Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

Prevalence

Preventing the transmission of BBVs among PWID is a major public health issue. Hepatitis C virus (HCV) is the most prevalent BBV among PWID, with 56% in Scotland (61% among needle exchange attenders),1 approximately 50% in England and Wales and 23% in Northern Ireland being HCV positive. 2 The rate of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) infection among PWID in the UK is low, ranging from 0% in Wales and Northern Ireland to 1.4% in England for HIV and from 6% in Northern Ireland to 18% in England for HBV. 2

Risk factors for blood-borne viruses

Hepatitis B virus and HIV are transmitted via blood or body fluids. Sharing injecting equipment poses the greatest risk of HCV transmission among PWID. 3 Although there is no increased risk of HCV transmission in a long-term heterosexual relationship, the risk of transmission increases with multiple sexual partners and among women who are infected with HIV or other sexually transmitted diseases. 4 Sex trading, younger age, cocaine injecting, depression, requiring help injecting, having unsafe sex with a regular partner and having an HIV-positive sexual partner are associated with HIV infection among PWID. 5–9 Risk factors for HCV among PWID include sharing needles and other injection equipment,10 longer duration of injecting career,11 increased frequency of injection,11,12 requiring help injecting,13 being female14 and a history of imprisonment. 11,12 Research suggests that a gap in HCV transmission knowledge among PWID is contributing to the high prevalence. 15–17 Higher HIV and HCV infection rates have been reported among people with mental health disorders. 6,18,19 PWID with mental health disorders report greater sharing of injection equipment, lower rates of condom use, multiple sexual partners, sex trading and having sex with PWID. 5,6,20,21 Depressive symptoms are also associated with drug21–23 and sexual risk behaviours. 23–25 The prevalence of intimate partner violence is high among people who use drugs. 23,26,27 Women who are survivors of intimate partner violence are less likely to use condoms and more likely to share needles, to have multiple sexual partners and to trade sex,26,28 all of which increase susceptibility to BBV transmission. 28 BBV transmission risk behaviours should be understood in the context of PWIDs’ sexual and drug-using relationships. 29 Some females who inject drugs share injecting equipment with their partners for trust and intimacy, perceiving less risk in such relationships. 30

Current policy and practice

Policy and practice with regard to public health generally, and the management of BBVs specifically, are driven by different policies and agendas in the four nations of the UK, although the overarching recovery agenda has dominated drug policy for a number of years. 31 In Scotland, The Road to Recovery: A New Approach to Tackling Scotland’s Drug Problem was published in 2008,32 and recovery became a central tenet of UK policy in 2010. 33 In a corresponding publication, Putting Full Recovery First: The Recovery Roadmap,34 the authors outlined the roadmap for the ways in which recovery would be fostered in communities in England and Wales, including the creation and utilisation of ‘recovery champions’. 34 Although the rhetoric of drug policy may have altered in the UK over the last 8 years from that of harm reduction to that of recovery, the extent to which the realities of drug treatment provision (including prevention) have changed remains largely unknown. Indeed, as commented by Duke ‘at the level of practice, it will be interesting to examine how day-to-day practice develops and changes with drug users under the new framework’. 31

With specific regard to the management and prevention of BBV infections, and HCV in particular, all four nations published their first action plans for the prevention and management of HCV around 10 years ago, and have had varying degrees of success. Very broadly, the action plans in all four countries set out key objectives that would need to be achieved in the realms of HCV prevention and treatment, with particular foci on PWID, in order to tackle the burden of HCV on individuals and on public health. Common objectives of the plans included developing a better evidence base for establishing prevalence figures through better monitoring and surveillance systems; increasing information on the disease; increasing the number of persons being tested and, therefore, diagnosed with HCV (as high numbers of people with the disease are undiagnosed); and increasing the number of people entering into treatment for HCV infection. It might be argued that harm reduction, rather than recovery, has been at the heart of the HCV action plans in the sense that other objectives of the plans involved not only providing more needle exchange outlets (including outreach distribution, as in Northern Ireland), but also increasing the number of needles, syringes and other injecting equipment that PWID can access.

Harm reduction approaches recognise that there is a need to reduce the risks associated with drug misuse (including injecting). This approach is facilitated in the UK by the provision of opioid substitution therapy (OST; e.g. with methadone or buprenorphine), key worker support, needle and syringe programmes that offer PWID free injecting equipment (and equipment), and information to reduce sharing behaviour and, therefore, the transmission of BBV, as well as support for stopping injecting. The use of psychosocial interventions to reduce risk behaviours among PWID is not routinely practised in the UK. Harm reduction messages are mainly provided by key workers, drug treatment staff and needle exchange staff, peer educators and BBV nurses.

Harm reduction approaches

Although advances have been made in treatment and pre-exposure prophylaxis for HIV infections and a vaccine is available for HBV, there is currently no vaccine available to prevent HCV infection. There is evidence to suggest that OST and needle exchanges35–38 are effective in reducing HIV and HCV infection prevalence among PWID. However, recent research stresses that, although increasing the coverage of these interventions can reduce HCV prevalence among PWID, these reductions are modest and psychosocial interventions are required to further decrease HCV prevalence36 by informing PWID about transmission risks and motivating them to reduce risky sexual and drug-taking behaviours. Although OST has been successful in reducing BBV, some PWID continue to inject and, therefore, may be at risk of acquiring or transmitting BBV. A meta-analysis found that the incidence of HCV reinfection following successful treatment for HCV among PWID was 2.4 per 100 person-years and 6.4 per 100 person-years among those who reported injecting drug use post sustained viral response (SVR). 39 A recent retrospective record linkage study in Scotland reported similar reinfection rates, 1.7 per 100 person-years among PWID and 5.7 per 100 person-years among those who had been admitted to hospital for injection-related causes. 40 Although there is a low risk of reinfection following successful treatment for HCV, a large cohort study in Scotland found that 10.6% of 1170 PWID who had achieved a SVR following treatment for HCV had been hospitalised for, or had died from, an injection-related cause in the first 3 years post SVR. 41 Moreover, findings highlight a rise in injection-related hospitalisation or death with time with increasing year of SVR attainment. In addition, women were more likely to have multiple injection-related hospitalisations post SVR. These findings highlight that ‘harm reduction interventions aimed at reducing the risk of HCV transmission should also continue to be promoted once treatment ceases’. 41

Recent systematic reviews and meta-analyses of psychosocial interventions to reduce HIV and HCV risk behaviours among PWID have reported modest effects42–44 and conclude that ‘limited progress [has been made] in developing more effective interventions’43 and that ‘multi-component interventions are required’. 44 A recent Cochrane review on Psychosocial Interventions for Reducing Injection and Sexual Risk Behaviour for Preventing HIV in Drug Users43 reported minimal differences identified between multisession psychosocial interventions and standard educational interventions for both injection and sexual risk behaviour. However, there were large pre–post changes for both groups, suggesting that both were effective in reducing risk behaviours. They also found evidence of benefit for multisession psychosocial interventions when compared with minimal controls. Moreover, people in formal treatment were more likely to respond to multisession psychosocial interventions, and single-gender groups were associated with greater benefit.

