Economic evaluation alongside a clinical trial of near-to-patient testing for sexually transmitted infections.

BACKGROUND: Current clinical care for common bacterial STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG)) involves empiric antimicrobial therapy when clients are symptomatic, or if asymptomatic, waiting for laboratory testing and recall if indicated. Near-to-patient testing (NPT) can improve pathogen-specific prescribing and reduce unnecessary or inappropriate antibiotic use in treating sexually transmitted infections (STI) by providing same-day delivery of results and treatment. METHODS: We compared the economic cost of NPT to current clinic practice for managing clients with suspected proctitis, non-gonococcal urethritis (NGU), or as an STI contact, from a health provider's perspective. With a microsimulation of 1000 clients, we calculated the cost per client tested and per STI- and pathogen- detected for each testing strategy. Sensitivity analyses were conducted to assess the robustness of the main outcomes. Costs are reported as Australian dollars (2023). RESULTS: In the standard care arm, cost per client tested for proctitis, NGU in men who have sex with men (MSM) and heterosexual men were the highest at $247.96 (95% Prediction Interval (PI): 246.77-249.15), $204.23 (95% PI: 202.70-205.75) and $195.01 (95% PI: 193.81-196.21) respectively. Comparatively, in the NPT arm, it costs $162.36 (95% PI: 161.43-163.28), $158.39 (95% PI: 157.62-159.15) and $149.17 (95% PI: 148.62-149.73), respectively. Using NPT resulted in cost savings of 34.52%, 22.45% and 23.51%, respectively. Among all the testing strategies, substantial difference in cost per client tested between the standard care arm and the NPT arm was observed for contacts of CT or NG, varying from 27.37% to 35.28%. CONCLUSION: We found that NPT is cost-saving compared with standard clinical care for individuals with STI symptoms and sexual contacts of CT, NG, and MG.

Brazilian Clinical Practice Guidelines for Sexually Transmitted Infections That Cause Urethral Discharge: Assessment According to the AGREE II and Critical Analysis Based on the WHO Recommendations.

BACKGROUND: Sexually transmitted infections (STI) can have severe consequences. In Brazil, case management is recommended by the Clinical Protocol and Therapeutical Guidelines for Comprehensive Care for People with STIs (PCDT-IST). This study assessed the quality of PCDT-IST (2021) and reviewed the main recommendations for the management of STI that cause urethral discharge compared with the World Health Organization (WHO) STI Guidelines. METHODS: The PCDT-IST (2021) quality was independently assessed by 4 appraisers using the Appraisal of Guidelines Research and Evaluation instrument, version II (AGREE II). The PCDT-IST (2021) and the WHO Guidelines for the Management of Symptomatic STI (2021) were compared considering 14 different assessment domains. RESULTS: The PCDT-IST (2021) scores in the AGREE II domains were: Rigor of Development (58%), Applicability (35%), Editorial Independence (38%), Scope and Purpose (78%), Stakeholder Involvement (74%), and Clarity and Presentation (82%). The overall score was 67%, and all appraisers recommended the Brazilian guideline. Regarding the PCDT-IST (2021) and the WHO STI Guidelines (2021) comparation, 10 domains would be relevant for further reviewing the Brazilian recommendations: Diagnostic tests; Etiological approach; Treatment for recurrent urethral discharge; Treatment for urethritis without etiological agent identification; Treatment for gonococcal urethritis; Treatment for chlamydial urethritis; Retreatment for gonococcal infections; Treatment for Mycoplasma genitalium urethritis; Treatment for Trichomonas vaginalis urethritis; 10. Flowcharts. CONCLUSIONS: The PCDT-IST (2021) has a reasonable degree of quality. However, the domains of Applicability, Rigor of Development, and Editorial Independence must be better ensured. The guidelines comparison will help to select key topics that should be addressed with priority in the following national STI guidelines updates.

[Primary care management of sexually transmitted infections (I). Epidemiology. Secreting syndrome]. / Manejo en atención primaria de las infecciones de transmisión sexual (I). Epidemiología. Síndrome secretor.

