Improving HIV pre-exposure prophylaxis (PrEP) uptake and initiation: process evaluation and recommendation development from a national PrEP program†.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is key to HIV transmission elimination but implementation is challenging and under-researched. We undertook a process evaluation of the first 2years of a national PrEP program to explore barriers and facilitators to implementation and to develop recommendations to improve implementation, focusing on PrEP uptake and initiation. METHODS: Stage 1 involved semi-structured telephone interviews and focus groups (September 2018-July 2019) with geographically and demographically diverse patients seeking/using/declining/stopping PrEP (n =39), sexual healthcare professionals (n =54), community-based organisation service users (n =9) and staff (n =15) across Scotland. We used deductive thematic analysis, to derive and then map key barriers and facilitators to priority areas that experts agreed would enhance uptake and initiation. In Stage 2, we used analytic tools from implementation science to systematically generate evidence-based, theoretically-informed recommendations to enhance uptake and initiation of PrEP. RESULTS: Barriers and facilitators were multi-levelled and interdependent. Barriers included the rapid pace of implementation without additional resource, and a lack of familiarity with PrEP prescribing. Facilitators included opportunities for acquisition of practice-based knowledge and normalisation of initiation activities. We refined our 68 'long-list' recommendations to 41 using expert input and the APEASE (Acceptability, Practicability, Effectiveness, Affordability, Side-effects, and Equity) criteria. Examples include: provision of PrEP in diverse settings to reach all in need; co-produced, culturally sensitive training resources for healthcare professionals, with focused content on non-daily dosing; meaningful collaborative working across all stakeholders. CONCLUSIONS: These evidence-based, theory informed recommendations provide a robust framework for optimising PrEP uptake and initiation in diverse settings to ensure PrEP reaches all who may benefit.

Improving HIV pre-exposure prophylaxis (PrEP) adherence and retention in care: Process evaluation and recommendation development from a nationally implemented PrEP programme.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP), in which people take HIV medication to prevent HIV acquisition, underpins global HIV transmission elimination strategies. Effective prevention needs people to adhere to PrEP and remain in care during periods of risk, but this is difficult to achieve. We undertook a process evaluation of Scotland's PrEP programme to explore barriers and facilitators to PrEP adherence and retention in care and to systematically develop evidence-based, theoretically-informed recommendations to address them. METHODS: We conducted semi-structured interviews and focus groups (09/2018-07/2019) with patients who identified as gay or bisexual men and were either using PrEP, had declined the offer of PrEP, had stopped PrEP, or had been assessed as ineligible for PrEP (n = 39 of whom n = 5 (13%) identified as trans, median age 31 years and interquartile range 14 years), healthcare professionals involved in PrEP provision (n = 54 including specialist sexual health doctors and nurses of various grades, PrEP prescribing general practitioners, health promotion officers, midwifes, and a PrEP clinical secretary), and clients (n = 9) and staff (n = 15) of non-governmental organisations with an HIV prevention remit across Scotland. We used thematic analysis to map key barriers and facilitators to priority areas that could enhance adherence and retention in care. We used implementation science analytic tools (Theoretical Domains Framework, Intervention Functions, Behaviour Change Technique Taxonomy, APEASE criteria) and expert opinion to systematically generate recommendations. RESULTS: Barriers included perceived complexity of on-demand dosing, tendency for users to stop PrEP before seeking professional support, troublesome side-effects, limited flexibility in the settings/timings/nature of review appointments, PrEP-related stigma and emerging stigmas around not using PrEP. Facilitators included flexible appointment scheduling, reminders, and processes to follow up non-attenders. Examples of the 25 recommendations include: emphasising benefits of PrEP reviews and providing appointments flexibly within individualised PrEP care; using clinic systems to remind/recall PrEP users; supporting PrEP conversations among sexual partners; clear on-demand dosing guidance; encouraging good PrEP citizenship; detailed discussion on managing side-effects and care/coping planning activities. CONCLUSIONS: PrEP adherence and retention in care is challenging, reducing the effectiveness of PrEP at individual and population levels. We identify and provide solutions to where and how collaborative interventions across public health, clinical, and community practice could address these challenges.

Understanding and responding to remote mental health help-seeking by gay, bisexual and other men who have sex with men (GBMSM) in the U.K. and Republic of Ireland: a mixed-method study conducted in the context of COVID-19.

Background: Gay, bisexual and other men who have sex with men (GBMSM) are at far greater risk of experiencing poor mental health (MH) than wider society. This disparity was exacerbated by additional 'unique to sexual minority status' COVID-19 stressors. Objective: This sequential, mixed-methods study examined remote MH help-seeking among GBMSM in the U.K. and Ireland during the first COVID-19 lockdown. Methods and Results: Quantitative survey data (n = 1368), analysed with logistic regression, suggested GBMSM experiencing moderate-to-severe anxiety and those with a past MH diagnosis were most likely to seek MH support. Thematic analysis of qualitative interview (n = 18) data identified multiple barriers and enablers to GBMSM seeking remote MH help, with the help primarily sought from GBMSM-facing organisations and generic online resources. Finally, the behaviour change wheel was used to generate theoretically informed recommendations to promote MH help-seeking among GBMSM in Scotland. Implications: We discuss how applying these recommendations in the short, medium and long term will begin to address GBMSM's MH needs, post COVID-19.