Harm reduction approaches mostly address risk factors associated with the sharing of injecting equipment and unprotected sex. Research has highlighted that PWID sometimes have different priorities, such as avoiding injecting-related scars or marks and maintaining venous access, which results in the use of sterile injecting equipment. 45 PWID have also stressed a need for ‘non-judgemental venous care and access advice’. 45 PWID who plan ahead to ensure that they have access to sterile injecting equipment are more likely to store clean needles; avoid sharing needles and syringes and other injecting equipment; and provide clean needles to sex partners. 46 Therefore, it is vital that harm reduction interventions include protective practices and strategies to avoid and plan for injecting risk situations, such as withdrawal and lack of preparedness. 47,48

Research has demonstrated that ‘symbiotic’ goals that are not directly focused on BBV risk reduction are important to PWID, such as avoiding withdrawal, maintaining social support, venous access and care, and image management,45,49 and may help them to ‘stay safe’ and avoid BBV. 50 Strategies described to avoid withdrawal include ‘back up methods, resorting to credit, collaborating with others, regimenting drug intake, balancing drug intake with money available, and/or resorting to treatment’. 47 PWID who have not become infected with HCV report protective practices, including principles about normative injecting practices; preparedness and contingency planning to avoid disruption to risk management; and the capacity for flexibility to adapt to changes in normative practices or intentions. 51

Phase I: determining the evidence base

• To update recent systematic reviews of the efficacy of psychosocial interventions to reduce drug and sexual risk behaviours associated with HIV, HCV and HBV transmission and/or reinfection.

• To conduct a brief scoping exercise of the UK grey literature to identify ongoing research, information about current services relevant to preventing the spread of BBV and reducing risk behaviours among PWID.

• To survey all UK-commissioning drug partnerships (previously Drug Action Teams) for information on psychosocial interventions available and their effectiveness in reducing BBV risk behaviours among PWID.

Phase II: understanding people who inject drugs’ influences on behaviour and views on psychosocial interventions

• To elicit why PWID engage in risk behaviours.

• To determine the type of psychosocial intervention acceptable and required by PWID to reduce BBV risk behaviours.

Phase III: key stakeholders’ views on the delivery and effectiveness of psychosocial interventions

• To ascertain key local and national stakeholders’ views on the delivery and effectiveness of psychosocial interventions.

Phase IV: intervention development

• To source and review content of all effective psychosocial interventions to reduce BBV risk behaviours among PWID.

• To develop a psychosocial intervention to reduce BBV risk behaviours among PWID.

Phase V: feasibility randomised controlled trial

• To demonstrate the feasibility of recruiting PWID to a group psychosocial intervention and delivering the intervention across four regions in the UK.

• To test the feasibility of training staff from existing services to deliver the developed intervention.

• To evaluate the level of intervention retention by participants randomised to the developed intervention.

• To explore staff and PWID views, acceptability and experiences of the intervention and the study process.

• To explore treatment effectiveness through quantitative outcome data.

• To explore the feasibility of collecting data for a large, definite RCT.

• To assess the feasibility of conducting a future large-scale effectiveness RCT.

Phase VI: considerations for future research

• To recommend specific interventions which could be tested in future research.

• To outline considerations for future research.

Participants/population

People who inject drugs aged ≥ 18 years. Studies of people who use drugs were included if the results were presented separately for PWID.

Interventions

Psychosocial interventions [e.g. cognitive–behavioural therapy (CBT), MI, CM, counselling, harm reduction, skills training] delivered to individuals, groups, couples or a mix of delivery methods.

Comparators/control

Usual care, education or information, HIV infection testing and counselling, or interventions of lesser frequency or intensity than the intervention (with or without OST).

Study selection and assessment

The electronic database searches to 26 May 2015 resulted in 2493 citations; an additional 77 citations were identified from 1 January 2015 to 9 December 2016 (Figure 1). One additional manuscript was identified from hand-searching other reviews’ reference lists. After removal of duplicates, 1903 citations remained. In total 1771 abstracts were excluded as they did not meet eligibility criteria and 132 abstracts were selected for full-text assessment, including four related manuscripts referenced in these selected texts. 83–86 Eighty-nine articles were excluded for the following reasons: they were not RCTs (n = 34);47,68,87–118 the outcomes of interest for this review were not assessed or presented at follow-up (n = 29);86,119–146 outcomes were not presented by PWID (n = 6);147–152 the number of PWID was not reported (n = 4);153–156 or the intervention studied was not psychosocial (n = 4). 157–160 Additionally, 10 manuscripts were excluded as the results did not compare intervention groups161–166 or did not evaluate the effect of the intervention. 167–170 One further manuscript was excluded because the same psychosocial intervention was delivered to each treatment group, and the difference between treatment groups was receipt of a coupon for 90 days of free methadone maintenance treatment (MMT). 171 One manuscript published in Chinese was excluded. 172

FIGURE 1.

Flow chart. a, Includes six trials listed in the clinical trials database for which no published papers could be found; b, includes four related manuscripts references in potentially eligible manuscripts.

In total, 42 manuscripts from 32 trials were eligible,22,68–77,81–85,173–198 41 originating from the electronic database searches, and one from hand-searching recent reviews and review of reviews178 was added as a result of this process. Twenty-four trials were included in the meta-analysis. 22,68–73,75,76,81,82,173,175,179,180,182,186,188,189,192–195,197 The reasons for excluding eight trials from the meta-analysis were not providing the number of PWID for control and intervention groups at follow-up,84,174,176,177,196 only providing risk ratios,178 outcome combined HIV infections with sexually transmitted infections77 and data for ‘unsafe injection practices’ were presented only at baseline. 74

Quality and publication bias assessment

The summary of authors’ judgements about the quality of each trial included in the systematic review is described in Figure 2. The risk of bias varied between trials. Incomplete outcome data was the most common risk of bias found in the trials included in the review, but selective outcome reporting also contributed to potential risk of bias for some trials. Other potential sources of bias included altering randomisation protocols depending on the number of participants enrolled on a particular day;182 statistically significant differences between groups at baseline in the injecting subscale;173 variation in the TAU group across sites;68 possible crossover contamination between groups;69,75,179,180,182,194 a high proportion of excluded individuals with the excluded individuals differing significantly to those included;71 and large variations reported in the follow-up period. 74

FIGURE 2.

Risk of bias for included trials. C&E, counselling and education; ENI, enhanced negotiation intervention.

Any injecting risk behaviour

Twenty-two trials assessed any injecting risk behaviour. Psychosocial interventions independently reduced injecting risk behaviours more than control interventions in seven trials. 72,73,76,179,182,188,192 A total of 3096 PWID were included in the intervention groups and 2971 in the control groups. Overall, psychosocial interventions showed a greater reduction in any injecting risk behaviour (SMD –0.29, 95% CI –0.42 to –0.15, I² = 61%; p < 0.01) than the control interventions (Figure 3). Psychosocial interventions also demonstrated greater reductions in any risk behaviours than education/information (SMD –0.41, 95% CI –0.79 to –0.04, I² = 62%; p = 0.03), HIV infection testing and counselling (SMD –0.24, 95% CI –0.44 to –0.03, I² = 0%; p = 0.02) and interventions of a lesser time or intensity (SMD –0.34, 95% CI –0.56 to –0.12, I² = 75%; p < 0.01), but no difference was found when compared with interventions of a lesser time or intensity that included OST (SMD 0.23, 95% CI –0.51 to 0.97, I² = 0%; p < 0.01) or TAU (SMD –0.09, 95% CI –0.32 to 0.15, I² = 26%; p = 0.54). Where outcomes were assessed ≤ 3 months or 4–6 months post intervention, psychosocial interventions reduced any injecting risk behaviour when compared with interventions of lesser time or intensity. Where outcomes were compared ≥ 9 months post intervention, psychosocial interventions reduced any injecting risk behaviour more than interventions that provided education/information alone. (Figure 4). Heterogeneity was moderate in psychosocial interventions compared with education/information (I² = 62%), possibly as a result of the variations in the mode of delivery and intervention components (see Table 2). The education/information interventions in the control conditions included a pamphlet compared with a six-session education/enablement intervention180 and ranged from comparing a one-session education intervention with a one-session motivational intervention175 to comparing 22 education sessions with referrals to drug treatment with a 22-week intervention including MI counselling sessions for both the male participant and the couple, monetary incentives for drug abstinence and research-supported detoxification followed by naltrexone treatment. 188 There was high heterogeneity in the analysis of psychosocial interventions compared with interventions of a lesser time or intensity (without OST) (I² = 75%), for similar reasons to those mentioned above. Six trials included equal-attention control conditions ranging from 275 to 10182 sessions, and three included control interventions with fewer sessions, ranging from four sessions versus one session173 to 10 versus eight sessions190 (see Table 2). All but one trial173 had at least two sessions in the control and/or intervention conditions. One trial compared a two-session woman-focused intervention with a two-session nutritional intervention. 75 The variation in intervention duration and content across conditions contributes to the high heterogeneity.

