Use of a meningococcal group B vaccine (4CMenB) in populations at high risk of gonorrhoea in the UK.

The meningococcal group B vaccine, 4CMenB, is a broad-spectrum, recombinant protein vaccine that is licensed for protection against meningococcal group B disease in children and adults. Over the past decade, several observational studies supported by laboratory studies have reported protection by 4CMenB against gonorrhoea, a sexually transmitted infection caused by Neisseria gonorrhoeae. Gonorrhoea is a major global public health problem, with rising numbers of diagnoses and increasing resistance to multiple antibiotics. In England, more than 82 000 cases of gonorrhoea were diagnosed in 2022, with nearly half of the cases diagnosed among gay, bisexual, and other men who have sex with men. There are currently no licensed vaccines against gonorrhoea but 4CMenB is estimated to provide 33-47% protection against gonorrhoea. On Nov 10, 2023, the UK Joint Scientific Committee on Vaccination and Immunisation agreed that a targeted programme should be initiated using 4CMenB to prevent gonorrhoea among individuals at higher risk of infection attending sexual health services in the UK. This decision was made after reviewing evidence from retrospective and prospective observational studies, laboratory and clinical data, national surveillance reports, and health economic analyses. In this Review, we summarise the epidemiology of invasive meningococcal disease and gonorrhoea in England, the evidence supporting the use of 4CMenB for protection against gonorrhoea, and the data needed to inform long-term programme planning and extension to the wider population.

Retrospective testing for mpox virus in routine STI screens from men who have sex with men in England, August-October 2022.

OBJECTIVES: A global outbreak of mpox (monkeypox) has been ongoing since 2022, with most cases in the UK detected in gay, bisexual and other men who have sex with men (GBMSM). Asymptomatic and pauci-symptomatic mpox infection has been reported outside of the UK. We aimed to investigate whether mpox could be detected in specimens from GBMSM in England who were attending sexual health services (SHSs) for asymptomatic sexually transmitted infection screening. METHODS: Anonymised, residual clinical specimens from GBMSM undertaking routine asymptomatic screening for gonorrhoea (Neisseria gonorrhoeae (NG)) and chlamydia (Chlamydia trachomatis (CT)) infection were tested for the presence of mpox virus. Specimens were collected between 1 August and 7 October 2022 from three SHSs in high-mpox incidence areas in England. Testing was performed using a dual-clade, mpox virus-specific real-time PCR. RESULTS: During the collection period, 2927 clinical specimens (951 pharyngeal swabs, 1022 urine specimens and 954 rectal swabs) were obtained from 1159 GBMSM. Mpox virus was detected in four specimens from two participants who attended the same SHS at different times (the first during the week 8-12 of August, the second during the week 19-23 of September). One participant was positive in the urine specimen only, while the other tested positive at all three sites. CONCLUSIONS: A very low prevalence (2 of 1159, 0.17%) of mpox infection was detected in GBMSM attending SHS in England for asymptomatic NG/CT screening, suggesting that undetected infection in this population was unlikely to be a main driver of transmission. Confirmed mpox cases in the UK declined from over 1100 per month in June and July to 764 cumulatively during the collection period. These data give reassurance that the observed reduction in cases during the collection period was not due to undetected infection or changes in presentation among SHS attendees. Currently, there is insufficient evidence to support routine testing of asymptomatic GBMSM for mpox infection in England.

STI testing, diagnoses and online chlamydia self-sampling among young people during the first year of the COVID-19 pandemic in England.

PURPOSE: COVID-19 control measures reduced face-to-face appointments at sexual health services (SHSs). Remote access to SHSs through online self-sampling was increased. This analysis assesses how these changes affected service use and STI testing among 15-24 year olds ('young people') in England. METHODS: Data on all chlamydia, gonorrhoea and syphilis tests from 2019-2020, among English-resident young people were obtained from national STI surveillance datasets. We calculated proportional differences in tests and diagnoses for each STI, by demographic characteristics, including socioeconomic deprivation, between 2019-2020. Binary logistic regression was used to determine crude and adjusted odds ratios (OR) between demographic characteristics and being tested for chlamydia by an online service. RESULTS: Compared to 2019, there were declines in testing (chlamydia-30%; gonorrhoea-26%; syphilis-36%) and diagnoses (chlamydia-31%; gonorrhoea-25%; syphilis-23%) among young people in 2020. Reductions were greater amongst 15-19 year-olds vs. 20-24 year-olds. Amongst people tested for chlamydia, those living in the least deprived areas were more likely to be tested using an online self-sampling kit (males; OR = 1.24 [1.22-1.26], females; OR = 1.28 [1.27-1.30]). CONCLUSION: The first year of the COVID-19 pandemic in England saw declines in STI testing and diagnoses in young people and disparities in the use of online chlamydia self-sampling which risk widening existing health inequalities.