Learning from guidelines on the sexual healthcare of men who have sex with men.

The British Association for Sexual Health and HIV (BASHH) United Kingdom national guideline on the sexual health care of men who have sex with men (MSM) was published in electronic format in this journal in 2018. In common with other BASHH guidelines, the document fulfils the dual role of scrutinising and evaluating the available evidence according to the accredited Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, as well as the often more challenging job of codifying and summarising expert opinion in areas where the evidence base is incomplete or lacking. In addition to the learning gained from developing the recommendations included in the final document, further benefit was derived from the process through a number of learning and development actions for the writing group and through this the MSM special interest group and the wider sexual health community.

2016 United Kingdom national guideline on the sexual health care of men who have sex with men.

This guideline is intended for use in UK Genitourinary medicine clinics and sexual health services but is likely to be of relevance in all sexual health settings, including general practice and Contraception and Sexual Health (CASH) services, where men who have sex with men (MSM) seek sexual health care or where addressing the sexual health needs of MSM may have public health benefits. For the purposes of this document, MSM includes all gay, bisexual and all other males who have sex with other males and both cis and trans men. This document does not provide guidance on the treatment of particular conditions where this is covered in other British Association for Sexual Health and HIV (BASHH) Guidelines but outlines best practice in multiple aspects of the sexual health care of MSM. Where prevention of sexually transmitted infections including HIV can be addressed as an integral part of clinical care, this is consistent with the concept of combination prevention and is included. The document is designed primarily to provide guidance on the direct clinical care of MSM but also makes reference to the design and delivery of services with the aim of supporting clinicians and commissioners in providing effective services. Methodology This document was produced in accordance with the guidance set out in the BASHH CEG's document 'Framework for guideline development and assessment' published in 2010 at http://www.bashh.org/guidelines and with reference to the Agree II instrument. Following the production of the updated framework in April 2015, the GRADE system for assessing evidence was adopted and the draft recommendations were regraded. Search strategy (see also Appendix 1) Ovid Medline 1946 to December 2014, Medline daily update, Embase 1974 to December 2014, Pubmed NeLH Guidelines Database, Cochrane library from 2000 to December 2014. Search language English only. The search for Section 3 was conducted on PubMed to December 2014. Priority was given to peer-reviewed papers published in scientific journals, although for many issues evidence includes conference abstracts listed on the Embase database. In addition, for 'Identification of problematic recreational drug and alcohol use' section and 'Sexual problems and dysfunctions in MSM' section, searches included PsycINFO. Methods Article titles and abstracts were reviewed and if relevant the full text article was obtained. Priority was given to randomised controlled trial and systematic review evidence, and recommendations made and graded on the basis of best available evidence. Piloting and feedback The first draft of the guideline was circulated to the writing group and to a small group of relevant experts, third sector partners and patient representatives who were invited to comment on the whole document and specifically on particular sections. The revised draft was reviewed by the CEG and then reviewed by the BASHH patient/public panel and posted on the BASHH website for public consultation. The final draft was piloted before publication. Guideline update The guidelines will be reviewed and revised in five years' time, 2022.

Regular STI testing amongst men who have sex with men and use social media is suboptimal - a cross-sectional study.

Sexually transmitted infections (STIs) disproportionately affect men who have sex with men, with marked increases in most STIs in recent years. These are likely underpinned by coterminous increases in behavioural risks which have coincided with the development of Internet and geospatial sociosexual networking. Current guidelines advocate regular, annual sexually transmitted infection testing amongst sexually active men who have sex with men (MSM), as opposed to symptom-driven testing. This paper explores sexually transmitted infection testing regularity amongst MSM who use social and sociosexual media. Data were collected from 2668 men in Scotland, Wales, Northern Ireland and the Republic of Ireland, recruited via social and gay sociosexual media. Only one-third of participants report regular (yearly or more frequent) STI testing, despite relatively high levels of male sex partners, condomless anal intercourse and high-risk unprotected anal intercourse. The following variables were associated with regular STI testing; being more 'out' (adjusted odds ratio = 1.79; confidence interval = 1.20-2.68), HIV-positive (adjusted odds ratio = 14.11; confidence interval = 7.03-28.32); reporting ≥10 male sex partners (adjusted odds ratio = 2.15; confidence interval = 1.47-3.14) or regular HIV testing (adjusted odds ratio = 48.44; confidence interval = 28.27-83.01). Men reporting long-term sickness absence from work/carers (adjusted odds ratio = 0.03; confidence interval = 0.00-0.48) and men aged ≤25 years (adjusted odds ratio = 0.36; 95% confidence interval = 0.19-0.69) were less likely to test regularly for STIs. As such, we identify a complex interplay of social, health and behavioural factors that each contribute to men's STI testing behaviours. In concert, these data suggest that the syndemics placing men at elevated risk may also mitigate against access to testing and prevention services. Moreover, successful reduction of STI transmission amongst MSM will necessitate a comprehensive range of approaches which address these multiple interrelated factors that underpin MSM's STI testing.

