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    DISCUSSION DOCUMENT:

    NUAA Wonders Forum Series on the World Health

    Organizations Guidance on prevention of viral hepatitis B

    and C among people who inject drugs

    July 2013

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    The New South Wales Users and AIDS Association

    NUAA is the state wide drug user organisation and our role is to represent those most affected by

    hepatitis C: people who inject drugs and are engaged in drug treatment as well as those that who

    use drugs illicitly across NSW.

    Founded in 1989, NUAA has contributed a great deal to achievements in NSW such as low rates of

    HIV amongst people who inject and as leaders in community controlled peer education, community

    development, peer support, research and policy we are ensuring that our community is at the

    forefront providing solutions to the challenges that viral hepatitis, illicit drug use and treatment

    pose.

    Introduction and scope of document

    In 2013, a series of forums entitled NUAA WONDERS... were held to discuss the five

    recommendations from the World Health Organisations (WHO) document, Guidance on prevention

    of hepatitis B and C among people who inject drugs.

    Each forum brought together a panel comprised of sector experts, members of the affected

    community and researchers to explore the WHO recommendations and their impact upon people

    who inject drugs (PWID) harm reduction and viral hepatitis prevention in NSW.

    The aim of this document is to:

    Give background detail and context to the WHOsGuidance document (referred to as theWHO Guidance document henceforth)

    Summarise each forum; including the main points discussed by the panel and audience Discuss the themes brought up in response to each recommendation in the WHO Guidance

    document that could impact on PWID in NSW

    Make recommendations for further action in NSW in relation to the WHO Guidancedocument recommendations

    Background to the World Health Organization Guidance Document

    The WHO is a specialised agency of the United Nations which deals with international public health.

    The WHO Guidance document is the first step in the provision of a comprehensive approach to viral

    hepatitis surveillance, prevention, and treatment by the WHO.1

    The WHO Guidance document includes background information regarding the global viral hepatitis

    epidemic. It states that 240 million people are living with chronic hepatitis B (HBV) and 170 million

    with chronic hepatitis C (HCV)2. The WHO sees the global response to these epidemics thus far as

    poor3. In Australia approximately 250,000 people have chronic hepatitis C (HCV). PWID are the

    population most at risk of hepatitis C transmission and acquisition.

    The primary concern for the WHO is that viral hepatitis has not been prioritised globally. The report

    states:

    1p7 World Health Organisation,(WHO), Guidance on prevention of viral hepatitis B and C among people who inject drugs ,Geneva (2012)

    available athttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html 2Ibid, 6

    3Ibid, 6

    http://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html
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    It is estimated that globally there are 16 million PWID and injecting drug use is reported in a least

    148 countries. Hepatitis B and hepatitis C and related diseases are endemic among PWID. To date,

    however, the urgency of preventing HIV among PWID has overshadowed the epidemic of viral

    hepatitis.4

    Focus, target audience, scope and objectives of the Guidance document

    The WHO Guidance document is aimed at low to middle income countries but appliesequally to high income countries

    5such as Australia.

    The target audience includes health professionals, policy makers, national programmemanagers, researchers, Non-Government Organisations (NGOs), community and civil society

    organisations and people who inject drugs (PWID).

    The main objective of the WHO Guidance document is to raise awareness on prevention ofhepatitis B and C transmission in PWID and to provide a tool for policy-making and advocacy

    as well as clinical guidance for front line professionals.6

    The recommendations regarding viral hepatitis prevention wereguided by systematic reviews of

    scientific evidence, community values and preferences, and implementation issues.7

    The WHO Guidance document uses the GRADE approach (Grading of Recommendations Assessment,

    Development and Evaluation) for the development and review of the recommendations, along with

    PICO questions. (See Appendix 1&2 for more detail).

    This system grades research according to a scale that prioritises quantitative research methods, such

    as randomised, blind control trials. On this scale the strength of the evidence base for the

    recommendations overall was not high. However, a very large amount of literature was not included

    in the evidence used as it did not match the strict criteria for inclusion. For example,

    Recommendation 5 had one of the strongest evidence bases compared with the other

    recommendations but still came out as having a low to moderate strength evidence base. Out of

    1258 citations screened in the systematic review process for the questions relating to this

    recommendation, just two studies fulfilled the eligibility criteria.8

    The recommendation process included a qualitative values and preferences survey review of each

    recommendation, comprised of interviews with seventeen service providers and peers. This was

    taken into account to ensure the acceptability of the recommendations with the key audiences.9

    This methodology and its influence on the recommendations was the subject of a number of

    presentations and discussions during the forums.

