8 Good Practice Guidance on HIV Prevention in Men who have Sex with Men (MSM) Health Protection Network Scottish Guidance November 2012 The Health Protection Network (HPN) is a network of existing professional organisations and networks in the health protection community across Scotland. It aims to promote, sustain, and coordinate good practice. The HPN supports a systematic approach to development, appraisal and adaptation of guidelines, seeking excellence in health protection practice. Health Protection Network site: http://www.hps.scot.nhs.uk/about/HPN.aspx Supported by Health Protection Scotland Health Protection Scotland (HPS) is a non-profit, public sector organisation which is part of the Scottish National Health Service. It is dedicated to the protection of the public’s health. Health Protection Scotland is a division of NHS National Services Scotland. Citation for this document Health Protection Network. Good Practice Guidance on HIV Prevention in Men who have Sex with Men (MSM). Scottish Guidance 8. Health Protection Scotland, Glasgow, 2012. First published October 2012 by Health Protection Scotland Meridian Court, 5 Cadogan Street, Glasgow, G2 6QE. Published November 2012 © Health Protection Network 2012 The Health Protection Network has made every effort to trace holders of copyright in original material and to seek permission for its use in this document and in any the associated quick reference guide. Should copyrighted material have been inadvertently used without appropriate attribution or permission, the copyright holders are asked to contact the Health Protection Network so that suitable acknowledgement can be made at the first opportunity. Health Protection Network consents to the photocopying of this document for the purpose of implementation in NHSScotland. All other proposals for reproduction of large extracts should be addressed to: Health Protection Network Health Protection Scotland Meridian Court 5 Cadogan Street Glasgow G2 6QE Tel: +44 (0) 141 300 1100 Email: [email protected] Professionals involved in the implementation of recommendations proposed in this document are expected to take them fully into account when exercising their professional judgment. The document does not, however, override the individual responsibility of professionals to make decisions appropriate to the circumstances of the individual cases, in consultation with partner agencies and stakeholders. Professionals are also reminded that it is their responsibility to interpret and implement these recommendations in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this document should be interpreted in a way which would be inconsistent with compliance with those duties. Designed and typeset by: Graphics Team, Health Protection Scotland Table of Contents List of Figures, Tables and Textboxes ii Guidance Development Group Membership iii Glossaryv Abreviationsvi Section A – Context, Evidence and Engagement 1 A1. The Aim of the Guidance 1 A2. HIV Prevention Approaches for MSM 2 A3. The MSM Population and Epidemiology 3 A4. Policy and Service Improvement Context 5 A5. Key Performance Indicators and Evaluation Outcomes 7 A6. Engagement of MSM in Intervention Development and Delivery 8 Section B - The Guidance Recommendations 9 Using the Evidence to Inform HIV Prevention Interventions Strength of Evidence B1. Recommendation on Content of Interventions 9 10 11 B1.1 Recommendations on Biomedical Intervention 11 B1.2 Recommendations on Behavioural Interventions 14 B1.2.1 Translating The Evidence Regarding ‘Interpersonal Skills’ and ‘Theory Informed’ Into Practice B1.3 Recommendation on Structural Intervention B2. The Delivery of Interventions Recommendations on Delivery of Interventions B3. Recommendations on the Evaluation of Interventions Recommendations on Evaluation of Interventions 16 19 21 23 26 30 B4. Recommendations to Meet Research Gaps 31 Appendix 1: Commissioning Template for MSM Interventions 35 Appendix 2: Needs Assessment Parameters 36 Appendix 3: Key Questions to Consider in Any Engagement with MSM 38 Appendix 4: Suggested Techniques of Sexual Health Behavioural Change Interventions and Links to Theoretical Frameworks 40 Appendix 5: Methodology Employed in Guideline Development 44 References49 Good Practice Guidance on HIV Prevention in Men who have Sex with Men List of Figures, Tables and Textboxes Figure 1: Combination HIV Prevention 2 Table 1: Evidence statements on miomedical intervention 12 Table 2: Evidence statements on behavioural intervention 15 Box 1: Range of Skills Acquisition Required in Negotiating Safe Sex in MSM 17 Box 2: Selected techniques of sexual health behavioural change interventions and links to theoretical frameworks 18 Table 3: Evidence statements on structural intervention content 20 Table 4: Intervention delivery – numbers of people 21 Table 5: Intervention delivery – setting of sex and service delivery 22 Table 6: Intervention delivery –types of MSM 23 Table 7: Provides evidence statements on hiv prevention intervention delivery 24 Table 8: Evidence typology 27 Table 9: Suggested outcome Hierarchy for MSM 32 Table 10: Evidence level criteria as per SIGN 50 Guideline Developer’s Handbook 44 Table 11: Recommendation grading criteria, SIGN 50 Guideline Developer’s Handbook 45 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Guidance Development Group Membership Primary Authorship Paul Flowers Professor of Health Psychology, Glasgow Caledonian University (Cochair) Phil Eaglesham Health Improvement Programme Manager (Sexual Health & HIV), NHS Health Scotland (Co-chair) Lisa McDaid Programme Leader for Sexual Health, MRC/CSO Social & Public Health Sciences Unit, Glasgow (from April 2011) Colin Anderson Senior Health Promotion Officer for Blood Borne Viruses and Sexual Health, NHS Lanarkshire Nick Putnam Learning Development Officer, HIV Scotland (from Jan 2011) Associate Members of Writing Group Simon Ellis Associate Director, National Institute for Health and Clinical Excellence (NICE) Marion Henderson Programme Leader for Sexual Health, MRC/CSO Social & Public Health Sciences Unit, Glasgow (Until March 2011) Alex Sánchez-Vivar National Coordinator of the Health Protection Network (HPN) and Guidelines Programme Lead, Health Protection Scotland Reference Group members Kirsty Abu-Rajab GUM Consultant, NHS Forth Valley (until Dec 2010) Steve Bagley GUM Consultant, NHS Grampian Dan Clutterbuck GUM Consultant, NHS Borders / NHS Lothian Noel Gill Health Protection Agency (Until Dec 2010) Nick Kennedy Infectious Diseases Consultant, NHS Lanarkshire / Clinical Advisor, Healthcare Improvement Scotland Roy Kilpatrick Chief Executive, HIV Scotland (until Dec 2010) Martin Murchie Senior Sexual Health Adviser, The Sandyford Initiative, NHS Greater Glasgow & Clyde Jim Sherval Consultant in Public Health Medicine (HIV), NHS Lothian Kate Templeton Consultant Microbiologist, NHS Lothian Lesley Wallace Epidemiologist, Health Protection Scotland Good Practice Guidance on HIV Prevention in Men who have Sex with Men iii Pre-consultation and preview of Brief Guidance Liaison with Local and National Networks Health Protection Network Board Scottish Sexual Health Improvement Specialists Group Scottish Sexual Health Lead Clinicians Scottish HIV Voluntary Sector Forum NHS Greater Glasgow & Clyde MSM Planning Forum NHS Lothian HIV Prevention MSM Planning Group NHS Lanarkshire BBV Prevention Planning Group Further Groups Contacted in Professional Consultation, Jan-March 2012 Sexual Health & BBV Executive Leads Sexual Health Clinical Leads Sexual Health Improvement Specialists HIV Voluntary Sector Forum British Psychological Society National AIDS Trust Terrence Higgins Trust British Association for Sexual Health and HIV British HIV Association iv Good Practice Guidance on HIV Prevention in Men who have Sex with Men Glossary Combination HIV Prevention - This term was coined by Prof K Holmes, University of Washington School of Medicine, Seattle, WA, USA. Lancet Infect Dis 2007; 7: 516–20. Coats et al. (2008) state: “Advances in biomedical HIV prevention, as in the case of male circumcision or the potential of antiretroviral therapies for prevention, provide substantial opportunities to re-invigorate behavioural approaches to HIV prevention and challenge us to advance structural approaches so that these advances can get to those who need them the most. All prevention approaches contribute to effective HIV prevention within communities, and thus behavioural strategies need to be used in combination with biomedical and structural approaches that are combined strategically to address local epidemics.” Bi-curious Commissioning Heteronormativity Trans Behaviourally bisexual but socially heterosexual The design, development and funding of interventions to improve health A cultural bias in favour of opposite-sex relationships of a sexual nature often leading to assumptions of monogamy. It therefore it is essential to value relationship choice in MSM. Transsexual / gender dysphoric Good Practice Guidance on HIV Prevention in Men who have Sex with Men v Abreviations AIDS Acquired Immune Deficiency Syndrome ART Antiretroviral therapy BASHH British Association of Sexual Health & HIV BBV Blood Borne Virus BHIVA British HIV Association BME Black and Minority Ethnic CDC Center for Disease Control, Atlanta USA CEL Chief Executive’s Letter (guidance from Scottish Government DASH Data Augmentation for Sexual Health GP General Practitioner GPS Global Positioning System GSR Government Social Research GUM Genitourinary medicine HAART Highly Active Antiretroviral Therapy HBV Hepatitis B Virus HCV Hepatitis C Virus HIV Human Immunodeficiency Virus HPS Health Protection Scotland HSV Herpes Simplex Virus IDU Injecting Drug User ISD Information and Statistics Division KPIs Key Performance Indicators, stipulated as required standards or milestones for service improvement. LGBT Lesbian, Gay, Bisexual, Transgender MSM Men who have Sex with Men NaSH National Sexual Health System NGOs Non-Governmental Organisations, generally within the voluntary and community sector. NHS National Health Service NICE National Institute for Health and Clinical Excellence NSS National Services Scotland PeP Post-exposure Prophylaxis PePSE Post-exposure Prophylaxis for Sexual Exposure. PrEP Pre-exposure Prophylaxis RCT Randomised Control Trial RSHP Relationship, Sexual health and Parenthood education SOA Single Outcome Agreement SIGN Scottish Intercollegiate Guidelines Network SNAP Scottish Needs Assessment Programme SSHI Scotland’s Sexual Health Information report STI Sexually Transmitted Infection WHO World Health Organisation vi Good Practice Guidance on HIV Prevention in Men who have Sex with Men Section A – Context, Evidence and Engagement A1.The Aim of the Guidance Men who have sex with men (MSM) remain a key population of concern in the epidemiology of HIV in Scotland. There are major inequalities with regards to sexual health and HIV incidence and prevalence according to the degree of same sex behavior. This guidance is founded on the best available evidence on HIV Prevention in MSM (Appendix 4: Suggested Techniques of Sexual Health Behavioural Change Interventions and Links to Theoretical Frameworks and Appendix 5: Methodology Employed in Guideline Development for further detail). It is intended to address this and will facilitate the commissioning process for interventions addressing this priority population. Implementing this guidance will: • Strengthen the commissioning and delivery process • Ensure that interventions are evidence informed • Ensure an authentic i MSM-informed, local approach • Strengthen skills/expertise already in place within NGO’s locally and nationally • Focus more attention on evaluation of intervention process and outcomes. The primary audience is local NHS commissioners and those who deliver HIV prevention services and activities in clinical and non-clinical settings (see Appendix 1: Commissioning Template for MSM Interventions). It has been written to dovetail with other sexual health governance documents (e.g. Sexual Health and BBV Framework, 2011-15,1 HIS Clinical Standards for HIV2). i Note: By ‘authentic’ we mean comprehensive, rigorous needs assessment and consultation processes informed by a representative sample of MSM Good Practice Guidance on HIV Prevention in Men who have Sex with Men 1 A2.HIV Prevention Approaches for MSM There is no single intervention - no ‘magic bullet’ - capable of eliminating onward transmission of HIV, needs and skills can vary among MSM as can the setting and level of intervention. Therefore using a ‘Combination HIV Prevention’ approach is integral to this guidance (see Figure 1). Biomedical Interventions Combination HIV prevention Behavioural Interventions Structural Interventions Content and Delivery Authentic Engagement Figure 1: Combination HIV Prevention Effective Evaluation Examples of these interventions would include for instance; Biomedical = PEP, Condoms Behavioural = Motivational Interviewing, CBT Structural = Equalities legislation, tackling homophobia Adapted from: Coates, Richter & Caceres (2008) Behavioural strategies to reduce HIV transmission: how to make them work better, Lancet, Published online August 6, 2008 In Scotland and elsewhere, MSM are a diverse population, with diverse needs. Critically inequalities between MSM vary by the intersection of other health determinants (e.g. ethnicity, identity, behaviour, HIV status, age, disability). Sexual ill health, HIV risk behaviours, HIV vulnerability and the locations used for meeting sexual partners are also patterned by this inequality. It is anticipated that a variety of approaches both across and within each of the categories below represents a minimum standard of appropriate combination prevention. The cost and ease of implementation of the approaches outlined here varies considerably. 