These days sexually transmitted infections (STIs) are important public health problems not only due to their high prevalence, but also because they require early diagnosis and treatment to avoid complications. In recent years, there has been an exponential increase in cases of infections caused by Chlamydia trachomatis and gonococcus in the population under 25years of age. In addition, an increase in the incidence of syphilis and hepatitisC (HCV) has also been detected, especially in men who have sex with other men (MSM). Genital herpes continues to be the second most frequent STI in the world, behind condyloma acuminata, and the first cause of genital ulcer among Spain in the sexually active population. A decrease in reported HIV cases was observed during 2020, but almost half of these new cases had a late diagnosis (<350CD4cell/µL). Current guidelines recommend offering STI annual screening to populations at risk or more often depending on the risk. STIs can appear in the form of syndromes, such as secretory syndrome (urethritis, proctitis, and cervicitis) or ulcerated syndrome (ulcers). The STIs that can cause secretory syndrome are mainly caused by Neisseria gonorrhoeae and C.trachomatis, which co-infect up to 40% of cases, and also cause urethritis, cervicitis or proctitis depending on where they are located. Gonococcus has an incubation period of 2-7days and Chlamydia 2-6weeks, and they are diagnosed using PCR and/or culture (the last one only valid for gonococcus) of samples collected according to sexual activities. Empirical treatment to cover both germs will be accomplished with ceftriaxone, 1g single intramuscular dose plus doxycycline 100mg every 12h orally for 7days, or azithromycin 1g single dose orally (we will use azithromycin only if we suspect a poor compliance with treatment, difficulty in going to the control or in pregnancy). Likewise, whenever we diagnose an STI firstly, we must offer advice and health education in order to promote the adoption of safe sexual behaviours and the correct use of barrier methods. Secondly, we must also screen for other STIs (HIV, syphilis, hepatitisB, and hepatitisA andC depending on the risk), offer HBV and HAV vaccination if it is appropriate, and finally study and treat all sexual partners from the previous 3months.

Microscopic examination of Gram-stained smears for anogenital gonorrhoea in men who have sex with men is cost-effective: evidence from a modelling study.

OBJECTIVE: To assess the cost-effectiveness of three testing strategies with or without light microscopic Gram-stained smear (GSS) evaluation for the detection of anogenital gonorrhoea among men who have sex with men (MSM) at the Amsterdam STI clinic using a healthcare payer perspective. METHODS: Three testing strategies for MSM were compared: (1) GSS in symptomatic MSM only (currently practised strategy), (2) no GSS and (3) GSS in symptomatic and asymptomatic MSM. The three testing protocols include testing with nucleic acid amplification test to verify the GSS results in (1) and (3), or as the only test in (2). A transmission model was employed to calculate the influence of the testing strategies on the prevalence of anogenital gonorrhoea over 10 years. An economic model combined cost data on medical consultations, tests and treatment and utility data to estimate the number of epididymitis cases and quality-adjusted life years (QALY) associated with gonorrhoea. Incremental cost-effectiveness ratios (ICERs) for the testing scenarios were estimated. Uncertainty and sensitivity analyses were performed. RESULTS: No GSS testing compared with GSS in symptomatic MSM only (current strategy) resulted in nine extra epididymitis cases (95% uncertainty interval (UI): 2-22), 72 QALYs lost (95% UI: 59-187) and €7300 additional costs (95% UI: -€185 000 (i.e.cost-saving) to €407 000) over 10 years. GSS testing in both symptomatic and asymptomatic MSM compared with GSS in symptomatic MSM only resulted in one prevented epididymitis case (95% UI: 0-2), 1.1 QALY gained (95% UI: 0.1-3.3), €148 000 additional costs (95% UI: €86 000 to-€217 000) and an ICER of €177 000 (95% UI: €67 000-to €705 000) per QALY gained over 10 years. The results were robust in sensitivity analyses. CONCLUSIONS: GSS for symptomatic MSM only is cost-effective compared with no GSS for MSM and with GSS for both symptomatic and asymptomatic MSM.

Cost-effectiveness of microscopy of urethral smears for asymptomatic Mycoplasma genitalium urethritis in men in England.

The objective was to determine whether or not the limited use of urethral microscopy to diagnose asymptomatic and symptomatic non-chlamydial, non-gonococcal urethritis (NCNGU) in men is a cost-effective strategy to avert pelvic inflammatory disease (PID), ectopic pregnancy or infertility in female partners. Outputs from a transmission dynamic model of NCNGU in a population of 16-30 year olds in England simulating the number of consultations, PID cases and patients treated over time amongst others, were used along with secondary data to undertake a cost-effectiveness analysis carried out from a health care provider perspective. The main outcome measure was cost per case of PID averted. A secondary outcome measure was cost per major outcome averted, where a major outcome is a case of symptomatic PID, ectopic pregnancy, or infertility. Offering a limited number of asymptomatic men urethral microscopy was more effective than the current practice of no microscopy in terms of reducing the number of cases of PID with an incremental cost-effectiveness ratio of £15,700, meaning that an investment of £15,800 is required to avert one case of PID. For major outcomes averted, offering some asymptomatic men urethral microscopy was again found to be more effective than no microscopy, but here an investment of £49,900 is required to avert one major outcome. Testing asymptomatic men for NCNGU in a small number of genitourinary medicine settings in England is not cost-effective, and thus by maintaining the current practice of not offering this patient group microscopy, this continues to make savings for the health care provider.