No widespread dissemination of Chlamydia trachomatis diagnostic-escape variants and the impact of Neisseria gonorrhoeae positivity on the Aptima Combo 2 assay.

OBJECTIVES: A Finnish Chlamydia trachomatis (CT) new variant was detected in 2019 that escaped detection in the Hologic Aptima Combo 2 (AC2) assay due to a C1515T mutation in the CT 23S rRNA target region. Reflex testing of CT-negative/CT-equivocal specimens as well as those positive for Neisseria gonorrhoeae (NG) with the Hologic Aptima CT (ACT) assay was recommended to identify any CT variants. METHODS: From June to October 2019, specimens with discrepant AC2/ACT CT results were submitted to Public Health England and screened for detectable CT DNA using an inhouse real-time (RT)-PCR. When enough DNA was present, partial CT 23S rRNA gene sequencing was performed. Analysis of available relative light units and interpretative data was performed. RESULTS: A total of 317 discordant AC2/ACT specimens were collected from 315 patients. Three hundred were tested on the RT-PCR; 53.3% (n=160) were negative and 46.7% (n=140) were positive. Due to low DNA load in most specimens, sequencing was successful for only 36 specimens. The CT 23S rRNA wild-type sequence was present in 32 specimens, and two variants with C1514T or G1523A mutation were detected in four specimens from three patients. Of the discordant specimens with NG interpretation, 36.6% of NG-negative/CT-negative AC2 specimens had detectable CT DNA on the inhouse RT-PCR vs 53.3% of NG-positive/CT-negative specimens. CONCLUSIONS: No widespread dissemination of AC2 diagnostic-escape CT variants has occurred in England. We however identified the impact of NG positivity on the discordant AC2/ACT specimens; a proportion appeared due to NG positivity and the associated NG signal, rather than any diagnostic-escape variants or low DNA load. Several patients with gonorrhoea may therefore receive false-negative AC2 CT results. Single diagnostic targets and multiplex diagnostic assays have their limitations such as providing selection pressure for escape mutants and potentially reduced sensitivity, respectively. These limitations must be considered when establishing diagnostic pathways.

Prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay, England, June to August 2019.

We identified two new Chlamydia trachomatis (CT) variants escaping Aptima Combo 2 (AC2) assay detection, in clinical specimens of two patients. One had a C1514T mutation the other a G1523A mutation, both within the AC2 23S rRNA target region. The prevalence of such variants among persons tested for CT in England was estimated to be fewer than 0.003%.

Qualitative impact assessment of an educational workshop on primary care practitioner attitudes to NICE HIV testing guidelines.

BACKGROUND: In 2013, Public Health England piloted the '3Cs (chlamydia, contraception, condoms) and HIV (human immunodeficiency virus)' educational intervention in 460 GP surgeries. The educational HIV workshop aimed to improve the ability and confidence of staff to offer HIV testing in line with national guidelines. AIM: To qualitatively assess the impact of an educational workshop on GP staff's attitudes to NICE HIV testing guidelines. DESIGN & SETTING: Qualitative interviews with GP staff across England before and after an educational HIV workshop. METHOD: Thirty-two GP staff (15 before and 17 after educational HIV workshop) participated in interviews exploring their views and current practice of HIV testing. Interview transcripts were thematically analysed and examined, using the components of the theory of planned behaviour (TPB) and normalisation process theory (NPT) as a framework. RESULTS: GPs reported that the educational HIV workshop resulted in increased knowledge of, and confidence to offer, HIV tests based on indicator conditions. However, overall participants felt they needed additional HIV training around clinical care pathways for offering tests, giving positive HIV results, and current treatments and outcomes. Participants did not see a place for point-of-care testing in general practice. CONCLUSION: Implementation of national HIV guidelines will require multiple educational sessions, especially to implement testing guidelines for indicator conditions in areas of low HIV prevalence. Additional role-play or discussions around scripts suggesting how to offer an HIV test may improve participants' confidence and facilitate increased testing. Healthcare assistants (HCAs) may need specific training to ensure that they are skilled in offering HIV testing within new patient checks.

Detection of Chlamydia trachomatis in rectal specimens in women and its association with anal intercourse: a systematic review and meta-analysis.

