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Expedited partner therapy (EPT), the practice of treating the sex partners of persons with sexually transmitted infections without their medical evaluation, increases partner treatment and decreases gonorrhea and chlamydia reinfection rates. We conducted a stepped-wedge, community-level randomized trial to determine whether a public health intervention promoting EPT could increase its use and decrease chlamydia test positivity and gonorrhea incidence in women. The trial randomly assigned local health jurisdictions (LHJs) in Washington State, US, into four study waves. Waves instituted the intervention in randomly assigned order at intervals of 6-8 mo. Of the state's 25 LHJs, 24 were eligible and 23 participated. Heterosexual individuals with gonorrhea or chlamydial infection were eligible for the intervention. The study made free patient-delivered partner therapy (PDPT) available to clinicians, and provided public health partner services based on clinician referral. The main study outcomes were chlamydia test positivity among women ages 14-25 y in 219 sentinel clinics, and incidence of reported gonorrhea in women, both measured at the community level. Receipt of PDPT from clinicians was evaluated among randomly selected patients. 23 and 22 LHJs provided data on gonorrhea and chlamydia outcomes, respectively. The intervention increased the percentage of persons receiving PDPT from clinicians (from 18% to 34%, p < 0.001) and the percentage receiving partner services (from 25% to 45%, p < 0.001). Chlamydia test positivity and gonorrhea incidence in women decreased over the study period, from 8.2% to 6.5% and from 59.6 to 26.4 per 100,000, respectively. After adjusting for temporal trends, the intervention was associated with an approximately 10% reduction in both chlamydia positivity and gonorrhea incidence, though the confidence bounds on these outcomes both crossed one (chlamydia positivity prevalence ratio = 0.89, 95% CI 0.77-1.04, p = 0.15; gonorrhea incidence rate ratio = 0.91, 95% CI .71-1.16, p = 0.45). Study findings were potentially limited by inadequate statistical power, by the institution of some aspects of the study intervention outside of the research randomization sequence, and by the fact that LHJs did not constitute truly isolated sexual networks. A public health intervention promoting the use of free PDPT substantially increased its use and may have resulted in decreased chlamydial and gonococcal infections at the population level. ClinicalTrials.gov NCT01665690.

The efficacy of azithromycin vs. doxycycline for urogenital Chlamydia trachomatis infection was assessed in this randomized clinical trial. In a directly observed treatment context, the efficacy of azithromycin was 97% and that of doxycycline was 100%. Urogenital Chlamydia trachomatis infection is the most prevalent bacterial sexually transmitted infection in the United States and worldwide. 1 , 2 Females are disproportionately affected by this infection because of the risk of pelvic inflammatory disease, which can lead to ectopic pregnancy and infertility. Efforts to prevent and control chlamydia infection, which have been aimed mainly toward the reduction of sequelae, have not diminished the high prevalence. Along with screening, the provision of effective treatment is a cornerstone of chlamydia control programs. For the treatment of chlamydia infection, the Centers for Disease Control and Prevention (CDC) recommends oral administration of either 1 . . .

Abstract Background World Health Organization (WHO) recommendations for starting and stopping mass antibiotic distributions are based on a clinical sign of trachoma, which is indirectly related to actual infection with the causative agent, Chlamydia trachomatis. Methods This study aimed to understand the effect of SAFE (surgery, antibiotics, facial cleanliness, and environmental improvement) interventions on ocular chlamydia in Amhara, Ethiopia, by describing the infection prevalence in a population-based sample of children aged 1-5 years. Trachoma surveys were conducted in all districts of Amhara, from 2011 to 2015 following approximately 5 years of SAFE. Ocular swabs were collected from randomly selected children to estimate the zonal prevalence of chlamydial infection. The Abbott RealTime polymerase chain reaction assay was used to detect C. trachomatis DNA. Results A total of 15632 samples were collected across 10 zones of Amhara. The prevalence of chlamydial infection in children aged 1-5 years was 5.7% (95% confidence interval, 4.2%-7.3%; zonal range, 1.0%-18.5%). Chlamydial infection and trachomatous inflammation-intense (TI) among children aged 1-9 years were highly correlated at the zonal level (Spearman correlation [r] = 0.93; P < .001), while chlamydial infection and trachomatous inflammation-follicular were moderately correlated (r = 0.57; P = .084). Conclusions After 5 years of SAFE, there is appreciable chlamydial infection in children aged 1-5 years, indicating that transmission has not been interrupted and that interventions should continue. The sign TI was highly correlated with chlamydial infection and can be used as a proxy indicator of infection. Appreciable ocular chlamydial infection remains in Amhara, Ethiopia, after 5 years of SAFE, indicating that transmission has not been interrupted. The sign trachomatous inflammation-intense was highly correlated with chlamydial infection and can be used as a proxy indicator of infection.

ObjectivesA new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741)MethodsAt 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated.ResultsClinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0).ConclusionsIn this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.

Background. Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy. Methods. Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days. Results. The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29% of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002). Conclusions. Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated with azithromycin; however, doxycycline had significantly better efficacy against Chlamydia, whereas azithromycin was superior to doxycycline for the treatment of M. genitalium.

Infection is often asymptomatic, causing the epidemiology to be underestimated. [...]we have developed a rapid, inexpensive, easy-to-interpret, sensitive and specific point-of-care (POC) C. trachomatis detection system, using loop-mediated isothermal amplification (LAMP) for target C. trachomatis DNA amplification, followed by gold nanoparticle probe (AuNP) for colorimetric C. trachomatis specific readout. Results Optimization of LAMP-AuNP Loop primers LF and LB, which specifically locate the dumbbell products of LAMP, allow for extra amplification of the loop amplicons. [...]a sufficient amount of amplicons for detection by GE (or AuNP) were made at the shorter assay time. The results demonstrated an LOD of 22.5 copies for PCR-GE and 45 copies for LAMP-GE and LAMP-AuNP. [...]increasing the LAMP reaction incubation from 20 to 35 minutes allowed the LOD to become consistent at 11.25 copies (S4 Fig, lane 1). The colorimetric change of the LAMP-AuNP was confirmed by UV-vis spectrophotometry [7]. [...]the LAMP-AuNP has an LOD of 45 copies when incubated for 20 minutes and 11.25 copies when incubated for 35 minutes.

