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Introduction Process evaluations examining programme implementation are often conducted in conjunction with effectiveness studies. Their inclusion in studies with Aboriginal participants can give an understanding of programme delivery in Aboriginal community contexts. The Ironbark: Standing Strong and Tall programme was codesigned with Aboriginal communities and includes exercise and facilitated € yarning' discussion about fall risk and prevention strategies. The programme pilot showed favourable outcomes and acceptability for Aboriginal people aged 45 years and over. The Ironbark: Standing Strong and Tall programme is now being compared with a € Healthy Community' programme in a cluster randomised controlled trial within Aboriginal health and community services. An embedded process evaluation aims to explore relationships between participation and programme outcomes and the quality of programme implementation. Methods and analysis The process evaluation will use a mixed methods design, guided by Indigenous research methodology. It will evaluate quantitative data (number of completed sessions, site coaching checklist tool, participant and facilitator questionnaire data and a participant habit formation scale), as well as qualitative data (open-ended responses from project and site staff and semistructured interviews using yarning with study participants and site managers). A programme logic model was developed to explain the intended inputs, activities, outputs and outcomes, which guided this process evaluation design. Conclusion This process evaluation of a fall prevention programme for older Aboriginal people using a mixed methods design and data triangulation will allow for a comprehensive understanding of study findings. Multiple study sites allow for generalisability of findings and exploration of variation across sites. Trial registration number ACTRN12619000349145.

Objectives and importance of study: Exercise prevents falls among community-dwelling older adults. Therefore, it is crucial that health and exercise professionals have the knowledge and skills to prescribe appropriate fall prevention exercise. This study evaluated the effect of a fall prevention education program, compared with a waitlist control group, on health and exercise professionals' fall prevention knowledge and behaviour, and their confidence to prescribe fall prevention exercises for older people. Study type: Randomised controlled trial. Methods: Participants were 200 health and exercise professionals recruited in New South Wales (NSW), Australia. The intervention group participated in a 1-day face-to-face education workshop on exercise to prevent falls in older age. The waitlist control group received the education intervention after completion of the 3-month follow-up. Primary outcomes were self-reported fall prevention knowledge, and change in prescribing behaviour for fall prevention exercise. Secondary outcomes were: confidence to prescribe fall prevention exercise; proportion of people aged 60 years and older seen in the past month who were prescribed fall prevention exercise; and proportion of fall prevention exercises prescribed in the past month that were evidence based. Data were analysed using analysis of covariance models for continuously scored outcomes and the differences in proportions between groups (relative risk [RR]). Results: The intervention significantly improved knowledge (between-group difference [BGD] 0.27 points out of a possible 6; 95% confidence interval [CI] 0.03, 0.51; p = 0.03), perceived clinical behaviour (RR 5.58; 95% CI 3.25, 9.59; p < 0.001), confidence (BGD 1.02/10 points; 95% CI 0.65, 1.39; p < 0.001) and the proportion of evidence-based exercise prescribed, in both the number of exercises (BGD 0.36; 95% CI 0.03, 0.68; p = 0.03) and percentage of participants who prescribed at least 2 hours/week of fall prevention exer

Introduction: Older Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people. Methods: We will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated. Conclusion: This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services. Trial registration number: ACTRN12619000349145.

Introduction: Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people.

Objective.-To compare safety and efficacy of lamivudine-zidovudine combination therapy with zidovudine monotherapy in treating human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral therapy-naive patients. Design.-Double-blind, randomized, multicenter, comparative trial of 129 patients throughout 24 weeks followed by 24 weeks of open-label lamivudine in combination with zidovudine. Setting.-Outpatients from 14 hospitals in Belgium, France, Germany, Spain, and the United Kingdom were enrolled within 6 months. Patients.-HIV-1-positive, antiretroviral-naive (less than or equal to 4 weeks prior zidovudine use) patients aged at least 18 years with CD4(+) cell counts between 0.10 x 10(9)/L and 0.40 x 10(9)/L (100-400/mu L). Intervention.-Patients received either 300 mg of lamivudine every 12 hours in combination with 200 mg of zidovudine every 8 hours for 24 weeks or zidovudine monotherapy for 24 weeks. All patients were then allowed to receive zidovudine in combination with open-label lamivudine (300 mg every 12 hours). Main Outcome Measures.-Efficacy was assessed by changes in CD4(+) cell counts, beta(2)-microglobulin, neopterin, HIV-1 immune-complex dissociated (ICD) p24 antigenemia, and HIV-1 viral load. Safety was assessed by incidence of adverse clinical events and defined laboratory-measured toxic effects. Results.-Combination therapy showed superior treatment effects compared with monotherapy during the first 24 weeks as documented by changes in CD4(+) cell counts (increase of 0.08 x 10(9)/L vs 0.02 x 10(9)/L, P<.001), ICD p24 (-88% vs -49%; P=.04), cellular viremia (-1.27 vs -0.20 log(10) median tissue-culture infected dose [TCID50] per 10(6) peripheral blood mononuclear cells; P=.001), and viral load measured by HIV-1 RNA polymerase chain reaction using a Roche method (-1.33 vs -0.57 log(10) copies/mL; P=.001) or an immune-capture method (-0.6 vs -0.14 log,, copies/mL; P=.008). Observed changes were sustained to 48 weeks for patients continuing to