2 Good Practice Guidance on HIV Prevention in Men who have Sex with Men A3.The MSM Population and Epidemiology National surveillance shows that men who have sex with men remain a key population of concern in the epidemiology of HIV in Scotland. Sexual contact between men now accounts for 71%3 of new HIV cases recorded. Among people undergoing repeat HIV antibody testing between 2005-2009, the incidence of infection rates (new transmissions) were 15, 1.5 and 1.5 per 1000 person years for MSM, heterosexual men and women and IDU respectively; the rate in MSM has remained unchanged since the late 1980s. In contrast to this national data, regional data is more limited but does suggest that within the central belt among MSM attending gay bars in Glasgow and Edinburgh there has been a plateau in HIV risk related behaviour,4 following the increases observed in earlier years.5 This research also shows that within the central belt there are also important differences in sexual health according to area of residence and health board region. Thus knowing the needs of your local MSM population is crucial to effective intervention targeting. Needs assessment should be carried out as a standard methodical process by commissioners as they would with any local minority or vulnerable population to inform planning and effectiveness. The suggested parameters of an effective MSM needs assessment are described in Appendix 1: Commissioning Template for MSM Interventions. One key element to consider is the location in which, or mode by which, men meet each other for sex, in your health board region, for example: • The commercial LGBT venues and community events • The internet and mobile phone apps • Public sex environments (such as parks, beaches and laybys) • Public sex venues (such as private saunas, gyms and sex clubs) • Private sex parties • Involvement in prostitution. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 3 It is important to think of MSM as a diverse population (not only as ‘out’ gay men) and acknowledge that use of these locations/modes is patterned by the types of MSM, for example:• rural men • BME men • asylum seekers and refugees • married men • bi-curious men • men in areas of deprivation • men with physical disabilities • men with learning disabilities • transmen. An appreciation of the diversity of MSM and its relevance for commissioning can be further developed through literature review, exploratory research, local engagement with MSM, and the agencies that represent them, and owners of settings/moderators of sites in which MSM meet. Key questions for commissioners to consider in the planning of interventions are included in more detail in Appendix 3: Key Questions to Consider in Any Engagement with MSM. 4 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Policy and Service Improvement Context The HIV Action Plan for Scotland, published in November 2009 explicitly included men who have sex with men as a population of focus and the Sexual Health & BBV Framework, 2011-15,1 published in August 2011 incorporates and strengthens the objectives and actions in this original plan within a wider context of sexual health, hepatitis B and hepatitis C. Continued focus on MSM through local interventions will be a requirement of NHS Boards in meeting the framework objectives and indicators to reduce BBV and STI prevalence, challenge stigma towards key minority populations and to reduce inequalities in health. Key performance indicators focused on HIV include: • A reduction in HIV and STI rates by risk group • Number of people newly diagnosed with late HIV disease • Proportion of diagnosed HIV infected people receiving treatment • Sexual well being, sex free from coercion and harm, and sexual regret. This guidance is intended to provide a useful contribution to ensure that local approaches can work towards delivering many of these key performance indicators through guiding service content and delivery which targets MSM and ensure that wherever possible it is evidence informed. These indicators also compliment the wider context of Hepatitis prevention and sexual health improvement, described below in the ‘Outcomes Hierarchy’ in Table 9. HIV Testing Guidance by NICE6 is intended to increase focus and effectiveness of testing of MSM through a range of settings and approaches and make specific recommendations on: • assessing local need and developing a strategic focus • promotion of HIV testing in a range of settings • testing in specialist sexual health services • testing in primary and secondary care • outreach and point of care testing • referral pathways • repeat testing. Parallel public health guidance by NICE on the most appropriate means of generic and specific interventions to support attitude and behaviour change at population and community levels7 and their assessment of community engagement and community development approaches including the collaborative methodology and community champions8 are also relevant wider guidance documents to consider to inform intervention design and delivery. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 5 In summary then, this guidance should be considered in conjunction with • Healthcare Improvement Scotland’s HIV Standards as it does not duplicate the relevant quality statements • BASHH Guidelines on HIV Testing9 and Safer Sex Advice10 • NICE Guidance on increasing HIV testing among MSM and • The Sexual Health and Blood Borne Virus Framework 2011-15. It also compliments recent British Psychological Society standards on psychological support for people living with HIV,11 UNAIDS Framework for Monitoring and Evaluating HIV Prevention programmes for Most-At-Risk Populations12 and WHO Recommendations on HIV prevention approaches with MSM and Transgender People.13 6 Good Practice Guidance on HIV Prevention in Men who have Sex with Men A4.Key Performance Indicators and Evaluation Outcomes Given the shared goal of sexual health improvement within this guidance and the Sexual Health and Blood Borne Virus Framework and the resulting commissioned interventions, it is important to consider the range and hierarchy of KPIs/outcomes that are employed within intervention design and evaluation. Reducing HIV incidence at a population level requires, at the very least sexual behaviour change, early detection and adherence to HIV treatment. A fuller description of wider performance indicators within an outcome hierarchy for intervention evaluation is shown in Table 9. Although all have merit as intervention outcomes, the outcomes selected will be determined by the needs of the local MSM population, the content of the chosen intervention and what it is expected to affect. While some interventions may conceivably set behavioural outcomes as their goal, arguably, only large-scale, resource intensive combination HIV prevention approaches can expect to achieve measurable changes in biological outcomes. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 7 A5.Engagement of MSM in Intervention Development and Delivery Balancing evidence informed ideas for interventions with direct involvement of men who have sex with men is crucial to effective design, delivery and acceptability of local interventions (see Appendix 3: Key Questions to Consider in Any Engagement with MSM). Secondary and tertiary level specialist clinical services, social marketing materials and policy development will all be improved and person-centred if the intended target audience inform the intervention content and delivery. This can occur at early or advanced stages of development and can also be a crucial aspect of evaluation. Further to public health guidance on community engagement by NICE stipulated above, a range of guidance, policy and standards contextualise and strengthen this involvement at every stage of intervention design, delivery and evaluation. These include: • The Scottish Health Council’s Public Involvement and Participation Standard http://www.scottishhealthcouncil.org/patient_public_participation/ participation_standard/participation_standard.aspx • The NHS Scotland Quality Strategy http://www.scotland.gov.uk/Topics/Health/ NHS-Scotland/NHSQuality • The Scottish Community Development Council’s National Standards for Community Engagement http://www.scdc.org.uk/what/national-standards/ • The NHS QIS Clinical Governance and Risk Management Standards (CGRM) http://www.healthcareimprovementscotland.org/previous_resources/ archived/clinical_governance_and_risk_m.aspx and http://www. clinicalgovernance.scot.nhs.uk/ • The Scottish Government’s CEL on ‘Informing, engaging and consulting people in developing health and community care services’ http://www.sehd. scot.nhs.uk/mels/CEL2010_04.pdf • Better Together: Scotland’s Patient Experience Programme http://www. bettertogetherscotland.com • Visioning Outcomes in Community Engagement (VOiCE) http://www.scdc. org.uk/what/voice/ • Checking for Change: A Building Blocks Approach to Race Equality in Health http://www.healthscotland.com/equalities/race.aspx • The Patients’ Rights (Scotland) Act http://www.legislation.gov.uk/asp/2011/5/ contents/enacted 8 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Section B - The Guidance Recommendations Across the ‘combination prevention’ approach outlined in Figure 1, the quality of evidence on effectiveness varies considerably across the types of intervention. Some interventions such as condom distribution or the supply of condoms in sex-on-premises venues for example, have no high level quality evidence illustrating their effectiveness but are nonetheless logical, plausible and necessary interventions. As a result of these dilemmas the recommendations detailed below can be considered as pragmatic; they are ‘evidence-informed’ rather than strictly ‘evidence-based’.14 When planning local approaches it is important to acknowledge that there are problems in distinguishing between any categorisation of HIV prevention interventions. Implementing interventions requires a multi-level process and a holistic understanding of intervention delivery. For example, implementing biomedical approaches necessarily involves engaging with an array of psychosocial, behavioural and structural processes (e.g. the acceptability of condoms, or beliefs around one’s capacity to take an HIV test, or the organisation of services to facilitate adequate distribution of PeP). Equally, delivery of intervention is multifaceted so, ‘community-level’ interventions are necessarily comprised of a number and series of one-to-one interactions. Unless specified – the recommendations below can all be considered acceptable and are likely to be effective amongst diverse populations with the majority of them only requiring audit or minimal evaluation. Those interventions which are experimental, innovative or emerging are clearly identified within the relevant section. Due consideration for the transferability of intervention across international contexts is also required. Using the Evidence to Inform HIV Prevention Interventions Although this guidance is ‘evidence informed’ rather than ‘evidence based’ where possible we illustrate the degree of evidence available to support our recommendations. This guidance utilises a framework based upon SIGN 50: A guideline developer’s handbook.15 It presents a series of levels of evidence relating to the research designs that have been employed in constructing evidence. It is essential that readers of this guidance familiarise themselves with these criteria in order to appraise the evidence statements supporting each recommendation. A more detailed description of the method employed to review and synthesise the evidence by Lorimer et al. (2011) to inform guideline development is included in Appendix 5: Methodology Employed in Guideline Development. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 9 Strength of Evidence This relates to the level of evidence, it’s applicability to a Scottish context and consistency not just the clinical importance (see Appendix 5: Methodology Employed in Guideline Development). Three overarching aspects should be considered in designing and commissioning HIV prevention interventions with this population; Content, Delivery, and Evaluation. With regards to the distinction between content and delivery, there is often some confusion within the literature. Existing evidence is usually structured by either content or mode of delivery. For example, there is little evidence which relates to the relative effectiveness of delivering the same intervention across different modes of delivery. These distinctions help shape the structure of the ‘Commissioning Template’ attached to this briefing (see Appendix 1: Commissioning Template for MSM Interventions). This is intended to frame preliminary discussions and ideas for intervention design and service level agreements. 