OBJECTIVES: Chlamydia trachomatis is the most commonly diagnosed bacterial STI. Lack of prevalence and risk factor data for rectal chlamydia in women has testing and treatment implications, as azithromycin (a first-line urogenital chlamydia treatment) may be less effective for rectal chlamydia. We conducted a systematic review of studies on women in high-income countries to estimate rectal chlamydia prevalence, concurrency with urogenital chlamydia and associations with reported anal intercourse (AI). DESIGN: Systematic review and four meta-analyses conducted using random-effects modelling. DATA SOURCES: Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO and the Cochrane Database were searched for articles published between January 1997 and October 2017. ELIGIBILITY CRITERIA: Studies reporting rectal chlamydia positivity in heterosexual women aged ≥15 years old in high-income countries were included. Studies must have used nucleic acid amplification tests and reported both the total number of women tested for rectal chlamydia and the number of rectal chlamydia infections detected. Conference abstracts, case reports and studies with self-reported diagnoses were excluded. Data extracted included setting, rectal and urogenital chlamydia testing results, AI history, and demographics. RESULTS: Fourteen eligible studies were identified, all among diverse populations attending sexual health services. Among routine clinic-attending women, summary rectal chlamydia positivity was 6.0% (95% CI 3.2% to 8.9%); summary concurrent rectal chlamydia infection was 68.1% in those who tested positive for urogenital chlamydia (95% CI 56.6% to 79.6%); and of those who tested negative for urogenital chlamydia, 2.2% (95% CI 0% to 5.2%) were positive for rectal chlamydia. Reported AI was not associated with rectal chlamydia (summary risk ratio 0.90; 95% CI 0.75 to 1.10). CONCLUSIONS: High levels of rectal chlamydia infection have been shown in women with urogenital chlamydia infection. The absence of association between reported AI and rectal chlamydia suggests AI is not an adequate indicator for rectal testing. Further work is needed to determine policy and practice for routine rectal testing in women.

Qualitative interviews with healthcare staff in four European countries to inform adaptation of an intervention to increase chlamydia testing.

OBJECTIVE: To determine the needs of primary healthcare general practice (GP) staff, stakeholders and trainers to inform the adaptation of a locally successful complex intervention (Chlamydia Intervention Randomised Trial (CIRT)) aimed at increasing chlamydia testing within primary healthcare within South West England to three EU countries (Estonia, France and Sweden) and throughout England. DESIGN: Qualitative interviews. SETTING: European primary healthcare in England, France, Sweden and Estonia with a range of chlamydia screening provision in 2013. PARTICIPANTS: 45 GP staff, 13 trainers and 18 stakeholders. INTERVIEWS: The iterative interview schedule explored participants' personal attitudes, subjective norms and perceived behavioural controls around provision of chlamydia testing, sexual health services and training in general practice. Researchers used a common thematic analysis. RESULTS: Findings were similar across all countries. Most participants agreed that chlamydia testing and sexual health services should be offered in general practice. There was no culture of GP staff routinely offering opportunistic chlamydia testing or sexual health advice, and due to other priorities, participants reported this would be challenging. All participants indicated that the CIRT workshop covering chlamydia testing and sexual health would be useful if practice based, included all practice staff and action planning, and was adequately resourced. Participants suggested minor adaptations to CIRT to suit their country's health services. CONCLUSIONS: A common complex intervention can be adapted for use across Europe, despite varied sexual health provision. The intervention (ChlamydiA Testing Training in Europe (CATTE)) should comprise: a staff workshop covering sexual health and chlamydia testing rates and procedures, action planning and patient materials and staff reminders via computer prompts, emails or newsletters, with testing feedback through practice champions. CATTE materials are available at: www.STItraining.eu.

Chlamydia and HIV testing, contraception advice, and free condoms offered in general practice: a qualitative interview study of young adults' perceptions of this initiative.

BACKGROUND: Opportunistic chlamydia screening is actively encouraged in English general practices. Based on recent policy changes, Public Health England piloted 3Cs and HIV in 2013-2014, integrating the offer of chlamydia testing with providing condoms, contraceptive information, and HIV testing (referred to as 3Cs and HIV) according to national guidelines. AIM: To determine young adults' opinions of receiving a broader sexual health offer of 3Cs and HIV at their GP practice. DESIGN AND SETTING: Qualitative interviews were conducted in a general practice setting in England between March and June 2013. METHOD: Thirty interviews were conducted with nine male and 21 female patients aged 16-24 years, immediately before or after a routine practice attendance. Data were transcribed verbatim and analysed using a thematic framework. RESULTS: Participants indicated that the method of testing, timing, and the way the staff member approached the topic were important aspects to patients being offered 3Cs and HIV. Participants displayed a clear preference for 3Cs and HIV to be offered at the GP practice over other sexual health service providers. Participants highlighted convenience of the practice, assurance of confidentiality, and that the sexual health discussion was appropriate and routine. Barriers identified for patients were embarrassment, unease, lack of time, religion, and patients believing that certain patients could take offence. Suggested facilitators include raising awareness, reassuring confidentiality, and ensuring the offer is made in a professional and non-judgemental way at the end of the consultation. CONCLUSION: General practice staff should facilitate patients' preferences by ensuring that 3Cs and HIV testing services are made available at their surgery and offered to appropriate patients in a non-judgemental way.

