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Background To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care, compared with hospital-based specialist care. Methods We randomized PWID with HCV attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care [SOC]). The primary outcome was to determine whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. Results We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7–100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P <.001; relative risk [RR] 2.48, 95% CI 1.54–3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P =.043; RR 1.63, 95% CI 1.0–2.65). Conclusions Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. Clinical Trials Registration NCT02555475. [ABSTRACT FROM AUTHOR]

Introduction. Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. Methods. At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Results. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOLat FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). Conclusion. The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. [ABSTRACT FROM AUTHOR]

Process evaluation is valuable in guiding development of effective intervention programmes but rare in adolescent weight management. This paper presents a process evaluation of the Loozit® randomized controlled trial, a community-based behavioural lifestyle intervention for obese 13-16 year olds. Adolescents were randomized to receive the two-phase Loozit® group programme, with (n = 73) or without (n = 78), additional therapeutic contact (telephone coaching, short message service and/or emails) in Phase 2. Quantitative and qualitative process data were collected. Facilitators used a standardized evaluation form to document participant attendance, and comment on lesson adherence and process delivery. Adolescents and parents completed satisfaction questionnaires at 2-, 12- and 24-month follow-ups. Following the intervention, 14 adolescents who provided informed written consent were interviewed about their experience with additional therapeutic contact. Data were analysed using descriptive statistics, parametric and non-parametric tests to compare group means, and thematic analyses. Group attendance rates averaged 85 and 47% during Phases 1 (0-2 months) and 2 (3-24 months), respectively. Facilitators frequently noted that participants reported making healthy lifestyle changes. Elements enjoyed in the sessions included practical activities, fun active games, resistance training and forming new friendships. Adolescents struggled with setting specific, measurable, achievable, realistic and timely (SMART) goals. Overall, participants were satisfied with the help received including the telephone and electronic contact. More than 80% of participants found the programme changed adolescents' eating and physical activity habits, and 89% of parents reported changing parenting strategies. Future adolescent group-based programmes may enhance participant engagement and programme effectiveness by including more interactive and frequent telephone and electronic contact. [ABSTRACT FROM AUTHOR]