The Adaptive Platform Trial Operations Special Interest Group (APTO-SIG) was established in 2022 and aims to provide relevant and informative guidance on mitigating identified operational challenges of adaptive platform trials. The APTO-SIG provides a forum for members to share information and collaborate in problem solving, to increase awareness of different adaptive platform trials, and to develop relevant resources.
The Group’s main focus is to:
– Share common key challenges and opportunities for adaptive platform trial operations
– Provide and explore best practice knowledge and resource opportunities
– Explore ways to support and foster growth of the adaptive platform trial operations workforce
– Provide representation and connection with ACTA’s Innovative Trials Working Group and Statistics in Trials Special Interest Group
The group comprises of membership representing 16 adaptive platform trials in Australia and is seeking to expand representation to all funded APTs in Australia. A list of currently represented adaptive platform trials and their trial summaries can be found below.
Adaptive Platform Trial Summaries Register
Please find below a list of adaptive platform trials currently represented in our group membership, and their trial summaries.
ASCOT-ADAPT: The Australasian COVID-19 Trial
Background:
The SARS-CoV-2 virus has caused over 1,000,000 deaths globally due to COVID-19. The global response is working to accelerate diagnostics, vaccines, and therapeutics. Despite some promising treatments (e.g., remdesivir and dexamethasone), more effective therapies are needed. ASCOT-ADAPT is a multi-centre, randomised, adaptive platform clinical trial to assess clinical, virological, and immunological outcomes in patients with SARS-CoV-2 infection.
Methodology:
Patients are initially admitted to hospital with a positive SARS-CoV-2 PCR test. During screening patients must meet all core inclusion/exclusion eligibility criteria, and consent to trial domains and interventions. Following screening and consent, patients are randomised to all eligible and available domains. The three ASCOT-ADAPT domains are Antiviral, Therapeutic Antibody, and Anticoagulation, these domains closed on August 2022, February 2021, and April 2022, respectively. The ASCOT-ADAPT domains include the following interventions:
- Antiviral Domain – Usual care vs. Nafamostat + Usual care.
- Therapeutic Antibody Domain – No antibody therapy against SARS-CoV-2 vs. Convalescent Plasma.
- Anticoagulation Domain – Prophylactic dose vs. Intermediate dose vs. Prophylactic dose + Aspirin (closed in September 2021) vs. Therapeutic anticoagulation (opened September 2021).
The primary outcome measure is death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor / inotropic support in the 28 days after randomisation.
Statistical inference is based on the analysis of accumulated trial data using pre-specified Bayesian models at regularly scheduled analyses. The Bayesian adaptive platform incorporates critical design features which enable enhanced efficiency and implementation of findings, including:
- A pragmatic trial design, embedded within routine care
- Implementation of universal trial master protocol with multiple domains and therapeutic questions
- Frequent interim analyses via Bayesian Hierarchical Model, enabling domain conclusion once robust statistical confidence is met
- Response adaptive randomisation, which involves updating patient allocation based on interim results
Aim:
ASCOT-ADAPT aims to identify the regimen (combination of interventions) associated with the highest chance of survival, free of advanced respiratory support or vasopressor / inotropic support at 28 days after randomisation, in adults hospitalized with COVID-19 but not requiring ICU-level care at baseline.
HREC name: Melbourne Health HREC
Link to ANZCTR registration: ACTRN12620000445976
Trial Contact email: ascot-team@unimelb.edu.au
Trial website link: https://www.ascot-trial.edu.au/
AuTOMATIC trial: a multi-arm Bayesian adaptive randomized controlled trial of text messaging to improve childhood immunisation coverage
Background:
While most Australian children are vaccinated, delays in vaccination can put them at risk from preventable infections. Widespread mobile phone ownership in Australia could allow automated short message service (SMS) reminders to be used as a low-cost strategy to effectively ‘nudge’ parents towards vaccinating their children on time.
Methodology:
AuTOMATIC is an adaptive randomised trial which aims to both evaluate and optimise the use of SMS reminders for improving the timely vaccination of children at primary care clinics across Australia. The trial will utilize high levels of digital automation to effect, including eligibility assessment, randomisation, delivery of intervention, data extraction and analysis, thereby allowing healthcare-embedded trial delivery. Up to 10,000 parents attending participating primary care clinics will be randomised to one of 12 different active SMS vaccine reminder content and timing arms or usual practice only (no SMS reminder). The primary outcome is vaccine receipt within 28 days of the scheduled date for the index vaccine (the first scheduled vaccine after randomisation). Secondary analyses will assess receipt and timeliness for all vaccine occasions in all children. Regular scheduled analyses will be performed using Bayesian inference and pre-specifed trial decision rules, enabling response adaptive randomisation, suspension of any poorly performing arms and early stopping if a single best message is identified.
