A service evaluation comparing home-based testing to clinic-based testing for HIV, syphilis and hepatitis B in Birmingham and Solihull.

The sexual health services in the Birmingham and Solihull area of the United Kingdom, called Umbrella, has been offering home-based testing for sexually transmitted infections to patients since August 2015. The aim of this service evaluation was to evaluate the uptake, return rate and new diagnosis rates of home-based testing in comparison with clinic-based testing for human immunodeficiency virus (HIV), syphilis (STS) and hepatitis B. Home-based testing, although popular, had low uptake amongst high-risk groups such as men who have sex with men (MSM), compared to the clinic-based group (1% versus 11%, p < 0.001). This resulted in low positivity rates for HIV (0.02%) and STS (0.17%) and no new cases of hepatitis B in the home-based group. Therefore, our results show that home-based testing is not a cost-effective method of testing for HIV and likely this is also the case for hepatitis B and STS. Our recommendation would be to encourage uptake of home-based testing in high-risk groups such as MSM and Black Africans to improve the diagnosis rates of HIV, STS and hepatitis B. Alternatively, the continuation of home-based blood testing in the Birmingham and Solihull area will need to be reviewed by Umbrella as a cost-saving strategy for the service in the future.

Auditing the use and assessing the clinical utility of microscopy as a point-of-care test for Neisseria gonorrhoeae in a Sexual Health clinic.

We assessed whether urethral microscopy was performed as per clinic protocol for male clinic attendees reporting contact with Neisseria gonorrhoeae (GC), urethral symptoms or given a diagnosis of epididymo-orchitis (EO) over a 12-month period (9732 patients). Prevalence of gonorrhoea in the contacts, urethral symptoms and EO groups was 50, 12.7 and 1.6%, respectively. Microscopy was performed reliably for contacts (96%), those with discharge/dysuria with evidence of urethritis on examination (98%), but not those with EO (43%). We explored the clinical utility of microscopy as a point-of-care test for identifying urethral GC in each subgroup, using the APTIMA Combo 2 CT/GC nucleic acid amplification test as the comparator (1710 patients). Sensitivity of microscopy for each subgroup was good; there was no statistical difference between subgroup sensitivity using Fisher's exact test. Microscopy is valuable to ensure prompt diagnosis and contact tracing. All GC contacts were treated 'epidemiologically'; however, half of GC contacts did not have GC. Microscopy identified the majority of GC cases, including amongst contacts (71% of heterosexual contacts, 66% of contacts reporting sex with men). We propose that epidemiological treatment for GC contacts should be reconsidered on the grounds of antibiotic stewardship, favouring use of microscopy to guide treatment decisions.

A service evaluation comparing home-based testing to clinic-based testing for Chlamydia and gonorrhoea in Birmingham and Solihull.

Home-based testing is an alternative, convenient and cost-effective method of testing for sexually transmitted infections compared to traditional clinic-based testing, in patients who are asymptomatic and, or, would otherwise feel stigmatised about attending sexual health clinics. The sexual health service in Birmingham and Solihull, called Umbrella, provides an online home-based testing service, which has been in operation since August 2015. The aim of this study was to evaluate the uptake and return rate of home-based testing kits and compare home-based testing to clinic-based testing in terms of diagnosis and treatment rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Our study showed that home-based testing is a popular method of testing and relatively more popular amongst asymptomatic, young, heterosexual female and White patients than clinic-based testing, with a return rate of 48%. The diagnosis rates for CT/GC are comparable to patients who attend clinic for testing (8% vs. 10% in home-based and clinic-based groups, respectively, p < 0.001). The overall treatment rate was lower in the home-based compared to the clinic-based group (82% vs. 88%, p < 0.001). Umbrella will continue to provide this service within Birmingham and Solihull and aim to provide patients with alternative pathways for more convenient access to treatment.

Highlighting the clinical need for diagnosing Mycoplasma genitalium infection.