Classification of common human diseases derived from shared genetic and environmental determinants.

In this study, we used insurance claims for over one-third of the entire US population to create a subset of 128,989 families (481,657 unique individuals). We then used these data to (i) estimate the heritability and familial environmental patterns of 149 diseases and (ii) infer the genetic and environmental correlations for disease pairs from a set of 29 complex diseases. The majority (52 of 65) of our study's heritability estimates matched earlier reports, and 84 of our estimates appear to have been obtained for the first time. We used correlation matrices to compute environmental and genetic disease classifications and corresponding reliability measures. Among unexpected observations, we found that migraine, typically classified as a disease of the central nervous system, appeared to be most genetically similar to irritable bowel syndrome and most environmentally similar to cystitis and urethritis, all of which are inflammatory diseases.

Frequency of Chlamydia trachomatis among male patients with urethritis in northeast of Iran detected by polymerase chain reaction.

Planning for appropriate preventive measures against Chlamydia trachomatis, a common cause of sexually transmitted disease, requires knowledge of prevalence of infection so that interventions can be targeted in a cost-effective manner. This study was performed on 178 male patients presenting with urethritis in the Mashhad province to determine the prevalence of chlamydial infection in Northeast Iran. A cotton swab and first voided urine specimen were collected according to standard procedures. Polymerase chain reaction (PCR) tests were used for the detection of C. trachomatis in the specimens collected and the results were analyzed using SPSS program. Results showed that 10.6% of male patients in this group were infected with C. trachomatis. This study provides strong evidence that prevalence of Chlamydia in the Northeast Iran is high and suggests that Chlamydia screening as a routine part of STD investigations is highly necessary in this area.

Long-term trends in Chlamydia trachomatis infections and related outcomes in a U.S. managed care population.

BACKGROUND: Given recent increasing case rates of Chlamydia trachomatis infection, we evaluated trends in chlamydia rates and related health outcomes in women and men aged 15 to 44 years who were enrolled in a Pacific Northwest health plan. METHODS: We identified chlamydia, pelvic inflammatory disease (PID), ectopic pregnancy, and male urethritis cases occurring annually during 1997-2007 using computerized health plan databases, calculating rates per 100,000 person-years (py) by gender and 5-year age groups. We also calculated annual chlamydia testing rates. RESULTS: In women, chlamydia testing rates increased by approximately 23% (220 tests per 1000 py in 1997 to 270 tests per 1000 in 2007). Chlamydia diagnosis rates rose from 449 cases/100,000 py in 1997 to 806/100,000 in 2007, a 79% increase (P = 0.01). Increases were greatest during 2005-2007, also the period of major conversion to nucleic acid amplification test. PID rates in this interval declined steadily from 823 cases/100,000 py to 473/100,000 (P < 0.01). Ectopic pregnancy rates remained unchanged. In men, chlamydia testing rates increased nearly 3.5-fold, from 12 to 42 tests per 1000 py. Chlamydia rates for men also rose significantly throughout the study interval (from 91 cases/100,000 py to 218/100,000; P < 0.01) as did urethritis diagnosis rates (P < 0.01). CONCLUSION: Between 1997 and 2007, annual health plan chlamydia rates increased significantly for both women and men. These trends may be due in part to increased testing rates and increased use of more sensitive tests, but they likely do not explain the increased urethritis rates. During this same interval, we observed steady declines in PID rates, consistent with other national data sources.

Is Accelerated Partner Therapy (APT) a cost-effective alternative to routine patient referral partner notification in the UK? Preliminary cost-consequence analysis of an exploratory trial.

