Michael W Traeger

Bio: Michael W Traeger is an academic researcher from Burnet Institute. The author has contributed to research in topics: Men who have sex with men & Pre-exposure prophylaxis. The author has an hindex of 3, co-authored 15 publications receiving 161 citations. Previous affiliations of Michael W Traeger include Monash University.

Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection.

Abstract: Importance Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016–April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). Conclusions and Relevance Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

Micro-elimination of hepatitis C among people with HIV coinfection: declining incidence and prevalence accompanying a multi-center treatment scale-up trial

Abstract: BACKGROUND: Gay and bisexual men (GBM) are a key population affected by HIV and hepatitis C (HCV) co-infection. Providing HCV treatment scale-up across specialist and non-hepatitis specialist settings may eliminate HCV in this population. We aimed to (1) deliver and measure HCV treatment effectiveness, and (2) determine the population impact of treatment on HCV prevalence and incidence longitudinally. METHODS: The co-EC Study (Enhancing care and treatment among HCV/HIV co-infected individuals to Eliminate Hepatitis C transmission) was an implementation trial providing HCV direct-acting antiviral treatment in Melbourne, Australia, from 2016-2018. Individuals with HCV/HIV co-infection were prospectively enrolled from primary and tertiary-care services providing care for 85% of GBM with HIV in our jurisdiction. HCV-viraemic prevalence and HCV-antibody/viraemic incidence were measured using a state-wide, individually-linked, electronic surveillance system. RESULTS: Among 200 participants recruited, 186 initiated treatment during the study period. Sustained virological response among primary care participants (98%, 95%CI:93-100%) was not different to tertiary care (98%, 95%CI:86-100%). From 2012-2019, between 2434 and 3476 GBM with HIV-infection attended our primary-care sites annually providing 13,801 person-years of follow-up; 50-60% received an HCV test annually, 10-14% were anti-HCV positive. Among those anti-HCV positive, viraemic prevalence declined 83% during the study (54% to 9%; 2016 to 2019). HCV incidence decreased 25% annually from 1.7/100 person-years in 2012 to 0.5/100 person-years in 2019 (incidence rate ratio 0.75; CI:0.68-0.83;p<0.001). CONCLUSION: High treatment effectiveness by non-specialists demonstrates the feasibility of treatment scale-up in this population. Substantial declines in HCV incidence and prevalence among GBM with HIV-infection provides proof-of-concept for HCV micro-elimination. REGISTRATION: ClinicalTrials.gov (Identifier: NCT02786758).

The impact of universal access to direct-acting antiviral therapy on the hepatitis C cascade of care among individuals attending primary and community health services.

Abstract: Background Hepatitis C elimination will require widespread access to treatment and responses at the health-service level to increase testing among populations at risk. We explored changes in hepatitis C testing and the cascade of care before and after the introduction of direct-acting antiviral treatments in Victoria, Australia. Methods De-identified clinical data were retrospectively extracted from eighteen primary care clinics providing services targeted towards people who inject drugs. We explored hepatitis C testing within three-year periods immediately prior to (pre-DAA period) and following (post-DAA period) universal access to DAA treatments on 1st March 2016. Among ever RNA-positive individuals, we constructed two care cascades at the end of the pre-DAA and post-DAA periods. Results The number of individuals HCV-tested was 13,784 (12.2% of those with a consultation) in the pre-DAA period and 14,507 (10.4% of those with a consultation) in the post-DAA period. The pre-DAA care cascade included 2,515 RNA-positive individuals; 1,977 (78.6%) were HCV viral load/genotype tested; 19 (0.8%) were prescribed treatment; and 12 had evidence of cure (0.5% of those RNA-positive and 63.6% of those eligible for cure). The post-DAA care cascade included 3,713 RNA-positive individuals; 3,276 (88.2%) were HCV viral load/genotype tested; 1,674 (45.1%) were prescribed treatment; and 863 had evidence of cure (23.2% of those RNA-positive and 94.9% of those eligible for cure). Conclusion Marked improvements in the cascade of hepatitis C care among patients attending primary care clinics were observed following the universal access of DAA treatments in Australia, although improvements in testing were less pronounced.