Despite Mycoplasma genitalium (MG) being increasingly recognised as a genital pathogen in men and women, awareness and utility of commercially available MG-testing has been low. The opinion of UK sexual health clinicians and allied professionals was sought on how MG-testing should be used. Thirty-two consensus statements were developed by an expert group and circulated to clinicians and laboratory staff, who were asked to evaluate their level of agreement with each statement; 75% agreement was set as the threshold for defining consensus for each statement. A modified Delphi approach was used and high levels of agreement obviated the need to test the original statement set further. Of 201 individuals who received questionnaires, 60 responded, most (48) being sexual health consultants, more than 10% of the total in the UK. Twenty-seven (84.4%) of the statements exceeded the 75% threshold. Respondents strongly supported MG-testing of patients with urethritis, pelvic inflammatory disease or unexplained persistent vaginal discharge, or post-coital bleeding. Fewer favoured testing patients with proctitis and support was divided for routinely testing Chlamydia-positive patients. Testing of current sexual contacts of MG-positive patients was supported, as was a test of cure for MG-positive patients, although agreement fell below the 75% threshold. Respondents agreed that all consultant- or specialist-led services should have access to testing for MG (98.3%). There was strong agreement for having MG-testing available for specific patient groups, which may reflect concern over antibiotic resistance and the desire to comply with clinical guidelines that recommend MG-testing in sexual health clinic settings.

An unusual vulval lesion in an HIV-infected woman.

This is the case of a black African woman who presented with three distinct episodes of herpes simplex virus (HSV) infection unresponsive to first-line therapy. Clinical and virological resistance to aciclovir therapy was demonstrated, and although the first two episodes manifested as the deep ulceration often associated with HIV/HSV coinfection, the third was an atypical hypertrophic lesion. This is despite her CD4 count being persistently above 300 and there being no previous diagnosis of AIDS.

The management of isolated positive syphilis enzyme immunoassay results in HIV-negative patients attending a sexual health clinic.

An unconfirmed positive treponemal enzyme immunoassay (enzyme immunoassay positive, Treponema pallidum particle agglutination negative and rapid plasma reagin negative) presents a clinical challenge to distinguish early syphilis infection from false-positive results. These cases are referred for syphilis line assay (INNO-LIA) and recalled for repeat syphilis serology. We performed a retrospective audit to establish the proportion of HIV-negative cases with unconfirmed positive enzyme immunoassay results, the proportion of these cases that received an INNO-LIA test and repeat syphilis serology testing and reviewed the clinical outcomes; 0.35% (80/22687) cases had an unconfirmed positive treponemal enzyme immunoassay result. Repeat syphilis serology was performed in 80% (64/80) cases, but no additional cases of syphilis were identified. Eighty-eight per cent (70/80) received an INNO-LIA test; 14% (5/37) unconfirmed enzyme immunoassay-positive cases with no prior history of syphilis were confirmed on INNO-LIA assay, supporting a diagnosis of latent syphilis. As a confirmatory treponemal test, the INNO-LIA assay may be more useful than repeat syphilis serological testing.

2015 UK national guideline for the management of infection with Chlamydia trachomatis.

This guideline offers recommendations on the diagnostic tests, treatment regimens and health promotion principles needed for the effective management of Chlamydia trachomatis genital infection. It covers the management of the initial presentation, as well the prevention of transmission and future infection. The guideline is aimed at individuals aged 16 years and older presenting to healthcare professionals working in departments offering Level 3 care in sexually transmitted infections management within the UK. However, the principles of the recommendations should be adopted across all levels, using local care pathways where appropriate.

UK guideline for the use of HIV Post-Exposure Prophylaxis Following Sexual Exposure, 2015.

We present the updated British Association for Sexual Health and HIV guidelines for HIV post-exposure prophylaxis following sexual exposure (PEPSE). This document includes a review of the current data to support the use of PEPSE, considers how to calculate the risks of infection after a potential exposure, and provides recommendations on when PEPSE should and should not be considered. We also review which medications to use for PEPSE, provide a checklist for initial assessment, and make recommendations for monitoring individuals receiving PEPSE. Special scenarios, cost-effectiveness of PEPSE, and issues relating to service provision are also discussed. Throughout the document, the place of PEPSE within the broader context of other HIV prevention strategies is considered.

British Association for Sexual Health and HIV: framework for guideline development and assessment.

The Clinical Effectiveness Group of the British Association for Sexual Health has updated their methodology for the production of national guidelines for the management of sexually transmitted infections and related conditions. The main changes are the adoption of the GRADE system for assessing evidence and making recommendations and the introduction of a specific Conflict of Interests policy for Clinical Effectiveness Group members and guideline authors. This new methodology has been piloted during the production of the 2015 British Association for Sexual Health & HIV guideline on the management of syphilis.

UK national guidelines on the management of syphilis 2015.

These guidelines are an update for 2015 of the 2008 UK guidelines for the management of syphilis. The writing group have piloted the new BASHH guideline methodology, notably using the GRADE system for assessing evidence and making recommendations. We have made significant changes to the recommendations for screening infants born to mothers with positive syphilis serology and to facilitate accurate and timely communication between the teams caring for mother and baby we have developed a birth plan. Procaine penicillin is now an alternative, not preferred treatment, for all stages of syphilis except neurosyphilis, but the length of treatment for this is shortened. Other changes are summarised at the start of the guideline.

