Building an Opt-Out Model for Service-Level Consent in the Context of New Data Regulations.

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual's right to withhold their data from trial analysis while routinely offering the same care to all patients.

How can we objectively categorise partnership type? A novel classification of population survey data to inform epidemiological research and clinical practice.

BACKGROUND: Partnership type is a determinant of STI risk; yet, it is poorly and inconsistently recorded in clinical practice and research. We identify a novel, empirical-based categorisation of partnership type, and examine whether reporting STI diagnoses varies by the resulting typologies. METHODS: Analyses of probability survey data collected from 15 162 people aged 16-74 who participated in Britain's third National Survey of Sexual Attitudes and Lifestyles were undertaken during 2010-2012. Computer-assisted self-interviews asked about participants' ≤3 most recent partners (N=14 322 partners/past year). Analysis of variance and regression tested for differences in partnership duration and perceived likelihood of sex again across 21 'partnership progression types' (PPTs) derived from relationship status at first and most recent sex. Multivariable regression examined the association between reporting STI diagnoses and partnership type(s) net of age and reported partner numbers (all past year). RESULTS: The 21 PPTs were grouped into four summary types: 'cohabiting', 'now steady', 'casual' and 'ex-steady' according to the average duration and likelihood of sex again. 11 combinations of these summary types accounted for 94.5% of all men; 13 combinations accounted for 96.9% of all women. Reporting STI diagnoses varied by partnership-type combination, including after adjusting for age and partner numbers, for example, adjusted OR: 6.03 (95% CI 2.01 to 18.1) for men with two 'casual' and one 'now steady' partners versus men with one 'cohabiting' partner. CONCLUSIONS: This typology provides an objective method for measuring partnership type and demonstrates its importance in understanding STI risk, net of partner numbers. Epidemiological research and clinical practice should use these methods and results to maximise individual and public health benefit.

Factors associated with asymptomatic non-chlamydial non-gonococcal urethritis in heterosexual men: findings from a case-control study.

The significance of asymptomatic non-chlamydial non-gonococcal urethritis (NCNGU) is unclear. Organisms associated with NCNGU, e.g. Mycoplasma genitalium, for which there is no widely available test, are linked to reproductive sequelae in women but UK guidance no longer recommends urethral smear microscopy to screen for asymptomatic NCNGU. This case-control study of heterosexual male genitourinary (GU) medicine clinic attenders aimed to identify clinical, demographic and sexual behaviour factors associated with asymptomatic NCNGU so that we could determine whether the presence or absence of symptoms provides a rational basis for deciding to whom we should offer microscopy and whom we should treat. Men with asymptomatic NCNGU were very similar to men with symptomatic NCNGU, except for more consistent condom use. Asymptomatic and symptomatic NCNGU could be different ends of the same clinical syndrome. Until the microbiological basis of NCNGU is understood, we recommend treatment of men with NCNGU irrespective of symptoms.

STIFCompetency: development and evaluation of a new clinical training and assessment programme in sexual health for primary care health professionals.

UK sexual health services are shifting from hospital-based clinics into primary care, creating a need for high quality clinical sexual health training for non-specialists. Here we describe development, evaluation and costing of a new competency-based training programme, the Sexually Transmitted Infection (STI) Foundation Competency (STIFCompetency) programme, based on the Department of Health's toolkit for delivering more specialized sexual health in primary care. We used an action research paradigm with two iterative cycles. Evaluation was to Kirkpatrick's third level with triangulation of results between trainers and trainees, and different methods, including portfolio evaluation, nominal group technique process, semi-structured interviews, Likert questionnaires and chlamydia testing rates. All 13 primary care clinicians completed the training successfully (median 20 hours) and rated STIFCompetency highly. Trainers needed to reduce their clinical workload to accommodate the training. Average cost per trainee was £1125, reflecting the need for direct observation of competence across a wide range of clinical skills.

Is asymptomatic non-chlamydial non-gonococcal urethritis associated with significant clinical consequences in men and their sexual partners: a systematic review.

