A holistic biopsychosocial management approach for cis-gender males with chronic pelvic pain syndrome attending sexual health services: a retrospective case review.

OBJECTIVES: Chronic pelvic pain syndrome (CPPS) in men is a condition associated with significant morbidity which is typically managed in sexual health services. We introduced a modified biopsychosocial approach for managing CPPS in men, reducing use of antibiotics and evaluated its application in a retrospective case review. METHODS: Patients attended for a full consultation covering symptomology, onset and social history. Examination included urethral smear and assessment of pelvic floor tension and pain. A focus on pelvic floor relaxation was the mainstay of management with pelvic floor physiotherapy if required. Prescribing of antibiotics being discontinued if no evidence of urethritis at first consultation. The main outcome was change in the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score (which patients completed at each attendance); significant clinical improvement was defined as a NIH-CPSI score reduction of >25% and/or ≥6 points. RESULTS: Among 77 consecutive patients diagnosed with CPPS between April 2017 and December 2018, the mean NIH-CPSI score at the initial visit was 24.1 (11-42). Antibiotics were prescribed to 38/77 (49.4%) and alpha-blockers to 58/77 (75.3%). Overall, 50 (64.9%) patients with a mean initial NIH-CPSI score of 25.4 (11-42) re-attended a CPPS clinic. Among these, the average NIH-CPSI score at the final CPPS clinic appointment declined to 15.9 (0-39) (p<0.001); 34/50 (68%) men experienced significant clinical improvement. Men who attended only one CPPS clinic compared with those who reattended had a shorter duration of symptoms (18 (1-60) vs 36 (1-240) months; p=0.038), a lower initial NIH-CPSI score (21.7 (11-34) vs 25.4 (11-44); p=0.021), but had attended a similar number of clinics prior to referral (2.9 (0-6) vs 3.2 (0-8); p=0.62). CONCLUSIONS: The biopsychosocial approach significantly reduced the NIH-CPSI score in those who re-attended, with 68% of patients having a significant clinical improvement. The first follow-up consultation at 6 weeks is now undertaken by telephone for many patients, if clinically appropriate.

Cost-effectiveness of testing for Mycoplasma genitalium among men who have sex with men in Australia.

OBJECTIVES: Mycoplasma genitalium (MG) disproportionately affects men who have sex with men (MSM). We determined the cost-effectiveness of different testing strategies for MG in MSM, taking a healthcare provider perspective. METHODS: We used inputs from a dynamic transmission model of MG among MSM living in Australia in a decision tree model to evaluate the impact of four testing scenarios on MG incidence: (1) no one tested; (2) symptomatic MSM; (3) symptomatic and high-risk asymptomatic MSM; (4) all MSM. We calculated the incremental cost-effectiveness ratios (ICERs) using a willingness-to-pay threshold of $A30 000 per quality-adjusted life year (QALY) gained. We explored the impact of adding an antimicrobial resistance (AMR) tax (ie, additional cost per antibiotic consumed) to identify the threshold, whereby any testing for MG is no longer cost-effective. RESULTS: Testing only symptomatic MSM is the most cost-effective (ICER $3677 per QALY gained) approach. Offering testing to all MSM is dominated (ie, higher costs and lower QALYs gained compared with other strategies). When the AMR tax per antibiotic given was above $150, any testing for MG was no longer cost-effective. CONCLUSION: Testing only symptomatic MSM is the most cost-effective option, even when the potential costs associated with AMR are accounted for (up to $150 additional cost per antibiotic given). For pathogens like MG, where there are anticipated future costs related to AMR, we recommend models that test the impact of incorporating an AMR tax as they can change the results and conclusions of cost-effectiveness studies.

Impact of rapid near-patient STI testing on service delivery outcomes in an integrated sexual health service in the United Kingdom: a controlled interrupted time series study.