OBJECTIVES: To undertake a cost-consequence analysis to assess two new models of partner notification (PN), known as Accelerated Partner Therapy (APT Hotline and APT Pharmacy), as compared with routine patient referral PN, for sex partners of people with chlamydia, gonorrhoea and non-gonococcal urethritis. METHODS: Comparison of costs and outcomes alongside an exploratory trial involving two genitourinary medicine clinics and six community pharmacies. Index patients selected the PN method (APT Hotline, APT Pharmacy or routine PN) for their partners. Clinics and pharmacies recorded cost and resource use data including duration of consultation and uptake of treatment pack. Cost data were collected prospectively for two out of three interventions, and data were synthesised and compared in terms of effectiveness and costs. RESULTS: Routine PN had the lowest average cost per partner treated (approximately £46) compared with either APT Hotline (approximately £54) or APT Pharmacy (approximately £53) strategies. The cost-consequence analysis revealed that APT strategies were more costly but also more effective at treating partners compared to routine PN. CONCLUSION: The hotline strategy costs more than both the alternative PN strategies. If we accept that strategies which identify and treat partners the fastest are likely to be the most effective in reducing reinfection and onward transmission, then APT Hotline appears an effective PN strategy by treating the highest number of partners in the shortest duration. Whether the additional benefit is worth the additional cost cannot be determined in this preliminary analysis. These data will be useful for informing development of future randomised controlled trials of APT.

A review of the epidemiology, diagnosis and evidence-based management of Mycoplasma genitalium.

Mycoplasma genitalium is attracting increasing recognition as an important sexually transmitted pathogen. Presented is a review of the epidemiology, detection, presentation and management of M. genitalium infection. Accumulating evidence suggests that M. genitalium is an important cause of non-gonococcal, non-chlamydial urethritis and cervicitis, and is linked with pelvic inflammatory disease and, possibly, obstetric complications. Although there is no standard detection assay, several nucleic acid amplification tests have >95% sensitivity and specificity for M. genitalium. To date, there is a general lack of established protocols for screening in public health clinics. Patients with urethritis or cervicitis should be screened for M. genitalium and some asymptomatic sub-groups should be screened depending on individual factors and local prevalence. Investigations estimating M. genitalium geographic prevalence document generally low incidence, but some communities exhibit infection frequencies comparable to that of Chlamydia trachomatis. Accumulating evidence supports an extended regimen of azithromycin for treatment of M. genitalium infection, as data suggest that stat 1 g azithromycin may be less effective. Although data are limited, azithromycin-resistant cases documented to date respond to an appropriate fluoroquinolone (e.g. moxifloxacin). Inconsistent clinical recognition of M. genitalium may result in treatment failure and subsequent persistence due to ineffective antibiotics. The contrasting nature of existing literature regarding risks of M. genitalium infection emphasises the need for further carefully controlled studies of this emerging pathogen.

The burden of asymptomatic sexually transmitted infections among men in Carletonville, South Africa: implications for syndromic management.

OBJECTIVES: To determine the prevalence of sexually transmitted infections (STI) and HIV among men attending an outreach STI/HIV screening service in informal settlements in South Africa over a 3-month period. METHODS: A mobile clinic van was utilised to offer men: (1) urine screening for gonorrhoea, trichomoniasis, chlamydial and Mycoplasma genitalium infections; (2) serological screening for syphilis and herpes simplex virus type 2 (HSV-2); (3) on-site HIV voluntary counselling and testing. Urethritis pathogens were detected by molecular methods. HIV serostatus was determined using rapid tests. Demographic, sexual behaviour and clinical data were recorded on a nurse-administered questionnaire. Statistical analysis utilised the chi(2) test. RESULTS: 309 men attended the service; 304 (98%) requested serological screening for syphilis and HSV-2, 301 (97%) underwent urine-based screening for urethritis pathogens and 269 (87%) had an HIV test. Over 90% of men were asymptomatic for STI. Gonorrhoea was more prevalent in the symptomatic group (p<0.001); there were no significant differences in the prevalence of other urethritis pathogens between the groups. The total number of infections with each urethritis pathogen was highest in the asymptomatic group with twice as much gonorrhoea, 25 times as much chlamydial infection, six times as much trichomoniasis and nine times as much M genitalium infection compared with the symptomatic group. The overall HIV prevalence among clinic attendees was 29.7%. CONCLUSIONS: The uptake of both STI and HIV testing was high among men attending the service. The relatively high burden of both STI and HIV among the male clinic attendees has implications for the transmission of HIV.

The cost-effectiveness of syndromic management for male sexually transmitted disease patients with urethral discharge symptoms and genital ulcer disease in Taiwan.

