Contemporary clinical trials最新文献

{"title":"Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial","authors":"Rachel M. Scrivano ,&nbsp;Brittney J. van de Water ,&nbsp;Nicolle Rueras ,&nbsp;Janin Alfonso ,&nbsp;Kimberly H. McManama O'Brien ,&nbsp;Ximena Soto ,&nbsp;Vannah Jiv S. Caumeran ,&nbsp;Barbara Mendez Campos ,&nbsp;Michael Mancusi ,&nbsp;Brian Diehl ,&nbsp;Elizabeth Southwick ,&nbsp;Elisabeth Moreno ,&nbsp;Celia Bora ,&nbsp;Stephanie Armbruster ,&nbsp;Nadia N. Abuelezam ,&nbsp;Rocío Calvo ,&nbsp;Sebastien Haneuse ,&nbsp;Kirsten K. Davison","doi":"10.1016/j.cct.2025.107987","DOIUrl":"10.1016/j.cct.2025.107987","url":null,"abstract":"<div><h3>Background</h3><div>While vaccines are safe and effective, vaccine hesitancy negatively impacts Latinx adults and adults with mental illness, resulting in low vaccination rates. Evidence suggests that Motivational interviewing (MI) may reduce vaccine hesitancy among underserved populations. This trial evaluates the effectiveness of MI integrated into behavioral health on vaccine hesitancy and COVID-19 and influenza vaccination among Latinx adults with mental illness.</div></div><div><h3>Methods</h3><div>Implemented in partnership with NeighborHealth, a Federally Qualified Health Center (FQHC) in a predominantly-Latinx community, Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna) is a novel intervention, comprised of Motivational Interviewing (MI) and a warm handoff, implemented by behavioral health (BH) clinicians to address vaccine hesitancy in their patients. Utilizing a pragmatic multiple-period, cluster-randomized crossover trial design this study: 1) tests the effectiveness of MI Vacuna on COVID-19 and influenza vaccine uptake among Latinx adults with mental illness; 2) investigates moderators of intervention effects including patient-provider ethno-language concordance and country of origin; and 3) examines theory-based elements on the causal pathway between the intervention and vaccine uptake. Primary outcomes include patient COVID-19 and influenza vaccine uptake extracted from electronic health records. Secondary outcomes include vaccine hesitancy and provider trust, evaluated using patient surveys and interviews. Implementation outcomes are measured using multiple data sources.</div></div><div><h3>Discussion</h3><div>This novel study tests the effect of MI within the context of BH on COVID-19 and influenza vaccine hesitancy and uptake among Latinx adults. Results inform the sustainability and scale-up of MI Vacuna and BH-centered efforts to target patient vaccine hesitancy.</div><div><strong>Trial Registration:</strong> <span><span>clinicaltrials.gov</span><svg><path></path></svg></span>, <span><span>NCT06062056</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107987"},"PeriodicalIF":2.0,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults","authors":"Morgan Justice ,&nbsp;Annie Piccorelli ,&nbsp;Andrew L. Avins ,&nbsp;Andrea J. Cook ,&nbsp;Carolyn M. Eng ,&nbsp;Arya Nielsen ,&nbsp;Alice Pressman ,&nbsp;Katie L. Stone ,&nbsp;Raymond Y. Teets ,&nbsp;Robert Wellman ,&nbsp;Lynn L. DeBar","doi":"10.1016/j.cct.2025.107981","DOIUrl":"10.1016/j.cct.2025.107981","url":null,"abstract":"<div><h3>Background</h3><div>Chronic low back pain (cLBP) is a leading cause of disability, particularly among older adults. Despite this, effective nonpharmacologic treatments such as acupuncture have not been adequately studied in older adults. The “BackInAction” pragmatic clinical trial aims to address this gap by evaluating the effectiveness of acupuncture in reducing back pain-related disability among adults aged ≥65. The purpose of this manuscript is to compare sample characteristics across sites and across waves of COVID-19.</div></div><div><h3>Methods</h3><div>We describe participant baseline characteristics for the BackInAction trial, a three-arm randomized trial conducted across four U.S. healthcare systems: two integrated care delivery, a fee-for-service (FFS) system, and an urban federally qualified health center (FQHC). Participants (<em>N</em> = 800) with cLBP were randomized to receive standard acupuncture, standard acupuncture plus maintenance sessions, or usual medical care. Baseline data were collected through self-reported measures and electronic health records. Recruitment trends are evaluated during COVID waves.