Background. Pelvic inflammatory disease (PID) is a leading cause of both tubal factor infertility and ectopie 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, 3.096-25.7%) 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.

Background Extragenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are prevalent among men who have sex with men (MSM). Self-sampling could potentially eliminate barriers to extragenital CT/NG testing for MSM that are hard to reach, who refuse to go for clinician-based testing, or who decline an examination. However, the required evidence to determine whether self-collected specimens are as accurate as clinician-taken specimens in terms of CT/NG diagnostic accuracy was limited in low and middle income countries. We therefore compared self-collected rectal and pharyngeal specimens with clinician-taken specimens for diagnostic accuracy among MSM in China. Methods This was a prospective convenience sample from 6 sexually transmitted infection (STI) clinics in China. We randomized the order of self-collected and clinician-taken specimens from the pharynx and rectum, plus first-void urine, for CT/NG detection. Self-sampling performance was compared with clinician-sampling as to agreement, sensitivity, and specificity. The acceptability of self-sampling was evaluated by questionnaire. Results Among the 325 participants, prevalences of rectal CT and NG infections were 13.6% and 5.2% and pharyngeal CT and NG prevalences were 1.5% and 2.8%, respectively. The agreements between the CT tests with the self-collected and clinician-taken specimens were 98.8% (κ = 0.95, 95% CI 0.89-1.00) for rectal site and 99.4% (κ = 0.83, 95% CI 0.60-1.00) for pharyngeal site; and the agreements between NG tests were 99.4% (κ = 0.94, 95% CI 0.86-1.00) for rectal site and 98.2% (κ = 0.72, 95% CI 0.50–0.93) for pharyngeal site. The sensitivity and specificity of self-collected swabs was as follows: rectal CT: 93.0% and 99.6%; pharyngeal CT: 100.0% and 99.4%; rectal NG: 100.0% and 99.4%; pharyngeal NG: 88.9% and 98.4%. Self-collection was highly acceptable, showing that 62.0% MSM preferred self-sampling over clinician-sampling; 90.2% would use self-sampling for detection of CT and NG again. Conclusions Extragenital screening for CT and NG should be recommended as part of STI services to MSM population. Self-collection of rectal and pharyngeal specimens had good performance for CT and NG tests and acceptability to the target population. Trial registration This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2300073473. Registered 12/07/2023.

BackgroundThe number of cases of Chlamydia trachomatis (Ct) diagnosed has increased in the past 15 years in France as well as in other European countries. This paper reports a randomised controlled trial (RCT) to evaluate whether the offer of home-based testing over the internet increased the number of young people tested for chlamydia compared with the current testing strategy and to estimate the number and risks factors of the infected population. This RCT took place as an element of the Chlamyweb Study—a study aiming to evaluate an intervention (the Chlamyweb Intervention) involving the offer of a free self-sampling kit online to sexually active men and women aged 18–24 years in France.MethodsParticipants in the Chlamyweb RCT (n=11 075) received either an offer of a free self-sampling kit (intervention group) or were invited to be screened in primary care settings (control group). Risks ratios were used to compare screening rates between the intervention and control groups. Risk factors were analysed for infected people in the intervention group.ResultsThe screening frequency was about three times higher among young people who received a self-sampling kit than those who only received a tailored recommendation to be screened (29.2% vs 8.7%). Although rates of screening among men were lower than among women (23.9% vs 33.9%), the intervention effect was greater among men (adjusted risk ratios (aRR)=4.55 vs aRR=2.94). Ct positivity (6.8%) was similar to that observed in STI clinics. It was higher in women (8.3%) than in men (4.4%).ConclusionsThese results invite us to consider the establishment of a large home-based screening programme, although additional studies including economic assessments are needed to evaluate the most appropriate combination of strategies in the French context.Trial registraion numberAFFSAPS n° IDRCB 0211-A01000-41; Results.

Background This study was conducted to understand the molecular epidemiology of circulating Chlamydia trachomatis (Ct) strains in Sapporo, Japan. Methods A total of 713 endocervical samples collected from April 2016 to March 2019 were screened for Ct. The obtained Ct positive samples were analyzed by ompA genotyping and multilocus sequence analysis (MLSA). Results Eighty-three (11.6%) samples were positive for Ct plasmid DNA. Sequence analysis of the ompA gene from the 61 positive cases revealed eight genotypes: F (40.9%), E (19.6%), D (14.7%), G (9.8%), H (6.5%), I (3.2%), K (3.2%), and J (1.6%). The globally dominant genotype E and F strains were highly conserved with 13 ompA genetic variants being detected, whereas genotype D strains were the most diverse. Genetic characterization of D strains revealed that D1 genetic variants may be potentially specific to Sapporo. MLSA revealed 13 unique sequence types (STs) including four novel STs from 53 positive samples, with the globally dominant STs 39 and 19 being predominant. STs 39, 34, and 21 were exclusively associated with genotypes E and F indicating their global dominance. Novel ST70 and ST30 were specifically associated with genotype D. Conclusion Our study has revealed the circulation of genetically diverse Ct strains in the women population of Sapporo, Japan. We suggest identifying a transmission network of those successful strains and implementing public health prevention strategies to control the spread of Ct in Sapporo.