Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol.

INTRODUCTION: Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+). METHODS AND ANALYSIS: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies. ETHICS AND DISSEMINATION: Ethical approval was obtained from the St Vincent's Hospital Human Research Ethics Committee, St Vincent's Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04415424.

An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol.

BACKGROUND: Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria gonorrhoeae infections each year, with several populations at higher risk for gonococcal infection, including gay and bisexual men (GBM). If left untreated, infection can lead to serious morbidity including infertility, sepsis and increased risk of HIV acquisition. Development of a gonorrhoea vaccine has been challenging, however there is observational evidence that serogroup B meningococcal vaccines, used to protect against the closely related bacteria Neisseria meningitidis, could provide cross-protection against N. gonorrhoeae. METHODS: The MenGO (Meningococcal vaccine efficacy against Gonorrhoea) study is a phase III open-label randomised control trial in GBM to evaluate the efficacy of the four-component meningococcal serogroup B vaccine, 4CMenB, against gonorrhoea. A total of 130 GBM will be recruited at the Gold Coast Sexual Health Clinic, Australia, and randomised to either receive 2 doses of 4CMenB or no intervention. Participants will be followed up for 24 months with testing for N. gonorrhoeae and other sexually transmissible infections every three months. Demographics, sexual behaviour risk, antibiotic use, and blood samples for analysis of N. gonorrhoeae-specific immune responses, will be collected during the study. The primary outcome is the number of N. gonorrhoeae infections in participants over 2 years measured by nucleic acid amplification test (NAAT). Secondary outcomes are vaccine-induced N. gonorrhoeae-specific immune responses, and adverse events in trial participants. DISCUSSION: This trial will determine if the 4CMenB vaccine is able to reduce N. gonorrhoeae infection. If shown to be effective, 4CMenB could be used in gonococcal prevention. Analysis of 4CMenB-induced immune responses will increase understanding of the type of immune response needed to prevent N. gonorrhoeae, which may enable identification of a potential correlate of protection to aid future gonorrhoea vaccine development. TRIAL REGISTRATION: The trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.

Testing for Mycoplasma genitalium in pelvic inflammatory disease: A clinical audit.

The records of women attending Gold Coast health hospital sites were retrospectively analysed to determine if women diagnosed with pelvic inflammatory disease (PID) were being tested for Mycoplasma genitalium (MG). Only 11.4% of 299 women were tested for MG despite 74.2% being tested for Chlamydia trichomonas (CT) and Neisseria gonorrhoeae (NG). Only 9% of the women were treated with antibiotics which would treat macrolide-sensitive MG infection. Increasing education and awareness of MG and utilising reflex macrolide testing for MG will help direct effective antibiotic therapy and prevent the long-term sequalae of PID.

Effectiveness of self-managed home and community exercise interventions in improving physical activity, body adiposity and related health indices in adults living with HIV: a protocol for a systematic review.

BACKGROUND AND OBJECTIVES: Disorders of adipose tissue distribution in people living with the human immunodeficiency virus (HIV) have been associated with significant metabolic derangements that increase their risk of cardiometabolic and other chronic diseases. Systematic reviews focusing on supervised laboratory-based exercise interventions demonstrate that these interventions improve adipose tissue distribution and related health outcomes in people living with HIV (PLWH). However, there is a need to examine the effectiveness of more pragmatic home or community exercise programmes. The aim of this review will be to synthesize existing evidence on the effectiveness of self-managed home or community exercise interventions to improve physical activity levels, adipose tissue distribution and associated health indices in PLWH. METHODS: This review will encompass interventional studies that evaluate the effect of prescribed exercise programmes performed in the home or community with minimal supervision, by adults living with HIV. The following will be searched from inception: PubMed, Embase, Scopus, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database, SPORTDiscus, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and Clinicaltrials.gov. Screening of studies and data extraction will be conducted by two independent reviewers. The risk of bias in included studies will be assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2) and the Risk of Bias In Non-Randomized Studies-of Interventions (ROBINS-I) tool for non-randomized concurrently controlled and single-arm interventional studies. A random effects meta-analysis will be used to pool effect estimates for outcomes of interest (measures of physical activity and body adiposity). However, if pooling is deemed inappropriate due to substantial differences between studies, a narrative synthesis will be performed. This protocol is written according to the Preferred Reporting Items for Systematic reviews and Meta-analysis Protocols 2015 statement (see Additional file 1). DISCUSSION: This review shall provide evidence to support or disapprove the prescription of self-managed exercise interventions in a particularly vulnerable population. We will equally explore the potential impact of technology in improving physical activity outcomes. Our findings could help guide clinicians involved in the care of PLWH in prescribing exercise and inform the design of future trials and research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021223357 .