Barriers and facilitators to pre-exposure prophylaxis among African migrants in high income countries: a systematic review

Abstract: Background The aim of this review is to explore acceptability, barriers, and facilitators to PrEP use among African migrants in high-income countries. Methods: A systematic review was conducted to explore reasons that contribute to low PrEP uptake in this population. Three online databases, abstracts from key conferences and reference lists of relevant studies articles published between the 2 July 2018 and 3 March 2019 were searched. Narrative synthesis was performed on quantitative data and thematic synthesis was performed on qualitative data. Results: Of 1779 titles retrieved, two cross-sectional studies (United States (US) (n = 1), United Kingdom (UK) (n = 1)) and six qualitative studies (US (n = 2), UK (n = 3), Australia (n = 1)) met inclusion criteria. PrEP acceptability was reported in one cross-sectional article and two qualitative articles. Cross-sectional studies measured acceptability and willingness to use PrEP; in one study, 46% of African migrant men found PrEP use acceptable, and following PrEP education, another study categorised 60% of participants as willing to use PrEP if it were cost-free. Qualitative studies reported mixed acceptability, with higher acceptability reported for serodiscordant couples. Barriers and facilitators to PrEP use were coded into five themes: cultural aspects of stigma; knowledge gap in health literacy; risks unrelated to HIV transmission; practical considerations for PrEP use; and the impact of PrEP use on serodiscordant couples. Conclusions: Several common barriers to PrEP use, including stigma, health literacy and risk perception and cost, were identified. Findings were limited by there being no published data on uptake. Additional work is needed to understand PrEP acceptability and uptake among African migrants.

Changes in HIV preexposure prophylaxis prescribing in Australian clinical services following COVID-19 restrictions.

Abstract: The first case of COVID-19 in Australia was diagnosed on 25 January 2020 [1]. In response, the Australian Federal and State governments implemented staged restrictions, including international and state border closures and physical distancing requirements in public spaces. Between 23 and 26 March, nonessential services, including gyms, restaurants and places of worship were closed, and, on 29 March, the government urged Australians to stay at home other than for essential reasons (i.e. care giving, exercise, and to access healthcare, food and supplies). Data from one large sexual health clinic in Melbourne showed a rapid decline in postexposure prophylaxis (PEP) dispensing following implementation of restrictions [2]. A survey of gay and bisexual men (GBM) accessing preexposure prophylaxis (PrEP) from the same clinic found that among 178 GBM reporting daily PrEP use in January to February 2020, 23% subsequently reported PrEP cessation in May (during restrictions) and 5% switched to on-demand PrEP, with participants reporting no longer engaging in casual sex and reduced number of sexual partners [3]. Although these data suggest that some GBM have reduced their PrEP use, findings are limited by self-report and it is not yet known whether these data reflect broader community trends beyond this single site.

The Modern Epidemic of Syphilis

Abstract: Syphilis Over the past two decades, the incidence of syphilis has increased sharply. The courses of both untreated and treated disease can be unpredictable. This review presents guidance on clinica...

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review

Abstract: Antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV transmission was first approved by the US Food and Drug Administration in 2012. Despite correlations of decreases in new HIV infections being greatest where PrEP has been deployed, the uptake of PrEP is lagging, particularly among populations with disproportionate HIV burden. This narrative review seeks to identify individual and systemic barriers to PrEP usage in the USA. A comprehensive search of recent literature uncovered a complex array of structural, social, clinical, and behavioral barriers, including knowledge/awareness of PrEP, perception of HIV risk, stigma from healthcare providers or family/partners/friends, distrust of healthcare providers/systems, access to PrEP, costs of PrEP, and concerns around PrEP side effects/medication interactions. Importantly, these barriers may have different effects on specific populations at risk. The full potential of PrEP for HIV prevention will not be realized until these issues are addressed. Strategies to achieve this goal should include educational interventions, innovative approaches to delivery of HIV care, financial support, and destigmatization of PrEP and PrEP users. Until then, PrEP uptake will continue to be suboptimal, particularly among those who need it most.