10 Good Practice Guidance on HIV Prevention in Men who have Sex with Men B1.Recommendation on Content of Interventions Effective intervention content requires a multi-level approach and a holistic understanding of intervention delivery. Implementing biomedical approaches necessarily involves engaging with a combination of psychosocial, behavioural and structural processes. Thus although an intervention itself, and its associated primary and secondary outcomes, are biomedical it is important to acknowledge the psychosocial and sociocultural mechanisms by which it operates. B1.1 Recommendations on Biomedical Intervention Regarding biomedical approaches, the recommendations and evidence statements below relate to the main biomedical interventions used within HIV prevention within developed countries. Although some of them are not supported by high level evidence of effectiveness they can be thought of as ‘tried and tested’, or simply both logical and plausible. In contrast, others have undergone systematic and rigorous trialling to ensure their utility on a number of dimensions. 1. Ensure that a range of condoms (male, female, various sizes and types) and lubricant are provided and available in a range of settings (e.g. where sex takes place, through postal delivery schemes, as well as in gay venues and events). 2. Ensure that information and advice on the availability of post-exposure prophylaxis (PEP) following sexual exposure are available to all MSM and that post exposure prophylaxis for HIV following sexual exposure (PEPSE) starter packs are readily available to men in sero-discordant relationships. 3. HIV treatment (as a key part of prevention) and support for treatment adherence (as a key part of prevention) are recommended; but it is NOT recommended that: pre-exposure prophylaxis (PrEP) is provided other than as part of a clinical trial. Note: There is currently insufficient evidence to support PrEP use as HIV prevention for MSM as it could potentially contribute to further sexual ill-health (e.g. increased incidence of syphilis, hepatitis C and drug resistant gonorrhoea in MSM). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 11 The following table provides supporting evidence statements on miomedical intervention. Table 1: Evidence statements on miomedical intervention Evidence Statement Strength of Evidence for Biomedical Interventions Evidence Source The male latex condom reduces the transmission of HIV in heterosexual couples, including those who have anal sex. (A) Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev 2002(1):CD003255 There is some evidence for a comparable effect in MSM. (D) Golden M. HIV serosorting among men who have sex with men: implications for prevention. Thirteenth Conference on Retroviruses and Opportunistic Infections. Denver, 2006. Female condoms confer as much protection from STIs as male condoms. (A) Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect 2005;81(3):193-200. French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Useeffectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis 2003;30(5):433-9 Female condoms may be used for anal sex. (D) Wolitski RJ, Halkitis PN, Parsons JT, Gomez CA. Awareness and use of untested barrier methods by HIVseropositive gay and bisexual men. AIDS Educ Prev 2001;13(4):291-301. Renzi C, Tabet SR, Stucky JA, Eaton N, Coletti AS, Surawicz CM, et al. Safety and acceptability of the Reality condom for anal sex among men who have sex with men. AIDS 2003;17(5):727-31 Free Condom distribution to settings where sex takes place increases condom use. (D) / X No specific evidence, but logical, good practice and theoretically plausible Condom by post delivery schemes increases condom use. (D) / X No specific evidence, but logical, good practice and theoretically plausible Thicker condoms are no less likely than standard condoms to break or slip off than standard condoms during anal sex. 12 (C) Golombok S, Harding R, Sheldon J. An evaluation of a thicker versus a standard condom with gay men. AIDS 2001;15(2):245-50. Good Practice Guidance on HIV Prevention in Men who have Sex with Men Evidence Statement Non-oil based lubricant should be applied all over the condom and inside the anus, but not inside the condom, before anal sex. Strength of Evidence for Biomedical Interventions (C) Evidence Source Golombok S, Harding R, Sheldon J. An evaluation of a thicker versus a standard condom with gay men. AIDS 2001;15(2):245-50 Providing a range of condom sizes is a quick and more practical alternative to formal condom sizing. (D) / X There is currently no public health evidence to recommend male circumcision as a strategy for HIV transmission reduction in the UK, either at a population or individual level although three randomised controlled trials have shown that male circumcision protects against the acquisition of HIV in men in the setting of a high prevalence (generalised) HIV epidemic. (C) No specific evidence, but logical, good practice and theoretically plausible Mills E, Cooper C, Anema A, Guyatt G. Male circumcision for the prevention of heterosexually acquired HIV infection: a meta-analysis of randomized trials involving 11,050 men. HIV Med 2008;9(6):332-5 McDaid LM, Weiss HA, Hart G. Circumcision among men who have sex with men in Scotland: Limited potential for HIV prevention. Sexually Transmitted Infection 2010; 86:404-6. Wiysonge CS, Kongnyuy EJ, Shey M, Muula AS, Navti OB, Akl EA, Lo Y-R. Male circumcision for prevention of homosexual acquisition of HIV in men. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD007496. DOI: 10.1002/14651858. CD007496.pub2 Post-exposure Prophylaxis amongst MSM following sexual exposure. HIV treatment (as a key part of prevention) and support for treatment adherence (as a key part of prevention) are recommended but it is not recommended that preexposure prophylaxis is provided other than as part of a clinical trial. (B) (D) / X Fisher M, Benn P, Evans B, Pozniak A, Jones M, Maclean S, et al. UK Guideline for the use of post-exposure prophylaxis for HIV following sexual exposure. Int J STD AIDS 2006;17(2):8192. HIV treatment as prevention has a limited evidence base but is logical, good practice and theoretically possible. There is currently insufficient evidence to support PrEP use as HIV prevention for MSM and could contribute to further sexual ill health (e.g. increased incidence of syphilis, hepatitis C and drug resistant gonorrhoea in MSM). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 13 B1.2 Recommendations on Behavioural Interventions Behavioural interventions are a useful component for prevention amongst MSM. Particularly for those who may require greater focus, motivation and skill to reduce risk of sexual ill health (including HIV transmission during sex). Healthcare Improvement Scotland Standards for HIV require that brief interventions focused on sexual risk reduction are available in all specialist sexual health and adult HIV clinics and tailored intensive behaviour change interventions are available and offered to those with ongoing HIV risk behaviour. 4. Ensure that ‘focus brief’ (15-20 minute) or ‘intensive’ (multi-session) behaviour change interventions are available and based on the acquisition of interpersonal skills*, and increasing motivation to adopt safer sexual behaviour (it is recommended that these interventions are theory informed**). 5. Ensure that all behaviour change interventions are provided by staff who have gained competency in their provision through training. Note: * see B1.2.1.1. Interpersonal Skills on page 16 ** see B1.2.1.2. Theoretical Underpinnings on page 17 and Appendix 3: Key Questions to Consider in Any Engagement with MSM on page 38 The evidence statements provided below relate to approaches which focus on modifying behaviours and improving HIV prevention outcomes. The general level evidence supporting these kinds of intervention is good in regard to reductions in UAI, although the high level review evidence tends to be aggregated and thus lacks specificity with regard to the details of specific intervention content. We provide evidence informed detail relating to best practice firstly within HIV prevention and secondly within the broader health behaviour change domain. It is anticipated that commissioning briefs, or tendering for prevention services, draw upon both the existing evidence relating to the broad health behaviour change literature (i.e. the conceptual and theoretical specificity outlined in Table 9 and Table 2). 14 Good Practice Guidance on HIV Prevention in Men who have Sex with Men The following table provides supporting evidence statements on behavioural intervention content. Table 2: Evidence statements on behavioural intervention Evidence Statement Behaviour change interventions can increase condom use Evidence Strength for Behavioural Interventions (A) Evidence Source Herbst JH, Sherba RT, Crepaz N, Deluca JB, Zohrabyan L, Stall RD, et al. A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men. J Acquir Immune Defic Syndr 2005;39(2):228-41. Noar SM. Behavioral interventions to reduce HIV-related sexual risk behavior: review and synthesis of meta-analytic evidence. AIDS Behav 2008;12(3):335-53. Downing J JL, Cook PA, Bellis MA. Prevention of sexually transmitted infections (STIs): a review of reviews into the effectiveness of non-clinical interventions Evidence Briefing Update: Liverpool John Moores University Centre for Public Health, 2009. Behaviour change interventions can result in reduced STI incidence. (A) Koblin B, Chesney M, Coates T. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet 2004;364(9428):41-50. Kamb ML, Fishbein M, Douglas JM, Jr., Rhodes F, Rogers J, Bolan G, et al. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group. JAMA 1998;280(13):1161-7. Johnson BT, Scott-Sheldon LA, Huedo-Medina TB, Carey MP. Interventions to reduce sexual risk for human immunodeficiency virus in adolescents: a meta-analysis of trials, 1985-2008. Arch Pediatr Adolesc Med 2011;165(1):77-84. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 15 Evidence Statement Evidence Strength for Behavioural Interventions Evidence Source Behaviour change interventions are cost effective for interventions preventing HIV in MSM. (A) Herbst JH, Sherba RT, Crepaz N, Deluca JB, Zohrabyan L, Stall RD, et al. A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men. J Acquir Immune Defic Syndr 2005;39(2):228-41. Behaviour change interventions most successful in reducing risky sexual behaviour are based on theoretic models and included interpersonal skills training. (A) Herbst JH, Sherba RT, Crepaz N, Deluca JB, Zohrabyan L, Stall RD, et al. A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men. J Acquir Immune Defic Syndr 2005;39(2):228-41 Johnson WD, Diaz RM, Flanders WD, Goodman M, Hill AN, Holtgrave D, Malow R, McClellan W. Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men. Cochrane Database Syst Rev. 2008:CD001230. B1.2.1Translating The Evidence Regarding ‘Interpersonal Skills’ and ‘Theory Informed’ Into Practice In this section we explore further how to interpret the evidence relating to ‘interpersonal skills’ and ‘theory informed’. It is important that the reader understands, that the material presented below is not ‘evidence-based’ (i.e. no interventions have been developed, or evaluated, which focus upon these very particular aspects). Instead the examples below represent a translation of the wider evidence into potential ideas for the content of HIV prevention in MSM (the latter does however provide overall direction and a sense of ‘proof of concept’). B1.2.1.1.Interpersonal Skills Interventions using the skills outlined in Box 1 would require formative, process and robust outcome evaluation in order to demonstrate effectiveness. When thinking about interpersonal skills it is important to consider the concept of ‘parsimony’. Parsimony suggests that the more specific the skills targeted within an intervention are, the more likely that the corresponding specific behaviour will change as a result. As such it is important to consider the specificities of interpersonal skills which may be relevant to sexual health improvement and provide interventions which focus on the acquisition of particular skills. For example, through scripting, role playing (or the range of techniques listed below), interventions can focus on the following skills across various intervention delivery modes. 