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.

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.

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.

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.

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.

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.

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.

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).

Risk of pelvic inflammatory disease following Chlamydia trachomatis infection: analysis of prospective studies with a multistate model.

Our objective in this study was to estimate the probability that a Chlamydia trachomatis (CT) infection will cause an episode of clinical pelvic inflammatory disease (PID) and the reduction in such episodes among women with CT that could be achieved by annual screening. We reappraised evidence from randomized controlled trials of screening and controlled observational studies that followed untreated CT-infected and -uninfected women to measure the development of PID. Data from these studies were synthesized using a continuous-time Markov model which takes into account the competing risk of spontaneous clearance of CT. Using a 2-step piecewise homogenous Markov model that accounts for the distinction between prevalent and incident infections, we investigated the possibility that the rate of PID due to CT is greater during the period immediately following infection. The available data were compatible with both the homogenous and piecewise homogenous models. Given a homogenous model, the probability that a CT episode will cause clinical PID was 0.16 (95% credible interval (CrI): 0.06, 0.25), and annual screening would prevent 61% (95% CrI: 55, 67) of CT-related PID in women who became infected with CT. Assuming a piecewise homogenous model with a higher rate during the first 60 days, corresponding results were 0.16 (95% CrI: 0.07, 0.26) and 55% (95% CrI: 32, 72), respectively.

Chlamydia screening, retesting and repeat diagnoses in Cornwall, UK 2003-2009.

OBJECTIVES: This study aims to describe the patterns of testing and retesting for chlamydia in Cornwall during the first 5 years of the National Chlamydia Screening Programme. We evaluate the factors associated with retesting and estimate the incidence of chlamydia diagnosis and repeat diagnosis. STUDY DESIGN: Secondary database analysis. SELECTION CRITERIA: men and women tested for chlamydia between March 2003 and January 2009 in Cornwall, aged ≥12 years and ≤25 years at the first test. The factors associated with retesting in those with at least one known test result and at least 14 days follow-up time were analysed using Cox regression and the incidence of diagnosis and repeat diagnosis were calculated. RESULTS: The final dataset consisted of 71 066 records from 49 941 individuals; of whom 59.0% were female and 75.4% were only tested once. There were 48 375 individuals with at least one known test result (negative or positive) and at least 14 days follow-up, included in the Cox regression analysis. Factors associated with testing more than once were (adjusted HR, 95% CI): being female (2.24; 2.14 to 2.34) and initially testing positive (1.43; 1.35 to 1.51). The positivity at first episode declined from 13.2% (1077 cases) in 2003/2004 to 5.8% (843 cases) in 2008/2009. The incidence of diagnosis at the second test was 5.9 per 100 person years in those testing negative at the first test compared with 18.1 per 100 person years in those initially positive. DISCUSSION: Most individuals in this analysis were tested only once, but the testing volume and proportion of repeat tests were highest at the end of the study period. As the testing rate stabilises to 30% coverage, maintaining retesting rates in those previously tested and especially in those previously diagnosed with chlamydia will be necessary for the sustainability of the screening programme. CONCLUSIONS: A key feature of the next 5 years of the screening programme will be to maintain screening and rescreening.

Mixture-of-exponentials models to explain heterogeneity in studies of the duration of Chlamydia trachomatis infection.

Published studies of the duration of asymptomatic Chlamydia trachomatis infection in women have produced diverse estimates, and most reviewers have not attempted an evidence synthesis. We review the designs of duration studies, distinguishing between the incident cases presenting soon after infection in clinic-based studies and prevalent cases ascertained in population screening studies. We combine evidence from all studies under fixed-effect (single clearance rate), random-effect (study-specific clearance rate), and mixture-of-exponentials models, in which there are either two or three classes of infection that clear at different rates. We can identify classes as 'passive' infection and fast-clearing and slow-clearing infections. We estimate models by Bayesian MCMC and compared them using posterior mean residual deviance and the deviance information criterion. The single fixed-effect clearance rate model fitted very poorly. The random-effect model was adequate but inferior to the two-class and three-class mixture of exponentials. According to the two-class model, the proportion in the first class was 23% (95% CI: 16-31%), and the mean duration of C. trachomatis infection is 1.36 years (95% CI: 1.13-1.63 years). With the three-rate model, duration was similar, but identification of the proportions in each class (19%, 31%, and 49%) was poor. Although the random-effect model was descriptively adequate, the extreme degree of between-study variation in the clearance rate it predicted lacked biological plausibility. Differences in study recruitment and sampling mechanisms, acting through a mixture-of-exponentials model, better explains the apparent heterogeneity in duration.

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.

Chlamydia trachomatis infection increases fallopian tube PROKR2 via TLR2 and NFκB activation resulting in a microenvironment predisposed to ectopic pregnancy.

Chlamydia trachomatis and smoking are major risk factors for tubal ectopic pregnancy (EP), but the underlying mechanisms of these associations are not completely understood. Fallopian tube (FT) from women with EP exhibit altered expression of prokineticin receptors 1 and 2 (PROKR1 and PROKR2); smoking increases FT PROKR1, resulting in a microenvironment predisposed to EP. We hypothesize that C. trachomatis also predisposes to EP by altering FT PROKR expression and have investigated this by examining NFκB activation via ligation of the Toll-like receptor (TLR) family of cell-surface pattern recognition receptors. PROKR2 mRNA was higher in FT from women with evidence of past C. trachomatis infection than in those without (P < 0.05), and was also increased in FT explants and in oviductal epithelial cell line OE-E6/E7 infected with C. trachomatis (P < 0.01) or exposed to UV-killed organisms (P < 0.05). The ability of both live and dead organisms to induce this effect suggests ligation of a cell-surface-expressed receptor. FT epithelium and OE-E6/E7 were both found to express TLR2 and TLR4 by immunohistochemistry. Transfection of OE-E6/E7 cells with dominant-negative TLR2 or IκBα abrogated the C. trachomatis-induced PROKR2 expression. We propose that ligation of tubal TLR2 and activation of NFκB by C. trachomatis leads to increased tubal PROKR2, thereby predisposing the tubal microenvironment to ectopic implantation.

How much tubal factor infertility is caused by Chlamydia? Estimates based on serological evidence corrected for sensitivity and specificity.

OBJECTIVES: To estimate the proportion of tubal factor infertility (TFI) caused by Chlamydia trachomatis (CT), the etiologic fraction, from a retrospective study of CT antibody prevalence in TFI cases and controls, adjusted for sensitivity and specificity. METHODS: We use published data on sensitivity and specificity to estimate the performance of assays in (a) women with a previous CT infection without sequelae and (b) women with TFI caused by CT. A model was developed and applied to antibody prevalence in TFI cases and controls from 1 published case-control study to estimate the proportion of TFI caused by CT. RESULTS: The proportion of TFI episodes that were due to CT infection was estimated to be 45% (credible intervals: 28%, 62%). Models which assume that test sensitivity is higher in women with CT-related TFI than women with previous infection and no sequelae fit the data significantly better than models that assume the same sensitivity in all those previously infected. CONCLUSIONS: Greater attention needs to be paid to methods for characterizing the performance of CT antibody tests. Serological studies could be given a greater role both in CT etiology and in monitoring the effects of prevention and control programmes.

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.