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.

Preparedness for use of the rapid result HIV self-test by gay men and other men who have sex with men (MSM): a mixed methods exploratory study among MSM and those involved in HIV prevention and care.

OBJECTIVES: The aim of the study was to explore preparedness for the HIV self-test among men who have sex with men (MSM) and those involved in HIV prevention and care. METHODS: A mixed methods exploratory research design was employed, detailing awareness and willingness to use the self-test and the perceived barriers and facilitators to implementation. Quantitative and qualitative data collection and analysis were completed in parallel. Descriptive and inferential analysis of cross-sectional bar-based survey data collected from MSM through a self-completed questionnaire and oral fluid specimen collection (n = 999) was combined with qualitative, thematic, analysis of data collected through 12 expert focus groups (n = 55) consisting of gay men, National Health Service (NHS) staff, community organizations, entrepreneurs and activists. Findings were subsequently combined and assessed for synergies. RESULTS: Among MSM, self-test awareness was moderate (55%). Greater awareness was associated with increased educational attainment [adjusted odds ratio 1.51; 95% confidence interval (CI) 1.00-2.30; P = 0.05] and previous history of sexually transmitted infection (STI) testing (adjusted odds ratio 1.63; 95% CI 1.11-2.39; P = 0.01). Willingness to use the test was high (89%) and associated with meeting sexual partners online (unadjusted odds ratio 1.96; 95% CI 1.31-2.94; P < 0.001). Experts highlighted the overall acceptability of self-testing; it was understood as convenient, discreet, accessible, and with a low burden to services. However, some ambivalence towards self-testing was reported; it could reduce opportunities to engage with wider services, wider health issues and the determinants of risk. CONCLUSIONS: Self-testing represents an opportunity to reduce barriers to HIV testing and enhance prevention and access to care. Levels of awareness are moderate but willingness to use is high. Self-testing may amplify health inequalities.

Increasing condom use in heterosexual men: development of a theory-based interactive digital intervention.

Increasing condom use to prevent sexually transmitted infections is a key public health goal. Interventions are more likely to be effective if they are theory- and evidence-based. The Behaviour Change Wheel (BCW) provides a framework for intervention development. To provide an example of how the BCW was used to develop an intervention to increase condom use in heterosexual men (the MenSS website), the steps of the BCW intervention development process were followed, incorporating evidence from the research literature and views of experts and the target population. Capability (e.g. knowledge) and motivation (e.g. beliefs about pleasure) were identified as important targets of the intervention. We devised ways to address each intervention target, including selecting interactive features and behaviour change techniques. The BCW provides a useful framework for integrating sources of evidence to inform intervention content and deciding which influences on behaviour to target.

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.

How do UK medical graduates rate their knowledge and skills in sexual health and HIV medicine? A national survey.

The objectives of this study are to determine self-assessed knowledge and skills in sexual health and HIV medicine in preregistration house officers and to explore undergraduate experiences of teaching and assessment in these subjects prior to the launch of National Core Learning Outcomes in Sexual and Reproductive Health and HIV. The study was designed as a postal questionnaire survey. The participants were all UK medical graduates of August 2004. The response rate 1737/4746 (36%). The main outcome measures were Doctors' views on their preparedness to manage patients with sexual health and HIV-related problems. Since graduation, 90% of respondents had seen at least one patient with a sexually transmitted infection or HIV-related issue. Seventy-six percent felt confident to take a sexual history. In all, 63% and 53% felt competent in male and female genital examination, respectively. Forty-three percent felt they could conduct an appropriate HIV pretest discussion and 59% felt they could recognize clinical indicators suggestive of HIV. Seventy-eight percent had been formally assessed in sexual health and 55% in HIV medicine. Increased confidence in sexual history taking, HIV pretest discussion and recognition of HIV indicators was associated with a longer duration of teaching and formal examination. In conclusion, although the proportion of recent graduates confident in sexual history taking is encouraging, their lack of skill in discussing HIV testing, risk assessment and recognition of possible HIV presentations must be addressed. Integration of National Core Learning Outcomes into all undergraduate curricula is a key step in reducing inconsistencies in undergraduate training.