Aim:
This study will aim to optimise SMS reminders for childhood vaccination in primary care clinics, directly comparing alternative message framing and message timing. Methods and findings from this study will help to inform strategies for implementing reminders and embedding analytics in primary health care settings.
HREC name: University of Western Australia (UWA) HREC
Link to ANZCTR registration: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371796&isReview=true
Trial Contact email: grace.currie@sydney.edu.au
Trial website link: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07097-3
BEAT-COVID-19: A BayEsian Adaptive platform, randomised controlled Trial to evaluate the efficacy and safety of interventions for COVID-19
Background:
Coronavirus disease 2019 (COVID-19) is a recent and one of the deadliest examples of cross-species viral transmission affecting the human population. By the end of 2022, COVID-19 has resulted in more than 665 million confirmed cases and 6.7 million confirmed deaths worldwide. The range of severity of disease is broad, ranging from no symptoms, through to respiratory failure, and death.
The COVID-19 pandemic has demonstrated unprecedented challenges in terms of healthcare and research delivery. As the clinical management of COVID-19 shifted from the hospital to community setting, the unmet need for an evidence base within community COVID-19 has unfolded.
Methodology:
BEAT COVID-19 is an investigator initiated, randomised controlled, adaptive platform trial, intended as a durable framework for delivering decentralised, community-based research with an aim to accelerate the assessment of interventions for preventing hospitalisation and death in adults with confirmed COVID-19 managed in the community. The study has initiated with a single domain evaluating an oral corticosteroid inhaler versus Placebo, recruiting its first participant on 16 March 2022 and has since recruited 100+ participants. Utilisation of a platform design allows adaption in time, for the study to integrate additional interventions as they become suitable for evaluation within the setting. To date there have not been any additional domains added to the platform. An independent Candidate Intervention Expert Committee will assess potential new interventions for integration into the platform.
Aim:
The primary objective is to assess the comparative effectiveness and safety of a range of interventions in reducing the incidence of hospital admission or death within 28 days of randomisation, in community-based adults with -confirmed SARS-CoV-2 infection.
HREC name: SLHD RPA Zone
Link to ANZCTR registration: ACTRN12620000566932
Trial Contact email: beatcovid19.study@sydney.edu.au
Trial website link : NHMRC CTC BEAT COVID-19
BEAT-BK: An adaptive, randomised controlled trial to treat polymoavirus infections (BKPyV) in kidney and simultaneous kidney pancreas transplant recipients
BKPyV infection is rare but devastating for kidney and SPK transplant recipients. While immunosuppression is necessary to prevent acute rejection and graft loss, it also increases the risk of opportunistic infections and reactivation of latent viruses, including BKPyV.
Currently, there are no approved anti-viral therapies or preventive measures for BKPyV-Viremia. IVIG has been proposed as a supportive treatment for BKPyV infections.
A systematic review shows a tendency towards improved viral clearance after 6 months in IVIG-treated patients. However, the effects are uncertain due to the absence of high-quality comparative data.
Methodology:
A multi-centre, adaptive, randomised, two-arm trial of immunosuppression reduction/modification (standard of care) with and without Intravenous immunoglobulin (IVIG) in kidney and SPK recipients with BKPyV infections. The defining features will be:
• Parallel appraisal of viraemia, allograft function, death, acute rejection, immunosuppression load, graft loss and adverse events.
• Regularly updated analyses using Bayesian inference with the potential for early trial success if the threshold for a superior intervention is met.
• Potential for efficient estimation of defined patient subgroup-specific intervention effects using information sharing (empiric Bayesian borrowing) in the hierarchical models
Aim: To compare the efficacy of immunosuppression reduction/modification strategy, with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV)
HREC name: Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)
Link to clinicaltrials.gov registration: NCT05325008
Trial Contact email : beat-bk@uq.edu.au
Trial website link : https://aktn.org.au/beat-bk/
BEAT-Calci: Better Evidence And Translation for Calciphylaxis
Calciphylaxis is a rare disease that is mainly seen in patients with kidney failure, who are receiving dialysis. In calciphylaxis, calcium builds up in the small blood vessels of fat and skin tissue. This can lead to blocked blood vessels, painful skin ulcers and sometimes complications including serious infections.
