.52-7.31; P < 0.01) and chlamydia infection (aOR, 4.20; 95% CI,3.22-5.47; P < 0.01). Among non-Aboriginal women, first-test positivity was independently associated with greater socioeconomic disadvantage (second quartile: aOR, 1.68 [95% CI, 1.31-2.16; P < 0.01]; third quartile: aOR, 1.54 [95% CI, 1.25-1.89; P < 0.01]) compared with least disadvantaged quartile: recent sex work (aOR, 1.69; 95% CI, 1.37-2.08; P < 0.01), recent injecting drug use (aOR, 1.85; 95% CI, 1.34-2.57; P < 0.01), and chlamydia infection (aOR, 2.35; 95% CI, 1.90-2.91; P < 0.01). For non-Aboriginal women, being aged 16 to 19 years (aOR, 0.62; 95% CI, 0.49-0.80; P < 0.01) compared with those ≥30 years was a protective factor. CONCLUSIONS: These findings highlight 2 different epidemics and risk factors for Aboriginal and non-Aboriginal women, which can inform appropriate health promotion and clinical strategies.

Perspectives of primary health care staff on the implementation of a sexual health quality improvement program: a qualitative study in remote aboriginal communities in Australia.

BACKGROUND: Young people living in remote Australian Aboriginal communities experience high rates of sexually transmissible infections (STIs). STRIVE (STIs in Remote communities, ImproVed and Enhanced primary care) was a cluster randomised control trial of a sexual health continuous quality improvement (CQI) program. As part of the trial, qualitative research was conducted to explore staff perceptions of the CQI components, their normalisation and integration into routine practice, and the factors which influenced these processes. METHODS: In-depth semi-structured interviews were conducted with 41 clinical staff at 22 remote community clinics during 2011-2013. Normalisation process theory was used to frame the analysis of interview data and to provide insights into enablers and barriers to the integration and normalisation of the CQI program and its six specific components. RESULTS: Of the CQI components, participants reported that the clinical data reports had the highest degree of integration and normalisation. Action plan setting, the Systems Assessment Tool, and the STRIVE coordinator role, were perceived as adding value to the program, but were less readily integrated or normalised. The remaining two components (dedicated funding for health promotion and service incentive payments) were seen as least relevant. Our analysis also highlighted factors which enabled greater integration of the CQI components. These included familiarity with CQI tools, increased accountability of health centre staff and the translation of the CQI program into guideline-driven care. The analysis also identified barriers, including high staff turnover, limited time involved in the program and competing clinical demands and programs. CONCLUSIONS: Across all of the CQI components, the clinical data reports had the highest degree of integration and normalisation. The action plans, systems assessment tool and the STRIVE coordinator role all complemented the data reports and allowed these components to be translated directly into clinical activity. To ensure their uptake, CQI programs must acknowledge local clinical guidelines, be compatible with translation into clinical activity and have managerial support. Sexual health CQI needs to align with other CQI activities, engage staff and promote accountability through the provision of clinic specific data and regular face-to-face meetings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000358044 . Registered 6/05/2010. Prospectively Registered.

Chronic hepatitis C burden and care cascade in Australia in the era of interferon-based treatment.

BACKGROUND AND AIM: Interferon-free direct-acting antiviral regimens for hepatitis C virus (HCV) infection have been recently available in Australia, beginning a new era in clinical and public health management of HCV infection. This study provided updated estimates of the HCV infection care cascade and burden in Australia as a reliable platform for assessing the future impact of interferon-free therapies. METHODS: A modeling approach was applied to estimate the number of individuals living with chronic HCV infection and with various liver disease stages. Data from national registries of HCV notification and liver transplantation, literature review, and expert consensus informed the model parameters. HCV notification and Pharmaceutical Benefits Scheme data were used to estimate the number of HCV diagnosed individuals and treatment uptake. RESULTS: In 2014, an estimated 230 470 individuals (range: 180 490-243 990) were living with HCV, among whom 75% were diagnosed (n = 172 720; range: 156 720-188 770), 20% had ever received treatment (n = 45 000; range: 39 280-50 720), and 11% had been cured (n = 24 750; range: 21 520-27 990). Among individuals with HCV infection, the proportion with hepatic fibrosis stage ≥F3 doubled during the last decade, increasing from 9% (n = 18 580) in 2004 to 19% (n = 44,730) in 2014. Individuals initiating HCV treatment increased from 1100 in 1997 to 3840 in 2007, plateaued until 2010 and decreased to 2790 in 2014. CONCLUSIONS: The burden of HCV-related liver disease has increased markedly. Although the proportion diagnosed was high, treatment uptake remained low, with no increase over the last 7 years. Reducing the HCV burden in Australia requires scale-up of interferon-free HCV therapies.