FIGURE 3.

Efficacy of psychosocial interventions vs. control interventions in reducing any injecting risk behaviours among PWID. df, degrees of freedom; IV, inverse variance; SE, standard error.

FIGURE 4.

Efficacy of psychosocial interventions vs. control interventions in reducing any injecting risk behaviours among PWID by control intervention and length of follow-up post intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

Sharing needles and syringes

Thirteen trials assessed the sharing of needles and syringes (Figure 5). Psychosocial interventions reduced with behaviour compared with the control interventions in five of those trials. 72,73,186,188,192 A total of 1411 PWID were included in the intervention groups and 1315 in the control groups. A total of 1411 and 1315 PWID were included in the intervention and control group, respectively. Overall, psychosocial interventions reduced sharing of needle/syringes (SMD –0.43, 95% CI –0.69 to –0.18, I² = 68%; p < 0.01) compared with control interventions. Psychosocial interventions reduced needle and syringe sharing compared with education/information (SMD –0.52, 95% CI –1.02 to –0.03, I² = 10%; p = 0.04), or HIV infection testing and counselling (SMD –0.24, 95% CI –0.44 to –0.03, I² = 0%; p = 0.02). However, no difference was found when psychosocial interventions were compared with interventions of a lesser time or intensity (SMD –0.56, 95% CI –1.22 to 0.09, I² = 90%; p = 0.09) or interventions of lesser time or intensity that included OST (SMD –0.13, 95% CI –1.32 to 1.05, I² = 63%; p = 0.83) or TAU (SMD –0.53, 95% CI –1.12 to 0.07; p = 0.08; one trial195). Where outcomes were assessed ≤ 3 months or 4–6 months post intervention, psychosocial interventions reduced needle and syringe sharing compared with interventions of lesser time or intensity. Where outcomes were assessed 4–6 months post intervention, psychosocial interventions reduced any injecting risk behaviour compared with HIV infection testing and counselling (Figure 6). There was moderate and high heterogeneity in the analysis of psychosocial interventions compared with interventions of a lesser time or intensity with OST (I² = 63%) and without OST (I² = 90%), again potentially explained by the differences in intervention content and delivery. The two trials that compared psychosocial interventions with OST with interventions of a lesser time/intensity with OST varied in length of OST treatment. Both included a 12-week psychosocial intervention; however, the trial in which methadone was prescribed for 6 months independently reduced needle and syringe sharing186 and the trial that prescribed methadone for 3 months did not. 71 Four trials compared psychosocial interventions with interventions of a lesser time or intensity without OST: the interventions that were delivered to couples73 or encouraged peer outreach72 independently reduced needle and syringe sharing, whereas those interventions delivered to individuals on their own or in groups did not. 81,194

FIGURE 5.

Efficacy of psychosocial interventions vs. control interventions in reducing sharing of needles or syringes among PWID by control intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

FIGURE 6.

Efficacy of psychosocial interventions vs. control interventions in reducing sharing of needles or syringes among PWID by control intervention and length of follow-up post intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

Sharing other injecting equipment

Seven trials assessed the sharing of injecting equipment (other than needles and syringes). None of these trials independently found the psychosocial intervention to be more efficacious than the control interventions. A total of 1209 and 1157 PWID were included in the intervention and the control group, respectively. Overall, psychosocial interventions reduced sharing of other injecting equipment (SMD –0.21, 95% CI –0.34 to –0.09, I² = 0%; p < 0.01) compared with control interventions. Psychosocial interventions reduced the sharing of other injecting equipment compared with interventions of a lesser time or intensity without OST (SMD –0.24, 95% CI –0.42 to –0.06, I² = 0%; p < 0.01), but were no different when compared with education/information (SMD –0.42, 95% CI –0.98 to 0.14; p = 0.15; one trial175) and HIV infection testing and counselling (SMD –0.17, 95% CI –0.34 to 0.00, I² = 0%; p = 0.05) (Figure 7). Where outcomes were compared 4–6 months post intervention, psychosocial interventions reduced sharing of other injecting equipment compared with interventions of lesser time or intensity (Figure 8).

FIGURE 7.

Efficacy of psychosocial interventions vs. control interventions in reducing sharing of other injecting equipment (not needle/syringes) among PWID by control intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

FIGURE 8.

Efficacy of psychosocial interventions vs. control interventions in reducing sharing of other injecting equipment (not needle/syringes) among PWID by control intervention and length of follow-up post intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

Frequency of injecting

Eight trials assessed the frequency of injecting (Figure 9). Psychosocial interventions independently reduced frequency of injecting compared with control interventions in four trials. 81,188,192,193 A total of 1168 PWID were included in the intervention group and 1177 in the control group. Overall, psychosocial interventions showed no difference in reducing frequency of injecting (SMD –0.17, 95% CI –0.35 to 0.00, I² = 61%; p = 0.05). Psychosocial interventions reduced the frequency of injecting compared with education/information (SMD –1.05, 95% CI –2.07 to –0.03; p = 0.04; one trial188), but no showed difference when compared with interventions of a lesser time or intensity with OST (SMD 0.09, 95% CI –0.61 to 0.79, I² = 76%; p = 0.20; one trial71) and without OST (SMD –0.46, 95% CI –1.02 to 0.21, I² = 66%; p = 0.80), HIV infection testing and counselling (SMD –0.16, 95% CI –0.40 to 0.08, I² = 76%; p = 0.20) and TAU (SMD 0.00, 95% CI –0.20 to 0.21; p = 0.96; one trial68). Where outcomes were compared 4–6 months post intervention, psychosocial interventions reduced the frequency of injecting compared with education/information (Figure 10). There was moderate to high heterogeneity in the analysis comparing psychosocial interventions with HIV infection testing and counselling (I² = 76%) and with interventions of a lesser time/intensity with OST (I² = 66%) and without OST (I² = 66%), again potentially explained by the differences in intervention content and delivery described above (see Study Characteristics). All HIV infection testing and counselling intervention control groups received two sessions whereas in the intervention conditions the number of sessions ranged from seven193 to 10. 69

FIGURE 9.

Efficacy of psychosocial interventions vs. control interventions in reducing frequency of injecting among PWID by control intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

FIGURE 10.

Efficacy of psychosocial interventions vs. control interventions in reducing frequency of injecting among PWID by control intervention and length of follow-up post intervention. df, degrees of freedom; IV, inverse variance; SE, standard error.

Any sexual risk behaviour

Ten trials assessed any sexual risk behaviour (Figure 11). Psychosocial interventions were independently more likely to reduce any sexual risk behaviour than the control interventions in two trials. 73,75 A total of 1359 and 1409 PWID were included in the intervention and control groups, respectively. Overall, psychosocial interventions reduced any sexual risk behaviour compared with control interventions (SMD –0.19, 95% CI –0.39 to 0.01, I² = 58%; p = 0.07). Psychosocial interventions were no different in reducing any sexual risk behaviours compared with education/information (SMD –0.12, 95% CI –0.32 to 0.09, I² = 34%; p = 0.27), interventions of a lesser time or intensity with OST (SMD –0.26, 95% CI –0.67 to 0.15, I² = 78%; p = 0.21), without OST (SMD –0.17, 95% CI –1.41 to 1.07, I² = 72%; p = 0.79) and HIV infection testing and counselling (SMD 0.14, 95% CI –0.81 to 1.09; p = 0.77; one trial82). Where outcomes were compared ≤ 3 months post intervention, psychosocial interventions reduced any sexual risk behaviour compared with interventions of a lesser time or intensity (without OST) (Figure 12). The high heterogeneity in the analysis comparing psychosocial interventions with interventions of a lesser time or intensity with OST (I² = 78%) and without OST (I² = 72%) has already been discussed.