Opinions are divided on whether to screen asymptomatic men for non-chlamydial non-gonococcal urethritis (NCNGU). We systematically reviewed the literature to determine whether male asymptomatic NCNGU is associated with significant clinical outcomes for men and/or their sexual partners. We searched electronic databases and reference lists from retrieved articles and reviews. No studies reporting clinical outcomes in men with asymptomatic NCNGU were identified. Two eligible studies report rates of sexually transmitted infections (STIs) in female partners of men with asymptomatic NCNGU; Chlamydia trachomatis was detected in 2.4% and 8.3% of these women. The evidence available is insufficient in quality and breadth to enable us to conclude whether asymptomatic NCNGU is associated with significant health consequences for men or their sexual partners; however, clinical consequences of asymptomatic NCNGU are poorly investigated. Clinicians should be aware of the limitations of the evidence on which current screening guidelines for asymptomatic men are based.

Achieving successful partner notification: putting together the pieces of the puzzle.

Partner notification as a public health measure to reduce transmission of sexually transmitted infections (STIs) is a cornerstone of STI control in most countries. The success of any partner notification strategy is conditional on its acceptability and feasibility to both patients and health-care professionals, its compliance with relevant professional and legislative guidance, and its cost-effectiveness.

Is accelerated partner therapy a feasible and acceptable strategy for rapid partner notification in the UK?: a qualitative study of genitourinary medicine clinic attenders.

Partner notification (PN) in the UK is of limited effectiveness. Expedited partner therapy improves PN outcomes but does not comply with existing UK professional guidance. We developed two new strategies, known as accelerated partner therapy (APT), based on elements of PN practice for which there is evidence of efficacy, and which conform to UK prescribing guidance. We explored the acceptability and feasibility of these models qualitatively in genitourinary medicine clinic attenders. Both strategies were viewed favourably. Preference was influenced by age, relationship type, whether participants were delivering or receiving APT and whether the sex partner was aware of the participant's clinic visit. APT provides a new approach to PN, which has strong patient support and complies with existing UK regulations. The complex factors that influence patients' choice of PN method suggest that provision of a range of PN options including APT may be central to improving the effectiveness of PN in the UK.

Male clients of female commercial sex workers: HIV, STDs and risk behaviour.

Social stigma and taboo limit current understanding of sexual behaviours and epidemiology of sexually transmitted infections (STIs) in clients of commercial sex workers/prostitutes. We designed a study to determine risk behaviours and prevalence of STIs in a group of sexual health clinic attending male clients of female commercial sex workers (FCSWs) in Sydney, and to compare these characteristics with men who denied any commercial sexual contact. Eight hundred and ninety cases and 2670 controls were included. Clients of FCSWs were older, more likely to be married and of non-English speaking background than controls. Clients had more sexual partners but reported more condom usage than controls. Prevalence of STIs at presentation was lower in clients than controls but clients were more likely to report STIs in the past than controls. HIV prevalence was low in both groups.

HIV, sexually transmitted infections, and risk behaviours in male commercial sex workers in Sydney.

OBJECTIVES: To assess prevalence of HIV and sexually transmitted infections (STIs), risk behaviours, and demographics in male commercial sex workers (CSWs)/prostitutes in Sydney. METHODS: Retrospective, cross sectional study with two comparison groups. Demographic, behavioural, and morbidity data were analysed from standardised medical records of patients attending a public STI and HIV service in Sydney between January 1991 and March 1998. Two comparison groups were used: female CSWs and non-CSW working homosexual men who attended over the same time. RESULTS: 94 male CSWs, 1671 female CSWs, and 3541 non-CSW working homosexual men were included. The prevalence of HIV in male CSWs tested (6.5%) was significantly greater than in female CSWs (0.4%, p = 0.0001), but less than in non-CSW homosexual men (23.9%, p < 0.0001). Genital warts occurred significantly more frequently in male CSWs than in comparison groups. Prevalence of other STIs was similar in all groups. Male CSWs saw significantly fewer clients per week than female CSWs and male and female CSWs used condoms with almost all clients. Male CSWs reported significantly more non-work sexual partners than female CSWs and non-CSW homosexual men and were significantly more likely to have unprotected penetrative sex with their non-work partners than non-CSW homosexual men. Injecting drug use was significantly more frequent in male CSWs than in both comparison groups. CONCLUSIONS: Although male CSWs use condoms with clients, they are more likely to practise unsafe sex with non-work partners (especially women) and inject drugs than female CSWs and non-CSW homosexual men. Some men with HIV are working within the commercial sex industry. Targeted health education to encourage safer drug use and safer sex outside work is needed.