An evaluation of the performance of OraQuick ADVANCE Rapid HIV-1/2 Test in a high-risk population attending genitourinary medicine clinics in East London, UK.

To date, no data have been published on the use of OraQuick ADVANCE Rapid HIV-1/2 Test (OraQuick) in the UK. We report preliminary findings of an ongoing evaluation of OraQuick in UK genitourinary (GU) medicine clinics. A total of 820 samples from patients in high-risk groups for HIV were tested with OraQuick and results were compared with standard HIV antibody testing. HIV prevalence (enzyme immunoassay [EIA]) was 5.73%, sensitivity of OraQuick was 93.64% (95% CI 82.46-98.66%), specificity 99.87% (99.28-100%), positive predictive value 97.78% (88.27-99.94%) and negative predictive value 99.61% (98.87-99.92%). This includes three false-negatives considered to be due to observer error and now rectified by further training. This has increased test sensitivity to 100%. Our observed test performance of OraQuick compares well with EIA and with other rapid tests. We believe that simple, non-invasive antibody detection tests such as OraQuick can increase HIV testing and diagnosis in UK GU medicine and community settings.

"We don't really have cause to discuss these things, they don't affect us": a collaborative model for developing culturally appropriate sexual health services with the Bangladeshi community of Tower Hamlets.

OBJECTIVE: To identify barriers to accessing sexual health care among the Bangladeshi community of east London and to develop a model of community participation in service development. METHODS: Qualitative study using one to one interviews with sexual health service users plus focus groups in community settings. RESULTS: 58 people participated in the study, 12 in individual interviews and the remainder in six focus groups. All were of Bangladeshi origin. Four main themes were reported as impacting on access to services; confidentiality concerns, relevance of services to the community, problems with discussing sexual issues, and problems with previous experiences of health promotion. Community values regarding sex outside of marriage were an important underlying factor in participants' responses. Existing sexual health services were seen as culturally insensitive by patients and community groups. CONCLUSIONS: Community based health initiatives among hard to reach ethnic minority groups should use existing networks of statutory and non-statutory groups to benefit from local expertise and relationships. Steering groups composed of members of the local communities served by the clinic can usefully inform service development.

How is the high vaginal swab used to investigate vaginal discharge in primary care and how do GPs' expectations of the test match the tests performed by their microbiology services?

OBJECTIVES: To describe the management of vaginal discharge in general practice, with particular regard to the use of the high vaginal swab (HVS), and to compare GPs' expectations of this test with the processing and reporting undertaken by different laboratories. METHODS: A postal questionnaire survey of 2146 GPs in the North Thames area and postal questionnaire study of the 22 laboratories serving the same GPs were carried out. GPs were asked how they would manage a young woman with vaginal discharge and what information they would like on an HVS report. Laboratories were asked how they would process and report on the HVS sample from the same patient. RESULTS: Response rate was 26%. 72% of GPs would take an HVS and 62% would refer on to a genitourinary medicine (GUM) clinic. 45% would offer empirical therapy and 47% of these would treat for candida initially. 75% of GPs routinely request "M,C&S" on HVS samples but 55% only want to be informed about specific pathogens. Routine processing of HVS samples varies widely between laboratories and 86% only report specific pathogens. 78% of GPs would like to be offered a suggested diagnosis on HVS reports, and 74% would like a suggested treatment. 43% of laboratories ever provide a diagnosis, and 14% provide a suggested treatment. CONCLUSIONS: GPs frequently manage vaginal discharge and most of them utilise the HVS. GPs' expectations of the test are not well matched to laboratory processing or reporting of the samples.

Symptomatic trichomoniasis, metronidazole allergic and pregnant--a management dilemma.

A case of persistent Trichomonas vaginalis (TV) in a pregnant, metronidazole-allergic woman is described. This case posed a management dilemma as untreated TV has been associated with adverse pregnancy outcomes but antibiotic desensitization is potentially dangerous during pregnancy.

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.