OBJECTIVE: To assess the cost-effectiveness of syndromic management for the treatment of sexually transmitted diseases (STD) in comparison with the strategies currently used in STD clinics in Taiwan. METHODS: Between July 2004 and June 2005, all male patients with genitourinary symptoms attending two hospitals were included in this study. Current clinical procedures (presumptive treatment and laboratory tests), aetiological diagnosis and syndromic management were compared in terms of diagnostic accuracy, treatment appropriateness, costs and effectiveness. RESULTS: 473 patients met the inclusion criteria and were enrolled in the study. 335 patients (71%) had urethral symptoms (discharge, dysuria or painful urination) and 138 (29%) had genital ulcers, sores and skin rashes. For the current approach, the sensitivity, specificity and positive predictive value (PPV) for the detection of chlamydial, gonococcal and combined forms of infection were 100%, 40.0% and 60.4%, respectively. In contrast, the sensitivity, specificity and PPV for the detection of syphilis were 100%, 86.7% and 70.2%, respectively. For syndromic management, the sensitivity, specificity and PPV detection of chlamydial, gonococcal and combined forms of infection were 85.0%, 40.0% and 56.4%, respectively. In contrast, the sensitivity, specificity and PPV for the detection of syphilis were 78.8%, 18.1% and 23.2%, respectively. The average cost of implementing a correct treatment using the current approach was US$54.27 and US$30.74 for urethritis and syphilis, respectively. For the aetiological approach, the average cost of implementing a correct treatment was US$32.83 and US$21.58 for urethritis and syphilis, respectively. For the syndromic approach, the average cost for a correct treatment was US$3.86 and US$14.30 for urethritis and syphilis, respectively. CONCLUSIONS: In this sample of patients attending STD clinics in Taiwan, syndromic management was found to be a more cost-effective protocol in terms of cost per treated STD patient compared with the current and aetiological protocols for STD.

Prevalence of genital Chlamydia in Iranian males with urethritis attending clinics in Mashhad.

Chlamydia trachomatis is a common cause of sexually transmitted disease which can cause severe consequences. Effective prevention requires knowledge of prevalence of infection in order to target interventions in a cost-effective manner. To determine the prevalence of chlamydial infection in Mashhad, northeastern Islamic Republic of Iran, this study was performed among male patients with urethritis. Urethral discharge was collected from 150 patients. Cell culture was established for diagnosis of Chlamydia in genital specimens. Cell culture showed that 9.3% of patients in this study were infected with Chlamydia. This study provides strong evidence that prevalence of Chlamydia in our region is quite high, which necessitates screening and treatment for the infection.

Coexistence of urethritis with genital ulcer disease in South Africa: influence on provision of syndromic management.

OBJECTIVE: To assess whether syndromic management of genital ulcer disease was sound, if based on the premise that men with genital ulcers rarely have a concomitant urethral infection. METHODS: Specimens were taken in 1998 from 186 mine workers in Carletonville, South Africa, who were seen consecutively with genital ulcers. The specimens comprised a swab from the ulcer, a urethral swab for a Gram stained smear, and 10-15 ml of a first catch urine sample. The latter was tested by ligase chain reaction assays for Neisseria gonorrhoeae and Chlamydia trachomatis specific DNA sequences and by a polymerase chain reaction (PCR) assay for Mycoplasma genitalium. Ulcer inducing micro-organisms were detected either by a multiplex PCR assay, or in the case of lymphogranuloma venereum (LGV) serologically, and human immunodeficiency virus (HIV) infection was detected by an enzyme linked immunosorbent assay (ELISA) test. RESULTS: Most (54%) of the ulcers were chancroidal, 18% were herpetic (HSV type 2), 6.5% primary syphilitic, and 3.2% due to LGV. More than one micro-organism was detected in 9.1% of the ulcers and less than 10% were undiagnosed. Microscopic examination of the urethral smears showed that 99 (53%) of the men had urethritis, of whom 45 (45%) were infected with N gonorrhoeae. Of the 54 men (55%) who had non-gonococcal urethritis (NGU), 11 (19.6%) harboured C trachomatis or M genitalium. Almost two thirds (64.5%) of the men had HIV infection, but this did not seem to have influenced the aetiology of the ulcers. Nor was a particular ulcer associated with one type of urethritis more than the other. Neither C trachomatis nor M genitalium was associated significantly with non-gonococcal urethritis (NGU) in either HIV positive or HIV negative men. CONCLUSION: The combination of antibiotics used for the management of genital ulcer disease in men in this South African mining population needs to be widened to encompass frequently occurring concomitant gonococcal urethritis and NGU infections. This means treatment with long acting penicillin, combined with ciprofloxacin and azithromycin or erythromycin. A similar situation may exist in other geographical locations with a need to provide appropriate antimicrobial combinations depending on the patterns of infection detected.