Randomized clinical trial: Direct-acting antivirals as treatment for hepatitis C in people who inject drugs: Delivered in needle and syringe programs via directly observed therapy versus fortnightly collection.

Hepatitis C virus (HCV) treatment in people who inject drugs (PWID) is delivered within settings frequented by PWID, such as needle and syringe programs (NSP). The optimal direct-acting antiviral (DAA) dispensing regimen among NSP clients is unknown. This study compared cures (Sustained virologic response 12 weeks post-treatment, [SVR12 ]) across three dispensing schedules to establish non-inferiority of fortnightly dispensing versus directly observed therapy. The ADVANCE HCV study was a randomized, unblinded trial, recruiting PWID attending NSP in Tayside, Scotland, between January 2018 and November 2019. HCV-positive participants were randomized to receive DAAs via directly observed therapy, fortnightly provision or fortnightly provision with psychological intervention. A modified intention to treat analysis was used to identify differences in cures between the three treatment regimes. The study was registered with clinicaltrials.gov; NCT03236506. A total of 110 participants completed the study. 33 participants received directly observed therapy, with 90.91% SVR12 ; 37 received fortnightly provision, with 86.49% SVR12 and 40 received fortnightly provision and psychological intervention at treatment initiation, with 92.50% SVR12 . Analysis showed no significant difference in SVR12 (p = 0.67). This study did not demonstrate a statistically significant difference in cure rate between groups. This provides evidence of the non-inferiority of fortnightly dispensing of direct-acting antivirals (DAAs) compared to directly observed therapy among PWID. It suggests that tight control of adherence through directly observed therapy dispensing of DAAs among this population offers no therapeutic advantage. Therefore, less restrictive dispensing patterns can be used, tailored to patient convenience.

Randomised controlled trial conducted in injecting equipment provision sites to compare the effectiveness of different hepatitis C treatment regimens in people who inject drugs: A Direct obserVed therApy versus fortNightly CollEction study for HCV treatment-ADVANCE HCV protocol study.

INTRODUCTION: Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. Over 85% of individuals who have HCV in Scotland became infected following injecting drug use. Since people who inject drugs (PWID) are the main source of new infections, theoretical modelling has suggested that treatment of HCV infection in PWID may effectively reduce HCV prevalence and accomplish elimination. This protocol describes a clinical trial delivering HCV treatment within injecting equipment provision sites (IEPS) in Tayside, Scotland. METHODS AND ANALYSIS: PWID attending IEPS are tested for HCV and, if they are chronically infected with HCV and eligible, invited to receive treatment within the IEPS. They are randomised to one of three treatment regimens; daily observed treatment, treatment dispensed every 2 weeks and treatment dispensed every 2 weeks together with an adherence psychological intervention (administered before treatment begins). The primary outcome is comparison of the rate of successful treatment (SVR12) in each treatment group. Secondary analyses include assessment of adherence, reinfection rates, viral resistance to treatment and interaction of the treatment with illicit drugs. ETHICS AND DISSEMINATION: The ADVANCE (A Direct obserVed therApy versus fortNightly CollEction) HCV trial was given favourable opinion by East of Scotland Research Ethics Committee (LR/17/ES/0089) prior to commencement. TRIAL REGISTRATION NUMBERS: European Clinical Trials Database (EudraCT) (2017-001039-38) and ClinicalTrials.gov (NCT03236506).

Effectiveness of Positive Youth Development Interventions: A Meta-Analysis of Randomized Controlled Trials.

Positive youth development is thought to be essential to the prevention of adolescent risk behavior and the promotion of thriving. This meta-analysis examined the effects of positive youth development interventions in promoting positive outcomes and reducing risk behavior. Ten databases and grey literature were scanned using a predefined search strategy. We included studies that focused on young people aged 10-19 years, implemented a positive youth development intervention, were outside school hours, and utilized a randomized controlled design. Twenty-four studies, involving 23,258 participants, met the inclusion criteria and were included in the analysis. The impact of the interventions on outcomes including behavioral problems, sexual risk behavior, academic achievement, prosocial behavior and psychological adjustment were assessed. Positive youth development interventions had a small but significant effect on academic achievement and psychological adjustment. No significant effects were found for sexual risk behaviors, problem behavior or positive social behaviors. Intervention effects were independent of program characteristics and participant age. Low-risk young people derived more benefit from positive youth development interventions than high-risk youth. The studies examined had several methodological flaws, which weakened the ability to draw conclusions. Substantial progress has been made in the theoretical understanding of youth development in the past two decades. This progress needs to be matched in the intervention literature, through the use of high-quality evaluation research of positive youth development programs.

Parental bonding and bulimic psychopathology: the mediating role of mistrust/abuse beliefs.

OBJECTIVE: To determine whether the previously reported relationship between parental bonding and bulimic psychopathology is mediated by the development of unhealthy core beliefs. METHOD: One hundred and two nonclinical women completed the Parental Bonding Instrument, the short form of the Young Schema Questionnaire, and the Bulimic Investigatory Test, Edinburgh. RESULTS: Mistrust/abuse beliefs were found to be a partial mediator in the relationship between paternal overprotection and the severity of bulimic attitudes. CONCLUSIONS: The findings suggest that the development of mistrust/abuse beliefs is important in determining the effect that paternal overprotection has on bulimic attitudes.