Developing evidence-based guidelines for the management of sexually transmitted diseases in former Soviet Union countries.

The countries of the former Soviet Union (FSU) are experiencing overlapping, interrelated and severe epidemics of sexually transmitted diseases (STD), HIV and intravenous drug use. There are reasons to believe that better control of STD in these countries will contribute to the amelioration of these problems. A project was carried out by IUSTI-Europe and World Health Organisation-Europe to facilitate the production of evidence-based management guidelines in the local language in each of five FSU countries. The goals of the project were achieved, although the challenge remains to be faced to ensure the implementation of the recommendations of the guidelines into routine clinical practice in those countries.

Treatment and partner notification outcomes for gonorrhoea: effect of ethnicity and gender.

We assessed if gender and ethnicity were associated with differences in the number of patients satisfactorily treated and number of partners successfully treated for genital gonococcal infection by reviewing 400 cases. There were no differences in the rates of satisfactory treatment of gonorrhoea between men and women and the different ethnic groups. There was no difference in satisfactory partner treatment rates by ethnic origin; however, men were less likely to have their contacts satisfactorily treated within 28 days of diagnosis (odds ratio = 0.05, 95% confidence interval 0.3-0.7). This inequality may lead to difficulties in reducing the number of new gonorrhoea cases. More research is needed to find out why men behave differently from women regarding partner notification for genital gonorrhoea infection.

The performance and clinical utility of cervical microscopy for the diagnosis of gonorrhoea in women in the era of the NAAT.

We evaluated the performance and clinical utility of cervical microscopy for diagnosing genital gonorrhoea (GC) in women, using the APTIMA Combo 2 dual GC/Chlamydia trachomatis assay as the gold standard. Test performance was assessed overall and for patient subgroups (symptomatic, GC contacts, pelvic inflammatory disease [PID] diagnosis). It was found that 93 women had positive GC genital NAAT results; 15 had positive cervical microscopy (8 were GC contacts). In all subgroups except GC contacts, the PPV of cervical microscopy was below the nationally accepted target of 90%. Compared to APTIMA Combo 2, cervical microscopy has poor sensitivity for diagnosing GC in women (16.1% overall, 17.3% symptomatic, 25% GC contacts, 10.5% PID). GC contacts accounted for over 50% of the positive microscopy results and would have received epidemiological treatment for GC, regardless of the microscopy result. Discontinuing the routine use of cervical microscopy would improve patient flow through the sexual health clinic and resources could be utilised more effectively.

Primary HIV infection.

Primary HIV can be asymptomatic or result in a severe symptomatic illness. Common symptoms are pyrexia, pharyngitis, malaise, lethargy, maculopapular rash, mucous membrane ulceration, lymphadenopathy and headache. It can be reliably diagnosed by a positive virologic test in the absence of HIV-specific antibodies. Progression to late-stage disease is influenced by the severity of the symptoms in primary HIV infection, the duration of the illness, the presence of neurological symptoms and the presence of oral candidiasis. This stage is characterized by a very high viral load and infectiousness. Currently the experimental data are insufficient to recommend whether or not those diagnosed with primary HIV infection should routinely receive antiretroviral therapy.

Impact of information leaflets on HIV test uptake amongst GUM clinic attendees: an update.

In the Sexual Health Strategy, the targets of HIV testing uptake in genitourinary medicine clinics (GUM) are set at 40% by year 2004 and 60% by 2007. We assessed the uptake of HIV test amongst GUM clinic attendees, more than six months after introducing an information leaflet in place of verbal pre-test counselling (PTC). The uptake rate was significantly higher than in a previous audit conducted in the same year, two weeks after introduction of the leaflets (62% vs 50%, P =0.001).

Managing genital chlamydial infection: the effects of ethnic origin and method of follow-up.

We assessed if ethnicity and method of follow-up were associated with differences in the number of patients and the number of partners successfully treated for genital chlamydial infection. This was done by retrospectively reviewing the first 400 cases of genital chlamydia diagnosed between February and June 2001 who had a traditional clinic follow-up and the first 400 cases from the same period in 2002 when the telephone follow-up was used. The telephone follow-up appointment system, when compared to a traditional clinic follow-up appointment system, eliminated differences between Black and White ethnic groups in the numbers of patients and partners satisfactorily treated.