FIGURE 11.

Efficacy of psychosocial interventions vs. control interventions in reducing ANY sexual risk behaviours among PWID by control intervention. IV, inverse variance.

FIGURE 12.

Efficacy of psychosocial interventions vs. control interventions in reducing ANY sexual risk behaviours among PWID by control intervention and length of follow-up post intervention. IV, inverse variance.

Unprotected sex

Eight trials assessed unprotected sex. Psychosocial interventions were more effective than control interventions in four trials. 73,75,81,186 A total of 876 and 930 PWID were included in the intervention and control group, respectively. Psychosocial interventions were independently more effective than the control interventions in four trials. 73,75,81,186 A total of 876 and 930 PWID were included in the intervention and control groups, respectively. Overall, psychosocial interventions reduced unprotected sex compared with control interventions (SMD –0.27, 95% CI –0.54 to –0.01, I² = 68%; p = 0.04). Psychosocial interventions reduced unprotected sex compared with interventions of a lesser time or intensity (without OST) (SMD –0.44, 95% CI –0.86 to –0.01, I² = 79%; p = 0.04), but there was no difference when compared with education/information (SMD 0.03, 95% CI –0.18 to 0.24; p = 0.79; one trial70), interventions of a lesser time or intensity with OST (SMD –0.13, 95% CI –1.21 to 0.94, I² = 70%; p = 0.81) and HIV infection testing and counselling (SMD 0.14, 95% CI –0.81 to 1.09; p = 0.77; one trial82). (Figure 13) Where outcomes were compared ≤ 3 and 4–6 months post intervention, psychosocial interventions reduced unprotected sex compared with interventions of a lesser time or intensity (without OST). Where outcomes were assessed ≥ 9 months post intervention, psychosocial interventions reduced unprotected sex compared with interventions of a lesser time or intensity (with OST) (Figure 14).

FIGURE 13.

Efficacy of psychosocial interventions vs. control interventions in reducing unprotected sex among PWID by control intervention. IV, inverse variance.

FIGURE 14.

Efficacy of psychosocial interventions vs. control interventions in reducing unprotected sex among PWID by control intervention and length of follow-up post intervention. IV, inverse variance.

Number of sexual partners

Two trials76,81 assessed the number of sexual partners (Figure 15). A total of 135 PWID were included in the intervention group and 140 in the control group. There was no difference between psychosocial interventions and education/information in reducing the number of sexual partners (SMD 0.01, 95% CI –0.14 to 0.17; p = 0.89; one trial76). Interventions of a lesser time or intensity (without OST) reduced the number of sexual partners compared with psychosocial interventions (SMD 3.24, 95% CI 2.36 to 4.12; p < 0.01; one trial81).

FIGURE 15.

Efficacy of psychosocial interventions vs. control interventions in reducing number of sexual partners among PWID by control condition and length of follow-up post intervention. IV, inverse variance.

Methods

A scoping review of UK grey literature was conducted during April 2015 to determine if any unpublished evidence on the efficacy of psychosocial interventions was available that had not been identified through the systematic review. Thirty-one databases were searched to identify psychosocial interventions to reduce injecting and sexual risk behaviours among PWID in the UK (Table 3). A combination of the following search terms were used to search for relevant interventions:

• UK/England/Scotland/Wales/Ireland

• Intervention/behavio*r/motivational counselling

• Inject*/intravenous

• Drug*/opiate/heroin/crack/cocaine

• Blood borne virus/hepatitis/HIV.

In addition, 64 academics/BBV experts identified by the Steering Group were sent requests for information on unpublished research in the UK that had taken place or that was ongoing on psychosocial interventions to reduce injecting and sexual risk behaviours associated with the transmission of BBV among PWID.

Aim

To survey all agencies responsible for alcohol and drug commissioning in the UK for information on psychosocial interventions available and their effectiveness in reducing BBV risk behaviours among PWID.

Methods

A brief survey was sent by e-mail to all agencies responsible for alcohol and drug commissioning in the UK (i.e. alcohol and drug commissioners in England, alcohol and drug partnerships in Scotland, health- and social-care trusts in Northern Ireland and substance misuse area planning boards in Wales). The survey was sent up to three times during January and February 2015, 1 week apart, to maximise response rates. Where contacts were out of date, telephone contact was made in an attempt to update the contact details.

Results

Surveys were emailed to 164 alcohol and drug commissioners in England from 150 commissioning teams. In Scotland, surveys were sent to 30 alcohol and drug partnerships. In Northern Ireland, surveys were sent to five health- and social-care trusts and, in Wales, surveys were sent to seven substance misuse area planning boards. In England, 93 surveys from 84 alcohol and drug commissioners were returned (84/150, 56%). In total, 26 surveys from 21 alcohol and drug partnerships in Scotland were returned (21/30, 70%). Two of the five health- and social-care trusts in Northern Ireland responded to the survey (2/5, 40%). In Wales, seven surveys were returned from five substance misuse area planning boards (5/7, 71.4%).

Table 5 describes the proportion of alcohol and drug commissioners by country that reported providing psychosocial interventions to PWID to reduce BBV risk behaviours. The most common psychosocial interventions used were CBT, coping skills training, relapse prevention training and MI/enhancement therapy.

If alcohol and drug commissioners reported providing any psychosocial interventions, they were asked whether or not it was evidence based (Table 6) and available as a manual or in written form (Table 7).

A review of the manuals/written materials identified suggested that no UK areas were currently delivering interventions (group or individual) that focused exclusively on BBV and injecting/sexual risk behaviours, although the interventions that were delivered could include discussion of BBV transmission risks and prevention within the wider context of substance use reduction or abstinence. The majority of interventions were delivered on a one-to-one basis by a key worker to a client. Group work primarily involved family members/significant others. Several areas had adapted toolkits from other instruments.

Figure 16 describes that, although 116 manuals/written materials (56 after duplicates removed) were identified from the survey, only 11 were considered potentially useful to the design of a BBV risk reduction intervention for PWID. Table 8 provides links and information to potentially useful content currently used in the UK.

FIGURE 16.

Flow diagram of drug and alcohol partnership survey. a, No BBV information or PSI included in manuals. PSI, psychosocial intervention.

Summary

A scoping of the UK grey literature provided no UK-based reports, papers or study protocols (in progress or completed) directly related to psychosocial interventions aimed at preventing or reducing BBV transmission risk behaviours among PWID and delivered in the UK. An information request about psychosocial interventions to reduce BBV transmission behaviours among PWID was sent to 64 UK academics/experts and the information provided was used in the development of the PROTECT intervention. In addition, a brief survey was sent by e-mail to all agencies responsible for alcohol and drug commissioning in the UK for information on psychosocial interventions available and their effectiveness in reducing BBV risk behaviours among PWID. A range of evidence-based psychosocial interventions were reported, with the most commonly used being CBT, coping skills training, relapse prevention training and MI/enhancement therapy. A review of the manuals/written materials suggested that there are currently no interventions that focus exclusively on BBV and injecting/sexual risk behaviours, although a small proportion was considered potentially useful to the design of the PROTECT intervention.