    Recommendations from the WHO Guidance Document

    The WHO sets out the principles underpinning their Guidance document as follows:

    4Ibid, 13

    5Ibid, 7

    6Ibid, 12

    7Ibid, 11

    8World Health Organization Guidance document,Annex 6:Evidence Summaries; WHO/HIV/2012.27

    9World Health Organization Guidance document,Annex 8: Values and Preference report, WHO/HIV/2012.29

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    The principles for this guidance, and for working with people who inject drugs, are the

    protection of human rights, access to health care, access to justice, acceptability of services,

    health literacy and integrated service provision. Interventions must be acceptable and

    appropriate for people who inject drugs. Consultation and cooperation with drug user groups is

    important when designing and implementing services.

    10

    The WHO Guidance on the prevention of hepatitis B and C among people who inject drugs

    contain five major recommendations:

    Recommendation 1

    It is suggested to offer people who inject drugs the rapid hepatitis B vaccination regimen.

    Recommendation 2

    It is suggested to offer people who inject drugs incentives to increase uptake and completion of thehepatitis B vaccine regime.

    Recommendation 3

    It is suggested that needle and syringe programs also provide low dead-space syringes for the

    distribution to people who inject drugs.

    Recommendation 4

    Psychosocial interventions are not suggested for people who inject drugs to reduce the incidence of

    viral hepatitis.

    Recommendation 5

    It is suggested to offer peer interventions to people who inject drugs to reduce the incidence of viral

    hepatitis.

    NUAA Wonders... Forum Overview

    The recommendations from the WHO Guidance document were discussed at four forums. The

    hepatitis B recommendations were combined and discussed at one forum. The recommendations

    were not discussed in numerical order.

    To ensure relevance for NSW, the scope of Recommendation 3 regarding low and high dead-space

    syringes was widened to discuss injecting technology availability more generally, including that ofwheel filters, large bore barrels and winged infusion sets.

    Forum 1: It is suggested to offer peer interventions to people who inject drugs to reduce the

    incidence of viral hepatitis.

    Presenters:

    Jude Byrne. President, INPUD (International Network of People who Use Drugs) & Senior Project

    Officer, Australian Injecting & Illicit Drug Users League (AIVL)

    10p10 World Health Organisation,(WHO), Guidance on prevention of viral hepatitis B and C among people who inject drugs ,Geneva (2012)

    available athttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html

    http://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html
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    Jake Rance. Research Associate, National Centre in HIV Social Research (NCHSR)

    Colette McGrath. Manager, HIV & Related Programs (HARP), South East Sydney & Illawarra Local

    Health District

    Sione Crawford. Director of Programs and Services, NUAA

    Facilitator: Leah McLeod, Communications Coordinator, NUAA

    As a recommendation of particular interest and relevance to NUAA this topic was chosen for the

    opening forum.

    Forum Notes:

    The definition of a peer intervention was not entirely clear in the WHO Guidance documentas it related solely to peer involvement in services for PWID. This definition was considered

    too narrow for the NSW context. In NSW NUAA defines peer interventions as originating

    from the affected community: conceived, planned and implemented by peers.

    Nevertheless, recognition that the affected community rightfully has a role in servicedelivery was cited as monumental. It was acknowledged that up until now, peer

    interventions had not been legitimised formally by the WHO.

    The WHO engaged the affected community in the working group that developed therecommendations. Jude Byrne noted that she was the sole representative and noted that it

    is vital that organisations working with and involving the affected community properly

    support community advocates.

    The WHO review methodology was complex and prioritised quantitative research. There is aclear lack of quantitative evaluations of peer based intervention: just two pieces of literaturemade the final evidence list.

    Presenters and audience members alike spoke about the need for the WHO process tovalidate qualitative social research. There is a growing body of qualitative research and

    evaluation of peer education and peer interventions that could be considered. For example;

    the evaluation of the NUAA ETHOS peer support projects.11

    Some forum participants felt

    that testimonies from peer workers and service users - should be sufficient evidence to

    legitimise peer community controlled interventions.

    Support within health care services and the bureaucracy in NSW for peer led interventionsand peer education was acknowledged.

    Health care representatives noted that demonstrating to their colleagues how the healthsystem can benefit from peer involvement was an important role for the public sector

    partners of peer organisations.