16 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Box 1: Range of Skills Acquisition Required in Negotiating Safe Sex in MSM Condom use skills with casual partners (e.g. timing skills, insistence skills), Condom use skills with regular partners (e.g. managing intimacy, managing sexual scripts), Condom use skills in group sex, Condom use skills in darkrooms Condom negotiation skills in a variety of locations in which sex takes place or is arranged (for example, PSE sites where verbal and non-verbal negotiation may take place, saunas, on-line, in group sex) Sexual communication skills with a variety of partner types and sites/modes of interacting (e.g. regular partners, casual partners, anonymous partners, partners picked up on-line) HIV testing skills Planning HIV testing and implementing testing intentions HIV status disclosure skills with a variety of partner types and sites/modes of interacting (e.g. regular partners, casual partners, anonymous partners, partners picked up on-line) Seroadaptive skills by HIV status and with a variety of partner types and sites/ modes of interacting (e.g. regular partners, casual partners, anonymous partners, partners picked up on-line) B1.2.1.2.Theoretical Underpinnings In terms of the different theories which may underpin behaviour change interventions, there is a range of useful guidance accessible to a variety of audiences, for example, NICE guidelines (2007) ‘Behaviour change at population, community and individual levels’7 cited above in Section A, from Government Social Research (GSR)16 or from the global HIV prevention group.17 Across the variety of theories of behaviour change there are commonalities and differences in concepts and concomitant techniques to change behaviour. Box 2, adapted from Abraham & Michie (2007)18 seeks to open up the issue of how theory can be useful in shaping interventions (across a range of outcomes and a range of modes of delivery). This is also illustrated in a fuller list of techniques and theories in Appendix 4: Suggested Techniques of Sexual Health Behavioural Change Interventions and Links to Theoretical Frameworks. Again, the ideas are an adaptation of what is known to be good practice (i.e. a translation of ‘theory informed’ rather than evidence-based). The techniques outlined below are selected as examples of how theory informed techniques may be used to structure intervention content. It may be useful to think for example, how these techniques can be used to enhance the skills outlined in Figure 4 in conjunction with thinking through how these techniques can be adapted to suit different intervention delivery approaches (see B2. The Delivery of Interventions on page 21). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 17 Box 2: Selected techniques of sexual health behavioural change interventions and links to theoretical frameworks (Note: A fuller list is attached as Appendix 4: Suggested Techniques of Sexual Health Behavioural Change Interventions and Links to Theoretical Frameworks) IMB = information-motivation-behavioural skills model; TRA = theory of reasoned action; TPB = theory of planned behaviour; SCogT = social-cognitive theory; CT = control theory; OC = operant conditioning. Provide information about the approval of key others (TRA, TPB, IMB) Inform about what significant others (e.g., friends, peers, partners) think about the person’s condom use and whether significant others will approve or disapprove of condom use/non-use/barebacking Model or demonstrate the behaviour (SCogT) An expert shows the person how to correctly perform a behaviour, for example, thinking through and identifying the correct size of condom, its correct application, and illustrating sexual positions that allow condom checking, for example, through one to one interactions, as a group exercise, or on line video clips. Prompt specific goal setting (CT) Involves detailed planning of what the person will do, for example, in terms of having an HIV test thinking through where, when, how, or with whom. This should involve including a definition of the behaviour (e.g. having an HIV antibody test), specifying frequency (e.g. once every six months), intensity, or duration (e.g. for the next 3 years) and a specification of at least one specific context (stating which HIV testing site to be used and within which clinic, for example, same day testing clinic). Prompt self-monitoring of behaviour (CT) The person is asked to keep a record of specified behaviour(s) (e.g., a sexual health diary which details condom use challenges and successes) Agree on behavioural contract (OC) Agreement (e.g., signing) of a contract specifying behaviour to be performed so that there is a written record of the person’s resolution witnessed by another. For example, using peer interactions between MSM as a mechanism by which MSM sign a commitment to themselves and each other to use condoms correctly and consistently for a specified duration of time. Provide opportunities for social comparison (SCompT) Facilitate observation of non- expert others’ performance for example, in a group class or using video or case study, for example, providing examples of other MSM and their sexual health behaviour as a means of benchmarking an individual’s sexual behaviour Source: Abraham, C & Michie, S (2007) A taxonomy of behaviour change techniques used in interventions. Health Psychology, 27, 379-87. 18 Good Practice Guidance on HIV Prevention in Men who have Sex with Men B1.3 Recommendation on Structural Intervention Lastly, a range of structural interventions which encompass a wide variety of cultural, social, economic and political determinants are also necessary. Here we highlight the evidence supporting a broad range of structural interventions which encompass a wide variety of cultural, social, economic and political interventions. It is worth bearing in mind that there is less robust evidence of effectiveness for many of these kinds of interventions as they are less amenable to Randomised Control Trial (RCTs) designs as a result of ethical and pragmatic reasons (e.g. the challenges of finding and randomising controls at national levels). Within this section it is worth noting that very little evidence is MSM specific. A range of structural interventions which encompass a wide variety of cultural, social, economic and political determinants are also necessary. 6. Ensure that interventions address the wider social and cultural determinants of HIV risk related behaviour amongst MSM (e.g. through challenging heteronormativity and homophobia, promoting social inclusion and well being, community development, community mobilization). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 19 The following table provides supporting evidence statements on structural intervention content Table 3: Evidence statements on structural intervention content Evidence Statement Evidence Strength for Structural Interventions Evidence Source Knowledge/Awareness raising (D) / X Logical and theoretical precursor to behaviour change. Necessary but not sufficient alone. Community development / mobilisation (D) / X Logical and plausible approach necessary for any community level intervention to be delivered. Challenges to randomisation and thus problems with production of trial evidence. Within mass media interventions, dose response effects are observed. (C) Noar, S. M., Palmgreen, P., Chabot, M., Dobransky, N., Zimmerman, R. S.(2009). A 10-year systematic review of HIV/AIDS mass communication campaigns: Have we made progress? Journal of Health Communication, 14 (1), 15-42.6. (C) Note: multimedia social marketing campaigns had a significant impact on HIV testing uptake but were not effective in increasing STI testing uptake. Moreover, small to moderate effects are observed. Social Marketing Noar, S. M., Palmgreen, P., Chabot, M., Dobransky, N., Zimmerman, R. S.(2009). A 10-year systematic review of HIV/AIDS mass communication campaigns: Have we made progress? Journal of Health Communication, 14 (1), 15-42.6. Wei C, Herrick A, Raymond HF, Anglemyer A, Gerbase A, Noar SM. Social marketing interventions to increase HIV/STI testing uptake among men who have sex with men and male-to-female transgender women. Cochrane Database of Systematic Reviews 2011, Issue 9. Art. No.: CD009337. DOI: 10.1002/14651858. CD009337 20 Good Practice Guidance on HIV Prevention in Men who have Sex with Men B2.The Delivery of Interventions A number of lenses can be applied to HIV prevention in MSM when considering intervention delivery. These include level of delivery (e.g. individual, group and community), the settings within which they take place (gay identified and commercial or discreet public spaces or health services) and specific target groups to consider (based on sexual orientation, demography, BBV status or use of technology). This section considers the delivery of HIV prevention. Like the previous section there are multiple ways of conceptualising the delivery of interventions (for example, community level interventions are simultaneously experienced at the level of the individual). Before highlighting the evidence of effectiveness of various modes of delivery it is worth considering some of the ways interventions may be delivered. We suggest three complementary ways of thinking about intervention delivery (broadly speaking numbers of people, setting of sex and service delivery and by examples of MSM). Table 4: Intervention delivery – numbers of people Levels of delivery of behavioural interventions Individual Group Community One-to-one or face-to-face interactive interventions. These include voluntary counselling and testing, one-on-one counselling on its own (i.e. without HIV testing), individual cognitive behavioural therapy, face-to-face detached or outreach work, couple counselling, telephone help lines and some Internet-based work. Delivered to small groups of individuals, often from the same peer group, and are facilitated in some way. Sessions can be one-off or multiple, of varying length and intensity, and either didactic or interactive (or a mixture of both). They include school-based sex education, small-group work, and cognitive behavioural therapy. Small-group interventions usually provide a mixture of information and risk reduction skills training (including sexual negotiation skills), often involving role-play. Some interventions are explicit about the use of cognitive behavioural principles in getting group members to think about risky situations (including “triggers”) and to plan how they would respond. Delivered by, or within a defined “community” or target population. They include both interventions aimed at the population at risk and those aimed at organisations and professionals working with these populations. Community-level interventions include small media (leaflet/booklet); mass media (e.g. gay press advertising), condom provision, peer education and social diffusion, community empowerment and development; some Internet interventions (e.g chat rooms); and some organisational/institutional interventions, including training and technical advice…community-based projects do not usually require that individuals seek out the programme. Rather, community-level strategies reach out to gay men through, for example, social and sexual networks and so have the potential to contact a large number of people Source: Ellis, S., Barnett-Page, E., Morgan, A. et al. (2003). HIV prevention: a review of reviews assessing the effectiveness of interventions to reduce the risk of sexual transmission. (London: HDA) Good Practice Guidance on HIV Prevention in Men who have Sex with Men 21 In addition to categorising the social aspects of intervention delivery it is possible to consider the delivery of interventions in terms of settings where MSM meet and/ or engage in sex. Within each commissioning area local needs assessment should identify the locations and modalities in which sex and HIV prevention services take place. Table 5: Intervention delivery – setting of sex and service delivery Settings of Sex and Service Delivery Gay settings: While it can require practical or occasionally ethical considerations, these settings lend themselves well to condom and lubricant distribution, social marketing, clinical interventions including HIV testing, sexual health screening and social or emotional support. These settings are also a useful location to recruit for and gather research and survey data, to provide outreach to strengthen interventions and develop understanding of sexual health and emotional needs. Involvement of a number of professional, community, local authority and business stakeholders is needed to ensure intervention effectiveness. GUM clinics, HIV clinics, commercial venues, local national community events, saunas, sex clubs and/ or gyms. Management of venues for example can change and premises can disappear not long after they emerge, so sustainability and repositioning must be considered as well as the sustainability of events which rely on community or statutory resources. Discrete settings: GUM clinics, HIV clinics, Public cruising areas, Public Toilets, the internet MSM use discreet modes and locations for sex. Outreach in public sex environments was a common aspect of services targeting MSM until recently when technology shifted the focus from physical environments to the internet and online media. Social marketing which promotes regular HIV testing, condom delivery schemes, outreach in website chatrooms and technology to support test results and partner notification have all been deployed to access and support MSM in these settings. Online settings are not distinct, often operating in tandem acting to network and group men for public sex or negotiated privacy in MSM sex parties. Nor are the MSM population always distinct from heterosexual and bisexual men who use online and public sites for exhibitionist and group sex parties. The internet can reach such MSM and has therefore become a useful focus of research to improve access and inform on local needs. Involvement of community, local authority and advocacy stakeholders is needed if effectiveness is to be ensured. 