There are many ways that doctors may approach the clinical care of people with calciphylaxis. These include pharmaceutical treatment, changing dialysis frequency or type, wound care, surgery and so on. At present, none of these approaches to manage calciphylaxis are supported by high-quality evidence.
Methodology:
BEAT-Calci is an investigator-initiated, multicentre, international, prospective, adaptive, platform, randomised controlled trial, involving multiple interventions spanning several domains of therapeutic care. The trial is commencing with a Dialysis Membrane Domain and Pharmacotherapy Domain;
1. Pharmacotherapy Domain, which aims to investigate whether treatment with different pharmacotherapeutic agents is superior in improving outcomes.
2. Dialysis Membrane Domain, which aims to investigate whether treatment with different dialysis technologies is superior in improving outcomes.
Additional domains of care, and additional interventions within existing domains, may be introduced into the platform as they become scientifically and operationally feasible.
Participants will be recruited from a number of countries, including but not limited to, Australia, New Zealand, Canada and the United Kingdom.
The University of Sydney is the Sponsor of the BEAT-Calci Study. Funders include the Medical Research Future Fund (MRFF) and Baxter Healthcare.
Aim:
The primary objective is to establish high-quality evidence on the effect of a range of interventions on the BEAT-Calci Wound Assessment Scale (BCWAS) in patients with kidney failure and newly diagnosed calciphylaxis.
HREC Name: Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital
Link to clintrials.gov registration: NCT05018221
Trial contact email: beat-calci.study@sydney.edu.au
Trial website link: BEAT-Calci: Better Evidence And Translation for Calciphylaxis or http://beat-calci.sydney.edu.au
BEAT CF: Bayesian Evidence Adaptive Treatment of Cystic Fibrosis
With every pulmonary exacerbation of CF, approximately 25% of patients do not return to their baseline lung function measured. Antibiotics are a cornerstone of treatment, but most antibiotic regimens are only informed by old, underpowered, or poor-quality trials so no consensus exists on the treatment of pulmonary exacerbations (PEx) of CF. Across Australia, CF centres use a range of approaches and antibiotic regimens. Because preservation of lung function is important for extending life and quality of life, there is a need to determine the most effective empirical treatments of exacerbations.
In addition to numerous antibiotic options, there are other unanswered questions pertaining to the use of mucolytic agents, anti-inflammatory medication and chest physiotherapy, alone and in combination. The range of regimens used for treating CF exacerbations cannot be feasibly compared using conventional clinical trials (comparing one treatment at a time to another treatment or placebo) due to the large number of comparisons that are needed.
Methodology:
Prospective cohort with a nested randomised embedded multi-arm adaptive platform (REMAP) nested within
Aim:
To identify the effectiveness, or comparative effectiveness, of alternative interventions that are currently in routine use, or proposed for future use, in the management of acute pulmonary exacerbations in children and adults with CF, with respect to short-term improvements in lung function.
HREC name: Child and Adolescent Health Service, WA
Link to ANZCTR registration: Cohort: ANZCTR 12621000638831, Domain A: ACTRN12622001063707, Domain B: ACTRN12622000950763
Trial Contact email: Beatcf.project@sydney.edu.au
Trial website link: www.beatcf.org.au
FORMaT: Finding the Optimal Regimen for Mycobacterium abscessus Treatment
Mycobacterium abscessus group (MABS) are a species of nontuberculous mycobacteria found in water and soil with high intrinsic multi-drug resistance that may infect lungs. Individuals may have positive respiratory cultures that clear spontaneously, present with established MABS-pulmonary disease (PD) or initially have positive cultures without disease but develop MABS-PD later. Individuals with underlying inflammatory lung diseases e.g. bronchiectasis and cystic fibrosis (CF) are more susceptible to MABS-PD, but individuals with no underlying condition may also develop disease. There is evidence that successfully clearing infection is associated with better health outcomes. Treatment regimens for MABS are highly variable, not evidence-based and involve complex, expensive, drug combinations with high toxicity for prolonged periods (>12 months).
Methodology:
Entry can occur at two different levels for participants at any age;
1- from their first MABS isolate and not receiving current MABS therapy are eligible to enrol in the observational cohort and
2- meeting the American Thoracic Society (ATS) criteria for the diagnosis of MABS-PD and are untreated for MABS-PD are eligible to enrol in the intervention program. Intervention program participants will be randomised to receive MABS-PD therapy combinations and additional outcomes will be assessed. The primary outcome of the intervention program is microbiological clearance of MABS taking intervention toxicity into account.