    It was recognised that supporting peer organisations to navigate the health system to obtainlegitimacy is an important role for governments to undertake. The dominance of the

    medical model of service delivery both within the document and the NSW health system was

    raised by forum participants. This was noted as a barrier to peer involvement in service

    delivery and hinders the legitimacy of drug user organisations.

    11

    Rance, J. & Treloar, C, 2012, National Centre in HIV Social Research, The University of New South Wales, Sydney, Integrating treatment:key findings from a qualitative evaluation of the Enhancing Treatment of Hepatitis C in Opiate Substitution Settings (ETHOS) study,

    Technical Report,http://nchsr.arts.unsw.edu.au/media/File/Integrating_treatment.pdf

    http://nchsr.arts.unsw.edu.au/media/File/Integrating_treatment.pdfhttp://nchsr.arts.unsw.edu.au/media/File/Integrating_treatment.pdfhttp://nchsr.arts.unsw.edu.au/media/File/Integrating_treatment.pdfhttp://nchsr.arts.unsw.edu.au/media/File/Integrating_treatment.pdf
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    The forum agreed that evidence is needed for true accountability and it was recognised thatNUAA welcomes and champions the evaluation of peer programs.

    The forum accredited NUAAs PeerLink project is an effective collaboration between a peerorganisation and government funders where the key performance indicators that were

    beneficial and meaningful for both parties were set through negotiation. Defining a peer was discussed in the forum. It was noted that in some developing countries

    peer involvement in blood borne virus programs involves only people who have ceased drug

    use and it is their past drug history that defines their peer status. While it was acknowledged

    that in some countries this is the only way in which peers can be involved it was agreed that

    this approach delegitimises the valuable role that people who inject drugs play in harm

    reduction and BBV prevention, treatment and care.

    NUAA recommends:

    1.

    That greater peer engagement and involvement in NSW viral hepatitis prevention befostered across the sector

    a. NSW Ministry of Health to ensure the NSW NSP is deregulated so that equipmentcan be passed on freely by people other than paid certified NSP workers.

    b. NSW Ministry of Health and Local Health Districts review potential barriers to peerinterventions and employment. Barriers include recruitment policy (e.g. restricting

    applications to current NSW Health staff) and criminal record checks for workers.

    c. NUAA to work in partnership to develop a model of peer engagement at NSW NSPsto ensure the meaningful and respectful involvement of peers in harm reduction at

    NSW NSPs.

    d. NUAA, the NSW Ministry of Health and Local Health Districts work in partnership toensure affected community control at all stages of project development for peer

    interventions in NSW.

    e. Local Health Districts establish Client / Consumer Advisory Committees to ensureaffected community involvement and approval of programs and service delivery.

    f. NSW Health includes community controlled peer interventions as recommendedactions in future NSW Hepatitis C Strategies and NSW NSP guidelines.

    g. NSW Health includes peer intervention strategies, which are genuinely inclusive ofthe community as per recommendations above, in performance indicators for NSW

    NSPs

    h. All sector partners legitimise evaluation methodologies for peer interventions bycontinuing to utilise these evaluation methods and referring to them in policy and

    guidelines.

    i. The NSW Ministry of Health encourage and resource innovative quantitativeevaluations of community controlled peer interventions

    2. NUAA recommends that there is greater representation of the affected community inthe WHO working groups in order to ensure members are appropriately supported and

    balance of representatives is achieved.

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    Forum 2: Hepatitis B vaccination: increasing uptake and incentivising completion of the

    vaccination schedule

    Presenters:

    Dr Craig Rodgers, GP East Sydney Doctors, Kirketon Road Centre Staff Specialist

    Annie Madden, CEO, Australian Injectors and illicit Drug Users League (AIVL)

    Associate Professor, Carolyn Day, Discipline of Addiction Medicine, Sydney Medical School,

    University of Sydney

    Chris Gough, Peer Educator, NUAA

    Facilitator: Leah McLeod, Communications Coordinator, NUAA

    Recommendations One and Two of the WHO Guidance document were combined for this forum as

    they both dealt with the hepatitis B vaccination schedule. The original recommendations from the

    Guidance document listed in their original order are:Recommendation 1:

    It is suggested to offer people who inject drugs the rapid hepatitis B vaccination regimen.Recommendation 2:

    It is suggested to offer people who inject drugs incentives to increase uptake and completion

    of the hepatitis B vaccine regime.