</div></div><div><h3>Results</h3><div>The sample was predominantly female (61.9 %) and non-Hispanic white (64.6 %), with an average age of 73.6 years. The FQHC enrolled a younger, more diverse and socioeconomically disadvantaged population with higher levels of back pain-related dysfunction. The FFS enrolled an older population but had similar rates of back pain-related dysfunction and pain intensity as in the integrated care delivery systems. There were no differences by site corresponding to the circulation of COVID-19 strains.</div></div><div><h3>Conclusion</h3><div>Findings suggest that FQHC populations have higher-than-average social and clinical risks, illustrating the complexity of delivering treatment for cLBP and the urgency to ensure such clinical environments are included in trials.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT04982315</span><svg><path></path></svg></span>. Clinical trial registration date: July 29, 2021.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107981"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prostate Assessment using Comparative Interventions – Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial","authors":"Nikhil Mayor ,&nbsp;Alexander Light ,&nbsp;Francesca Rawlins ,&nbsp;Emma Cullen ,&nbsp;Natalia Klimowska-Nassar ,&nbsp;Thiagarajah Sasikaran ,&nbsp;Puja Jadav ,&nbsp;Heminder Sokhi ,&nbsp;Andrew Smith ,&nbsp;Darren Walls ,&nbsp;Robert Oldroyd ,&nbsp;Derek Price ,&nbsp;Clare Robinson ,&nbsp;Emily Lane ,&nbsp;Andrea Rockall ,&nbsp;Rakesh Heer ,&nbsp;Luke Vale ,&nbsp;Anwar R. Padhani ,&nbsp;Mathias Winkler ,&nbsp;Taimur T. Shah ,&nbsp;Hashim U. Ahmed","doi":"10.1016/j.cct.2025.107983","DOIUrl":"10.1016/j.cct.2025.107983","url":null,"abstract":"<div><h3>Background</h3><div>Multiparametric MRI (mpMRI) with contrast medium is recommended in the prostate cancer diagnostic pathway. It is unclear if MRI without contrast medium (biparametric [bp]) can be used instead whilst remaining sensitive to detection of clinically significant cancers. For those with a positive MRI, is image-fusion targeting better than visual-registration (cognitive) targeting in detecting clinically significant prostate cancer? And does bpMRI represent better value for money than mpMRI? A randomised controlled trial testing clinical utility and cost-effectiveness of these approaches is vital before changes in practice.</div></div><div><h3>Methods</h3><div>IP7-PACIFIC is a prospective, multicentre, co-enrolment trial with two randomisations and embedded economic evaluation. The first randomisation will evaluate non-inferiority of bpMRI compared to mpMRI in those with clinical suspicion of prostate cancer. Men with a suspicious MRI will undergo a second randomisation to evaluate if image-fusion targeting is superior to standard visual-registration targeted biopsy. Ethics committee approval has been granted by the London Bromley Research Ethics Committee.</div></div><div><h3>Results</h3><div>The primary objective for Randomisation 1 is to determine non-inferiority of bpMRI to detect Gleason score ≥ 7 [ISUP Grade Group ≥2] cancer compared to mpMRI. The objective for Randomisation 2 is to determine if image-fusion targeted biopsy is superior to visual-registration targeted biopsy. An internal pilot phase will enrol 700 patients; the overall recruitment target is 3600.</div></div><div><h3>Discussion</h3><div>IP7-PACIFIC aims to provide randomised comparative evidence for the clinical utility and cost-effectiveness of using bpMRI and image-fusion biopsy. The findings will inform guidelines. The sequential randomised co-enrolment design allows simultaneous evaluation of two research questions and avoids heterogeneity of trial populations. By contrast to previous paired-cohort studies, the randomised design will reduce reporter bias, providing the highest level of diagnostic evidence.