Low HIV testing rates among people with a sexually transmissible infection diagnosis in remote Aboriginal communities.

OBJECTIVE: To determine the rates of HIV testing among people who had received positive test results for chlamydia, gonorrhoea and trichomoniasis, or who had been tested for syphilis. DESIGN, SETTING AND PARTICIPANTS: Pathology data for the period January 2010 - December 2014 from 65 remote Aboriginal communities participating in the STRIVE trial of sexually transmissible infection (STI) control were analysed. MAIN OUTCOME MEASURES: Rates of HIV testing within 30 and 90 days of an STI test (for chlamydia, gonorrhoea or trichomoniasis), the result of which was positive, and within 30 days of a test for syphilis; factors independently associated with concurrent HIV testing. RESULTS: 31.8% of 15 260 positive STI test results were linked with an HIV test within 30 days of the test (including 5.6% not on the same day), and 34.8% within 90 days; 44.1% were linked with syphilis testing within 30 days. 53.4% of all those tested for syphilis were also tested for HIV within 30 days. Multivariate analysis found that HIV testing was more likely for men, in geographical regions 3 and 4, in association with positive STI test results during 2012, 2013 or 2014 (v 2010), and in association with positive test results for gonorrhoea or chlamydia. Similar associations with these factors were found for syphilis testing. CONCLUSIONS: A significant challenge in Aboriginal health is avoiding an increase in the number of HIV infections. One critical intervention in this regard is timely and appropriate testing. Adhering to screening recommendations is clearly an aspect of the delivery of sexual health services to remote communities that can be improved in striving to achieve this aim.

Coinfection with Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis: a cross-sectional analysis of positivity and risk factors in remote Australian Aboriginal communities.

OBJECTIVES: To determine the co-occurrence and epidemiological relationships of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) in a high-prevalence setting in Australia. METHODS: In the context of a cluster randomised trial in 68 remote Aboriginal communities, we obtained laboratory reports on simultaneous testing for CT, NG and TV by nucleic acid amplification tests in individuals aged ≥16 years and examined relationships between age and sex and the coinfection positivity. ORs were used to determine which infections were more likely to co-occur by demographic category. RESULTS: Of 13 480 patients (median age: 30 years; men: 37%) tested for all three infections during the study period, 33.3% of women and 21.3% of men had at least one of them, highest in patients aged 16-19 years (48.9% in women, 33.4% in men). The most frequent combination was CT/NG (2.0% of women, 4.1% of men), and 1.8% of women and 0.5% of men had all three. In all co-combinations, coinfection positivity was highest in patients aged 16-19 years. CT and NG were highly predictive of each other's presence, and TV was associated with each of the other two infections, but much more so with NG than CT, and its associations were much stronger in women than in men. CONCLUSIONS: In this remote high-prevalence area, nearly half the patients aged 16-19 years had one or more sexually transmitted infections. CT and NG were more common dual infections. TV was more strongly associated with NG coinfections than with CT. These findings confirm the need for increased simultaneous screening for CT, NG and TV, and enhanced control strategies. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000358044.

Incidence of curable sexually transmissible infections among adolescents and young adults in remote Australian Aboriginal communities: analysis of longitudinal clinical service data.

OBJECTIVES: To undertake the first comprehensive analysis of the incidence of three curable sexually transmissible infections (STIs) within remote Australian Aboriginal populations and provide a basis for developing new control initiatives. METHODS: We obtained all results for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing conducted during 2009-2011 in individuals aged ≥16 years attending 65 primary health services across central and northern Australia. Baseline prevalence and incidence of all three infections was calculated by sex and age group. RESULTS: A total of 17 849 individuals were tested over 35 months. Baseline prevalence was 11.1%, 9.5% and 17.6% for CT, NG and TV, respectively. During the study period, 7171, 7439 and 4946 initially negative individuals had a repeat test for CT, NG and TV, respectively; these were followed for 6852, 6981 and 6621 person-years and 651 CT, 609 NG and 486 TV incident cases were detected. Incidence of all three STIs was highest in 16-year-olds to 19-year-olds compared with 35+ year olds (incident rate ratio: CT 10.9; NG 11.9; TV 2.5). In the youngest age group there were 23.4 new CT infections per 100 person-years for men and 29.2 for women; and 26.1 and 23.4 new NG infections per 100 person-years in men and women, respectively. TV incidence in this age group for women was also high, at 19.8 per 100 person-years but was much lower in men at 3.6 per 100 person-years. CONCLUSIONS: This study, the largest ever reported on the age and sex specific incidence of any one of these three curable infections, has identified extremely high rates of new infection in young people. Sexual health is a priority for remote communities, but will clearly need new approaches, at least intensification of existing approaches, if a reduction in rates is to be achieved.