    Forum Notes

    The forum acknowledged that Australia has not dealt effectively with hepatitis B amongstPWID. This is despite an effective vaccination that is available free to PWID.

    It was noted that while hepatitis B vaccinations are free of charge, for many, negotiatingservices and attending successive appointments can be a barrier to accessing the

    vaccination.

    Advice given at the forum was: when in doubt, vaccinate, as there are no adversereactions from additional vaccinations.

    Rapid schedule hepatitis B vaccination is available at the Kirketon Rd Centre in Sydney. Oneissue raised during the forum is that the rapid vaccination is a more expensive option. The

    Federal Government will not cover the additional cost via the PBS system. This means in

    practice that health centres are less likely to offer rapid schedule hepatitis B vaccinations. .

    The Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT) was a randomisedcontrol trial in NSW that showed providing small incentives to PWID to complete the

    hepatitis B vaccination schedule can be successful.

    The forum highlighted that such incentive programs are not new. The example of parentsbeing paid to vaccinate their children was cited, illustrating that incentives are not new in

    Australia and are acceptable within the community.

    A crucial question relating to hepatitis B and PWID in Australia was asked by Annie Madden,referencing the AIVL/ Scarlet Alliance Discussion Paper on hepatitis B:

    12

    12

    Australian Injecting and Illicit Drug Users League (AIVL)& Scarlet Alliance, Australian Sex Workers Association Access to Hepatitis BVaccination for People Who Inject Drugs, (2013)available at HTTP/www.aivl.org.au/database/sites/default/files/Joint

    s%20to%20Hep%20B%

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    There is a point at which we must ask why rates for hepatitis B are so consistently

    poor among PWIDs when this group has now been identified as an at-risk population

    for targeted vaccination programs for over two decades?13

    The gaps in hepatitis B vaccination delivery regardless of the National Immunisation Scheme(for infants), and (the soon to be phased outAdolescent Catch up Scheme) wereacknowledged.

    The Forum reflected on a variety of incentives that would increase uptake other thanfinancial options. Peer support and peer vaccination projects, campaigns and social

    marketing were suggested as potentially successful ways to increase vaccination uptake. .

    The forum recognised and discussed the issues relating to hepatitis C treatment. Astreatment regimens improve panellists raised concerns that there would still be major

    uptake problems such as those we are working to overcome to promote uptake for hepatitis

    B vaccination.

    NUAA recommends:

    3. NUAA recommends that the NSW Ministry of Health explore how the use of the rapidvaccine schedule can be increased across NSW for PWID.

    a. The Ministry of Health and Local Health Districts work in partnership with andresource NUAA to develop, pilot and evaluate for state wide implementation

    financial and non-financial incentive programs for PWID to complete the hepatitis B

    vaccination schedule. This would include the development of innovative peer based

    interventions, social marketing and peer support initiatives

    Forum 3: Dead space syringes and other injecting technologies that may assist in BBV prevention

    should be provided.

    Presenters:

    Dr Peter Higgs, National Drug Research Institute, Curtin University

    Gary Gahan, Coordinator Harm Minimisation and HCV Programs, SESIAHS

    Sam Liebelt, Communications Coordinator, Australian Injecting and Illicit Drug Users League. (AIVL)

    Facilitator: Leah McLeod, Communications Coordinator, NUAA

    Low dead-space syringes have long been used in Australia for injecting illicit

    drugs. They are not as common in many other parts of the world. High

    dead space syringes, which are the alternative, are typically composed of a

    syringe barrel with a detachable needle tip. These tend to have more space

    for blood to collect, as in the image. This results in more space for blood-

    borne viruses such as HIV and viral hepatitis to potentially exist. Research

    20Vaccination%20for%20PWID%20%20SW%20Policy%20Disccussion%20Paper.pdf13

    Ibid, 11

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    from the US14

    has shown that reusing or sharing this type of equipment carries greater risk of virus

    transmission.

    Discussion on this topic led to focused discussions on the gaps in equipment availability across the

    NSW NSP.

    Forum Notes:

    The forum considered the possibility that the culture of using low dead-space syringes inAustralia has contributed to the low rate of HIV transmission amongst PWID. It was noted

    that Bill Zule, a US researcher claims that changing from high to low dead space syringes

    would see enormous reductions in HIV transmission.

    Injecting drug use cultures differ around the world just as other customs do. It wasacknowledged that in Amsterdam the syringe of choice was generally a 2ml high dead space

    syringe. A contributing factor to this was that there was a culture of preparing drugs directly

    in the syringe.