OBJECTIVES: To evaluate the impact of a new clinic-based rapid sexually transmitted infection testing, diagnosis and treatment service on healthcare delivery and resource needs in an integrated sexual health service. DESIGN: Controlled interrupted time series study. SETTING: Two integrated sexual health services (SHS) in UK: Unity Sexual Health in Bristol, UK (intervention site) and Croydon Sexual Health in London (control site). PARTICIPANTS: Electronic patient records for all 58 418 attendances during the period 1 year before and 1 year after the intervention. INTERVENTION: Introduction of an in-clinic rapid testing system for gonorrhoea and chlamydia in combination with revised treatment pathways. OUTCOME MEASURES: Time-to-test notification, staff capacity, cost per episode of care and overall service costs. We also assessed rates of gonorrhoea culture swabs, follow-up attendances and examinations. RESULTS: Time-to-notification and the rate of gonorrhoea swabs significantly decreased following implementation of the new system. There was no evidence of change in follow-up visits or examination rates for patients seen in clinic related to the new system. Staff capacity in clinics appeared to be maintained across the study period. Overall, the number of episodes per week was unchanged in the intervention site, and the mean cost per episode decreased by 7.5% (95% CI 5.7% to 9.3%). CONCLUSIONS: The clear improvement in time-to-notification, while maintaining activity at a lower overall cost, suggests that the implementation of clinic-based testing had the intended impact, which bolsters the case for more widespread rollout in sexual health services.

Environmental contamination by Chlamydia trachomatis and Neisseria gonorrhoeae: is it time to change our infection control practices? Results of a regional study.

OBJECTIVES: Nucleic acid amplification tests (NAATs) are highly sensitive for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA/ribosomal RNA (rRNA). Previous studies have demonstrated contamination of surfaces in sexual health clinics (SHCs) with CT/NG. False positive results can occur if patient samples are contaminated by environmental DNA/rRNA. This can have a dramatic impact on patients' lives and relationships. Previous attempts to reduce contamination, through staff training alone, have been unsuccessful. We aimed to investigate environmental contamination levels in SHCs and to assess a two-armed intervention aimed at reducing surface contamination. METHODS: Questionnaires were sent to 10 SHCs. Six clinics, with differing characteristics, were selected to participate in sample collection. Each clinic followed standardised instructions to sample surfaces using a CT/NG NAAT swab. Clinics were invited to introduce the two-armed intervention. The first arm was cleaning with a chlorine-based cleaning solution once daily. The second arm involved introducing clinic-specific changes to reduce contamination. RESULTS: 7/10 (70%) clinics completed the questionnaire. Overall, 88/263 (33%) swabs were positive for CT/NG. Clinics 1, 3 and 4 had high levels of contamination, with 28/64 (44%), 17/33 (52%) and 30/52 (58%) swabs testing positive, respectively. Clinics 2 and 6 had lower levels of contamination, with 7/46 (15%) and 6/35 (17%), respectively. 0/33 (0%) of swabs were positive at clinic 5 and this was the only clinic already using a chlorine-based solution to clean all surfaces and delivering twice-yearly clinic-specific infection control training. Following both intervention arms at clinic 1, 2/50 (4%, p<0.0001) swabs tested positive for CT/NG. Clinic 4 introduced each arm separately. After the first intervention, 13/52 (25%, p=0.003) swabs tested positive and following the second arm 4/50 (8%, p<0.0001) swabs were positive. CONCLUSIONS: Environmental contamination is a concern in SHCs. We recommend that all SHCs monitor contamination levels and, if necessary, consider using chlorine-based cleaning products and introduce clinic-specific changes to address environmental contamination.

Assessment of online self-testing and self-sampling service providers for sexually transmitted infections against national standards in the UK in 2020.