Settings

People who inject drugs aged ≥ 18 years who had injected drugs within the past 4 weeks were recruited from drug treatment and harm reduction centres, needle exchanges (including pharmacy and mobile), sexual health services and homeless hostels in Glasgow, London, Yorkshire and north Wales during May–July 2015. Settings were chosen to reflect the range of settings that PWID attend for substance use and sexual health-related issues and settings attended by particular at-risk PWID who are not engaged with addiction treatment.

Sample

A convenience sample of 60 PWID (15 from each locality) were recruited using a purposive sampling approach to ensure that a variety of perspectives were accessed, including those most at risk (Table 9). Sampling was thus stratified according to known BBV risk variables, including gender, length of time injecting, drugs injected, involvement in sex trading and homelessness.

Service users at each setting were eligible to participate if they were aged ≥ 18 years, had injected illicit drugs [other than image- and performance-enhancing drugs (IPEDs)] within the past 4 weeks and were able to speak English well enough to complete a 45-minute interview. Given inability to provide informed consent, service users were not recruited if/when experiencing withdrawal or intoxication.

Data collection

A number of recruitment approaches were taken to achieve the purposive sampling parameters. Flyers were left in participating services to promote the study to service users. Staff at each of the services also informed eligible service users about the study and either passed on the researcher’s details to those who were interested or, with the service user’s permission, passed their contact details to the researcher, who rang potential participants to discuss the study. Researchers also recruited participants from the waiting rooms in services (except sexual health clinics) using a short screening questionnaire to ascertain study eligibility. All participants received a written study information leaflet (see Appendix 1) and verbal explanation of the study from the researcher, and were given an opportunity to ask any questions. Participants indicated their consent to participate in the study by signing a consent form (see Appendix 1). Participants received a £20 voucher in compensation for their time and expenses on completion of the interview.

Semistructured in-depth interviews were conducted with individual participants within a private room at each setting by trained researchers (DS, AS, NM and ST). Interviews lasted approximately 45 minutes and were audio-recorded with the interviewee’s permission. The interview topic guide (see Appendix 2) included questions on participants’ knowledge and perceptions of BBV transmission (HIV, HCV and HBV), perceptions of personal vulnerability to BBV, influences on the sharing of needles, syringes and other drug-using equipment, influences on sexual risk taking (such as non-condom use), and past interventions they had received on safer drug use and safer sex. Participants were also asked for their suggestions on how to support safer drug use and safer sex in the light of the influences on risk identified and their preferences for the PROTECT psychosocial intervention (content, format, venue, interventionist, duration, barriers/facilitators).

Ethics approval

The study was approved by the National Research Ethics Service Committee South East Coast – Brighton & Sussex (reference number 15/LO/0387).

Data coding and analysis

Interviews were transcribed by professional transcription services and analysed using qualitative framework analysis. 223 The framework approach allows the description and interpretation of what is happening among a predesigned sample with a set of a priori issues. The approach involves five key steps: familiarisation with the data; identifying a thematic framework; indexing the data; charting categories and themes; and mapping and interpretation. The framework approach was developed to answer policy-relevant research questions and can facilitate inductive, deductive or combined approaches to analysis. It is especially amenable to projects where analysis will be conducted by more than one researcher. 224

The research team (DS, GG, AS, AM, NM, EH, ST and NC) independently coded the first six interview transcripts, then reviewed the coding at a face-to-face team meeting and collaboratively generated an initial thematic framework. This coding framework was applied to the remaining interviews (indexing) by Davina Swan, April Shaw, Noel Crane and Kideshini Widyaratna. Weekly Skype (Microsoft Corporation, Redmond, WA, USA) meetings were held between the analysts to ensure consistency of coding across the interviews and to agree new codes to be added to the framework. This also included the researchers analysing one interview independently and reviewing how each had coded it to ensure validity. When first-level coding had been completed, Davina Swan and April Shaw reviewed all coding and charted and mapped the data.

Qualitative software (NVivo 10, QSR International, Warrington, UK) was used to manage and code the interviews. Several methods were utilised to enhance the validity of our findings: (1) triangulation of data across multiple settings and localities; (2) triangulation of coding across several co-researcher perspectives; (3) presentation of analysis and supporting quotes to service user representatives for feedback/critique (credibility); and (4) identification and questioning of researchers’ underlying assumptions at the weekly skype meetings between analysts (reflexivity). 225

Factors influencing risk behaviour for blood-borne viruses

Summary of key findings

The above analysis of 60 qualitative interviews with current PWID highlights that a wide range of individual, situational and structural factors contribute to injecting risk behaviours in this population, and thus preventing BBV infection and transmission among PWID is a challenge that will require a multilayered response. Figures 17 and 18 summarise the identified themes and subthemes. Relationships and social networks are identified as crucial influences on risk behaviours, whereas access to needle exchanges and safe injecting environments are vital for maintaining safer injecting behaviours. Drug states, such as withdrawal and craving, and the trajectory of drug use generate priorities of more immediate concern to PWID than BBVs. Furthermore, perceptions of BBV transmission risks change over time as knowledge is gained and the interviews illustrate that there remains a great deal of uncertainty around BBV acquisition. The perceived seriousness of HCV infection may be undermined by the view that it is an inevitable consequence of injecting drug use, thereby leading to less safe injecting practices. Despite this, participants described managing risk situations by planning ahead and being more vigilant regarding hygiene practices when using with others. In addition, changes in life circumstances, such as access to stable housing, facilitated improvements in risk behaviours. Risk management strategies were not necessarily intentionally BBV protective, but were often employed to manage other risks such as overdose and soft-tissue infections. For many of those interviewed, any intervention aimed at reducing risk behaviours should include behavioural and skills components such as health advice, hygiene promotion and injecting skills. Functional content, such as BBV information and injecting equipment/condom provision, along with psychosocial content, such as assertiveness training, were also suggested. No consensus was drawn from the participants regarding the length of sessions, preferred venues or style of delivery, suggesting that one size will not necessarily fit all. However, interventions that are delivered locally by informed trainers and are cognisant of the challenges PWID encounter in attending were considered important by the participants.

FIGURE 17.

Themes and subthemes relating to factors influencing risk behaviours for BBVs.

FIGURE 18.

Themes and subthemes relating to participants’ intervention preferences for reducing BBV risk behaviours. NA, Narcotics Anonymous.

Implications for intervention development

The wide range of factors identified, which contribute to risk behaviours for BBVs, highlights the importance of maintaining other efficacious interventions as well as developing psychosocial interventions (including OST, adequate access to NSP and harm reduction advice). Consideration should also be given to the provision of injecting rooms in the UK. The findings from the qualitative interviews with PWID were used to develop the PROTECT intervention focusing on increasing knowledge about BBV transmission and protective practices, and strategies to avoid risk situations such as withdrawal and lack of preparedness.

Session 1: improving injecting technique and good vein care

Session 2: planning for risky situations

Session 3: understanding blood-borne virus transmission

London

Participants were recruited from three drug and alcohol services (in two districts in the south of the city) that provided a tier 2 service, including advice and needle exchange, and tier 3 treatment to people aged over 18 years who have substance misuse (drug and/or alcohol)-related problems, including a prescribing clinic within a hostel for homeless people. The intervention was delivered in one community drug and alcohol service. Transport costs to attend the intervention were reimbursed.

York

Participants were recruited from a third-sector substance misuse organisation that provides tiers 1–3 addiction treatment. The service provides counselling and advice, as well as offering free needles, syringes, condoms and specialist advice, assessment and referral to residential rehabilitation, specialist NHS drug units and other agencies providing treatment for addiction and BBV infection testing. The intervention was scheduled to be delivered in a third-sector service in the city centre.

Glasgow

Participants were recruited from a drugs crisis centre in the city centre which provides both treatment and needle exchange services. The intervention was delivered in the drugs crisis centre.

