Evaluating the sensitivity and specificity of dried blood spots for serological testing of HIV, syphilis, hepatitis B and C Elecsys assays on the Roche Cobas system.

This study was performed to validate a dried blood spot (DBS) method for the serological screening of HIV, syphilis, hepatitis B and C. It included 250 paired DBS and serum samples and 116 unpaired DBS samples from 366 unique patients from two laboratories between 8 October and 2 November 2021. As determined by original test request, these were tested using a DBS method for HIV Ag/Ab (n=216), anti-treponemal Ab (n=166), hepatitis B sAg (n=100), and hepatitis C Ab (n=100) Elecsys assays on the Roche Cobas automated platform. Using the manufacturer's (serum) cut-off for reactivity ('positivity'), the sensitivity and specificity of DBS testing compared with serum were: for HIV Ag/Ab 100% and 100%, for anti-treponemal Ab 68.3% and 100%, for hepatitis B sAg 95.9% and 100%, and for hepatitis C Ab 84.0% and 100%, respectively. Adjusting the assay cut-off using receiver operator curve analysis increased sensitivity of DBS testing for anti-treponemal Ab to 90.0%, hepatitis B sAg to 97.9% and hepatitis C Ab to 94.0% whilst maintaining specificity of 98.8%, 100% and 100%, respectively. With optimisation of assay cut-off, DBS can perform comparably with serum for serological testing for HIV, syphilis, hepatitis B and C and may be a valuable tool in increasing access to testing in New Zealand.

Adherence, Sexual Behavior and Sexually Transmitted Infections in a New Zealand Prospective PrEP Cohort: 12 Months Follow-up and Ethnic Disparities.

Inequities in pre-exposure prophylaxis (PrEP) experiences will impede HIV epidemic elimination among gay and bisexual men (GBM). Ethnicity is a strong marker of inequity in the United States, but evidence from other countries is lacking. We investigated experiences on-PrEP to 12 months follow-up in a prospective cohort of 150 GBM in Auckland, New Zealand with an equity quota of 50% non-Europeans. Retention at 12 months was 85.9%, lower among Maori/Pacific (75.6%) than non-Maori/Pacific participants (90.1%). Missed pills increased over time and were higher among Maori/Pacific. PrEP breaks increased, by 12 months 35.7% of Maori/Pacific and 15.7% of non-Maori/Pacific participants had done so. Condomless receptive anal intercourse partners were stable over time. STIs were common but chlamydia declined; 12-month incidence was 8.7% for syphilis, 36.0% gonorrhoea, 46.0% chlamydia, 44.7% rectal STI, 64.0% any STI. Structural interventions and delivery innovations are needed to ensure ethnic minority GBM gain equal benefit from PrEP.Clinical trial number ACTRN12616001387415.

Demographic and behavioural factors associated with antimicrobial susceptibility to azithromycin and ceftriaxone in Neisseria gonorrhoeae.

Antimicrobial resistance of Neisseria gonorrhoeae (NG) is of global public health concern. The aim of this study was to explore demographic and behavioural factors associated with antimicrobial susceptibility of NG to ceftriaxone and azithromycin. Gonococcal isolates (n = 391) from clients attending the Auckland Sexual Health Service, New Zealand, from July 2014 - June 2015 (n = 206), and July 2017 - June 2018 (n = 185), were tested for susceptibility to ceftriaxone and azithromycin. Laboratory data were linked with behavioural and demographic data. Geometric mean azithromycin MICs increased across the two time periods (0.239 mg/L in 2014/15 to 0.347 mg/L in 2017/18, p < 0.001), and ceftriaxone MICs decreased (0.007 mg/L in 2014/15 to 0.005 mg/L in 2017/18, p < 0.001). Demographic and behavioural factors were not associated with differences in ceftriaxone MICs; however azithromycin MICs were higher in men who have sex with men (0.356 mg/L) compared with the heterosexual study population (0.192 mg/L, p < 0.001) and were lower in Pacific peoples (0.201 mg/L, p < 0.001) and Maori (0.244 mg/L, p = 0.05) compared with those of European ethnicity (0.321 mg/L). Our findings show that azithromycin MICs increased in our region between 2014 and 2018; associations were seen with sexual orientation and ethnicity.