22 Good Practice Guidance on HIV Prevention in Men who have Sex with Men An additional way of conceptualising intervention delivery is to think about key target groups, so some approaches to intervention such as social marketing highlight the issue of segmentation and targeting. Again local needs assessment will identify key signifiers within the local population. Table 6: Intervention delivery –types of MSM Examples of MSM Sexual orientation Gay, bisexual, bi curious, straight Demographics Young gay men, older gay men, white gay men, South Asian MSM, social deprivation, transmen Behavioural Those reporting a particular behavioural profile, for example, number of UAI partners Biomedical HIV positive, HCV co-infected, living with chronic illness Technology Those who use internet, those who use mobile phone technologies. In applying these different lenses and in terms of the existing evidence base, the following evidence statements, supported by the review of reviews (Lorimer et al. 2012) on intervention delivery apply; Recommendations on Delivery of Interventions 7. Ensure that full consideration is given to the combination of individual, group and community level interventions to be provided for MSM. 8. Ensure that full consideration is given to appropriate assessment of the implementation of existing or new technologies (e.g. computer assisted, video, text messaging, mobile phone applications, GPS) for intervention delivery. 9. Ensure that full consideration is given to time frame of intervention delivery and follow-up (booster) sessions. 10. Ensure that interventions are delivered in settings where sex takes place, gay venues and events and a provide information in a range of broader social settings (e.g. Bars, Gyms, GP surgeries, Libraries). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 23 The following table provides evidence statements on hiv prevention intervention delivery. Table 7: Provides evidence statements on hiv prevention intervention delivery Evidence Statement Evidence Strength Evidence Source There is inconsistent evidence across four meta-analyses to suggest that individual-level interventions are effective in reducing UAI among MSM. (A) Lorimer et al. 2012 There is consistent evidence across three meta-analyses (all 1++) for group-level HIV behavioural interventions being effective in changing risky sexual behaviour associated with HIV acquisition. (A) Lorimer et al. 2012 There is consistent evidence from four meta-analyses (three 1++ and one 1+) to suggest that community-level interventions are effective in changing sexual risk behaviours associated with HIV acquisition. (A) Lorimer et al. 2012 Computer assisted interventions are comparable in effect and should be considered as an alternative or adjunct to human delivered interventions (Not MSM specific) (C) Johnson WD, Hedges LV, Diaz RM. Interventions to modify sexual risk behaviors for preventing HIV infection in men who have sex with men The Cochrane Database of Systematic Reviews 2002, Issue 4, Art. No.: CD001230. DOI: 10.1002/14651858.CD001230 Bailey JV, Murray E, Rait G, Mercer CH, Morris RW, Peacock R, et al. Interactive computer-based interventions for sexual health promotion. Cochrane Database Syst Rev 2010(9):CD006483. Noar SM, Black HG, Pierce LB. Efficacy of computer technology-based HIV prevention interventions: a metaanalysis. AIDS 2009;23(1):107-15. There is evidence that safer sex advice videos in waiting rooms reduce rates of subsequent STI diagnosis but the effect size was not sufficient to recommend that this intervention is routinely introduced across all clinics (Not MSM specific). 24 (C) Warner L, Klausner JD, Rietmeijer CA, Malotte CK, O’Donnell L, Margolis AD, et al. Effect of a brief video intervention on incident infection among patients attending sexually transmitted disease clinics. PLoS Med 2008;5(6):e135. Good Practice Guidance on HIV Prevention in Men who have Sex with Men Evidence Statement Evidence Strength Evidence Source Intervention development needs to give consideration to the timeframe of intervention delivery and followup (booster) sessions that might ameliorate the diminishing effects in the medium- to long-term. (A) Johnson WD, Diaz RM, Flanders WD, Goodman M, Hill AN, Holtgrave D, Malow R, McClellan W. Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men. Cochrane Database Syst Rev. 2008:CD001230. New technological developments – smartphone applications etc. (D) Under theorised but likely important candidate in future research Interventions work best when delivered where sex takes place (D) No specific evidence but logical, good practice and theoretically plausible (proximal rather than distal determinants of behaviour) Good Practice Guidance on HIV Prevention in Men who have Sex with Men 25 B3.Recommendations on the Evaluation of Interventions Rigorous, robust and co-ordinated evaluation of HIV prevention interventions are an essential component of delivering effective HIV prevention. It is essential that they are funded and resourced and that commissioners ensure they take place in addition to, and as a result of, local needs assessment, planning and community consultation. Evaluation should focus upon intervention development, process evaluation and outcome evaluation. Intervention outcomes should be established at the start of projects, and should be appropriate to the intervention, be realistic and measurable. Table 9 provides a hierarchy of potential intervention outcomes, their policy drivers and details of how to measure them. Lowe et al. (1999) describe three main types of evaluation: • Process evaluation focuses on and measures the processes, activities and methods of planning and implementation. It covers issues of reach, quality, client satisfaction and cost. Both qualitative and quantitative research can be used in process evaluation. Process evaluations are valuable to practitioners in giving an understanding of how and why interventions work, and whether they are practical in other settings • Impact evaluation measures the immediate effects of health promotion activity, i.e. the changes in modifying factors (e.g. increased knowledge or skills, or availability of services). These effects may then contribute to longer-term outcomes such as sexual behaviour change. Impact evaluations indicate what changed and by how much • Outcome evaluation measures the long-term effects of health promotion interventions in achieving higher level goals like behaviour change and incidence (Hawe, 1990). Summary from Ellis et al.2003 pp17-18 see also Nutbeam, 1998 26 Good Practice Guidance on HIV Prevention in Men who have Sex with Men An evaluation should be appropriate to the intervention being evaluated and best able to answer the questions posed. Table 8 shows which study types best answer the questions likely to be posed in an intervention evaluation. Process of service delivery How does it work? Salience Does it matter? Safety Will it do more good than harm? Acceptability Will MSM be willing to or want to take up the service offered? ✓✓ ✓ ✓✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓ Cost effectiveness Is this the right service for these MSM? Satisfaction with the service ✓✓ ✓ ✓ ✓ ✓ ✓ ✓✓ Is it worth buying this service? Appropriateness Nonexperimental evaluations Quasiexperimental studes Does this work? Does doing this work better than doing that? RCTs Effectiveness Cohort studies Case-control studies Survey Qualitative research Table 8: Evidence typology ✓✓ ✓✓ ✓✓ ✓✓ ✓ ✓ Are users, providers and other stakeholders satisfied with the service? Adapted from Petticrew & Roberts, 200319 Table 8 also demonstrates that a combination of study types may be necessary to fully evaluate an intervention. The chosen evaluation design should be justified as part of the commissioning process. Intervention providers should consider partnership working with academic/commercial researchers to provide expertise and to facilitate the best possible evaluation. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 27 The majority of the successful interventions in the Lorimer et al. 2012 review were conducted in the US and replication of successful interventions in new settings is not always straightforward. Although the review assessed the transferability of the successful interventions, evaluation is key to assessing this and to ensuring intervention impact on MSM is measured. Previous experience has shown that interventions proven as effective in the US can produce different results in the UK and even do harm. The Gay Men’s Task Force intervention failed to replicate reductions in sexual risk behaviour of the US intervention study on which it had been modelled20,21 while another group-based intervention, effective in the US, actually increased STIs in the intervention group in the UK.22 Interventions should be subject to initial testing prior to full initiation and evaluation. Ideally, intervention evaluations should assess biological outcomes, which could make them necessarily large and expensive. Therefore, it is important to first demonstrate the feasibility and acceptability of such interventions for the population concerned. Successful evaluations have incorporated detailed evaluation of the intervention’s development and testing, prior to initiation of intervention implementation and outcome evaluation. Intervention providers should ask themselves and demonstrate (either prior to or in the evaluation of the commissioned intervention) what interventions aim to do: • What outcomes will the intervention aim to change? • How will change be brought about? • Does the intervention have a strong theoretical basis? • What does the intervention involve exactly? • Can it be fully described (and therefore replicated)? • Is it supported by existing evidence? Intervention providers should ask themselves and demonstrate (either prior to or as part of the evaluation of the commissioned intervention) if the intervention is feasible: • Can the intervention be delivered as intended? • Is the intervention acceptable to the target population and service providers? • Will participant recruitment and retention rates be adequate to evaluate the intervention? • What numbers will be required for the main intervention evaluations to assess biological outcomes? Is this feasible? The answers to these questions should determine if, and how, the intervention proceeds to a full evaluation. Even well established interventions (i.e. free condom distribution) should employ some level of evaluation such as measuring uptake or conducting occasional surveys of user experience. As advised by NICE in Section A, all interventions need to be developed and evaluated in stages, using an established approach such as the Medical Research Council’s framework23 along with the evidence informed advice within their guidance for the development and evaluation of complex interventions.24, 25, 26, 27 28 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Such an approach will help ensure interventions are based on the best available evidence of feasibility, acceptability, safety, effectiveness, efficiency or equity. This section draws heavily on this current HIV prevention guidance and its recommendations mainly represent good practice, but refer to studies that have successfully employed such evaluation approaches where possible. Outcome evaluation – the measure of effect that an intervention has – is essential and should be included, particularly for any new or novel intervention. The outcomes to be measured should be clearly defined at the start. Tried and tested outcome measures, comparable to other available data, should be used where possible. New outcome measures should be properly piloted and tested before use. Routinely collected data (e.g. HIV/STI rates and testing levels, NaSH clinical data) can be used as outcomes where possible and if appropriate to the intervention. Process evaluation is useful, particularly for understanding the relative contribution of intervention’s components on outcomes, and should be included in evaluation. Process evaluation should include monitoring of the delivery of the evaluation. Qualitative research can be used to explore the experiences of intervention participants and providers and these data, Cost-effectiveness / Economic Evaluation should be included if possible, though it is recognised that this is a difficult area and there is a lack of evidence to inform such economic evaluations of interventions for MSM (NICE, 2011). At the very least, the cost of the intervention versus the potential benefit to be achieved should be assessed (e.g. total cost of the intervention/number of HIV cases prevented = cost per HIV case prevented28). Economic evaluations require: • Comparison of the intervention with standard