Telehealth for sexual and reproductive health issues: a qualitative study of experiences of accessing care during COVID-19.

BACKGROUND: Medicare, the health insurance system underpinning free healthcare in Australia, introduced free telehealth items in 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. Their uptake among healthcare providers was significant, including among general practitioners and sexual health services. Here, we report people's experiences of accessing sexual and reproductive health (SRH)-related care via telehealth collected as part of a survey exploring the impact of COVID on SRH health. METHODS: This study utilises qualitative data from two online surveys conducted in 2020. Surveys were advertised through social media and professional and personal networks. Anyone aged≥18years and living in Australia was eligible to participate. Respondents were asked whether they accessed care for their SRH via telehealth. A free-text question asking for further detail about their experience was analysed using content analysis. RESULTS: A total of 114/1070 respondents (10.7%) accessed healthcare services via telehealth for SRH-related reasons within the previous 4weeks. Three themes were identified from 78 free-text comments: (1) accessibility and convenience of telehealth; (2) appropriateness of telehealth for SRH issues; and (3) connecting and communicating with clinicians via telehealth. Respondents had a wide range of experiences. Telehealth improved access to services for some participants, and it was appropriate for some, but not all SRH issues. Difficulties connecting with clinicians on both an interpersonal and technical level was a key barrier to a satisfactory patient experience. CONCLUSIONS: Telehealth can offer a viable alternative to face-to-face care, providing patients can overcome key connection and communication barriers.

Antiseptic mouthwash for gonorrhoea prevention (OMEGA): a randomised, double-blind, parallel-group, multicentre trial.

BACKGROUND: To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM). METHODS: The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471). FINDINGS: Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7). INTERPRETATION: Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission. FUNDING: Australian National Health and Medical Research Council.

Prevalence of mutations associated with resistance to macrolides and fluoroquinolones in Mycoplasma genitalium: a systematic review and meta-analysis.

BACKGROUND: Mycoplasma genitalium is now recognised as an important bacterial sexually transmitted infection. We summarised data from studies of mutations associated with macrolide and fluoroquinolone resistance in M genitalium to establish the prevalence of resistance. We also investigated temporal trends in resistance and aimed to establish the association between resistance and geographical location. METHODS: In this systematic review and meta-analysis, we searched PubMed, Embase, and MEDLINE for studies that included data for the prevalence of mutations associated with macrolide and fluoroquinolone resistance in M genitalium published in any language up to Jan 7, 2019. We defined prevalence as the proportion of M genitalium samples positive for key mutations associated with azithromycin resistance (23S rRNA gene, position 2058 or 2059) or moxifloxacin resistance (S83R, S83I, D87N, or D87Y in parC), or both, among all M genitalium samples that were successfully characterised. We used random-effects meta-analyses to calculate summary estimates of prevalence. Subgroup and meta-regression analyses by WHO region and time period were done. This study was registered with PROSPERO, number CRD42016050370. RESULTS: Overall, 59 studies from 21 countries met the inclusion criteria for our study: 57 studies of macrolide resistance (8966 samples), 25 of fluoroquinolone resistance (4003 samples), and 22 of dual resistance to macrolides and fluoroquinolones (3280 samples). The summary prevalence of mutations associated with macrolide resistance among M genitalium samples was 35·5% (95% CI 28·8-42·5); prevalence increased from 10·0% (95% CI 2·6-20·1%) before 2010, to 51·4% (40·3-62·4%) in 2016-17 (p<0·0001). Prevalence of mutations associated with macrolide resistance was significantly greater in samples in the WHO Western Pacific and Americas regions than in those from the WHO European region. The overall prevalence of mutations associated with fluoroquinolone resistance in M genitalium samples was 7·7% (95% CI 4·5-11·4%). Prevalence did not change significantly over time, but was significantly higher in the Western Pacific region than in the European region. Overall, the prevalence of both mutations associated with macrolide resistance and those associated with fluoroquinolone resistance among M genitalium samples was 2·8% (1·3-4·7%). The prevalence of dual resistance did not change significantly over time, and did not vary significantly by geographical region. INTERPRETATION: Global surveillance and measures to optimise the efficacy of treatments-including resistance-guided strategies, new antimicrobials, and antimicrobial combination approaches-are urgently needed to ensure cure in a high proportion of M genitalium infections and to prevent further spread of resistant strains. FUNDING: Australian National Health and Medical Research Council.

Macrolide resistance and azithromycin failure in a Mycoplasma genitalium-infected cohort and response of azithromycin failures to alternative antibiotic regimens.