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107983"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care” [Contemporary Clinical Trials Volume 147, December 2024, 107713].","authors":"Samantha A. Carreon ,&nbsp;Charles G. Minard ,&nbsp;Sarah K. Lyons ,&nbsp;Wendy Levy ,&nbsp;Stephanie Camey ,&nbsp;Kishan Desai ,&nbsp;Brenda Duran ,&nbsp;Randi Streisand ,&nbsp;Barbara J. Anderson ,&nbsp;Siripoom V. McKay ,&nbsp;Tricia S. Tang ,&nbsp;Sridevi Devaraj ,&nbsp;Ryan Ramphul ,&nbsp;Marisa E. Hilliard","doi":"10.1016/j.cct.2025.107977","DOIUrl":"10.1016/j.cct.2025.107977","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107977"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144223213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A multi-site randomized clinical trial of socially assistive robots on engaging older adults with cognitive impairment residing in long-term care settings: A protocol paper","authors":"Judith A. Tate ,&nbsp;Lorraine C. Mion ,&nbsp;Miroslava Migovich ,&nbsp;Ritam Ghosh ,&nbsp;Nibraas Khan ,&nbsp;Abigail Kilpatrick ,&nbsp;Douglas W. Scharre ,&nbsp;Paul A. Newhouse ,&nbsp;Cathy A. Maxwell ,&nbsp;Alai Tan ,&nbsp;Nilanjan Sarkar","doi":"10.1016/j.cct.2025.107980","DOIUrl":"10.1016/j.cct.2025.107980","url":null,"abstract":"<div><div>Apathy is common in persons with dementias, especially those in long-term care facilities (LTCs). Few pharmacologic options exist; a major strategy is to foster engagement in social, physical, and cognitive activities, but requires extensive personnel time. Non-immersive virtual environments (VE) combined with socially assistive robots (VE-SARs) can support LTC staff.</div><div>We are conducting a randomized multi-site clinical trial to compare the effect of usual care (UC) to VE-SAR + UC on reducing apathy (primary outcome) among 188 older adults with cognitive impairment and enhancing executive cognitive function (secondary outcome). Eligibility of state-licensed LTCs include an hour's drive from the principal investigators' offices, activity personnel willing to interact with research staff, certified by the U.S. Centers for Medicare and Medicaid, and physical space for equipment storage and robot set-up. Eligibility for older adults include age ≥ 60 years, LTC residance &gt;3 months, evidence of mild cognitive impairment or dementia, and symptoms of apathy. Older adults randomized to VE-SAR + UC are paired and participate in twice-weekly sessions for 8 weeks. Staff are interviewed using the Apathy Evaluation Scale-Clinician for apathy ratings. Older adults are interviewed on executive cognitive function using the Trail Making Tests A and B and Animal Naming Test. Data are collected at baseline, Week 4, and Week 8. Field notes are taken throughout and sessions are videorecorded. We will use mixed-effects linear modeling for repeated measures to model apathy as a function of fixed-effects of intervention (VE-SAR + UC vs. UC), time, and intervention by time interaction, adjusting for covariates (e.g., baseline cognitive function).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107980"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Choice architecture in cascade genetic testing (CHARGE study) for hereditary cancer: Design of a hybrid type I randomized feasibility trial","authors":"Sukh Makhnoon ,&nbsp;Grace Getchell ,&nbsp;Yanete Rodriguez ,&nbsp;Luis Pena ,&nbsp;Jennifer Rodriguez ,&nbsp;Tiwatope Ibidapo ,&nbsp;Nora B. Henrikson ,&nbsp;MinJae Lee ,&nbsp;Shelly Wu ,&nbsp;Sara Pirzadeh-Miller","doi":"10.1016/j.cct.2025.107979","DOIUrl":"10.1016/j.cct.2025.107979","url":null,"abstract":"<div><h3>Background</h3><div>Although cascade testing affords disease-free relatives the opportunity for genetically targeted primary disease prevention and is endorsed by multiple guidelines, utilization studies reveal that rates remain low. Lack of family communication and high testing costs are two of the most commonly documented barriers to testing. We leverage two well-known choice-architecture tools from psychology and behavioral science – default effect and zero price effect – to address these barriers and improve cascade testing rates in hereditary cancer. By altering the underlying choice architecture, individual decision-making can be influenced with minimal effort to support behavioral changes.</div></div><div><h3>Methods/Design</h3><div>This two-arm, single site, hybrid type I effectiveness-implementation randomized trial compares the effectiveness of a choice-architecture based cascade testing intervention versus usual care control among English-speaking patients with a pathogenic variant in a cancer susceptibility gene receiving care at a tertiary cancer center. The intervention includes proband-mediated recruitment of at-risk relatives, provision of genetic counseling, educational information about cascade genetic testing and free testing window, and return of results. The usual care arm follows standard of care for cascade genetic testing. The primary study outcome is cascade genetic testing rate measured by proband self-report. The study evaluates implementation process via survey, administrative, and interview data including acceptability, feasibility, and process outcomes.