Annex 5. Decision Tables

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WHO/HIV/2012.26

Annex 5. Decision Tables

Question 1. Should an accelerated HBV vaccination regimen versus a standard HBV vaccination regimen be used among PWID?

Recommendation Using an accelerated HBV vaccination regimen is suggested over using a standard HBV vaccination regimen among PWID

(Conditional recommendation, very low quality evidence)

Key considerations - HBV vaccine is already strongly recommended for PWID as per WHO guidelines.

- A higher dose HBV vaccine should be used with the rapid regimen.

- The priority for any regimen is delivery of the first vaccine dose.

- Completion of three doses is more important than following a specific schedule. The implication is that a missed dose should be given at the earliest opportunity without re-‐initiating the regimen.

- Individuals with inadequately treated HIV or with chronic HCV may have a suppressed immunogenicity and may benefit more from the standard regime

Justification - Evidence suggests benefits, particularly in terms of vaccination completion, may outweigh potential harms. The

recommendation is conditional given the very low quality evidence and the intervention may be resource intensive.

Implementation considerations

- More intensive regimens may increase workload and vaccine stocks

- High dose regimens require increased vaccine stock

- Both the rapid and standard regimens should be offered to PWID.

Research priorities - RCTs comparing the effectiveness of rapid HBV vaccine versus the standard HBV vaccine among PWID

- RCT comparing the effectiveness of high dose vaccine to standard dose, regardless of delivery schedule.

-

RCTs comparing the effectiveness of new adjuvant vaccines versus the standard HBV vaccine among PWID

-

RCTs comparing intramuscular versus intradermal

administration of the HBV vaccine among PWID

-

Immunogenicity studies of rapid and standard HBV

vaccination regimens among PWID co-‐infected with HIV

and HCV

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Question 2. Should incentives for HBV vaccination completion versus no incentives be used among PWID?

Recommendation Offering incentives for completion of the HBV vaccine schedule is suggested over not offering incentives to PWID. (Conditional recommendation, low quality evidence)

Key considerations - Vaccinations should be provided at a location and time convenient for PWID

- This recommendation applies to settings with lower vaccination uptake among PWID and where other efforts to increase vaccination uptake are already in place.

- This recommendation is conditional on local acceptability and resource availability

- An inability to provide incentives should not bar countries or settings from offering HBV vaccination to PWID.

Justification - Evidence suggests benefits, particularly in terms of vaccination completion, may outweigh potential harms. The

recommendation is conditional given the very low to low quality evidence and the intervention may be resource intensive.

- Vaccinations should be provided at a location and time convenient for PWID

- Consider financial resources required for provision of monetary incentives..

- Feasibility varies dependent on setting

Research priorities -

RCTs comparing the effectiveness of providing incentives versus not providing incentives on the initiation/completion of HBV vaccination regimen among PWID

-

Operational research on the preferences of PWID and service providers for the type of incentive e.g. cash, voucher, other.

-

Cost effectiveness studies of incentives in local settings, especially resource limited settings

-

Study of whether the provision of cash incentives for public health interventions leads to decreased rates of participation in subsequent interventions

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Question 3. Should low dead space-‐syringes versus high dead space syringes be provided to PWID?

Recommendation Offering low dead space syringes is suggested over offering high-‐

dead-‐space syringes to PWID at needle syringe programs.

(Conditional recommendation, very low quality evidence)

Key considerations - Syringe programs should offer all types of syringes appropriate for local needs

- LDSS are produced in a limited number of sizes. Larger syringes should also be offered if appropriate to local needs regardless of dead space volume.

- Education should be provided to PWID on why LDSS syringes are preferable.

Justification - Evidence suggests benefits, in reduction of HCV and HIV

infection, may outweigh potential harms. The recommendation is conditional given the very low quality evidence.

- Switching from HDSSs to LDSSs may incur cost differences. In general, the cost of LDSS and HDSS is the same.

- LDSSs are only available in a limited number of sizes and may not be appropriate for all PWID, nor all drug types.

RCTs comparing the effectiveness of LDSS versus HDSS in decreasing the incidence of HIV, HBV and HCV infection among PWID

-

Operational research on acceptability and preferences for different syringe sizes with detachable needles among PWID;

-

Studies modelling potential harms if preferred equipment is not available (e.g. potential increases in re-‐use of (own) syringes, receptive syringe sharing, injecting related injuries and blood-‐borne infections);

-

Observational studies assessing:

o Impact of changes in types of syringes distributed in different settings;

o Within country variations in types of equipment distributed

o Types of equipment distributed in high and low HCV incidence locations

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Question 4. Should psychosocial interventions versus no psychosocial interventions be used among PWID?

Recommendation

Not offering psychosocial interventions is suggested over offering psychosocial interventions to PWID, when the goal is to reduce the incidence of viral hepatitis.

(Conditional recommendation, low quality evidence)

Key considerations - Psychosocial interventions should not be precluded as part of comprehensive interventions with goals broader than reducing the incidence of viral hepatitis. However, they should not be recommended as a standalone intervention.

- This recommendation does not address peer delivered interventions

- Referral to psychosocial pharmacotherapy guidelines¹

o PWID should be offered access to needle and syringe programs

o PWID should be offered access to effective substance use treatment programs.

Justification - There is lack of evidence for the effectiveness of psychosocial interventions and it’s uncertain whether benefits outweight harms. The intervention require significan human and other resources. The quality of evidence is low

- When implemented, psychosocial interventions need to be part of a comprehensive approach aiming at a wider range of behavioural problems as recommended by the psychosocial pharmacotherapy guidelines²

Research priority - RCTS comparing the effects of psychosocial interventions versus no psychosocial interventions on HCV, HBV, and HIV incidence, and on quality of life among PWID.

1 WHO, WHO Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. Geneva, WHO, 2009.

http://whqlibdoc.who.int/publications/2009/9789241547543_eng.pdf

2 WHO, WHO Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. Geneva, WHO, 2009.

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Question 5.

Should peer based interventions versus no peer based interventions be used among PWID?

Recommendation

Offering peer-‐based interventions is suggested over not offering peer-‐based interventions to PWID, when the goal is to reduce the incidence of viral hepatitis.

(Conditional recommendation, low quality evidence)

Key considerations - Including peers is an important component of service delivery to PWID.

- Refer to related WHO recommendations³

Justification - Evidence suggests benefits, particulary needle sharing behavior, may outweigh potential harms. The recommendation is

conditional given the low quality evidence.

- Feasibility depends on capacity and availability of human resources, will vary by setting

RCTs comparing peer based interventions to other prevention interventions (e.g. opioid substitution therapy and needle syringe program coverage) on HBV, HCV and HIV incidence among PWID

-

RCTs of peer-‐driven interventions in multiple settings

-

Operational research in resource limited settings

3 WHO, Mental Health Gap Action Programme (mhGAP) intervention guide for mental, neurological and substance abuse disorders in non-‐specialised health settings. Geneva, WHO, 2010.

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Annex 5. Decision Tables