Aims:
1. Build an iterative, standing, platform trial with innovative and adaptive properties to evaluate therapy combinations for patients with MABS-PD.
2. Use the opportunities afforded by the clinical trial platform to establish discovery studies investigating:
a. effects of MABS-PD and therapeutic interventions on health-related quality of life, and cost effectiveness of these therapies;
b. drug dosing using robust pharmacokinetics;
c. biomarkers for susceptibility to MABS-PD;
d. the genomics of human MABS strains and antibiotic resistance genes and impact of therapeutic interventions.
3. Investigate the use of registries to facilitate long-term monitoring.
HREC name: 53810: Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)
Link to ANZCTR registration: ANZCTR – Registration
Trial Contact email: formattrial@health.qld.gov.au
Trial website link : https://formattrial.com/
M-FIT: Structured exercise program to reduce fatigue in patients receiving dialysis: an adaptive trial
The global Standardised Outcomes in Nephrology (SONG) initiative, involving over 2000 patients receiving dialysis, caregivers, and health professionals across 100 countries, established fatigue as a critically important core outcome. Lifestyle (including exercise) interventions was the top priority identified through the research priority setting partnership. Evidence for exercise interventions remains very uncertain due to factors such as the plethora of measurements used to assess fatigue and small sample size. A patient workshop was convened to identify and prioritise exercise interventions for the M-FIT study to ensure acceptability and feasibility.
Methodology:
Multi-centre, adaptive, randomised, comparative effectiveness trial of exercise programs and a control in adult patients receiving dialysis (>3 months), using intention-to-treat analyses. Participants will initially be randomised with equal chance, to 1 of 3 exercise prescriptions or control. The allocation to the control arm will be fixed throughout the trial as a proportion of the number of available arms. At each interim analysis the target allocations to the exercise arms will be updated via response adaptive randomisation, with the probability of allocation to an exercise arm proportional to the relative effectiveness of that exercise arm.
Aim:
To assess the comparative effectiveness of alternative structured exercise programs and a control, co-designed with patients, on fatigue, as measured by FACIT-Fatigue, in patients receiving dialysis
HREC name: Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)
Link to ANZCTR registration: ACTRN12620000408987
Trial Contact email: m-fit@uq.edu.au
Trial website link: https://aktn.org.au/m-fit/
Optimum: OPTimising IMmunisation Using Mixed schedules
Background:
The incidence of atopic diseases, particularly food allergy, has risen significantly in Australia in recent decades. This has coincided with a change from the routine use of ‘whole cell’ pertussis (whooping cough) vaccine to ‘acellular’ pertussis vaccine in the infant immunisation schedule. Vaccines train the immune system to recognise certain pathogens and induce a protective response. Researchers believe that some vaccines may also drive an immune response to food allergens and that a causal relationship may exist between the vaccine and predisposition to atopy.
The OPTIMUM study is looking to determine whether one dose of ‘whole cell’ pertussis vaccine given at 2 months of age instead of the current ‘acellular’ pertussis vaccine can help protect young children against allergic outcomes.
Methodology:
This is a Phase IV, double-blinded, randomized controlled trial. The trial uses a Bayesian group sequential design allowing for an adaptive sample size.
Aim: The primary objective of the study is to assess the allergy protective benefits of the addition of an early, single dose of whole cell pertussis vaccine into the infant schedule. Infants will be assessed for development of allergic disease and atopic sensitisation.
HREC name: Child and Adolescent Health Service (RGS000019)
Link to ANZCTR registration: ANZCTR – Registration
Trial Contact email: Optimum.project@sydney.edu.au
Trial website link: OPTIMUM: OPTimising IMmunisation Using Mixed schedules – The University of Sydney
The ORVAC Trial: Optimising Rotavirus Vaccine in Aboriginal Children
Australian Aboriginal and Torres Strait Islander children, particularly those living in remote communities, suffer a
disproportionately high burden of rotavirus diarrhoeal disease. Despite the introduction of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in 2006, the rate of hospitalization for rotavirus for NT Aboriginal children < 5 years continues to be much higher than for children in other states and territories. The reasons for sub-optimal response to rotavirus vaccine are not completely understood, but both reduced vaccine immune responses and low vaccine coverage are likely to be important factors.
The purpose of the ORVAC study is to evaluate if administering a third or ‘booster dose’ of oral rotavirus vaccine to Northern Territory Aboriginal children 6 to 11 months old, results in improved vaccine immune response and decreased medical presentations (remote clinic, emergency department, hospitalisations) with gastroenteritis in the first three years of life.