BACKGROUND: Our aim was to determine the efficacy of 1 g azithromycin and alternative antibiotic regimens in a prospective cohort of Mycoplasma genitalium-infected participants, and factors associated with azithromycin failure. METHODS: Consecutive eligible M. genitalium-infected men and women attending the Melbourne Sexual Health Centre between July 2012 and June 2013 were treated with 1 g of azithromycin and retested by polymerase chain reaction (PCR) on days 14 and 28. Cure was defined as PCR negative on day 28. Cases failing azithromycin were treated with moxifloxacin, and those failing moxifloxacin were treated with pristinamycin. Pre- and posttreatment samples were assessed for macrolide resistance mutations (MRMs) by high-resolution melt analysis. Mycoplasma genitalium samples from cases failing moxifloxacin were sequenced for fluoroquinolone resistance mutations. Multivariable analysis was used to examine associations with azithromycin failure. RESULTS: Of 155 participants treated with 1 g azithromycin, 95 (61% [95% confidence interval {CI}, 53%-69%]) were cured. Pretreatment MRM was detected in 56 (36% [95% CI, 28%-43%]) participants, and strongly associated with treatment failure (87% [95% CI, 76%-94%]; adjusted odds ratio, 47.0 [95% CI, 17.1-129.0]). All 11 participants who had MRM detected in posttreatment samples failed azithromycin. Moxifloxacin was effective in 53(88% [95% CI, 78%-94%]) of 60 cases failing azithromycin; all failures had gyrA and parC mutations detected in pretreatment samples. Six of 7 patients failing moxifloxacin treatment received pristinamycin, and all were PCR negative 28 days after pristinamycin treatment. CONCLUSIONS: We report a high azithromycin failure rate (39%) in an M. genitalium-infected cohort in association with high levels of pretreatment macrolide resistance. Moxifloxacin failure occurred in 12% of patients who received moxifloxacin; all had pretreatment fluoroquinolone mutations detected. Pristinamycin was highly effective in treating macrolide- and quinolone-resistant strains.

Persistence of Neisseria gonorrhoeae DNA following treatment for pharyngeal and rectal gonorrhea is influenced by antibiotic susceptibility and reinfection.

BACKGROUND: To guide interpretation of gonorrhea tests of cure using nucleic acid amplification testing, this study examined the persistence of Neisseria gonorrhoeae DNA following treatment for pharyngeal and rectal gonorrhea. METHODS: Men who had sex with men diagnosed with pharyngeal or rectal gonorrhea underwent swabbing from the pharynx or rectum 7 and 14 days following treatment. Repeat testing for N. gonorrhoeae was undertaken using real-time polymerase chain reaction (PCR) assays targeting the opa gene and porA pseudogene. RESULTS: One hundred pharyngeal and 100 rectal gonorrhea infections in 190 men were included. For pharyngeal gonorrhea, positivity of N. gonorrhoeae DNA on both PCR assays was present at days 7 or 14 in 13% (95% confidence interval [CI], 6.4%-19.6%) and 8% (95% CI, 2.7%-13.3%), respectively. For rectal gonorrhea, DNA positivity was present in 6% (95% CI, 1.4%-10.7%) and 8% (95% CI, 2.7%-13.3%), respectively. Among 200 baseline pharyngeal and rectal isolates, there were 10 with ceftriaxone minimum inhibitory concentration (MIC) ≥0.06 mg/L and azithromycin MIC ≥0.5 mg/L, of which 3 (30%) had DNA detected at day 14; among the 190 isolates with lower ceftriaxone and azithromycin MICs, only 13 (7%) had persistent DNA (odds ratio, 5.8 [95% CI, 1.3-25.4]; P = .019). One man initially infected with N. gonorrhoeae multiantigen sequence type 2400 had type 4244 infection at day 14, indicating reinfection. CONCLUSIONS: Pharyngeal and rectal gonorrhea DNA persisted in 8% of men 14 days after treatment. Persistence was associated with elevated ceftriaxone and azithromycin MICs. Persistence can also reflect reinfection.

A cohort study of Chlamydia trachomatis treatment failure in women: a study protocol.