    It was recognised that cost is an important consideration when delivering health services.An example of the situation in Vietnam was given. While syringes are freely provided, the

    equipment offered is high dead space syringes simply because they are cheaper than the low

    dead-space alternatives.

    It was recognised that the NSP in NSW remains a target for change due to politicalvulnerability rather than for protecting the lives of PWID. An example of this is the removal

    of larger bore barrels and winged infusion sets or butterflies in NSW. This was due solely to

    political intervention around the perceived dangers from methadone injection some years

    ago.

    The WHO Guidance document states that all types of syringes appropriate to local need beprovided. This is not the case in NSW where much needed equipment is prohibited.

    The forum summed up the NSW situation with regard to the NSP as being: Access to theequipment that you need to use to prevent HIV and viral hepatitis is dependent on what drug

    you want you use ... NSPs will provide you with the equipment you need providing you use

    the right drug. In other words the NSW NSP protects the lives of some people and not

    others.

    The lack of responses from the NSW NSP to changing drug trends was noted at the forum. Inaddition it was acknowledged that rather than the NSW NSP being a harm reduction service;

    it solely focused on BBV prevention. For example wheel filters would reduce injecting

    related harms linked to increasing pharmaceutical injecting but they are not being madefreely available in NSW NSP. Abscess reduction, endocarditis prevention and other health

    issues are not seen to be important.

    A dramatic growth in the use of performance and image enhancing drugs is also having animpact on NSW NSP.

    NUAA Recommends:

    14William A. Zule, Harry E. Cross, John Stover, Carel Pretorius.Are major reductions in new HIV infections possible with people who inject

    drugs? The case for low dead-space syringes in highly affected countries, The International journal on drug policy, 1 January 2013 (volume24 issue 1), Pages 1-7

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    a. NSW Ministry of Health to ensure the NSW NSP is deregulated so that equipmentcan be passed on freely by people other than paid certified NSP workers.

    b. NSW Ministry of Health and Local Health Districts review potential barriers to peerinterventions and employment. Barriers include recruitment policy (e.g. restricting

    applications to current NSW Health staff) and criminal record checks for workers.c. NUAA to work in partnership to develop a model of peer engagement at NSW NSPs

    to ensure the meaningful and respectful involvement of peers in harm reduction at

    NSW NSPs.

    d. NUAA, the NSW Ministry of Health and Local Health Districts work in partnership toensure affected community control at all stages of project development for peer

    interventions in NSW.

    e. Local Health Districts establish Client / Consumer Advisory Committees to ensureaffected community involvement and approval of programs and service delivery.

    f. NSW Health includes community controlled peer interventions as recommendedactions in future NSW Hepatitis C Strategies and NSW NSP guidelines.

    g. NSW Health includes peer intervention strategies, which are genuinely inclusive ofthe community as per recommendations above, in performance indicators for NSW

    NSPs

    h. All sector partners legitimise evaluation methodologies for peer interventions bycontinuing to utilise these evaluation methods and referring to them in policy and

    guidelines.

    i. The NSW Ministry of Health encourage and resource innovative quantitativeevaluations of community controlled peer interventions

    2. NUAA recommends that there is greater representation of the affected community inthe WHO working groups in order to ensure members are appropriately supported and

    balance of representatives is achieved.

    3. NUAA recommends that the NSW Ministry of Health explore how the use of the rapidvaccine schedule can be increased across NSW for PWID.

    b. The Ministry of Health and Local Health Districts work in partnership with andresource NUAA to develop, pilot and evaluate for state wide implementation

    financial and non-financial incentive programs for PWID to complete the hepatitis B

    vaccination schedule. This would include the development of innovative peer based

    interventions, social marketing and peer support initiatives4. Ensure the continued provision of low-dead space syringes in NSW and the scaling up

    of NSP services so that maximum coverage is achieved.

    h. NSW Health review the policy that is prohibiting the availability of larger barrels andwinged infusion sets through NSW NSPs. NUAA notes that this recommendation

    needs to occur with no changes being made to the way in which the NSW Opioid

    Treatment Program delivers methadone treatment programs. NUAA does not

    support the volume expansion of methadone.

    i. NSW Ministry of Health expands the Pharmacy Fitpack schemej. NSW Ministry of Health investigates feasibility of expanding the Pharmacy Fitpack

    Scheme to include injecting equipment other than 1ml syringes.