Wrexham

Participants were recruited from a number of services including a NHS drug service, a drop-in centre and needle exchange for homeless people and a mobile harm reduction service that reaches PWID who are not currently engaged in treatment. The intervention was delivered at the drop-in centre and needle exchange for homeless people. Transport costs for intervention participants were reimbursed where requested.

Participant eligibility

Recruitment into the trial

All clients in the waiting rooms of drug treatment and needle exchange services of participating sites were considered potential participants by researchers and were screened for eligibility (see Appendix 6). In addition, staff at the drug treatment and needle exchange services informed their clients about the study. If interested, staff asked for permission to share their contact details with the researcher who then contacted the potential participant to discuss the study with them in more detail.

Eligibility assessment

All potential participants were given a participant information sheet (PIS) (see Appendix 7) by the researcher (London, Glasgow and Wrexham) or Clinical Research Network (CRN) nurse (York and London). Those interested were screened for eligibility by the researcher/CRN nurse and given the opportunity to ask any questions about participating in the research. If interested and eligible, they were invited to participate. Potential participants were assured of confidentiality, but also informed regarding limitations to it (see Consent procedure). They were also informed of what to expect during the study and given contact details in case of complaint or need for further information. They were informed that participation was not compulsory and that they could withdraw at any time without affecting their care.

Consent procedure

The researcher or CRN nurse fully explained the study to those eligible and interested in participating, providing an opportunity for the PWID to ask questions. Those willing to participate signed a consent form including a statement on limitations to confidentiality (see Appendix 7). These limitations referred to a need to revoke confidentiality should they, at any time during the study, express current or future harm to themselves or others, in which case their key worker would be informed by the researcher or CRN nurse. Potential participants who were clearly intoxicated or under the influence of drugs were not considered as able to give consent.

In addition, consent was gained from participants for their contact details (mobile, house telephone, e-mail) and those of a close friend/relative to be recorded, as well as e-mail and Facebook accounts (Facebook Inc., Menlo Park, CA, USA) to enable the researcher to call to remind participants of their appointments and to arrange follow-up interviews. Participants were also asked to consent to researchers liaising with the service from which they were recruited, should it not have been possible to contact them through details provided. This method had been successfully used in the Reducing hepatitis C sexual and drug taking risk behaviours among female drug users in Europe (REDUCE): translating evidence into practice study237 to improve engagement and retention in research studies. In cases where participants did not show up three or more times for their follow-up research appointment, telephone follow-up interviews were offered.

Baseline data were collected by the researcher or CRN nurse (see Appendix 8) after written informed consent was obtained.

Trial completion

Participants were deemed to have completed the trial when:

• their final follow-up had been completed.

Participants were deemed to have fully withdrawn from the trial when:

• they wished to exit the trial fully

• their service withdrew them fully from the trial.

Instead of withdrawing fully from the trial, participants had the option of:

• withdrawing only from receiving trial treatment, but continuing to complete follow-up data collection.

Participants electing to withdraw from both the trial treatment and the follow-up data collection were deemed as full withdrawals.

Recruitment rates

The quantitative assessment of the acceptability of the research was measured by numbers eligible and those agreeing to participate.

Retention in treatment

Retention in treatment was evaluated by number of sessions attended as a measure of acceptability of the interventions to participants.

Follow-up completion rates

A quantitative assessment of the number of follow-up questionnaires completed.

Injecting risk behaviour in past 30 days

The frequency with which participants had participated in specific injecting risk behaviours, that may have exposed them to BBVs in the previous month, were assessed using questions from the Health Protection Agency’s survey of PWID. 2

Participants indicated whether or not they had engaged in nine different risk practices in the past month relating to the use of sharing injection equipment. Events summed to a total ranging from 0 (engaged in no risk events) to 9 (engaged in all of the risk events).

Self-efficacy around injecting and sexual behaviours

Using questions from the Injection Drug Users – Research and Evaluation (INSPIRE) study,190 self-efficacy about injecting skills and about avoiding risk behaviours were measured. For example, ‘I can avoid sharing a needle even if I am in withdrawal’.

Self-efficacy about injecting drug use

Participants indicated agreement with eight self-efficacy questions around finding a vein, sharing equipment, cleaning equipment and talking about safe drug use. Agreement was rated between 1 (absolutely cannot) and 4 (absolutely can). Responses were added up to arrive at a total score between 8 (low self-efficacy) and 32 (high self-efficacy). 190

Number of sexual risk behaviours

Sexual risk behaviours were defined by seven items. The first two items related to having had sex with more than one partner in the past month and not always having used a condom when having sex in the past month. The remaining five items were based on the agreement with five self-efficacy questions about being able to use a condom with regular or casual partners while intoxicated or not and being able to talk about safe sex. Responses were counted as a risk behaviour if participants were not ‘absolutely sure’ they would use a condom in a given situation or that they would be able to talk about safe sex. Events were added up to a total ranging from 0 (no risk behaviours) to 7 (all risk behaviours).

Withdrawal Prevention Tactics scale

This five-item scale asks whether or not participants had done any of four listed tactics to avoid withdrawal episodes in the last 6 months: saved a bag for the next morning; put aside additional drugs; stored methadone; or put aside money for getting the next bag in an emergency. 238 A fifth item asked about use of other substances, such as painkillers, to avoid withdrawal symptoms until they are able to obtain their drug of choice. Participants were asked how frequently they have undertaken each of the withdrawal activities in the past month, with responses ranging from 0 (never) to 4 (very often). A total score was calculated by adding up responses, resulting in a total score from 0 (never taken any of the preventative actions) to 20 (taken preventative actions very often for all of the activities).

Blood-borne virus transmission knowledge

Motivation to change behaviour

Participants were asked to rate their motivation from extremely motivated to not at all motivated to protect themselves and others from acquiring BBVs. Motivation scores for the two items ranged from 1 (not at all motivated) to 5 (extremely motivated).

Vignettes

Three scenarios were presented to participants regarding risky situations. They were then asked to describe what they would do if they found themselves in these situations. Responses were recorded verbatim.

Health-related quality of life

The EuroQol-5 Dimensions, five-level version (EQ-5D-5L) is a standardised measure of health status developed by the EuroQol group in order to provide a simple, generic measure of health for clinical and economic appraisal, where health is characterised on five dimensions (mobility, self-care, ability to undertake usual activities, pain, anxiety/depression). 242

Health and social resource used

The feasibility of collecting details regarding hospital and primary health care service use, drug service use, other health-related services and contact with the police and criminal justice system was tested in this participant group. The service use questionnaire covered a retrospective 1-month period. Current medications were also collected.

In addition, the following demographic data were collected at baseline: age, gender, age when they first started injecting and type of service they had been recruited from.

Participants received £10 for their time involved in completing the baseline and each of the follow-up questionnaires. Those in the intervention arm received a further £10 if they participated in a focus group about their experience of participating in the trial and the group intervention. In all sites except London, participants received a high-street gift voucher for their time. In London, participants received payment in cash.

Focus groups with participants who attended the intervention and staff who delivered the intervention

Researchers moderating the focus groups used topic guides to lead the group through a discussion of the key issues, allowing and encouraging elaboration of views by participants as seemed appropriate (see Appendix 9).

Gender-specific intervention focus groups were conducted in each region where the intervention was delivered (London, Glasgow and Wrexham), with intervention group participants who had attended at least one intervention session (see Appendix 10 for consent form and PIS). These examined barriers to participation and what worked/worked less well within the intervention including:

1. overall impressions: views regarding the intervention as a whole and each individual session, reasons for attendance/non-attendance at sessions, and thoughts on the trial randomisation process

2. intervention content: most/least useful aspects of the intervention, whether or not they had learned anything new, whether or not any intervention content had been shared with others (if so, what and with whom), and any other information they would have liked provided

3. logistics: views regarding the location and timing of the intervention, ease of getting to the group sessions, whether or not anything would have made it more convenient, potential barriers to uptake of, and attendance at, the intervention, and suggestions to improve uptake and attendance

4. quality, safety and comfort: views regarding facilitators delivering the intervention, intervention materials used (videos, handouts), and whether or not they felt comfortable during the sessions and safe sharing their experiences within the group

5. gendered groups: views regarding single versus mixed gender groups

6. behaviour changes: whether or not there had been any changes in behaviour as a result of taking part in the intervention

7. final comments: whether or not they would recommend the intervention to others, including why/why not, and any final thoughts.