Cross-sectional survey of Chinese-speaking and Thai-speaking female sex workers in Sydney, Australia: factors associated with consistent condom use.

Background Previous studies have described inconsistent condom use in Chinese- and Thai-speaking female sex workers in Sydney, Australia. In the present study, we describe the demographics and safe sexual practices in the Chinese- and Thai-speaking female sex workers attending the Sydney Sexual Health Centre (SSHC) in 2014-15. METHODS: A self-completed 60-item anonymous questionnaire, adapted from previous surveys conducted in 1993 and 2003, was translated into Chinese and Thai and administered to female sex workers attending the SSHC or seen on outreach. RESULTS: In all, 488 surveys were distributed, of which 435 were returned; 43% in Chinese and 57% in Thai. Most women did not plan on sex work before their arrival in Australia. Compared with Chinese-speaking women, Thai-speaking women rated themselves higher on English language literacy, had better knowledge of the transmission of HIV and sexually transmissible infections (STIs) and were more likely to practice 100% condom use. Overall, 72% of the sex workers surveyed reported consistent condom use for vaginal sex at work. CONCLUSIONS: Consistent condom use for vaginal sex at work among Chinese- and Thai-speaking female sex workers has decreased slightly from that reported in a similar survey conducted by the SSHC in 2003, when 85% of sex workers reported consistent condom use. There are significant differences between Chinese- and Thai-speaking sex workers in terms of both knowledge and safer sex practices. Ongoing health promotion efforts should focus on providing culturally appropriate education around STIs and safe sex practices not only to workers, but also to parlour owners, managers and consumers.

A Review of Sexually Transmitted Infections in Australia - Considerations in 2018.

Sexually transmitted infections (STIs) bear a high burden of disease and, subsequently, high health costs globally. Chlamydia, gonorrhoea, syphilis, and trichomoniasis contribute to nearly one million infections every day worldwide. Sexually transmitted infections continue to be the most frequently notified condition to the Australian National Notifiable Diseases Surveillance System and the numbers continue to increase. Australia has achieved several significant successes in reducing STIs and blood-borne viruses (BBV) including the significant decrease in genital warts in those less than 30 years old since 2007 following the launch of human papillomavirus vaccines in women, the virtual elimination of mother to child transmission of HIV, and the increased uptake of successful hepatitis C treatment following the availability of direct acting antiviral treatment on the Pharmaceutical Benefits Scheme. However, several challenges remain, including the ongoing rise of chlamydia, gonorrhoea, and syphilis over the last five years; the emergence of antibiotic resistance; and the increasing disparity in the prevalence of STIs and BBV in men who have sex with men, young people, and Aboriginal and Torres Strait Islander people, and challenges in the delivery of services to rural and remote Australia. In this paper, we aim to provide a snapshot of the current landscape and challenges for chlamydia, gonorrhoea, mycoplasma, syphilis and HIV infections in Australia.

Rates of advertised condomless sex in the online profiles of private sex workers: a cross-sectional study.