care or treatment; • Clearly defined intervention so all resources (i.e. staff, equipment, supplies and services etc.) are included in the evaluation; • Clear outcomes, which can be combined into a generic measure (e.g. Quality Adjusted Life Years) for comparison; • Recording of costs and effects across the intervention period (longer term effects can be modelled); • Inclusion of external, routine data where appropriate; and, • Clear perspective, whether health service specific or wider societal impact to be assessed. Intervention providers should consider partnership working with health economists to provide expertise and support and to facilitate the best possible economic evaluation. Examples of economic evaluations for STI interventions are also available.29, 30 Ethical and Data Protection Considerations Due consideration should be given to the ethical implications of any evaluation, with formal ethical approval sought as necessary. Legal compliance with the Data Protection Act should be assured. Evaluations should, as standard, follow research governance and good practice guidance.31 Good Practice Guidance on HIV Prevention in Men who have Sex with Men 29 As noted in the Introduction, a combination approach to HIV prevention, which aims to select the optimal mix of interventions that will have the greatest impact on reducing HIV transmission should be employed. As such, interventions may seek to affect a number of outcomes. However, central to this should ultimately be the reduction of HIV transmission at the population level, and how interventions, and their related outcomes, will aim to facilitate this should be made clear during the commissioning process. Outcomes should be established at the start of projects, appropriate to the intervention, realistic and measurable. Consideration of outcomes cannot be separated from consideration of intervention content, delivery and evaluation. Recommendations on Evaluation of Interventions 11. Ensure that the most rigorous and appropriate intervention evaluation design is deployed, which should encompass formative, process, outcome and economic components. 12. Ensure clear alignment of evaluation outcomes to the intervention’s intended impacts (e.g. an intervention designed to change specific behaviours must measure those behaviours – and / or the behaviours / determinants preceding the interventions). 13. Ensure comprehensive evaluation is given to assess the effectiveness of novel interventions and their transferability and feasibility. 14. Ensure that expertise, partnership and adequate funding are sought whenever possible (e.g. in relation to ethics, research methods and analysis, sampling and recruitment, user engagement and intervention transferability). 15. Ensure that independent evaluation is commissioned separately from intervention / service delivery. 16. Ensure the maximisation of evaluation capacity through innovative – potentially regional or national – partnership work with external commercial agencies, academic institutions and funding bodies. 30 Good Practice Guidance on HIV Prevention in Men who have Sex with Men B4.Recommendations to Meet Research Gaps The guideline development process has also highlighted a number of gaps in knowledge regarding the health needs, communication methods and the transferability of interventions to a Scottish MSM population. These are most relevant at national level and are recommended for consideration by the Sexual Health and Blood Borne Virus Framework’s Data and Monitoring Group. 1. A systematic mapping of the effectiveness of a range of means of sampling, recruiting and engaging the full diversity of MSM in Scotland should be conducted. 2. Examination of the potential of new and developing communication technologies for intervention delivery (e.g. systematic review, formative evaluation, feasibility study) should be conducted. 3. Assessment of the transferability (e.g. feasibility to target populations, settings and service providers) of effective interventions which have been developed outwith the UK is required. As interventions are delivered in a more combined and cohesive way, sharing findings and outcomes (whether successful or unsuccessful) is an essential component of learning and improvement. This can be done formally through academic routes such as publication of results in a range of formats (conferences, journals, e.g. WiSH, or informally through other professional networking). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 31 Table 9: Suggested outcome Hierarchy for MSM Intervention Type Biomedical Intended Outcomes HIV • Transmission or acquisition • Undiagnosed HIV infection • Late diagnosis of HIV (a CD4 count less than 350) • Recency of HIV infection • HIV / Hepatitis C coinfection How To Measure Sexual Health & BBV Framework 2011-15 HPS Surveillance Reports NHS Clinical Standards for HIV ISD / NaSH Data BASHH / BHIVA Guidance on Testing ISD Annual Reports & KCIs Other sexually transmitted infections Sexual Health & BBV Framework 2011-15 HPS Surveillance Reports • Rectal gonorrhoea ISD Annual Reports & KCIs ISD / NaSH Data • Other bacterial STI’s Behavioural Key Drivers • HIV / syphilis co-infection HPS Surveillance Reports Unprotected anal intercourse BASHH / BHIVA Guidance on Safer Sex Making it Count Condom use BASHH / BHIVA Guidance on Safer Sex Making it Count Number of sexual / anal / unprotected partners Making it Count Needs assessment / Survey Data* MRC Bar Survey Needs assessment / Survey Data* MRC Bar Survey Needs assessment / Survey Data* MRC Bar Survey Partners of unknown HIV status Making it Count Needs assessment / Survey Data* MRC Bar Survey Partners of discordant HIV status Making it Count Needs assessment / Survey Data* MRC Bar Survey Frequency / number of casual partners Making it Count Needs assessment / Survey Data* MRC Bar Survey Oral intercourse 32 BASHH / BHIVA Guidance on Safer Sex Good Practice Guidance on HIV Prevention in Men who have Sex with Men Intervention Type Intended Outcomes Sexual risk reduction strategies • Negotiated safety • Serosorting Key Drivers BASHH / BHIVA Guidance on Safer Sex Making it Count How To Measure Needs assessment / Survey Data* MRC Bar Survey • Strategic positioning • Withdrawal before ejaculation Service uptake Abstinence Making it Count Needs assessment / Survey Data* HIV testing Sexual Health & BBV Framework 2011-15 HPS Surveillance Reports NHS Clinical Standards for HIV ISD / NaSH Data • Ever testing • Recency of testing • Frequency of testing (6 monthly / annual etc) BASHH / BHIVA Guidance on Testing NICE Guidance and Scottish Briefing Making it Count HPS Surveillance Reports STI testing • Recency of testing • Frequency of testing (6 monthly / annual etc) HIV treatment and care • Treatment uptake (when clinically indicated) • Treatment response (viral load suppression) Sexual Health & BBV Framework 2011-15 HPS Surveillance Reports ISD Annual reports & KCIs ISD / NaSH Data Sexual Health & BBV Framework 2011-15 HPS Surveillance Reports NHS Clinical Standards for HIV Making it Count • Adherence Knowledge, attitudes, norms and intentions Knowledge of HIV, STIs, sexual risk behaviours, condom use, testing and other service use Needs assessment / Survey Data* Attitudes to HIV, STIs, sexual risk behaviours, condom use, testing and other service use Making it Count Needs assessment / Survey Data* Norms of HIV, STIs, sexual risk behaviours, condom use, testing and other service use Making it Count Needs assessment / Survey Data* Good Practice Guidance on HIV Prevention in Men who have Sex with Men 33 Intervention Type Intended Outcomes Key Drivers How To Measure Intentions to change sexual risk behaviour, adopt condom use, go for HIV or other STI testing Making it Count Levels of coercion and sexual harm Sexual Health & BBV Framework 2011-15 Needs assessment / Survey Data* Levels of sexual regret Sexual Health & BBV Framework 2011-15 Needs assessment / Survey Data* Source: Adapted from Noar SM. Behavioural interventions to reduce HIV-related sexual risk behaviour: review and synthesis of meta-analytic evidence. AIDS and Behaviour 2008;12:335-353 34 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Appendix 1: Commissioning Template for MSM Interventions Note: This is suggested as a basic structure for detailed discussion and decisions on local intervention approaches and to inform the development of Service Level Agreements and Contracts for HIV Prevention work with MSM. Key Considerations 1. Effective Targeting Agreed Local Intervention / Approach Measured in Service Level Agreement or Contract (Y / N) Consultation and needs assessment Non-homogenous Population; age, identity, ethnicity, social class. Settings where sex takes place; discreet, gay identified, private Use of technologies 2. Combination Approach Biomedical, behavioural, structural dimensions Cohesion and partnership / coordination 3. Effective Content Effective biomedical aspects Effective behavioural aspects Theoretical underpinning and skills focus. 4. Effective Delivery Level of delivery to individual, group or community. Strength of evidence of delivery mechanism. 5. Appropriate Outcomes Specific biomedical and / or behavioural outcomes identified. 6. Effective Evaluation Design Impact, process and economic evaluation components. Ethical considerations 7. Shared Learning Transferability of learning through formal published or informal networking. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 35 Appendix 2: Needs Assessment Parameters A needs assessment should include diverse research methods; each particular method can be employed for its specific strengths. This series of steps will contribute to a rigorous mapping of the MSM population and an engagement with their needs. 1. Epidemiology Secondary data analysis of existing local and regional epidemiology will present a rigorous, yet limited broad brush account of your region in terms of incidence, prevalence, CD4 counts, time since HIV diagnosis, and some limited indication of local demographics (e.g. age, country of HIV acquisition). 2. Mapping the local population a) Scope the locations in which, and modes by which, men meet each other for sex, social engagement or health engagement, for example: • Consult gay travel guides such as ‘Spartacus’ • Use the internet and internet dating sites such as ‘gaydar’ and ‘squirt’ or • Employ smartphone applications such as ‘grindr’, ‘scruff’ or ‘growlr’. b) Engage in focussed dialogue with MSM ‘gate-keepers’ (i.e. approachable individuals who are willing to share their expert local knowledge) to identify a list of specific sites (both virtual and real). c) Engage in systematic participant observation of each site and track site users by time (of the week, and of the day / night) and assess volume of men and record demographic information where available (e.g. age, ethnicity, use of family cars). 3. Assessing Service Provision Map existing services, both geographically and in terms of opening hours, engage in systematic participant observation of service users by time and assess volume of men and record demographic information where available (e.g. age and ethnicity). 4. Stagger different research methods In general it is best to use exploratory methods of data collection first (e.g. qualitative, participant-led approaches such as one-to-one interviews or focus groups which allow the exploration participant expertise, local knowledge and culture). Systematic methods which can assess exploratory qualitative findings more rigorously should follow (e.g. quantitative approaches such as questionnaires or audit). 36 Good Practice Guidance on HIV Prevention in Men who have Sex with Men 5. Collecting comparable data Always record response rates and calculate the number of men who are approached to take part in any research / consultation exercise and the number of men who refuse. Do not count those who have already provided data, or those who have already refused to participate. Data should be collected across all the sites identified above through mapping (thus capturing both service users and non-users). Ensure that when collecting data, it is comparable (and also comparable to other National Data sets where possible, see the main guideline document for details: http://www.hps.scot.nhs.uk/ bbvsti/publicationsdetail.aspx?id=52709). When assessing acceptability of services, knowledge levels, and perceptions of sexual health need, sexual risk behaviour or sexual health behaviours the exact same questions should be asked in all sites, and details of the time and location of data collection should be recorded. Together these steps enable a sense of how representative findings are (through response rate) and how diverse the populations are at various sites. 