Diagnosing PID--getting the balance right.

The objective of the study was to determine the clinical manifestations and diagnostic criteria used to diagnose presumptive pelvic inflammatory disease (PID) at the Sydney Sexual Health Centre (SSHC). The study was a retrospective, case-note review of all women diagnosed with presumptive PID between April 1991 and December 1997. Seven hundred and thirteen women were included. The commonest recorded symptoms were vaginal discharge (68%), lower abdominal pain (65%) and dyspareunia (57%), while adnexal tenderness (83%), cervical motion tenderness (75%) and cervicitis (56%) were the most frequently recorded examination findings. Sixty-two per cent were prescribed doxycycline and metronidazole. The recording of signs and symptoms in women with presumptive PID was poor and only 22% met the current Centers for Disease Control (CDC) diagnostic criteria. It is likely that PID is over diagnosed in this group of women. This may lead to under diagnosis of other conditions causing pelvic pain and may be detrimental to reproductive health.

Sexually transmitted infections and risk behaviours in women who have sex with women.

OBJECTIVES: To assess the prevalence of sexually transmitted infections (STIs) and blood borne viruses, risk behaviours, and demographics in women who have sex with women (WSW). METHODS: Retrospective cross sectional study using a multivariate model. Demographic, behavioural, and morbidity data were analysed from standardised medical records of patients attending a public STI and HIV service in Sydney between March 1991 and December 1998. All women with any history of sex with a woman were compared with women who denied ever having sex with another woman (controls). RESULTS: 1408 WSW and 1423 controls were included in the study. Bacterial vaginosis (BV) was significantly more common among WSW (OR 1.7, p < 0.001). Abnormalities on cervical cytology were equally prevalent in both groups, except for the higher cytological BV detection rate in WSW (OR 5.3, p = 0.003). Genital herpes and genital warts were common in both groups, although warts were significantly less common in WSW (OR 0.7, p = 0.001). Prevalence of gonorrhoea and chlamydia were low and there were no differences between the groups. The prevalence of hepatitis C was significantly greater in WSW (OR 7.7, p < 0.001), consistent with the more frequent history of injecting drug use in this group (OR 8.0, p < 0.001). WSW were more likely to report previous sexual contact with a homo/bisexual man (OR 3.4, p < 0.001), or with an injecting drug user (OR 4.2, p < 0.001). Only 7% of the WSW reported never having had sexual contact with a male. CONCLUSION: We demonstrated a higher prevalence of BV, hepatitis C, and HIV risk behaviours in WSW compared with controls. A similar prevalence of cervical cytology abnormalities was found in both groups. Measures are required to improve our understanding of STI/HIV transmission dynamics in WSW, to facilitate better health service provision and targeted education initiatives.

Assessment of risk for pelvic inflammatory disease in an urban sexual health population.

OBJECTIVES: To determine the sexual and demographic risk factors for the acquisition of presumptive pelvic inflammatory disease (PID). METHODS: A retrospective, case-control study in women, who attended the Sydney Sexual Health Centre (SSHC), between April 1991 and December 1997. Logistic regression analysis was used to adjust for confounding variables. RESULTS: 741 women with PID and an equal number of controls were included. Cases were significantly younger than controls (p < 0.001). 42% of cases were born in north or South East Asia, compared with 12% of the controls (p < 0.001). The adjusted odds ratio for being born in north or South East Asia was 2.8 (95% CI 1.70-4.46), for not speaking English at home was 1.6 (95% CI 1.02-2.55), for having had previous PID was 5.9 (95% CI 3.59-9.73), and for being employed in the commercial sex industry and being born in north or South East Asia was 2.8 (95% CI 1.22-6.22). Women aged 15-19 were at considerable risk of developing PID (OR 5.3 (95% CI 2.76-10.11)). Women with previous human papillomavirus infection were significantly less likely to develop PID (OR 0.6 (95% CI 0.42-0.79)). The use of IUCDs (OR 4.5 (95% CI 2.14-9.39)), condoms (OR 1.4 (95% CI 1.03-1.87)), and not using contraception (OR 1.8 (95% CI 1.20-2.76)) was each associated with an increased risk. CONCLUSIONS: Several measures may help to reduce the burden of PID. Women should be encouraged to delay the onset of sexual activity and IUCDs should not be used in young women. Sexual health services for women whose home language is not English, and for commercial sex workers born in north or South East Asia should be improved.