OBJECTIVES: Online testing for STIs may help overcome barriers of traditional face-to-face testing, such as stigma and inconvenience. However, regulation of these online tests is lacking, and the quality of services is variable, with potential short-term and long-term personal, clinical and public health implications. This study aimed to evaluate online self-testing and self-sampling service providers in the UK against national standards. METHODS: Providers of online STI tests (self-sampling and self-testing) in the UK were identified by an internet search of Google and Amazon (June 2020). Website information on tests and associated services was collected and further information was requested from providers via an online survey, sent twice (July 2020, April 2021). The information obtained was compared with British Association for Sexual Health and HIV and Faculty of Sexual and Reproductive Healthcare guidelines and standards for diagnostics and STI management. RESULTS: 31 providers were identified: 13 self-test, 18 self-sample and 2 laboratories that serviced multiple providers. Seven responded to the online survey. Many conflicts with national guidelines were identified, including: lack of health promotion information, lack of sexual history taking, use of tests licensed for professional-use only marketed for self-testing, inappropriate infections tested for, incorrect specimen type used and lack of advice for postdiagnosis management. CONCLUSIONS: Very few online providers met the national STI management standards assessed, and there is concern that this will also be the case for service provision aspects that were not covered by this study. For-profit providers were the least compliant, with concerning implications for patient care and public health. Regulatory change is urgently needed to ensure that all online providers are compliant with national guidelines to ensure high-quality patient care, and providers are held to account if non-compliant.

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.

What can be learnt from a qualitative evaluation of implementing a rapid sexual health testing, diagnosis and treatment service?

OBJECTIVES: To investigate experiences of implementing a new rapid sexual health testing, diagnosis and treatment service. DESIGN: A theory-based qualitative evaluation with a focused ethnographic approach using non-participant observations and interviews with patient and clinic staff. Normalisation process theory was used to structure interview questions and thematic analysis. SETTING: A sexual health centre in Bristol, UK. PARTICIPANTS: 26 patients and 21 staff involved in the rapid sexually transmitted infection (STI) service were interviewed. Purposive sampling was aimed for a range of views and experiences and sociodemographics and STI results for patients, job grades and roles for staff. 40 hours of observations were conducted. RESULTS: Implementation of the new service required co-ordinated changes in practice across multiple staff teams. Patients also needed to make changes to how they accessed the service. Multiple small 'pilots' of process changes were necessary to find workable options. For example, the service was introduced in phases beginning with male patients. This responsive operating mode created challenges for delivering comprehensive training and communication in advance to all staff. However, staff worked together to adjust and improve the new service, and morale was buoyed through observing positive impacts on patient care. Patients valued faster results and avoiding unnecessary treatment. Patients reported that they were willing to drop-off self-samples and return for a follow-up appointment, enabling infection-specific treatment in accordance with test results, thus improving antimicrobial stewardship. CONCLUSIONS: The new service was acceptable to staff and patients. Implementation of service changes to improve access and delivery of care in the context of stretched resources can pose challenges for staff at all levels. Early evaluation of pilots of process changes played an important role in the success of the service by rapidly feeding back issues for adjustment. Visibility to staff of positive impacts on patient care is important in maintaining morale.

Incidence of Pelvic Inflammatory Disease Associated With Mycoplasma genitalium Infection: Evidence Synthesis of Cohort Study Data.

We synthesized evidence from the POPI sexual-health cohort study and estimated that 4.9% (95% credible interval, .4-14.1%) of Mycoplasma genitalium infections in women progress to pelvic inflammatory disease versus 14.4% (5.9-24.6%) of chlamydial infections. For validation, we predicted PID rates in 4 age groups that agree well with surveillance data.

Modelling patient flows and resource use within a sexual health clinic through discrete event simulation to inform service redesign.