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    k. The NSW Ministry of Health ensure that wheel filters are available from the NSWNSP at no cost or reduced cost.

    l. The NSW Ministry of Health and Local Health Districts encourage pharmacies acrossNSW to make wheel filters available at no cost or reduced cost The Ministry of

    Health and Local Health Districts ensure that a full range of equipment is madeavailable via ADMs and dispensing chutes.

    m. Local Health Districts ensure that secondary NSP outlets to provide the full range ofinjecting equipment that is authorised by the NSW NSP.

    n. NSW Ministry of Health and Local Health Districts consult with the affectedcommunity on any and all equipment provision issues, in particular when

    considering changes to types of equipment provided.

    5. NSW Health deprioritise provision of psychosocial and brief interventions for viralhepatitis prevention.

    a. NSW Health reviews its policy and guidelines referring to brief interventions andreferral processes for the NSW NSP.

    b. Review minimum data set and performance indicators for the NSW NSP thatprioritise brief and psychosocial interventions with a view to removing requirement

    to provide these.

    6. NUAA recommends that rather than focus on psychosocial interventions, the NSW NSPin furthering its commitment to preventing BBVs and reducing harm undertakes the

    following:

    g. Scale up the coverage and availability of Automated Dispensing Machine locationsh. Ensure that Automated Dispensing Machines stock a full range of injecting

    equipment

    i. Local Health Districts investigate more innovative NSP models with fewer barriers,including self service models

    j. Local Health Districts encourage the provision of a wider range of Secondary NSPsites.

    k. Local Health Districts work to remove the need for supervised equipment provisionto be undertaken. NUAA recommends the wider availability of free dispensing

    machines across all health sites such as emergency rooms, hospital, community

    health centres, youth services, welfare organisations and other government and

    non-government sites.l. NSW Ministry of Health and Local Health Districts trial models which provide sterile

    equipment in wide range of non-traditional outlets. For example: allow provision in

    supermarkets, petrol stations, convenience stores, transit stations including train

    stations and airports.

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    Appendix 1

    Stages in WHO GRADE methodology for WHO Guidance Document

    2010: Scoping exercise. Literature review and identification of key programmatic issuesrelated to viral hepatitis transmission among PWID

    2010: Expert consultation with civil society representatives and the Cochrane CollaborationDrug and Alcohol Review Group to formulate the PICO questions

    Three systematic reviews were conducted later to address these questions using GRADEmethodology

    A series of semi structured interviews with service providers and PWID carried out in late2011 to obtain their perspectives, values and preferences on the draft recommendations

    A technical consultation was in 2012 to reach consensus on recommendations on co-infection with people with co-infection with HIV and viral hepatitis

    Expert panel including public health professional, clinicians, academics, program managers,civil society representatives, and a GRADE methodologist. Gender and countryrepresentation were considered. The panel assessed the evidence, risks, and benefits, and

    values and preferences for each recommendation. They determined the direction and

    strength of each recommendation. Consensus was reached in all decisions.

    Planned revision in 201615.Appendix 2:

    Methodology: Population, Intervention, Comparison and Outcomes (PICO) questions; GRADE

    The WHO Guidance document uses the GRADE approach (Grading of Recommendations

    Assessment, Development and Evaluation) for the development and review of the

    recommendations.16

    The first step of the GRADE approach is to rate the quality of evidence for each PICO question by

    outcome. This step entails consideration of study limitations, inconsistency, indirectness, imprecision

    and other limitations. The quality of the evidence is then graded as high, moderate, low or very low.

    A standardized table, the GRADE evidence table, presents the quantitative summary of the evidence

    and the assessment of its quality.

    The second step of the GRADE approach is to move from evidence to recommendation for each of

    the PICO questions. This includes consideration of the quality of evidence, the balance of benefits

    and harms, community values and preferences and resource use. These factors affect both the

    recommendations direction (for or against) and its strength (strong or conditional). Decision tablessummarize these factors.

    17

    This is a stringent approach and tends to rule out far more evidence than it accepts. The approach

    gives very high weight to traditional quantitative evidence and research such as randomised control

    trials. This weighting of evidence and the enormous amount of research that is disregarded as a

    result is discussed in the forums.

    15p16-17, World Health Organisation,(WHO), Guidance on prevention of viral hepatitis B and C among people who inject drugs ,Geneva

    (2012) available athttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html 16Ibid, 16

    17Ibid, 16

    http://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.htmlhttp://www.who.int/hiv/pub/guidelines/hepatitis/en/index.html