Service evaluation of an educational intervention to improve sexual health services in primary care implemented using a step-wedge design: analysis of chlamydia testing and diagnosis rate changes.

BACKGROUND: Providing sexual health services in primary care is an essential step towards universal provision. However they are not offered consistently. We conducted a national pilot of an educational intervention to improve staff's skills and confidence to increase chlamydia testing rates and provide condoms with contraceptive information plus HIV testing according to national guidelines, known as 3Cs&HIV. The effectiveness of the pilot on chlamydia testing and diagnosis rates in general practice was evaluated. METHODS: The pilot was implemented using a step-wedge design over three phases during 2013 and 2014 in England. The intervention combined educational workshops with posters, testing performance feedback and continuous support. Chlamydia testing and diagnosis rates in participating general practices during the control and intervention periods were compared adjusting for seasonal trends in chlamydia testing and differences in practice size. Intervention effect modification was assessed for the following general practice characteristics: chlamydia testing rate compared to national median, number of general practice staff employed, payment for chlamydia screening, practice urban/rurality classification, and proximity to sexual health clinics. RESULTS: The 460 participating practices conducted 26,021 tests in the control period and 18,797 tests during the intervention period. Intention-to-treat analysis showed no change in the unadjusted median tests and diagnoses per month per practice after receiving training: 2.7 vs 2.7; 0.1 vs 0.1. Multivariable negative binomial regression analysis found no significant change in overall testing or diagnoses post-intervention (incidence rate ratio (IRR) 1.01, 95 % confidence interval (CI) 0.96-1.07, P = 0.72; 0.98 CI 0.84-1.15, P = 0.84, respectively). Stratified analysis showed testing increased significantly in practices where payments were in place prior to the intervention (IRR 2.12 CI 1.41-3.18, P < 0.001) and in practices with 6-15 staff (6-10 GPs IRR 1.35 (1.07-1.71), P = 0.012; 11-15 GPs IRR 1.37 (1.09-1.73), P = 0.007). CONCLUSION: This national pilot of short educational training sessions found no overall effect on chlamydia testing in primary care. However, in certain sub-groups chlamydia testing rates increased due to the intervention. This demonstrates the importance of piloting and evaluating any service improvement intervention to assess the impact before widespread implementation, and the need for detailed understanding of local services in order to select effective interventions.

Screening for gonorrhoea using samples collected through the English national chlamydia screening programme and risk of false positives: a national survey of local authorities.

OBJECTIVES: To investigate use of dual tests for Chlamydia trachomatis and Neisseria gonorrhoeae on samples collected through the National Chlamydia Screening Programme (NCSP) in England. DESIGN AND SETTING: During May-July 2013, we delivered an online survey to commissioners of sexual health services in the 152 upper-tier English Local Authorities (LAs) who were responsible for commissioning chlamydia screening in people aged 15-24 years. MAIN OUTCOME MEASURES: (1) The proportion of English LAs using dual tests on samples collected by the NCSP; (2) The estimated number of gonorrhoea tests and false positives from samples collected by the NCSP, calculated using national surveillance data on the number of chlamydia tests performed, assuming the gonorrhoea prevalence to range between 0.1% and 1%, and test sensitivity and specificity of 99.5%. RESULTS: 64% (98/152) of LAs responded to this national survey; over half (53% (52/98)) reported currently using dual tests in community settings. There was no significant difference between LAs using and not using dual tests by chlamydia positivity, chlamydia diagnosis rate or population screening coverage. Although positive gonorrhoea results were confirmed with supplementary tests in 93% (38/41) of LAs, this occurred after patients were notified about the initial positive result in 63% (26/41). Approximately 450-4500 confirmed gonorrhoea diagnoses and 2300 false-positive screens might occur through use of dual tests on NCSP samples each year. Under reasonable assumptions, the positive predictive value of the screening test is 17-67%. CONCLUSIONS: Over half of English LAs already commission dual tests for samples collected by the NCSP. Gonorrhoea screening has been introduced alongside chlamydia screening in many low prevalence settings without a national evidence review or change of policy. We question the public health benefit here, and suggest that robust testing algorithms and clinical management pathways, together with rigorous evaluation, be implemented wherever dual tests are deployed.