The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development.

BACKGROUND: Men who have sex with men (MSM) experience significant inequalities in health and well-being. They are the group in the UK at the highest risk of acquiring a human immunodeficiency virus (HIV) infection. Guidance relating to both HIV infection prevention, in general, and individual-level behaviour change interventions, in particular, is very limited. OBJECTIVES: To conduct an evidence synthesis of the clinical effectiveness of behaviour change interventions to reduce risky sexual behaviour among MSM after a negative HIV infection test. To identify effective components within interventions in reducing HIV risk-related behaviours and develop a candidate intervention. To host expert events addressing the implementation and optimisation of a candidate intervention. DATA SOURCES: All major electronic databases (British Education Index, BioMed Central, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Educational Resource Index and Abstracts, Health and Medical Complete, MEDLINE, PsycARTICLES, PsycINFO, PubMed and Social Science Citation Index) were searched between January 2000 and December 2014. REVIEW METHODS: A systematic review of the clinical effectiveness of individual behaviour change interventions was conducted. Interventions were examined using the behaviour change technique (BCT) taxonomy, theory coding assessment, mode of delivery and proximity to HIV infection testing. Data were summarised in narrative review and, when appropriate, meta-analysis was carried out. Supplemental analyses for the development of the candidate intervention focused on post hoc realist review method, the assessment of the sequential delivery and content of intervention components, and the social and historical context of primary studies. Expert panels reviewed the candidate intervention for issues of implementation and optimisation. RESULTS: Overall, trials included in this review (n = 10) demonstrated that individual-level behaviour change interventions are effective in reducing key HIV infection risk-related behaviours. However, there was considerable clinical and methodological heterogeneity among the trials. Exploratory meta-analysis showed a statistically significant reduction in behaviours associated with high risk of HIV transmission (risk ratio 0.75, 95% confidence interval 0.62 to 0.91). Additional stratified analyses suggested that effectiveness may be enhanced through face-to-face contact immediately after testing, and that theory-based content and BCTs drawn from 'goals and planning' and 'identity' groups are important. All evidence collated in the review was synthesised to develop a candidate intervention. Experts highlighted overall acceptability of the intervention and outlined key ways that the candidate intervention could be optimised to enhance UK implementation. LIMITATIONS: There was a limited number of primary studies. All were from outside the UK and were subject to considerable clinical, methodological and statistical heterogeneity. The findings of the meta-analysis must therefore be treated with caution. The lack of detailed intervention manuals limited the assessment of intervention content, delivery and fidelity. CONCLUSIONS: Evidence regarding the effectiveness of behaviour change interventions suggests that they are effective in changing behaviour associated with HIV transmission. Exploratory stratified meta-analyses suggested that interventions should be delivered face to face and immediately after testing. There are uncertainties around the generalisability of these findings to the UK setting. However, UK experts found the intervention acceptable and provided ways of optimising the candidate intervention. FUTURE WORK: There is a need for well-designed, UK-based trials of individual behaviour change interventions that clearly articulate intervention content and demonstrate intervention fidelity. STUDY REGISTRATION: The study is registered as PROSPERO CRD42014009500. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Sensitivity of microscopy for the rapid diagnosis of gonorrhoea in men and women and the role of gonorrhoea serovars.

Auditing the sensitivity of microscopic diagnosis of gonorrhoea is recommended by the current guidelines. A retrospective study was performed of 596 cases of positive cultures for Neisseria gonorrhoeae in modified New York City culture (MNYC) media diagnosed from 1995 to 1999. The sensitivity of the cervical slides in women was 51% while in men who have sex with men (MSM) the sensitivity of urethral and rectal slides were 89% and 54% respectively. The sensitivity of urethral slides in heterosexual men was 84%. Neisseria serovar 1B02 among MSM and serovar 1B31 among women were mostly undiagnosed with microscopy. Serovars 1A05, 1A21, B08 among heterosexual men were exclusively associated with negative microscopy. Microscopy is important in the rapid detection and treatment of gonorrhoea. Infections with certain serovars are less likely to be detected by microscopy; making them more likely to spread within the community. Culture from different ano-genital sites is essential to maximize detection of gonorrhoea in all patients.