6. Assessing patterns of travel and sexual mixing Throughout the above process, focus upon collecting available data relating to travel and sexual mixing. Do men travel to other regions, cities, or particular venues to meet other men for sex, or for other social reasons? Do men from other regions visit or pass through yours? (e.g. a local cruising site recommended by word of mouth or online). Good Practice Guidance on HIV Prevention in Men who have Sex with Men 37 Appendix 3: Key Questions to Consider in Any Engagement with MSM • Who are you asking to engage, with what and why? • What precisely do you want from the engagement? • What decisions have already been made? What is negotiable? • Are you serious about listening to the response and incorporating it into your decision making? • Have MSM been involved in the planning stage? • How will you feedback to those who have engaged? • Should an independent community based advocate, service or agency lead this consultation? • Are there any conflicts of interest, loyalties to specific services to be taken into account? Who to engage with in preventing HIV among MSM Public Health, Clinical and Health Improvement Specialists In particular those with a remit for men who have sex with men (MSM) should be involved in design, development, delivery and to ensure the evaluation of interventions. Wider public health specialists in communicable diseases and stakeholders involved in health improvement and inequalities, including local authorities should also be involved or engaged in the process. Community Workers, Outreach Workers and other Detached (non-clinic-based) Staff In particular those who work with MSM. They can be essential to ensure relevance and effective targeting of MSM. In many parts of Scotland, expertise exists in community based and peer-led projects to deliver interventions and is hence often a chosen route for commissioning of MSM targeted activity. Owners of Commercial LGBT Venues These stakeholders have been supportive of condom distribution and social marketing in premises and these venues have been included in distribution schemes. They can also provide a safe and useful informal meeting place for MSM based on age, ethnicity or HIV status. Sponsors and Organisers of LGBT Events: Local and national events can be a useful means of distributing condoms and social marketing materials while promoting equality and access to services for MSM. The scale of such events varies across Scotland and any likely sustained impact should be critically considered. 38 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Owners and Managers of Private Saunas and Gyms These have rapidly developed in urban settings and engagement with these stakeholders is therefore essential. Condom distribution, social marketing and promotion or delivery of clinical interventions, including HIV testing is increasingly deployed in saunas but challenges on effective positioning of media, lighting, location of sex, privacy and substance use by MSM can confound these interventions. Less intervention is offered in private gym clubs but these may require focus and active engagement will ensure effectiveness. Owners of UK-based Online Websites where MSM arrange Sex Engagement is important but often requires financial investment and significant negotiation to be authentic. Many websites are non-UK based companies, so there is a limit to the influence which those offering interventions can exert. The relationship between ‘dating’ websites where sex can be arranged and potential promotion of the selling of sex should be noted as a particular ethical dimension of engagement with these stakeholders. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 39 Appendix 4: Suggested Techniques of Sexual Health Behavioural Change Interventions and Links to Theoretical Frameworks Source: Abraham, C & Michie, S (2007) A taxonomy of behaviour change techniques used in interventions. Health Psychology, 27, 379-87 Note: IMB = information-motivation-behavioural skills model; TRA = theory of reasoned action; TPB = theory of planned behaviour; SCogT = social-cognitive theory; CT = control theory; OC = operant conditioning. Provide information about behaviour health link (IMB) Provide general information about sexual risk behaviours, for example, susceptibility to HIV transmission. Provide information on consequences of sexual behaviour change (TRA, TPB, SCogT, IMB) Inform about the benefits and costs of using condoms or UAI and, focus upon what will happen if the person does or does not perform the behaviour (i.e. transmission of STIs/HIV or side effects of ART). Provide information about the approval of key others (TRA, TPB, IMB) Inform about what significant others (e.g., friends, peers, partners) think about the person’s condom use and whether significant others will approve or disapprove of condom use/non-use/barebacking. Prompt intention formation (TRA,TPB, SCogT, IMB) Encourage the person to decide to act or set a goal, for example, to make a behavioral resolution such as “I will take an HIV test next week‘. Prompt barrier identification (SCogT) Identify barriers to performing a behaviour and plan ways of overcoming them, for example, identify the barriers to condom use within a sex party and systematically think of the particular ways of overcoming these barriers (e.g. carry own condom/ lube supply). Provide general encouragement (SCogT) Praising or rewarding the person for effort or performance without this being contingent on specified behaviors or standards of performance, for example always reward safer sexual behaviours even when HIV risk behaviours are reported. 40 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Set graded tasks (SCogT) Set easy tasks (e.g. locating condom supply), and increase difficulty of tasks (e.g. practising using them correctly, discussing them with sexual partners) until target behaviour is performed (e.g. consistent condom use with all sexual partners). Provide instruction (SCogT) Tell the person how to perform a behaviour and/or preparatory behaviour, for example, provide detailed instructions of correct condom use rather than suggesting ‘Use a condom’. Model or demonstrate the behaviour (SCogT) An expert shows the person how to correctly perform a behaviour, for example, thinking through and identifying the correct size of condom, its correct application, and illustrating sexual positions that allow condom checking, for example, through one to one interactions, as a group exercise, or on line video clips. Prompt specific goal setting (CT) Involves detailed planning of what the person will do, for example, in terms of having an HIV test thinking through where, when, how, or with whom. This should involve including a definition of the behaviour (e.g. having an HIV antibody test), specifying frequency (e.g. once every six months), intensity, or duration (e.g. for the next 3 years) and a specification of at least one specific context (stating which HIV testing site to be used and within which clinic, for example, same day testing clinic). Prompt review of behavioural goals (CT) Review and/or reconsideration of previously set goals or intentions. Encourage ongoing reflection and self-appraisal regarding correct and consistent use of condoms for example. Prompt self-monitoring of behaviour (CT) The person is asked to keep a record of specified behaviour(s) (e.g., a sexual health diary which details condom use challenges and successes) Provide feedback on performance (CT) Providing data about recorded behaviour or evaluating performance in relation to a set standard or others ‘performance, i.e., the person received feedback on their behaviour. Within one to one work (for example, on-line, or face to face) provide feedback on sexual health diary or record of safer sex challenges and successes. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 41 Provide contingent rewards (OC) Praise, encouragement, or material rewards that are explicitly linked to the achievement of specified behaviours such as HIV testing or consistent condom use. Teach to use prompts or cues (OC) Teach the person to identify environmental cues that can be used to remind them to perform a behaviour, including times of day or elements of contexts (for example, focus upon building cues between the use of poppers and condom checking) Agree on behavioural contract (OC) Agreement (e.g., signing) of a contract specifying behaviour to be performed so that there is a written record of the person’s resolution witnessed by another. For example, using peer interactions between MSM as a mechanism by which MSM sign a commitment to themselves and each other to use condoms correctly and consistently for a specified duration of time. Prompt practice (OC) Prompt the person to rehearse and repeat the behaviour or preparatory behaviours, for example, encourage positive men to rehearse and practice online HIV disclosure skills within netreach or peer support groups, as a means of mastering seroadaptive skills. Use follow-up prompts. Contacting the person again after the main part of the intervention is complete (so resourcing and providing follow up interactions between peer educators for example) Provide opportunities for social comparison (SCompT) Facilitate observation of non- expert others’ performance for example, in a group class or using video or case study, for example, providing examples of other MSM and their sexual health behaviour as a means of benchmarking an individual’s sexual behaviour Plan social support or social change (social support theories) Prompting consideration of how others could change their behaviour to offer the person help or (instrumental) social support, including “buddy “systems and/or providing social support. For example, working with MSM and providing supportive sexual health mentors or buddies for newly diagnosed positive men. Prompt identification as a role model Indicating how the person may be an example to others and influence their behaviour or provide an opportunity for the person to set a good example, so encourage self-reflection and public presentation of safer sex heroes for example. 42 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Prompt self-talk Use of self-instruction and self-encouragement (aloud or silently) to support action (for example, focusing upon self-dialogue and self-praise regarding each step of condom use within group sex in sex on premises venues) Relapse prevention (relapse prevention therapy) Following initial change (e.g. condom use), help identify situations likely to result in failure to maintain new behaviours (e.g. the start of a romantic relationship) and help the person plan to avoid or manage these situations (e.g. through a variety of techniques outlined here) Stress management (stress theories) May involve a variety of specific techniques (e.g., progressive relaxation) that do not target the behaviour but seek to reduce anxiety and stress Motivational interviewing Prompting the person to provide self-motivating statements and evaluations of their own behaviour to minimize resistance to change Time management Helping the person make time for the behaviour (e.g., to fit it into a daily schedule) Good Practice Guidance on HIV Prevention in Men who have Sex with Men 43 Appendix 5: Methodology Employed in Guideline Development This guidance represents the view of a multidisciplinary group convened in Scotland under the auspices of the Health Protection Network (HPN). The guideline development group (GDG) followed a systematic development framework proposed by the HPN32 in line with the principles of SIGN methodology. The grading of evidence is detailed above in evidence statements to support this guideline’s recommendations. As part of this methodology, the evidence level of each component of this literature was also categorised as detailed in Table 10. Table 10: Evidence level criteria as per SIGN 50 Guideline Developer’s Handbook Evidence Level 1++ Sign 50 Criteria High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 44 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series, qualitative research 4 Expert opinion Good Practice Guidance on HIV Prevention in Men who have Sex with Men Table 11: Recommendation grading criteria, SIGN 50 Guideline Developer’s Handbook Grading SIGN 50 Criteria A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ X Good practice points Recommended best practice based on the clinical experience of the guideline development group. (Note: For a definition of evidence level criteria 1++ to 4, see Table 10) Recommendations given in this guideline resulted after careful review and consideration of the evidence available and principles of best practice. It is evidence based where possible and evidence informed where necessary. The evidence base for this guideline was synthesised from three sources. These included a systematic review of reviews commissioned specifically for this guidance development (Lorimer et al. 2011): a summary is included below and the full review report will be published on the NHS Health Scotland website to coincide with final guideline publication. The systematic reviewing and evidence grading associated with the development of the ‘The United Kingdom National guideline on safer sex advice. In July 2011 Clutterbuck et al. (2011) was also incorporated into this process and finally, these systematic reviews were supplemented by consultation with the guidance development group, additional focussed searches and evidence scoping within the gray literature. The GDG agreed that given problems with extracting directly useful and transferable knowledge from some of the review level evidence (i.e. The Lorimer 2011 review), the proportion of recommendations which are not supported by high level evidence but that do relate to common sense, logic or inherent problems with operationalising interventions within an evidence-based framework, the GDG made a pragmatic decision not to grade individual recommendations, but where possible to grade the supporting evidence statements utilising a framework based upon SIGN 50: a developer’s handbook. Throughout reference to supportive evidence has been given, though. