Good Practice Guidance on HIV Prevention in Men who have Sex

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
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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
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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
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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
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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
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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.
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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
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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.
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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
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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
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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
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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
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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
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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.
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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
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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.
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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
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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).
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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.
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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.
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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.
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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).
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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
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