Variability in Azithromycin Susceptibility Results for Neisseria gonorrhoeae Obtained Using Gradient MIC Strip and Agar Dilution Techniques.

Azithromycin is a component of empirical treatment regimens for Neisseria gonorrhoeae infections, but antimicrobial susceptibility testing for this agent is technically challenging. We compared the intertest variability, MIC values, and CLSI/EUCAST categorization of clinical and reference isolates of N. gonorrhoeae treated with azithromycin by testing 107 clinical isolates and nine reference isolates by agar dilution and in duplicates using MIC test strips (Liofilchem, Italy) and Etests (bioMérieux, France). Replicate isolate agreement within 1 log2 between duplicate tests was 87% for MIC test strips and 100% for Etests (P < 0.001). Essential agreement with the agar dilution method was higher for Etests (91%) than for MIC test strips (44%, P < 0.001). The geometric mean MIC was highest for MIC test strips (0.8 mg/liter) and significantly higher than both Etest (0.47 mg/liter, P < 0.001) and agar dilution (0.26 mg/liter, P < 0.001) methods. Etest MICs were higher than those obtained with agar dilution (P < 0.001). Agar dilution, MIC test strip, and Etest methods categorized 96%, 85%, and 95% (P = 0.003) of clinical isolates, respectively, as susceptible/wild type according to CLSI/EUCAST criteria. Our results illustrate the difficulties underlying azithromycin susceptibility testing for N. gonorrhoeae and demonstrate that results can vary using different methods. This variability could influence antimicrobial resistance reporting between laboratories involved in N. gonorrhoeae surveillance programs.

NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand.

INTRODUCTION: New Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this. METHODS AND ANALYSIS: NZPrEP (A demonstration project of HIV preexposure prophylaxis in Aotearoa New Zealand) is an open-label, single-arm treatment evaluation study to investigate feasibility, retention, adherence, and clinical and behavioural outcomes of HIV pre-exposure prophylaxis (PrEP) provision to gay and bisexual men (GBM) in a publicly funded secondary sexual health service in Auckland, New Zealand. The sample size is 150 GBM. Inclusion criteria were specific behavioural risk factors indicating an increased risk of HIV infection. Exclusion criteria were hepatitis B infection, any medical contraindications to prescribing tenofovir/emtricitabine or factors limiting ability to adhere to the study protocol. Eligible participants will be screened for HIV and other sexually transmissible infections (STIs) and for any medical contraindications to PrEP, and enrolled for a maximum follow-up period of 96 weeks. They will be required to attend for 3-monthly testing for HIV and STIs and monitoring for renal and liver toxicity. Participants will also be required to complete an online behavioural survey after each study visit. The outcomes of interest are feasibility of PrEP provision in a sexual health clinic setting, PrEP acceptability, and adverse medical and behavioural effects of PrEP. The study sample is limited to 150 participants due to funding and service constraints. Statistical analysis of all primary and secondary outcomes will be performed using Stata V.14 at the University of Auckland. Results for primary and secondary endpoints will be reported after the conclusion of the study in March 2019. ETHICS AND DISSEMINATION: The study was approved by the Health and Disability Ethics Committee on 15 September 2016 (16/NTA/112). Key findings will be submitted to peer-reviewed journals. A summary report will be circulated to the study and community stakeholders, and to the Auckland District Health Board, Ministry of Health and Pharmac. TRIAL REGISTRATION NUMBER: ACTRN12616001387415; Pre-results.

Baseline characteristics of gay and bisexual men in a HIV pre-exposure prophylaxis demonstration project with equity quotas in Auckland, New Zealand.