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 45 To further illustrate, a) a narrative case study of the Lorimer et al. 2011 review and b) a summary of the development of BASHH Guidance on Safer Sex are also included below: a) Systematic review of reviews of behavioural HIV prevention interventions among men who have sex with men Karen Lorimer,1† Lisa Kidd,1 Maggie Lawrence,1 Kerri McPherson,1 Sandi Cayless,1 Flora Cornish1 Glasgow Caledonian University, School of Health and Life Sciences, Glasgow, Scotland, UK, G4 0HF † Corresponding author: E-Mail: [email protected] Tel: ++44 (0)141 331 8860 Fax: ++44 (0)141 273 1133 Funding for the work: NHS Health Scotland 1 Identification of studies In October 2010, electronic databases were searched i.e. Cochrane Database of Systematic Reviews; The Centre for Reviews and Dissemination’s Database of Abstracts of Reviews of Effectiveness; JBI (Joanna Briggs Institute) Library of Systematic Reviews; Medline; EMBASE; Web of Science (including Social Science Citation Index); PsycINFO; CINAHL. The database searches were supplemented by visually scanning the reference lists of retrieved documents to identify any additional relevant systematic reviews. Topic experts were also consulted to ensure inclusion of all relevant material. A comprehensive search was developed for Ovid Medline and adapted for other databases using subject headings (e.g. MeSH) and key words and their synonyms, relating to HIV prevention, MSM, behavioural interventions and systematic review methods. Currency (January 2000 – October 2010) and language (English) limiters were applied. Inclusion criteria Titles and abstracts of retrieved bibliographic records were screened independently by two reviewers, with duplicate records filtered out at this stage. Two reviewers then independently screened the titles and abstracts of retrieved bibliographic records for relevance and potential inclusion, using the following inclusion criteria: 1) study design limited to systematic reviews, meta-analyses or meta syntheses; 2) exclusive focus on MSM, or mixed population studies that included MSM and from which MSM-specific data could be extracted; 3) focus on behavioural interventions; 4) published in English; 5) published since January 2000; 6) the included review is the up-to-date version of multiple papers. We rejected reviews if all, or most, studies included in the paper were also included in other, larger, more comprehensive reviews, which is more recent and/or of higher quality (according to SIGN 50 [Scottish Intercollegiate Guidelines Network] methodology checklist for systematic reviews and meta-analyses). 46 Good Practice Guidance on HIV Prevention in Men who have Sex with Men Study quality We developed a critical appraisal tool (CAT), informed by SIGN 50 and Ellis et al. 2003, which focused on issues of methodological quality, e.g. the systematic nature of the review process, transparency of process and application of appropriate methods of analysis. Quality appraisal was undertaken on full text documents that met our review-specific criteria. We used the SIGN 50 methodology checklist for systematic reviews and meta-analyses to grade the papers: where high quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias are graded 1++; and, well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias are graded 1+ (see Table 10). No reviews were excluded on the basis of low quality. Data extraction and synthesis Data were extracted by two reviewers independently using a standardised template developed specifically for this review of reviews, informed by previous ‘review of review’ data extraction tools. Disagreements between reviewers were resolved through discussion and in one case by involving a third member of the research team to reach a resolution. Due to issues of heterogeneity, data were not combined statistically; therefore, data synthesis was conducted, using narrative methods. Good Practice Guidance on HIV Prevention in Men who have Sex with Men 47 b) The United Kingdom National guideline on safer sex advice The Clinical Effectiveness Group of the British Association for Sexual Health and HIV (BASHH) and the British HIV Association (BHIVA). Post Consultation Draft 1. July 2011 D.J. Clutterbuck,1 P.Flowers,1 A.Fakoya,2 T.Barber,3 H.Wilson,1 M.Nelson,3 S.Kapp,4 B.Hedge,4 A.K. Sullivan5 British Association for Sexual Health and HIV, 2British HIV Association, 3BASHH HIV Special Interest Group, 4British Psychological Society, 5BASHH Clinical Effectiveness Group 1 Rigour of development The guideline was developed by review of Cochrane Library, Medline, Embase and Conference reports and existing guidelines from 2000-Week 40 2008. Following consultation main title searches and searches relating to seroadaptive behaviours and HIV transmission were repeated and updated to May 2011. Main title searches included keywords ‘Condoms’ (1762 citations), ‘Behavioural interventions’ and ‘Motivational interviewing’. Other keyword searches included ‘STI prevention’, ‘combination prevention’, safer sex, ‘condom error/s’, ‘condom breakage’, ‘female condom’ ‘partner reduction’, ‘abstinence’, ‘contraception’, ‘negotiated safety’, ‘serosorting’, seroadaptive, ‘testing in relationships’, ‘frequency AND rescreening’, ‘seminal viral load’ and others. ‘Oral sex’, ‘anal sex’, ‘digital’, ‘non-sexual’, ‘accidental’, ‘non-sexual’ and ‘kissing’ were combined individually without mapping with sexually transmitted infections, HIV, syphilis, HSV chlamydia, gonorrhoea, warts. STI risk combined with ‘sex workers’, sex work, ‘prisoners’, ‘looked after, accommodated, adolescents’, Title searches were used by individual co-authors to identify articles of relevance. Articles published in English only were included. In the absence of directly applicable evidence, recommendations are based on expert opinion and practice. Qualifying statement The recommendations in this guideline may not be appropriate for use in all clinical situations. Decisions to follow these recommendations must be based on the professional judgement of the clinician and consideration of individual patient circumstances and available resource. 48 Good Practice Guidance on HIV Prevention in Men who have Sex with Men References 1 The Sexual Health & BBV Framework, 2011-15, Scottish Government, 2011. Available online at: http://www.scotland.gov.uk/Resource/ Doc/356286/0120395.pdf 2 Standards for Human Immunodeficiency Virus (HIV) Services, Healthcare Improvement Scotland 2011. Available online at: http://www. healthcareimprovementscotland.org/programmes/long_term_conditions/ hiv_treatment_and_care/hiv_standards.aspx 3 Sex Transm Infect. 2011 Dec 8. Trends in the incidence of HIV in Scotland, 1988-2009. McDonald SA, Hutchinson SJ, Wallace LA, Cameron SO, Templeton K, McIntyre P, Molyneaux P, Weir A, Codere G, Goldberg DJ. Available online at: http://www.ncbi.nlm.nih.gov/pubmed/22158935# 4 Knussen C, Flowers P, McDaid LM, Hart GJ. HIV-related sexual risk behaviour between 1996 and 2008, according to age, among men who have sex with men (Scotland). Sexually Transmitted Infections 2011; 87:257-9. http://sti.bmj. com/content/87/3/257.full.pdf+html 5 Hart G, Williamson L. Increase in HIV sexual risk behaviour in gay men in Scotland, 1996-2002: Prevention failure? Sexually Transmitted Infections 2005; 81:367-372. 6 Increasing the uptake of HIV testing among men who have sex with men (PH34), National Institute for Clinical and Healthcare Excellence, 2011. Available online at: http://www.nice.org.uk/PH34 7 Behaviour change (PH6) National Institute for Clinical and Healthcare Excellence, October 2007. Available online at: http://www.nice.org.uk/PH006 8 Community engagement (PH9) National Institute for Clinical and Healthcare Excellence, February 2008. Available online at:http://guidance.nice.org.uk/ PH9 9 United Kingdom National Guidelines On HIV Testing 2006, Clinical Effectiveness Group of the British Association of Sexual Health and HIV, 2006. Available online at: http://www.bashh.org/documents/63/63.pdf 10 The United Kingdom National guideline on safer sex advice The Clinical Effectiveness Group of the British Association for Sexual Health and HIV (BASHH) and the British HIV Association (BHIVA), Draft for Consultation. January 2011. Available online at: http://www.bashh.org/documents/3220 11 Standards for Psychological Support for adults with HIV, British Psychological Society, MedFASH, BHIVA, November 2011. Available online at: http://www. bps.org.uk/standards-psychological-support-adults-living-hiv 12 A Framework for Monitoring and Evaluating HIV Prevention Programmes for Most-At-Risk Populations, UNAIDS, World Health Organization, December 2010. Available online at: http://data.unaids.org/pub/Manual/2008/jc1519_ framework_for_me_en.pdf Good Practice Guidance on HIV Prevention in Men who have Sex with Men 49 13 Prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people Recommendations for a public health approach, World Health Organization (2011). Available online at: http://whqlibdoc.who.int/ publications/2011/9789241501750_eng.pdf 14 Medical Research Council (2011) Using natural experiments to evaluate population health interventions: guidance for producers and users of evidence: (http://www.mrc.ac.uk/Utilities/Documentrecord/index. htm?d=MRC008043) 15 Scottish Intercollegiate Guidelines Network, SIGN 50 Guideline Developer’s Handbook. Revised version Nov 2011. Available online at:http://www.sign. ac.uk/pdf/sign50.pdf 16 GSR Behaviour Change Knowledge Review, Government Social Research, 2008. Available online at: http://www.civilservice.gov.uk/wp-content/ uploads/2011/09/Behaviour-change_practical_guide_tcm6-9696.pdf 17 Behaviour Change and HIV Prevention:{Re} Considerations for the 21st Century, Global HIV Prevention Group, august 2008. Available online at: http://www.globalhivprevention.org/pdfs/PWG_behavior%20report_FINAL.pdf 18 Abraham, C & Michie, S (2007), A taxonomy of behaviour change techniques used in interventions. Health Psychology, 27, 379-87. Available online at: http://prepare.b.uib.no/files/2010/10/Charles-Abraham-Michie-2008taxonomy-paper.pdf 19 Petticrew M, Roberts H. Evidence, hierarchies and typologies: horses for courses. J Epidemiol Community Health 2003 57(7):527-9 20 Kelly JA, St. Lawrence JS, Diaz YE, Stevenson LY, Hauth AC, Kalichman SC, et al. HIV risk-related behaviour reduction following intervention with key opinion leaders of population: An experimental analysis. American Journal of Public Health 1991;81:168-171 21 Flowers P, Hart GJ, Williamson LM, Frankis JS, Der GJ. Does bar-based, peer-led sexual health promotion have a community-level effect amongst gay men in Scotland? International Journal of STD & AIDS. 2002;13(2):102-8. 22 Imrie J, Stephenson JM, Cowan FM, Wanigaratne S, Billington AJP, Copas AJ, et al. A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial. BMJ 2001;322:1451-1456. 23 Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: new guidance. London: Medical Research Council; 2008. British Medical Journal;337:a1655 24 Campbell M, Fitzpatrick R, Haines A et al. (2000) Framework for design and evaluation of complex interventions to improve health. British Medical Journal 321:694–6. 25 Campbell NC, Murray E, Darbyshire J et al. (2007) Designing and evaluating complex interventions to improve health care. British Medical Journal 334: 455–9. 50 Good Practice Guidance on HIV Prevention in Men who have Sex with Men 26 Flay BR (1986) Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programmes. Preventive Medicine 15: 451–74. 27 Nutbeam D (1998) Evaluating health promotion – progress, problems and solutions. Health Promotion International 13: 27–44. 28 Cohen D.A. et al. (2004) Comparing the cost-effectiveness of HIV prevention interventions. JAIDS Journal of Acquired Immune Deficiency Syndromes: 2004 - Volume 37 - Issue 3 - pp 1404-1414 29 Barham et al One to one interventions to reduce sexually transmitted infections and under the age of 18 conceptions: a systematic review of the economic evaluations. Sexually Transmitted Infections 2007;83:441-447. 30 Marseille E et al. (2011) The cost-effectiveness of HIV prevention interventions for HIV-infected patients seen in clinical settings. JAIDS;56:e87-e94. 31 British Psychological Society Ethical Guidance, August 2009. Available online at: http://www.bps.org.uk/sites/default/files/documents/code_of_ethics_and_ conduct.pdf 32 Health Protection Network for Scotland. Review of Activities 2007-2008. Available online at; http://www.hps.scot.nhs.uk/pubs/redirect.aspx?id=38927 Good Practice Guidance on HIV Prevention in Men who have Sex with Men 51
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