Background:
Despite the availability of rotavirus vaccines, rotavirus continues to cause approximately 22 hospitalisations per 1000 NT Aboriginal and Torres Strait Islander children < 5 years each year. The rate of hospitalisation among NT Aboriginal children is 5-10 times higher than for other Australian children. Data from remote communities in the Northern Territory, suggests that 77% of children have at least one documented episode of diarrhoea before their first birthday, and that there is a median of three clinic presentations for diarrhoea per child in the first year of life.
Methodology:
This is a phase IV, randomised, placebo-controlled Bayesian trial with two strata representing residency based on a standard geographical classification of remoteness. It has the following key features:
1. Double-blind, randomised, placebo-controlled trial;
2. The procedures for enrolment, intervention, end-point and analysis are based on the principles of pragmatic trial design;
3. Non-fixed sample size up to 1,000 participants based on Bayesian stopping rules;
4. Fixed 1:1 enrolment into the active and control arm throughout the trial;
5. Frequent interim analyses can result in the trial stopping early for futility or expected success.
Aim:
The aim of the study is to determine if routinely scheduling a third dose of oral rotavirus vaccine for Australian Aboriginal and Torres Strait Islander children 6 to 11 months old will confer significantly better protection against clinically important gastroenteritis than the current two-dose schedule of oral rotavirus vaccine administered at 2 months old and 4 months old.
HREC name: The Human Research Ethics Committee of NT Health and Menzies School of Health Research (NT HREC)
Link to ANZCTR registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=7011&isClinicalTrial=True
Trial Contact email: sarah.gallagher@menzies.edu.au
Trial website link: https://www.telethonkids.org.au/projects/the-orvac-trial/
PICOBOO: The Platform trial In COVID-19 priming and BOOsting.
Background:
PICOBOO is a pragmatic Bayesian Adaptive, Randomised Controlled trial. Immunocompetent children and adults will receive a COVID-19 vaccine(s) authorised for use (including emergency use authorisation) by the Therapeutic Goods Administration (TGA) or equivalent regulatory authority. Allocation of COVID-19 vaccine to participants will be centrally determined using computer generated random sequences according to the participant’s stratum. Equal assignment probabilities will be used for the COVID-19 vaccine interventions.
Aims:
Aims of the study are to generate evidence to compare the:
1. protective immune responses to alternative COVID-19 vaccines.
2. reactogenicity of alternative COVID-19 vaccines.
3. safety of alternative COVID-19 vaccines and schedules.
The primary objective is for Australians, eligible for enrolment, stratified by prior vaccination history and age cohort, to generate high-quality evidence of the immunogenicity and reactogenicity of alternative COVID-19 vaccination strategies against SARS-CoV-2.
The primary outcome, is the concentration of anti-spike SARS-CoV-2 IgG antibodies against SARS-CoV-2 measured ~28 days after receipt of the assigned COVID-19 vaccine and summarised as the geometric mean concentration (GMC), estimated for each COVID-19 vaccine in each stratum.
Analysis is through Bayesian Hierarchical models.
HREC Name: Child and Adolescent Health Service HREC (Perth) – HREA
Link to ANZCTR registration: Australian New Zealand Clinical Trials Registry (ACTRN12622000238774)
Trial contact email: PICOBOO@telethonkids.org.au
Trial website:
REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia)
Background:
Respiratory infections that are of sufficient severity to require admission to hospital are associated with substantial mortality. Hospitalized patients with respiratory infections will receive therapy that consists of a combination of multiple different treatments, however current conventional clinical trial methods used to assess the efficacy of treatments for respiratory infections generally compare two treatment options in a series of separate and sequential trials. This takes an inordinate length of time to study all available treatment options and does not allow for the evaluation of interactions between treatment options. In addition, with each trial, there is a risk of an indeterminate result.
REMAP-CAP utilizes a number of novel trial design features to allow for the efficient evaluation of multiple interventions simultaneously; avoid indeterminate results; and adapt seamlessly over time to add or remove interventions, to answer emerging clinical questions including evaluating candidate interventions in the event of a respiratory pandemic.
Methodology:
REMAP-CAP enrols hospitalised patients with respiratory tract infections using a design known as a REMAP, which is a type of adaptive platform trial. Within this REMAP, eligible participants will be randomised to receive one intervention in each of one or more “domains” of therapy. The adaptive design allows new interventions to be added or removed over time. Routine analyses are performed on accumulating trial data using a Bayesian hierarchical model, with results reported once pre-defined statistical thresholds are reached.