STI in times of PrEP: high prevalence of chlamydia, gonorrhea, and mycoplasma at different anatomic sites in men who have sex with men in Germany

Abstract: Men who have sex with men (MSM) are disproportionally affected by sexually transmitted infections (STI). STI are often extragenital and asymptomatic. Both can delay diagnosis and treatment. Approval of HIV pre-exposure prophylaxis (PrEP) might have influenced sexual behaviour and STI-prevalence of HIV- MSM. We estimated STI-prevalence and risk factors amongst HIV- and HIV+ MSM in Germany to plan effective interventions. We conducted a nationwide, cross-sectional study between February and July 2018. Thirteen MSM-friendly STI-practices screened MSM for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Neisseria gonorrhea (NG), and Trichomonas vaginalis (TV) using self-collected rectal and pharyngeal swabs, and urine samples. APTIMA™ STI-assays (Hologic™ Inc., San Diego, USA) were used for diagnostics, and samples were not pooled. We collected information on socio-demographics, HIV-status, clinical symptoms, sexual behaviour within the last 6 months, and PrEP use. We combined HIV status and PrEP use for defining risk groups, and used directed acyclic graphs and multivariable logistic regression to identify risk factors for STI. Two thousand three hundred three MSM were included: 50.5% HIV+, median age 39 [18–79] years. Median number of male sex partners within the last 6 months was five. Sex without condom was reported by 73.6%, use of party drugs by 44.6%. 80.3% had a STI history, 32.2% of STI+ MSM reported STI-related symptoms. 27.6% of HIV- MSM used PrEP. Overall STI-prevalence was 30.1, 25.0% in HIV−/PrEP- MSM (CT:7.2%; MG:14.2%; NG:7.4%; TV:0%), 40.3% in HIV−/PrEP+ MSM (CT:13.8%; MG:19.4%; NG:14.8%; TV:0.4%), and 30.8% in HIV+ MSM (CT:10.1%; MG:18.4%; NG:8.6%; TV:0.1%). Being HIV+ (OR 1.7, 95%-CI 1.3–2.2), using PrEP (OR 2.0, 95%-CI 1.5–2.7), having > 5 sex partners (OR:1.65; 95%-CI:1.32–2.01.9), having condomless sex (OR:2.11.9; 95%-CI:1.65–2.86), and using party drugs (OR:1.65; 95%-CI:1.32–2.0) were independent risk factors for being tested positive for at least one STI. We found a high STI-prevalence in MSM in Germany, especially in PrEP users, frequently being asymptomatic. As a relevant proportion of PrEP users will not use a condom, counselling and comprehensive STI screening is essential and should be low threshold and preferably free of cost. Counselling of PrEP users should also address use of party drugs.

Daily and event-driven pre-exposure prophylaxis for men who have sex with men in Belgium: results of a prospective cohort measuring adherence, sexual behaviour and STI incidence.

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

Diagnosing sexually transmitted infections in resource-constrained settings: challenges and ways forward.

Abstract: Introduction Sexually transmitted infections (STIs) remain prevalent and are increasing in several populations. Appropriate STI diagnosis is crucial to prevent the transmission and sequelae of untreated infection. We reviewed the diagnostic accuracy of syndromic case management and existing point-of-care tests (POCTs), including those in the pipeline, to diagnose STIs in resource-constrained settings. Methods We prioritized updating the systematic review and meta-analysis of the diagnostic accuracy of vaginal discharge from 2001 to 2015 to include studies until 2018. We calculated the absolute effects of different vaginal flowcharts and the diagnostic performance of POCTs on important outcomes. We searched the peer-reviewed literature for previously conducted systematic reviews and articles from 1990 to 2018 on the diagnostic accuracy of syndromic management of vaginal and urethral discharge, genital ulcer and anorectal infections. We conducted literature reviews from 2000 to 2018 on the existing POCTs and those in the pipeline. Results and discussions The diagnostic accuracy of urethral discharge and genital ulcer disease syndromes is relatively adequate. Asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections limit the use of vaginal discharge and anorectal syndromes. The pooled diagnostic accuracy of vaginal syndromic case management for CT/NG is low, resulting in high numbers of overtreatment and missed treatment. The absolute effect of POCTs was reduced overtreatment and missed treatment. Findings of the reviews on syndromic case management underscored the need for low-cost and accurate POCTs for the identification, first, of CT/NG, and, second, of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) and NG and MG resistance/susceptibility testing. Near-patient POCT molecular assays for CT/NG/TV are commercially available. The prices of these POCTs remain the barrier for uptake in resource-constrained settings. This is driving the development of lower cost solutions. Conclusions The WHO syndromic case management guidelines should be updated to raise the quality of STI management through the integration of laboratory tests. STI screening strategies are needed to address asymptomatic STIs. POCTs that are accurate, rapid, simple and affordable are urgently needed in resource-constrained settings to support the uptake of aetiological diagnosis and treatment.