BACKGROUND: Chlamydia trachomatis is the most commonly diagnosed bacterial sexually transmitted infection in the developed world and diagnosis rates have increased dramatically over the last decade. Repeat infections of chlamydia are very common and may represent re-infection from an untreated partner or treatment failure. The aim of this cohort study is to estimate the proportion of women infected with chlamydia who experience treatment failure after treatment with 1 gram azithromycin. METHODS/DESIGN: This cohort study will follow women diagnosed with chlamydia for up to 56 days post treatment. Women will provide weekly genital specimens for further assay. The primary outcome is the proportion of women who are classified as having treatment failure 28, 42 or 56 days after recruitment. Comprehensive sexual behavior data collection and the detection of Y chromosome DNA and high discriminatory chlamydial genotyping will be used to differentiate between chlamydia re-infection and treatment failure. Azithromycin levels in high-vaginal specimens will be measured using a validated liquid chromatography-tandem mass spectrometry method to assess whether poor azithromycin absorption could be a cause of treatment failure. Chlamydia culture and minimal inhibitory concentrations will be performed to further characterize the chlamydia infections. DISCUSSION: Distinguishing between treatment failure and re-infection is important in order to refine treatment recommendations and focus infection control mechanisms. If a large proportion of repeat chlamydia infections are due to antibiotic treatment failure, then international recommendations on chlamydia treatment may need to be re-evaluated. If most are re-infections, then strategies to expedite partner treatment are necessary.

Australian general practitioner chlamydia testing rates among young people.

OBJECTIVE: To describe the proportion of 16-29-year-olds tested for chlamydia by Australian general practitioners in a 12-month period. DESIGN AND SETTING: Between October 2007 and September 2008, the national chlamydia testing rate in 16-29-year-olds was calculated by dividing the number of Medicare-reimbursed chlamydia tests by two denominators: (i) Medicare-reimbursed GP consultations; and (ii) estimated resident populations adjusted for the proportion who were sexually active. MAIN OUTCOME MEASURES: GP chlamydia testing rates in 16-29-year-olds per 100 patients attending a GP consultation and per 100 sexually active population, by patient age and sex, state/territory of residence, and remoteness area. RESULTS: Among the estimated Australian population of 16-29-year-olds, 85.6% of females and 64.4% of males had at least one GP consultation in the 12-month period. The national GP chlamydia testing rate per 100 patients was 8.9% (95% CI, 8.88%-8.94%). The national GP chlamydia testing rate per 100 sexually active population was 8.0% (95% CI, 7.92%-7.98%). The rate per 100 sexually active population was higher in females (12.5%) compared with males (3.7%) (P < 0.01); higher in 20-24-year-olds (9.0%) compared with 16-19-year-olds (8.7%) and 25-29-year-olds (6.6%) (P < 0.01); higher in those living in non-metropolitan areas (11.0%) compared with metropolitan areas (8.4%) (P < 0.01); and highest in those living in the Northern Territory (21.4%) compared with other jurisdictions (P < 0.01). CONCLUSIONS: Despite clinical guidelines recommending annual chlamydia testing for sexually active 15-29-year-olds, our analysis showed that a high proportion of young people aged 16-29 years attend a GP each year, but few of the sexually active population in this age group were tested for chlamydia in general practice. Strategies are needed to support GPs to enhance chlamydia testing in young people.

A cost-effectiveness analysis of adding a human papillomavirus vaccine to the Australian National Cervical Cancer Screening Program.

BACKGROUND: The cost-effectiveness of adding a human papillomavirus (HPV) vaccine to the Australian National Cervical Screening Program compared to screening alone was examined. METHODS: A Markov model of the natural history of HPV infection that incorporates screening and vaccination was developed. A vaccine that prevents 100% of HPV 16/18-associated disease, with a lifetime duration of efficacy and 80% coverage offered through a school program to girls aged 12 years, in conjunction with current screening was compared with screening alone using cost (in Australian dollars) per life-year (LY) saved and quality-adjusted life-year (QALY) saved. Sensitivity analyses included determining the cost-effectiveness of offering a catch-up vaccination program to 14-26-year-olds and accounting for the benefits of herd immunity. RESULTS: Vaccination with screening compared with screening alone was associated with an incremental cost-effectiveness ratio (ICER) of $51 103 per LY and $18 735 per QALY, assuming a cost per vaccine dose of $115. Results were sensitive to assumptions about the duration of vaccine efficacy, including the need for a booster ($68 158 per LY and $24 988 per QALY) to produce lifetime immunity. Accounting for herd immunity resulted in a more attractive ICER ($36 343 per LY and $13 316 per QALY) for girls only. The cost per LY of vaccinating boys and girls was $92 052 and the cost per QALY was $33 644. The cost per LY of implementing a catch-up vaccination program ranged from $45 652 ($16 727 per QALY) for extending vaccination to 14-year-olds to $78 702 ($34 536 per QALY) for 26-year-olds. CONCLUSIONS: These results suggest that adding an HPV vaccine to Australia's current screening regimen is a potentially cost-effective way to reduce cervical cancer and the clinical interventions that are currently associated with its prevention via screening alone.