Low HIV drug resistance prevalence among recently diagnosed HIV-positive men who have sex with men in a setting of high PrEP use.

INTRODUCTION: New South Wales (NSW) has one of the world's highest uptake rates of HIV pre-exposure prophylaxis (PrEP). This uptake has been credited with sharp declines in HIV transmission, particularly among Australian-born gay and bisexual men. Concerns have been raised around the potential for the emergence of tenofovir (TFV) and XTC (lamivudine/emtricitabine) resistance in settings of high PrEP use. Such an emergence could also increase treatment failure and associated clinical outcomes among people living with HIV (PLHIV). Despite low levels of nucleoside reverse-transcriptase inhibitor (NRTI) resistance relating to PrEP use in clinical settings, there are few published studies describing the prevalence of NRTI resistance among people newly diagnosed with HIV in a setting of high PrEP use. METHODS: Using HIV antiretroviral drug resistance data linked to NSW HIV notifications records of people diagnosed from 1 January 2015 to 31 December 2021 and with HIV attributed to male-to-male sex, we described trends in TFV and XTC resistance. Resistance was identified using the Stanford HIV Drug Resistance genotypic resistance interpretation system. To focus on transmitted drug resistance, resistance prevalence estimates were generated using sequences taken less than 3 months post-HIV diagnosis. These estimates were stratified by timing of sequencing relative to the date of diagnosis, year of sequencing, birthplace, likely place of HIV acquisition, and stage of HIV at diagnosis. RESULTS: Among 1119 diagnoses linked to HIV genomes sequenced less than 3 months following diagnosis, overall XTC resistance prevalence was 1.3%. Between 2015 and 2021, XTC resistance fluctuated between 0.5% to 2.9% and was 1.0% in 2021. No TFV resistance was found over the study period in any of the sequences analysed. Higher XTC resistance prevalence was observed among people with newly acquired HIV (evidence of HIV acquisition in the 12 months prior to diagnosis; 2.9%, p = 0.008). CONCLUSIONS: In this Australian setting, TFV and XTC resistance prevalence in new HIV diagnoses remained low. Our findings offer further evidence for the safe scale-up of PrEP in high-income settings, without jeopardizing the treatment of those living with HIV.

Trends in HIV testing and HIV stage at diagnosis among people newly diagnosed with HIV.

OBJECTIVE: To identify groups more likely to be referred for HIV testing because of symptomatic presentation rather than as part of asymptomatic screening. DESIGN: A retrospective analysis of Australian National HIV Registry (NHR) surveillance data including sociodemographic and clinical data, as well as reasons for HIV test. METHODS: Using notification records from 2017 to 2022, we summarised reasons for testing leading to an HIV diagnosis. Reasons for testing were combined with clinical status at diagnosis to derive HIV testing categories: testing while symptomatic; asymptomatic HIV screening; seroconversion; and other test reason. We stratified these categories by stage of HIV at diagnosis with late-stage HIV defined as a CD4 + cell count <350 cells/µl at time of diagnosis. RESULTS: Among 4134 HIV notifications with at least one reason for testing recorded, STI screening was the predominant reason for test referral (38%), followed by HIV indicative symptoms (31%), and risk behaviour (13%). By testing category, people aged 50 years or older (24%), people with HIV attributed to heterosexual sex (21%), people born in sub-Saharan Africa (19%), and women (17%) had lower levels of asymptomatic screening. More late-stage HIV diagnoses resulted from testing while symptomatic (58%) compared with asymptomatic screening (25%). CONCLUSIONS: Older people and heterosexuals may not access HIV focused healthcare where HIV screening is routinely offered. Instead, HIV testing opportunities may arise in other settings. By normalising HIV testing and offering low-cost HIV screening in a range of settings, it may be possible to facilitate earlier HIV diagnoses, better health outcomes, and reduced onward transmission.