OBJECTIVES: Continuous improvement in the delivery of health services is increasingly being demanded in the UK at a time when budgets are being cut. Simulation is one approach used for understanding and assessing the likely impact of changes to the delivery of health services. However, little is known about the usefulness of simulation for analysing the delivery of sexual health services (SHSs). We propose a simulation method to model and evaluate patient flows and resource use within an SHS to inform service redesign. METHODS: We developed a discrete event simulation (DES) model to identify the bottlenecks within the Unity SHS (Bristol, UK) and find possible routes for service improvement. Using the example of the introduction of an online service for sexually transmitted infection (STI) and HIV self-sampling for asymptomatic patients, the impact on patient waiting times was examined as the main outcome measure. The model included data such as patient arrival time, staff availability and duration of consultation, examination and treatment. We performed several sensitivity analyses to assess uncertainty in the model parameters. RESULTS: We identified some bottlenecks under the current system, particularly in the consultation and treatment queues for male and female walk-in patients. Introducing the provision of STI and HIV self-sampling alongside existing services decreased the average waiting time (88 vs 128 min) for all patients and reduced the cost of staff time for managing each patient (£72.64 vs £88.74) compared with the current system without online-based self-sampling. CONCLUSIONS: The provision of online-based STI and HIV self-sampling for asymptomatic patients could be beneficial in reducing patient waiting times and the model highlights the complexities of using this to cut costs. Attributing recognition for any improvement requires care, but DES modelling can provide valuable insights into the design of SHSs ensuing in quantifiable improvements. Extension of this method with the collection of additional data and the construction of more informed models seems worthwhile.

Genital Chlamydia trachomatis Infections Clear More Slowly in Men Than Women, but Are Less Likely to Become Established.

Background: Rigorous estimates for clearance rates of untreated chlamydia infections are important for understanding chlamydia epidemiology and designing control interventions, but were previously only available for women. Methods: We used data from published studies of chlamydia-infected men who were retested at a later date without having received treatment. Our analysis allowed new infections to take one of 1, 2, or 3 courses, each clearing at a different rate. We determined which of these 3 models had the most empirical support. Results: The best-fitting model had 2 courses of infection in men, as was previously found for women: "slow-clearing" and "fast-clearing." Only 68% (57%-78%) (posterior median and 95% credible interval [CrI]) of incident infections in men were slow-clearing, vs 77% (69%-84%) in women. The slow clearance rate in men (based on 6 months' follow-up) was 0.35 (.05-1.15) year-1 (posterior median and 95% CrI), corresponding to mean infection duration 2.84 (.87-18.79) years. This compares to 1.35 (1.13-1.63) years in women. Conclusions: Our estimated clearance rate is slower than previously assumed. Fewer infections become established in men than women but once established, they clear more slowly. This study provides an improved description of chlamydia's natural history to inform public health decision making. We describe how further data collection could reduce uncertainty in estimates.

Chlamydia trachomatis Incidence Using Self-Reports and Serology by Gender, Age Period, and Sexual Behavior in a Birth Cohort.

BACKGROUND: Although understanding chlamydia incidence assists prevention and control, analyses based on diagnosed infections may distort the findings. Therefore, we determined incidence and examined risks in a birth cohort based on self-reports and serology. METHODS: Self-reported chlamydia and behavior data were collected from a cohort born in New Zealand in 1972/3 on several occasions to age 38 years. Sera drawn at ages 26, 32, and 38 years were tested for antibodies to Chlamydia trachomatis Pgp3 antigen using a recently developed assay, more sensitive in women (82.9%) than men (54.4%). Chlamydia incidence by age period (first coitus to age 26, 26-32, and 32-38 years) was calculated combining self-reports and serostatus and risk factors investigated by Poisson regression. RESULTS: By age 38 years, 32.7% of women and 20.9% of men had seroconverted or self-reported a diagnosis. The highest incidence rate was to age 26, 32.7 and 18.4 years per 1000 person-years for women and men, respectively. Incidence rates increased substantially with increasing number of sexual partners. After adjusting age period incidence rates for partner numbers, a relationship with age was not detected until 32 to 38 years, and then only for women. CONCLUSIONS: Chlamydia was common in this cohort by age 38, despite the moderate incidence rates by age period. The strongest risk factor for incident infection was the number of sexual partners. Age, up to 32 years, was not an independent factor after accounting for partner numbers, and then only for women. Behavior is more important than age when considering prevention strategies.