Focus groups were also conducted in each region with staff who had delivered or who intended to deliver the group intervention to determine the acceptability of delivering the intervention and to identify barriers to, and facilitators of, its uptake and delivery. Staff were provided with a PIS and asked to complete a consent form (see Appendix 11). For the focus groups with intervention facilitators, the following topics were covered:

1. training event: overall views regarding usefulness, comments regarding format (venue, duration, delivery style), suggestions for improvement of training, what else facilitators did to prepare for intervention delivery

2. intervention materials: comments regarding intervention manual (content, clarity, flow, layout, ease of maintaining fidelity to manual), exercises/activities, videos, overheads and handouts

3. intervention delivery: time spent preparing for delivery of sessions, ease of incorporating intervention delivery into overall workload, which parts of intervention they felt most confident/comfortable delivering, which parts they found challenging to deliver, experience of staff/peer co-delivery in London, views regarding what worked well/less well about the intervention, suggestions for changes/additions to intervention, views regarding logistics of sessions (day/time, venue), whether or not they would use the intervention in its entirety in their own practice [if not, what elements would they use (why, with what clients)], other thoughts regarding how the intervention could be used or developed

4. facilitator learning: from intervention participants regarding injecting practices

5. participant engagement and attendance: views regarding participant engagement with intervention and suggestions to improve attendance.

The topic guide can be seen in Appendix 12.

Intervention arm

Participants randomly allocated to the intervention arm were invited to attend three 1-hour sessions (ideally, one a week for 3 consecutive weeks). Session 1 covered improving injection skills and good vein care, session 2 covered planning for risk situations and session 3 aimed to increase participants’ knowledge about BBVs and transmission risk behaviours. The content of the intervention was developed in an earlier phase of work (as detailed in Chapter 5). Each session was scheduled to last 1 hour and it had been anticipated that there would be up to eight people in the group. Separate groups were held for women and men. The delivery of the intervention varied across sites to reflect current service delivery in each area. In London the group was co-facilitated by a drugs worker and peer educator (gender of co-facilitators matched that of the gender of the group), in Glasgow groups were co-facilitated by one male group worker and one female service co-ordinator, in Wrexham the groups were co-facilitated by one male and one female harm reduction worker and in York the groups were to be delivered by one male BBV nurse. Refreshments were provided at all sessions. The sessions used videos, games and exercise to facilitate discussion and build skills, and strategies to reduce and avoid risk. All sessions also included a didactic education session. Any questions that facilitators were unable to answer during the session were answered at the following session, to ensure that participants’ needs were met.

In addition, at baseline assessment, all participants were provided with a booklet containing information on HCV and a one-page information sheet developed specifically for the trial about a recent HIV outbreak among PWID (see Appendix 13). The HCV booklet Booklet 1. Hep C Info. Understanding Hepatitis C and Staying Safe231 was developed through a joint working initiative between Dr Magdalena Harris at the London School of Hygiene & Tropical Medicine and the London Joint Working Group on Substance Use and Hepatitis C. The booklet draws on the research of Dr Harris and was written by Danny Morris and Dr Harris.

Participants also received TAU from the service from which they were recruited.

Contingency management was used to try and retain participants in the psychosocial intervention. Contingency management, as recommended by the National Institute for Health and Care Excellence (NICE), offers incentives or rewards (usually vouchers or privileges such as take-home methadone doses) contingent on retention or positive engagement in treatment (e.g. drug-negative urine sample). 243 Participants allocated to the intervention arm received £10 for each of the three sessions attended. A ‘bonus’ £10 was given to those who attended all three sessions. Participants in London were rewarded in cash, in the other three sites payment was in the form of a high-street gift voucher.

Control arm

Participants randomly allocated to the control arm were given the same booklet containing information on HCV and the information about the HIV infection outbreak. They also received TAU from the service from which they were recruited.

Evaluation of each session

Intervention group participants anonymously self-completed evaluation forms immediately after each of the three sessions. Evaluation forms asked participants to indicate the extent to which they agreed or disagreed with a series of statements about the intervention materials and delivery, and the achievement of session goals (e.g. increased knowledge, self-efficacy or motivation). Participants indicated their agreement/disagreement with each statement on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The higher the score, the more positively the session was rated. Participants were also asked to give an overall rating for the session (‘in general how would you rate today’s session’) on a scale of 1 to 5, where 1 was poor and 5 was excellent. Finally, they were asked three open-ended questions: ‘what did you like most about today’s session?’, ‘what did you like least about today’s session?’ and ‘how could today’s session be improved?’.

Intervention facilitators also self-completed an evaluation form immediately after each of the three sessions. Similar to the participant evaluation forms, the facilitator evaluation forms asked facilitators to rate the extent to which they agreed or disagreed with a series of statements about the session materials and delivery, the achievement of session goals, how well prepared they felt to deliver the session and their ability to answer participants’ questions. Responses were given on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The higher the score, the more positively the session was rated. They were also asked to give an overall rating for the session (‘in general how would you rate today’s session’) on a scale of 1 to 5, where 1 was poor and 5 was excellent. Finally, they were asked four open-ended questions: ‘what do you think worked best in today’s session?’, ‘what do you think worked less well in today’s session?’, ‘how do you think today’s session could be improved?’ and ‘any additional comments?’.

All sessions were observed by at least one researcher to assess the feasibility of the quality assurance methods proposed for the main trial, including acceptability to drug worker/nursing staff and service users. Following completion of this study, this information may also be used to inform refinement of the training manual and/or the intervention itself and is expected to suggest the level of supervision likely to be required. During each session, researchers completed a brief checklist to identify what aspects of the manual were implemented. Participants and staff were also asked to complete an evaluation after each session (see Appendix 14).

Primary outcomes: feasibility parameters

Secondary outcomes: intervention effectiveness

Intervention effectiveness was explored for selected outcome measures (see Outcome measures). An overview of the time points at which trial data were collected is presented in Table 16. The original plan was to present descriptive statistics for all outcomes across all stratification factors. However, given the low follow-up rates and small numbers for some strata, this was not deemed informative and average outcomes are presented in total and by gender only. Tables include summaries grouped by randomised allocation as well as grouped by attendance of intervention sessions.

Longitudinal regression analyses were conducted, predicting each outcome at the two follow-up points from the outcome at baseline and allocation by follow-up interaction, adjusting for gender and recruitment site. Estimated mean group differences from these analyses are presented by intention-to-treat (ITT) and per-protocol groups together with 80% and 95% CIs. As a feasibility trial, no p-values are presented.

Trial progression

The flow of participants is shown in Figure 21. Of 176 eligible drug users, 99 individuals were randomised into the feasibility trial during January and February 2016. One person was erroneously randomised twice (therefore 100 randomisations); however, their second randomisation was subsequently withdrawn and the person remained in the trial according to their initial allocation. Of the 99 individuals randomised, 52 were allocated to the intervention arm and 47 were allocated to the control arm. A total of 20 participants attended at least one intervention session and just under half of participants were followed up until 1 month post intervention.

FIGURE 21.

Study flow diagram.