Aim:
The primary objective of this REMAP is, for patients hospitalized with respiratory tract infection, to identify the effect of a range of interventions to improve patient outcomes.
HREC name: Sydney Local Health District – RPAH Zone HREC
Link to ANZCTR registration: ClinicalTrials.gov reference: NCT02735707
Trial Contact email: info@remapcap.org
Trial website link: www.remapcap.org
SNAP: Staphylococcus aureus Network Adaptive Platform trial
Staphylococcus aureus bacteraemia (SAB) is a common and severe infection with a 90-day mortality of 15—30% in adults, and 5% in children. Despite the burden of disease, <3000 participants have been enrolled in completed randomized clinical trials for SAB from 2000 to 2021.
SNAP is an adaptive platform trial that aims to improve treatment outcomes for patients with SAB infection.
The trial currently recruits patients (including adults, children, and pregnant women) across Australia, New Zealand, Canada, Singapore, and Israel, with plans to recruit up to 7,000 patients over 4—5 years.
Methodology:
SNAP is a multicenter, pragmatic, multi-arm, open-label adaptive platform trial addressing multiple therapeutic questions in SAB patients. There are currently three treatment domains (Antibiotic Backbone, Adjunctive Treatment, Early Oral Switch), and three ‘silos’ representing the antibiotic susceptibility profiles (PSSA, MSSA, MRSA).
Treatment domains:
· Antibiotic Backbone:
– PSSA treatment – (Flu)cloxacillin vs. Penicillin
– MSSA treatment – (Flu)cloxacillin vs. Cefazolin
– MRSA treatment – Vancomycin/Daptomycin vs. Vancomycin/Daptomycin + Cefazolin
· Adjunctive Treatment:
– Treatment for all silos – No Clindamycin vs Clindamycin
· Early Oral Switch:
– Treatment for all silos – Continued IV vs. Early Oral Switch
Patients will be enrolled into all domains for which they are eligible and provide consent for. Patients who are not eligible for, or who do not consent to the platform, will be asked to participate in the SNAP registry. All participants will be followed up for 90 days.
Aim:
– The primary objective of the SNAP trial is to examine the effect of a range of clinical interventions on all-cause 90-day mortality in patients with SAB.
– The secondary objectives include examining the effect of a range of interventions on several secondary endpoints including mortality, hospital length of stay, treatment failure, treatment complications, and healthcare costs.
HREC name: RMH (Royal Melbourne Hospital) HREC
Link to ANZCTR registration: NCT05137119
Trial Contact email: snap-trial@unimelb.edu.au
Trial website link: https://www.snaptrial.com.au/
Motivate C: The Methodical evaluation and Optimisation of Targeted IncentiVes for Accessing Treatment of Early-stage hepatitis C
Financial incentives (for patients and primary care providers) are a straightforward strategy for improving the uptake of hepatitis C treatment in primary care. In the MOTIVATE-C project, individuals with hepatitis C will be randomly assigned to usual care or to receive incentives of various dollar values for commencing hepatitis C treatment. By assigning patients to different values of incentive and evaluating their effect on treatment initiation, we aim to directly inform the future implementation of incentives by identifying the most cost-efficient strategy. The participant’s nominated/preferred primary care provider will also be randomly assigned to usual care or to receive a fixed incentive of AUD 100.
Methodology
Pragmatic, Bayesian response-adaptive, multi-arm, randomised, optimisation trial of financial incentives paid to adults with chronic HCV infection, their GPs, or both.
Aim:
To evaluate and optimise the implementation of financial incentives to increase initiation of DAA therapy in primary care.
Objectives:
1: Does offering a financial incentive to people with HCV to initiate DAA therapy in primary care, increase the probability of treatment initiation compared to usual care (no incentive)?
2: What is the relationship between the dollar value of the offered financial incentive (up to $1000) and the probability of treatment initiation?
3. What participant incentive is optimal in terms of minimising the costsexpended under theincentive program relative to the costs averted from the progression of untreated chronic HCV?
HREC name: Sydney Local Health District Ethics Review Committee (RPAH Zone), Prince Alfred. Link to ANZCTR registration: https://www.anzctr.org.au/ACTRN12623000024640.aspx
Trial Contact email : motivatec.project@sydney.edu.au
Trial website link: https://motivatec-project.sydney.edu.au/