Background In New Zealand, pre-exposure prophylaxis (PrEP) should target gay and bisexual men (GBM), and equity is an important principle. Baseline characteristics of GBM offered PrEP in a demonstration project with an enrolment quota of 50% non-Europeans are described. METHODS: An open-label, single-arm treatment evaluation study design ('NZPrEP') was used. The settings were four publicly funded sexual health clinics in Auckland in 2017. The study population was 150 GBM recruited from clinics, community sources and social media. Participants self-completed an online questionnaire about PrEP awareness, attitudes and sexual risk behaviour in the last 3 months. Baseline characteristics are described and examined to determine whether these were associated with PrEP initiation status (self-referral vs doctor/nurse recommendation). RESULTS: In total, 150 GBM of whom half (52%) were non-European, including 21.3% Maori, 19.3% Asian and 8.7% Pacific, were enrolled into the study. Two-thirds (65.3%) self-referred for PrEP and one-third (34.7%) were recommended PrEP by the doctor/nurse. Participants reported a high number of male condomless receptive anal intercourse partners (MenAICLR) (median 3, range 0-50), with 10% reporting 10 or more MenAICLR and 45.3% reporting group sex. In the previous year, 65.3% had a sexually transmissible infection (STI); 18% had rectal chlamydia or gonorrhoea at enrolment. Almost half (47.7%) had recently used drugs with sex, including 8.1% who used methamphetamine. Participants recommended PrEP had lower education, lived less centrally and had a higher STI prevalence than PrEP self-referrers, but their risk behaviour was similar. CONCLUSIONS: Early PrEP adopters in New Zealand have high HIV risk. Demonstration projects should consider equity mechanisms so that minorities can participate meaningfully.

Keeping track of antimicrobial resistance for Neisseria gonorrhoeae in Auckland, New Zealand: past, present and future considerations.

AIMS: Neisseria gonorrhoeae (NG) has developed resistance to a wide range of antimicrobials. Population level data is essential to determine empiric treatment regimes. We sought to identify antimicrobial resistance patterns for NG in the Auckland region from 2008-2016, and review the utility of current methods of antimicrobial resistance testing. METHODS: Antimicrobial susceptibilities and demographic data from NG isolates derived from patients attending the Auckland Regional Sexual Health Service and Auckland City Hospital were analysed to determine resistance rates and trends over time. Antimicrobial susceptibility testing was performed by agar dilution using Clinical and Laboratory Standards Institute (CLSI) interpretation criteria. RESULTS: Results for 2,302 isolates from 1,941 patients were analysed. While ciprofloxacin resistance increased between 2008 and 2011, resistance rates for all antibiotics declined from 2013-2016. In 2016, 22% (53) of isolates were resistant to ciprofloxacin, 7% (17) to penicillin, 31% (76) to tetracycline and 0.8% (2) exhibited decreased susceptibility to ceftriaxone. CONCLUSION: Ceftriaxone is still suitable as a component of gonorrhoea treatment in our region but resistance to other agents prohibits their use for empiric treatment regimens. Current methods of detecting antimicrobial resistance for NG needed to be updated so that they are fit for purpose.

Treatment of gonorrhoea in Auckland, New Zealand: marked variation in prescriber adherence to treatment guidelines.

BACKGROUND: The relentless emergence and spread of strains of Neisseria gonorrhoeae that are resistant to many antimicrobial agents has led to frequent changes in treatment guidelines, with a consequent risk that prescribers may not be aware of current guidelines. AIM: To determine the proportion of patients with gonorrhoea who were treated with a regimen consistent with the New Zealand Sexual Health Society (NZSHS) guidelines. METHODS: We audited the treatment given to adult patients with laboratory-proven gonorrhoea in Auckland, New Zealand, during the first 6 months of 2015. RESULTS: Treatment compliant with the current NZSHS guidelines was administered in only 65% (458/706) episodes overall. Guideline-compliant treatment was much more likely to be prescribed for patients who presented to a sexual health clinic (89%) than for patients who presented to either a general practice or other community clinic (52%) or to a hospital (56%) (P < 0.0001). Overall, 52 of 706 (7%) episodes were not treated with any antimicrobial regimen by the service that diagnosed the patients' gonorrhoea, 13 of 62 (21%) episodes in patients who presented to a hospital, 34 of 403 (8%) episodes in patients who presented to a general practice or other community clinic and 5 of 241 (2%) episodes in patients who presented to a sexual health clinic (P < 0.0001). CONCLUSION: Low levels of compliance with treatment guidelines increase the risk that antibiotic-resistant strains of N. gonorrhoeae will spread within the Auckland region. Improved compliance with treatment guidelines, particularly in patients who present either to general practice or to hospitals, is necessary to maintain the efficacy of current treatment regimens.