Proportion of Pelvic Inflammatory Disease Cases Caused by Chlamydia trachomatis: Consistent Picture From Different Methods.

BACKGROUND: Pelvic inflammatory disease (PID) is a leading cause of both tubal factor infertility and ectopic pregnancy. Chlamydia trachomatis is an important risk factor for PID, but the proportion of PID cases caused by C. trachomatis is unclear. Estimates of this are required to evaluate control measures. METHODS: We consider 5 separate methods of estimating age-group-specific population excess fractions (PEFs) of PID due to C. trachomatis, using routine data, surveys, case-control studies, and randomized controlled trials, and apply these to data from the United Kingdom before introduction of the National Chlamydia Screening Programme. RESULTS: As they are informed by randomized comparisons and national exposure and outcome estimates, our preferred estimates of the proportion of PID cases caused by C. trachomatis are 35% (95% credible interval [CrI], 11%-69%) in women aged 16-24 years and 20% (95% CrI, 6%-38%) in women aged 16-44 years in the United Kingdom. There is a fair degree of consistency between adjusted estimates of PEF, but all have wide 95% CrIs. The PEF decreases from 53.5% (95% CrI, 15.6%-100%) in women aged 16-19 years to 11.5% (95% CrI, 3.0%-25.7%) in women aged 35-44 years. CONCLUSIONS: The PEFs of PID due to C. trachomatis decline steeply with age by a factor of around 5-fold between younger and older women. Further studies of the etiology of PID in different age groups are required.

The natural history of Chlamydia trachomatis infection in women: a multi-parameter evidence synthesis.

BACKGROUND AND OBJECTIVES: The evidence base supporting the National Chlamydia Screening Programme, initiated in 2003, has been questioned repeatedly, with little consensus on modelling assumptions, parameter values or evidence sources to be used in cost-effectiveness analyses. The purpose of this project was to assemble all available evidence on the prevalence and incidence of Chlamydia trachomatis (CT) in the UK and its sequelae, pelvic inflammatory disease (PID), ectopic pregnancy (EP) and tubal factor infertility (TFI) to review the evidence base in its entirety, assess its consistency and, if possible, arrive at a coherent set of estimates consistent with all the evidence. METHODS: Evidence was identified using 'high-yield' strategies. Bayesian Multi-Parameter Evidence Synthesis models were constructed for separate subparts of the clinical and population epidemiology of CT. Where possible, different types of data sources were statistically combined to derive coherent estimates. Where evidence was inconsistent, evidence sources were re-interpreted and new estimates derived on a post-hoc basis. RESULTS: An internally coherent set of estimates was generated, consistent with a multifaceted evidence base, fertility surveys and routine UK statistics on PID and EP. Among the key findings were that the risk of PID (symptomatic or asymptomatic) following an untreated CT infection is 17.1% [95% credible interval (CrI) 6% to 29%] and the risk of salpingitis is 7.3% (95% CrI 2.2% to 14.0%). In women aged 16-24 years, screened at annual intervals, at best, 61% (95% CrI 55% to 67%) of CT-related PID and 22% (95% CrI 7% to 43%) of all PID could be directly prevented. For women aged 16-44 years, the proportions of PID, EP and TFI that are attributable to CT are estimated to be 20% (95% CrI 6% to 38%), 4.9% (95% CrI 1.2% to 12%) and 29% (95% CrI 9% to 56%), respectively. The prevalence of TFI in the UK in women at the end of their reproductive lives is 1.1%: this is consistent with all PID carrying a relatively high risk of reproductive damage, whether diagnosed or not. Every 1000 CT infections in women aged 16-44 years, on average, gives rise to approximately 171 episodes of PID and 73 of salpingitis, 2.0 EPs and 5.1 women with TFI at age 44 years. CONCLUSIONS AND RESEARCH RECOMMENDATIONS: The study establishes a set of interpretations of the major studies and study designs, under which a coherent set of estimates can be generated. CT is a significant cause of PID and TFI. CT screening is of benefit to the individual, but detection and treatment of incident infection may be more beneficial. Women with lower abdominal pain need better advice on when to seek early medical attention to avoid risk of reproductive damage. The study provides new insights into the reproductive risks of PID and the role of CT. Further research is required on the proportions of PID, EP and TFI attributable to CT to confirm predictions made in this report, and to improve the precision of key estimates. The cost-effectiveness of screening should be re-evaluated using the findings of this report. FUNDING: The Medical Research Council grant G0801947.