Chlamydia trachomatis infection mimicking testicular malignancy in a young man.

A young man with a low risk history for sexually transmitted diseases presented with an apparently longstanding, previously asymptomatic scrotal mass, highly suggestive of testicular malignancy on palpation. Ultrasound sited the lesion in the epididymis. Although there was no evidence of urethritis, chlamydia polymerase chain reaction testing was positive. Tumour markers were negative. Complete clinical and radiological response was achieved after a long course of doxycycline treatment, without surgical exploration of the scrotum, confirming the diagnosis of chlamydial epididymitis.

Risk factors for the acquisition of genital warts: are condoms protective?

OBJECTIVES: To characterise risk factors for the acquisition of genital warts and specifically to determine whether condoms confer protection from infection. METHODS: A retrospective case-control study comparing demographic, behavioural, and sexual factors in men and women with and without newly diagnosed genital warts, who attended Sydney Sexual Health Centre (SSHC), an inner city public sexual health centre, in 1996. Data were extracted from the SSHC database. Crude odds ratios (OR) were calculated to compare cases and controls and significant factors were then controlled for using multivariate logistic regression to obtain adjusted odds ratios (ORs). RESULTS: 977 patients with warts and 977 controls matched by sex and date of attendance were included. In both sexes, univariate analysis revealed that younger age, more lifetime sexual partners, failure to use condoms, greater cigarette smoking and alcohol consumption were associated with warts, and there was a negative association with previous infection with Chlamydia trachomatis, Neisseria gonorrhoeae, hepatitis B, and genital herpes. In males, on multivariate analysis, factors which remained significant were younger age, more lifetime sexual partners; failure to use condoms, greater cigarette smoking, and previous chlamydia. In women, factors which remained significant were younger age, more lifetime sexual partners, condom use, marital status, and previous infections with Chlamydia trachomatis and herpes. CONCLUSIONS: Independent risk factors for genital warts include younger age, greater number of lifetime sexual partners, and smoking. Consistent condom use significantly reduces the risk of acquiring genital warts.

Patients with genital warts: how are they managed by general practitioners?

This study was carried out to assess the management by general practitioners of patients with genital warts. An anonymized postal questionnaire was sent to 2060 general practitioners in the north west of England; 1260 (61.2%) completed questionnaires were returned. A total of 76.69% of GPs saw one or more cases per quarter. Of 468 (37.1%) GPs who managed patients in-house, 393 (83.9%) used podophyllin of concentration between 0.5 and 50%; 169 (43%) did not specify the podophyllin concentration and 112(23.9%) used podophyllotoxin. Of 395 GPs (31.3%) prescribing patient self-treatment, 259 (65.6%) prescribed podophyllin, but 60.23% did not specify the concentration; 134(33.9%) prescribed podophyllotoxin. Screening for selected sexually transmitted infections (STIs) was performed by 258/618 (41.7%) GPs. Only 74 (11.97%) screened for Chlamydia trachomatis and Neisseria gonorrhoeae and Trichomonas vaginalis. Partner notification was advised by 1138 (90.3%) and condom use by 1027 (81.5%). Only 333 (26.4%) referred all patients to GUM departments. Many GPs manage patients in-house, most using podophyllin solutions which vary in concentration, are non-standardized and potentially hazardous. Most GPs who instigate patient self-treatment prescribe podophyllin which is not licensed for this usage. Podophyllotoxin 0.5% is a safe, effective alternative. Few non-referring GPs screened for the 3 common STIs, thus putting patients at risk of complications such as pelvic inflammatory disease. Non-referral of patients with genital warts to GUM departments may have costly medical and financial consequences.