Participant randomisation was stratified by recruitment site (London, York, Glasgow or Wrexham), service type (needle exchange or community drug service) and gender (male or female). Balanced allocation across these factors was achieved (Table 17). Recruitment from needle exchanges was substantially lower than anticipated. Owing to the small number of these participants, result summaries will not be presented separately for these groups, as was originally planned. The focus of the results will be on the potential population differences between recruitment sites and any differences between male and female participants.

Feasibility parameters

Feasibility was assessed as the proportion of patients consented and randomised, as well as compliance with the intervention and attrition throughout follow-up. Recruitment was relatively straightforward in most settings, with an expected number of presenting drug users being eligible for inclusion in the trial. Many service users were not eligible as they did not currently inject drugs. In general, women were harder to recruit, as fewer than anticipated attended the target services and not as many of those who did were injecting drugs. The rate of recruitment was 57% (99 participants of 175 eligible, excluding the participant who was randomised twice in error). Reasons for otherwise eligible drug users not being entered into the trial (n = 76) included that they were not interested (n = 17), too busy to discuss study/participate (n = 18), not able to (re)contact (n = 14), did not attend appointment (n = 14), intervention dates were not suitable (n = 4), they entered rehabilitation treatment (n = 3), they were worried regarding confidentiality of injecting status (n = 2), English was not their first language (n = 2), they were too ill (n = 1) or were with others on day of recruitment (n = 1).

Compliance and attrition by recruitment site are summarised in Table 18. Attendance for at least one intervention session was highest in London (63%) and Wrexham (54%), whereas only 25% attended in Glasgow and no participants attended in York. Follow-up at a minimum of one time point (at the end of the intervention or 1 month post intervention) was also highest in London (83%) and Wrexham (63%), and significantly lower in Glasgow (55%) and York (43%).

Compliance and attrition were further broken down by gender (Tables 19–21). Overall, men were more likely to attend at least one intervention session. Women were more likely to attend follow-up in London and York, but not in Glasgow and Wrexham. The possible reasons behind these gender differences were not clear. Possible associations of compliance and attrition rates with other characteristics of each population were explored as part of the next section (see Baseline characteristics).

Baseline characteristics

Characteristics of the trial population at baseline by allocation and gender are presented in Table 22. Participants were predominantly males in their late thirties/early forties, with an average history of between 14 and 22 years of injecting. Baseline characteristics were comparable between randomised treatment groups for males, despite the relatively small number of participants. Potential imbalances were observed in the smaller group of women (e.g. with a greater number of heroin users and homeless women in the intervention arm).

Following marked differences in compliance and follow-up at the four trial recruitment sites, population characteristics were additionally compared between sites (Table 23), between those attending at least one intervention session and those attending none [total including statistical test for differences (Table 24) and by gender (Table 25)], and between those attending at least one follow-up session and those attending none [including statistical test for differences (Table 26)].

Compared with participants who did attend at least one intervention session (n = 20), participants who did not attend any sessions (n = 32) were more likely to be homeless (56% vs. 25%; p = 0.044), injected drugs for a greater number of days in the last month (median 25 vs. 6.5 days; p = 0.019) and used a greater number of needles from a needle exchange in the last month (median 31 vs. 20 needles; p = 0.056). They were more likely to be predominant heroin injectors (69% vs. 40%; p = 0.055 for type of drug) and less likely to inject crack (31% vs. 55%; p = 0.146) (see Table 24). These differences were true for males and females, apart from homelessness, which did not show differences for women, although numbers were small (see Table 25).

More participants attended at least one intervention session in London (63%) and Wrexham (54%) than in Glasgow (25%) and York (0%) (see Table 18). Glasgow and York, however, had higher levels of homelessness, and participants injected for a greater number of days and used more needles from a needle exchange (see Table 23). As per the influential characteristics identified above, these factors may have contributed towards lower attendance rates. Specific contributing factors to non-attendance in Glasgow were that two female participants and three male participants had entered residential rehabilitation, and one male participant was incarcerated. In addition, in York, text messages were sent to remind participants of intervention session times and dates from the service (reported preference of participants), whereas in other sites the researcher contacted participants by telephone to remind them of session dates and times 1 day in advance and also sent a reminder text the day of the intervention. Thus, talking with the researcher and the additional reminder may have resulted in increased attendance at the other sites. Moreover, as a result of the dedicated researcher leaving their position at the University of York, four staff from the CRN York Teaching Hospitals NHS Trust were responsible for recruitment and follow-up of participants, whereas in other sites participants had contact with the same named researcher throughout the trial, and this established relationship could also have contributed to increased attendance. Additional potential contributing factors for the differences in compliance and attendance across trial sites include reimbursement of travel (bus ticket or receipt for bus travel), reimbursement of time and CM paid in cash (vs. high-street vouchers in other sites) and co-facilitation of the intervention by peer educators (in the London site only).

Follow-up attendance (one or both times) was associated with fewer days of injecting drugs in the last month (median 14 vs. 27 days; p = 0.030) and fewer injections of cocaine (13% vs. 30%; p = 0.063), but none of the other characteristics identified for compliance above to a substantial extent (see Table 26). More participants were followed up in London (83%) and Wrexham (63%) than in Glasgow (55%) and York (43%) (see Table 26), which may in part be linked to factors associated with higher injecting frequencies in Glasgow and York. In addition, at the 1-month follow-up, two female participants in London were in hospital; one male participant was in prison in Wrexham; and in Glasgow, three female and three male participants were in residential rehabilitation, one male participant was in prison and one male participant was in hospital. As these participants were not contactable, it was not possible to conduct follow-up interviews.

Outcome measures

Outcome measures that were collected from participants at baseline and at the end of the intervention and 1 month post intervention are summarised by randomised allocation in Table 27 (total) and Tables 28 and 29 (by gender).

Following advice from the DMEC, outcomes were further grouped by compliance [i.e. participants who attended at least one intervention session compared with those who attended none (Table 30)]. See Outcome measures for a full description of the derivation and interpretation of each outcome.

In addition to the summary statistics, outcomes were analysed by longitudinal regression analysis, predicting each outcome from treatment arm and follow-up point (and their interaction), the outcome at baseline, gender and recruitment site. Estimated group differences and CIs from these analyses are presented in Table 31. Following advice from the DMEC, both ITT and per-protocol analyses (by attendance of at least one intervention session) were conducted with both 95% and 80% CIs.

The summary of group differences for each outcome (see Table 31) is based on longitudinal regression analyses, adjusting for gender, recruitment site and the outcome in question at baseline. See Outcome measures for a full description of each outcome. Analyses revealed improved (fewer) injecting risk practices, improved self-efficacy, better HCV and HBV transmission knowledge and greater use of withdrawal prevention techniques in the intervention arm. This was true at both follow-up time points and both analyses for randomised groups and groups based on attendance of the intervention. Little change for any group was seen for HIV transmission knowledge.

A number of results appeared counterintuitive. Participants in the randomised intervention group engaged in a greater number of sexual risk behaviours at both follow-up time points, although group differences were reduced to minimal in the attendance-based analysis. Motivation to change both to protect the participant themselves and to protect others was greater for control arm participants/participants who did not attend any interventions. This outcome was highly skewed, with most participants indicated being highly motivated. There is no explanation for this high motivation, and this could potentially be a result of these participants hoping to be randomly allocated to the intervention group.

Sample sizes were too small to investigate possible interactions with baseline characteristics and outcomes (e.g. whether or not score changes can only be seen in a subset of the participant population). A larger pilot might have revealed meaningful trends for such subgroups.

All outcome measures were reviewed with regard to the number of missing items that contribute to each outcome (Table 32). Overall, data completeness was very high across all questionnaire responses, and most items were only missing sporadically. Notable exceptions were items 4 and 6 of the sexual risk behaviours. Both of these are questions relating to a casual sexual partner rather than a regular one, which may not have been applicable to some participants, although the question does ask to answer the question hypothetically if not applicable.