HIV incidence in people receiving government-subsidised pre-exposure prophylaxis in Australia: a whole-of-population retrospective cohort study.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective and has been government subsidised in Australia since April, 2018. We examined HIV incidence over 5 years in a retrospective observational cohort of people who had received subsidised PrEP. METHODS: Linked de-identified dispensing records for all government-subsidised oral PrEP, HIV antiretroviral therapy (ART), and hepatitis C treatment were used. We included all people dispensed subsidised PrEP from April 1, 2018, to March 31, 2023, and examined records up to Sept 30, 2023. Exposure was measured from date of first PrEP prescription and days covered by PrEP calculated for individuals based on quantity and date supplied. Assuming that HIV was diagnosed 30 days before ART initiation, we imputed the date of acquisition as the midpoint between the diagnosis and the later of the last PrEP prescription or 6 months before the diagnosis. We calculated HIV incidence and its predictors using Poisson regression. FINDINGS: We included 66 206 people dispensed PrEP: 64 757 (97·8%) were men; median age was 33 years (IQR 27-43). 207 people acquired HIV, with an overall incidence of 1·07 per 1000 person-years (95% CI 0·93-1·23). Incidence was 2·61 per 1000 person-years among those dispensed PrEP once only. Using this group as a comparator, those with 60% or more days covered by PrEP had a 78·5% reduction in incidence (0·56 per 1000 person-years, p<0·0001) and those with less than 60% days covered had a 61·6% reduction (0·99 per 1000 person-years, p=0·0045). Independent predictors of HIV acquisition were a record of hepatitis C treatment (9·83 per 1000 person-years, adjusted incident rate ratio [aIRR] 8·70, 95% CI 4·86-15·56), only attending prescribers outside of areas with a high estimated prevalence of gay men (1·66 per 1000 person-years, aIRR 1·50, 1·08-2·09), age 18-29 years (1·33 per 1000 person-years, aIRR 1·56, 1·11-2·21), and earlier year of first PrEP. INTERPRETATION: The low observed incidence of HIV among people receiving government-subsidised PrEP highlights the success of a national programme of oral PrEP scale-up in achieving sustained reduction in community HIV transmission. However, incidence varied greatly, indicating that more research is needed to understand why people were not taking PrEP at times of risk and emphasising the need for new interventions focused on this population to achieve elimination of HIV transmission. Individuals dispensed PrEP once only and less frequent users might benefit from more support. FUNDING: None.

STI in remote communities: improved and enhanced primary health care (STRIVE) study protocol: a cluster randomised controlled trial comparing 'usual practice' STI care to enhanced care in remote primary health care services in Australia.

BACKGROUND: Despite two decades of interventions, rates of sexually transmissible infections (STI) in remote Australian Aboriginal communities remain unacceptably high. Routine notifications data from 2011 indicate rates of chlamydia and gonorrhoea among Aboriginal people in remote settings were 8 and 61 times higher respectively than in the non-Indigenous population. METHODS/DESIGN: STRIVE is a stepped-wedge cluster randomised trial designed to compare a sexual health quality improvement program (SHQIP) to usual STI clinical care delivered in remote primary health care services. The SHQIP is a multifaceted intervention comprising annual assessments of sexual health service delivery, implementation of a sexual health action plan, six-monthly clinical service activity data reports, regular feedback meetings with a regional coordinator, training and financial incentive payments. The trial clusters comprise either a single community or several communities grouped together based on geographic proximity and cultural ties. The primary outcomes are: prevalence of chlamydia, gonorrhoea and trichomonas in Aboriginal residents aged 16-34 years, and performance in clinical management of STIs based on best practice indicators. STRIVE will be conducted over five years comprising one and a half years of trial initiation and community consultation, three years of trial conditions, and a half year of data analysis. The trial was initiated in 68 remote Aboriginal health services in the Northern Territory, Queensland and Western Australia. DISCUSSION: STRIVE is the first cluster randomised trial in STI care in remote Aboriginal health services. The trial will provide evidence to inform future culturally appropriate STI clinical care and control strategies in communities with high STI rates. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000358044.

The application of new metrics for understanding trends in undiagnosed HIV among key populations.

OBJECTIVE: Investigate the utility of novel metrics for understanding trends in undiagnosed HIV. METHODS: We produced estimates for the number of people with undiagnosed HIV and the number of new HIV infections using Australian surveillance data and the European Centre for Disease Prevention and Control HIV modelling tool. Using these estimates, we calculated: the total diagnosed fraction, the proportion of all people with HIV diagnosed; the yearly diagnosed fraction, the proportion of people who have not yet received a diagnosis who received a diagnosis during each year; and the case detection rate, which is the annual ratio of new HIV diagnoses to new HIV infections each year; from 2008 to 2019. We report trends in these metrics for Australian-born and overseas-born men who reported male-to-male sex and heterosexual women and men. RESULTS: Each metric for the Australian-born male-to-male sexual contact group improved consistently. In contrast, the metrics for the overseas-born group worsened (total diagnosed fraction: 85.0-81.9%, yearly diagnosed fraction: 23.1-17.8%, and case detection rate: 0.74-0.63). In heterosexuals, women and men had consistent increasing trends for the total diagnosed fraction and yearly diagnosed fraction but with women having consistently higher estimates. Heterosexual men had a declining case detection rate, falling to less than one in 2011, compared to an increase for women. CONCLUSIONS: The additional metrics provided important information on Australia's progress toward HIV elimination. The more dynamic changes in the undiagnosed population seen highlight diverging trends for key populations not seen in the total diagnosed fraction.