Which sexually active young female students are most at risk of pelvic inflammatory disease? A prospective study.

OBJECTIVE: To identify risk factors for pelvic inflammatory disease (PID) in female students. METHODS: We performed a prospective study set in 11 universities and 9 further education colleges in London. In 2004-2006, 2529 sexually experienced, multiethnic, female students, mean age 20.8 years, provided self-taken vaginal samples and completed questionnaires at recruitment to the Prevention of Pelvic Infection chlamydia screening trial. After 12 months, they were followed up by questionnaire backed by medical record search and assessed for PID by blinded genitourinary medicine physicians. RESULTS: Of 2004 (79%) participants who reported numbers of sexual partners during follow-up, 32 (1.6%, 95% CI 1.1% to 2.2%) were diagnosed with PID. The strongest predictor of PID was baseline Chlamydia trachomatis (relative risk (RR) 5.7, 95% CI 2.6 to 15.6). After adjustment for baseline C. trachomatis, significant predictors of PID were ≥2 sexual partners or a new sexual partner during follow-up (RR 4.0, 95% CI 1.8 to 8.5; RR 2.8, 95% CI 1.3 to 6.3), age <20 years (RR 3.3, 95% CI 1.5 to 7.0), recruitment from a further education college rather than a university (RR 2.6, 95% CI 1.3 to 5.3) and history at baseline of vaginal discharge (RR 2.7, 95% CI 1.2 to 5.8) or pelvic pain (RR 4.1, 95% CI 2.0 to 8.3) in the previous six months. Bacterial vaginosis and Mycoplasma genitalium infection were no longer significantly associated with PID after adjustment for baseline C. trachomatis. CONCLUSIONS: Multiple or new partners in the last 12 months, age <20 years and attending a further education college rather than a university were risk factors for PID after adjustment for baseline C. trachomatis infection. Sexual health education and screening programmes could be targeted at these high-risk groups. TRIAL REGISTRATION NUMBER: (ClinicalTrials.gov NCT00115388).

An observational study to evaluate three pilot programmes of retesting chlamydia-positive individuals within 6†months in the South West of England.

OBJECTIVES: To evaluate 3 pilot chlamydia retesting programmes in South West England which were initiated prior to the release of new National Chlamydia Screening Programme (NCSP) guidelines recommending retesting in 2014. METHODS: Individuals testing positive between August 2012 and July 2013 in Bristol (n=346), Cornwall (n=252) and Dorset (n=180) programmes were eligible for inclusion in the retesting pilots. The primary outcomes were retest within 6 months (yes/no) and repeat diagnosis at retest (yes/no), adjusted for area, age and gender. RESULTS: Overall 303/778 (39.0%) of participants were retested within 6 months and 31/299 (10.4%) were positive at retest. Females were more likely to retest than males and Dorset had higher retesting rates than the other areas. CONCLUSIONS: More than a third of those eligible were retested within the time frame of the study. Chlamydia retesting programmes appear feasible within the context of current programmes to identify individuals at continued risk of infection with relatively low resource and time input.