This study aimed to assess the level of condomless sex advertised online by private sex workers (PSW) in Sydney. In 2015, 750 online profiles of PSW, including 339 female, 53 male and 39 transgender PSWs, were reviewed. It was found that PSWs advertise protected anal and vaginal sex. However, 50% of female PSW advertised condomless oral sex. Age less than 25 years was associated with advertised condomless oral sex (odds ratio 1.56; 95% confidence interval 1.03-2.37; P=0.037). Online platforms are widely used for advertising, especially by female PSWs. Levels of condom use advertised reflect that of other studies of sex workers in Sydney.

Screening for asymptomatic neurosyphilis in HIV patients after treatment of early syphilis: an observational study.

OBJECTIVE: To determine the prevalence of asymptomatic neurosyphilis (ANS) in HIV-positive individuals after treatment of early syphilis with single-dose benzathine penicillin G (BPG) or oral antibiotic alternatives. METHODS: Patients at high risk of neurosyphilis (defined by serum rapid plasma reagin (RPR) titre ≥1:32 and/or peripheral blood CD4 lymphocyte count ≤350/µL) underwent lumbar puncture (LP) at a median time of 8.2 months post treatment. ANS was diagnosed by a reactive cerebrospinal fluid (CSF) RPR test or CSF white blood cells (WBC) >20/µL plus a reactive CSF Treponema pallidum particle agglutination (TPPA) ≥1:640. RESULTS: Of 133 eligible patients, all were men who have sex with men. Of these, 64 consented to LP. Full CSF results were available for 59 patients. Inclusion criteria were serum RPR (21/59), CD4 count (22/59) and combined RPR and CD4 (16/59). The LP patients were white British (82%), median age 40. Syphilis stages were primary (17%) secondary (43%) and early latent (41%). Syphilis was treated with BPG (47/59), doxycycline 100 mg two times per day for 14 days (10/59) and for 21 days (1/59). Azithromycin 500 mg one time per day for 10 days was given to 1/59. At the time of LP, 100% of patients had achieved serological cure, and 66% were taking antiretroviral treatment. Only 1/59 was diagnosed with ANS. The CSF showed: RPR non-reactive (59/59); TPPA non-reactive in 54/59; WBC ≤5/µL in 51/59. CONCLUSIONS: Although the number of patients in our study is modest, single-dose BPG appears to be highly effective even in patients at high risk of neurosyphilis.

Audit of HIV testing frequency and behavioural interventions for men who have sex with men: policy and practice in sexual health clinics in England.

BACKGROUND: National guidance recommends targeted behavioural interventions and frequent HIV testing for men who have sex with men (MSM). We reviewed current policy and practice for HIV testing and behavioural interventions (BI) in England to determine adherence to guidance. METHODS: 25 sexual health clinics were surveyed using a semistructured audit asking about risk ascertainment for MSM, HIV testing and behavioural intervention policies. Practice was assessed by reviewing the notes of the first 40 HIV-negative MSM aged over 16 who attended from 1 June 2010, in a subset of 15 clinics. RESULTS: 24 clinics completed the survey: 18 (75%) defined risk for MSM and 17 used unprotected anal intercourse (UAI) as an indication of high risk. 21 (88%) offered one or more structured BI. Of 598 notes reviewed, 199 (33%) MSM reported any UAI. BI, including safer sex advice, was offered to and accepted by 251/598 (42%) men. A low proportion of all MSM (52/251: 21%) accepted a structured one-to-one BI as recommended by national guidance and uptake was still low among higher risk MSM (29/107: 27%). 92% (552/598) of men had one or more HIV test over a 1-year period. CONCLUSIONS: In 2010, the number of HIV tests performed met the national minimum standard but structured behavioural interventions were being offered to and accepted by only a small proportion of MSM, including those at a higher risk of infection. Reasons for not offering behavioural interventions to higher risk MSM, whether due to patient choice, a lack of staff training or resource shortage, need to be investigated and addressed.