</div></div><div><h3>Discussion</h3><div>This trial will generate findings about the effectiveness of a cascade testing intervention targeting patients with a pathogenic variant in a cancer susceptibility gene and identify barriers and facilitators that influence implementing this intervention in clinical cancer genetic settings (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06284330</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107979"},"PeriodicalIF":2.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expedition for new symptom-specific TMS targets: Protocol for the first randomized causal circuit mapping trial","authors":"Emily Aquadro ,&nbsp;Leanna Bomer ,&nbsp;Ryan Webler ,&nbsp;Andrew Pines ,&nbsp;Danielle D. DeSouza ,&nbsp;David Carreon ,&nbsp;Nicole Chiulli ,&nbsp;Summer Frandsen ,&nbsp;Joseph J. Taylor ,&nbsp;Shan H. Siddiqi","doi":"10.1016/j.cct.2025.107978","DOIUrl":"10.1016/j.cct.2025.107978","url":null,"abstract":"<div><h3>Background</h3><div>Functional neuroimaging has been used to map brain organization, but only identifies correlates of brain functions rather than causes. Causal brain mapping can be conducted by randomly applying transcranial magnetic stimulation (TMS) to different targets, as randomization controls for all confounders, and comparing clinical outcomes across different targeted circuits. Random targets can be systematically compared by mapping their functional connectivity to specific circuits. This study will build a multidimensional atlas of circuits that are causally involved in human brain function. We aim to identify TMS targets for a wide range of transdiagnostic constructs relevant to psychopathology from broad spectra (e.g., internalizing) to specific symptoms (e.g., worry) and processes (e.g. emotional regulation).</div></div><div><h3>Methods/design</h3><div>90 participants with major depression, obsessive-compulsive disorder, generalized anxiety disorder, or schizophrenia will receive 40 total sessions of accelerated intermittent theta burst stimulation (aiTBS). The first 20 sessions will be applied over two days to a random target in the left prefrontal cortex (PFC). A deep circuit-based phenotyping battery pre- and post-aiTBS will be conducted. Six weeks later, participants will receive 20 sessions of aiTBS to a different random target in the left PFC. Patients with schizophrenia will be offered an open-label extension with aiTBS to the rostromedial prefrontal cortex (rmPFC), a previously proposed, novel target for schizophrenia.</div></div><div><h3>Discussion</h3><div>We aim to map circuitry connected to TMS sites that causally modify transdiagnostic and diagnosis-specific behaviors. This will complement prior retrospective studies using incidental lesions and stimulation sites and aim to define optimal TMS target circuits across diagnoses.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107978"},"PeriodicalIF":2.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of the SHARE study: A randomized controlled trial evaluating the regulation of cues treatment for adults with overweight or obesity and high food responsiveness","authors":"Kerri N. Boutelle ,&nbsp;Dawn M. Eichen ,&nbsp;Saori Obayashi ,&nbsp;Ellen K. Pasquale ,&nbsp;David R. Strong ,&nbsp;Allison S. Tietz ,&nbsp;Kristie L. Reed ,&nbsp;Carol B. Peterson","doi":"10.1016/j.cct.2025.107970","DOIUrl":"10.1016/j.cct.2025.107970","url":null,"abstract":"<div><div>Obesity is a heterogeneous disease influenced by individual behavioral factors, environment, genes, and neural processes. Behavioral weight loss (BWL), the current gold-standard treatment for overweight and obesity (OW/OB), does not produce sustained weight loss for all individuals. Appetitive traits, such as food responsiveness (FR), are risk factors that could account for differences in how individuals interact with today's food environment and increase susceptibility for overeating and weight gain. Research shows that individuals high in FR have attenuated weight loss in BWL programs. We developed the Regulation of Cues (ROC) program to reduce overeating through improving sensitivity to hunger and satiety cues and decreasing FR. In this study, we combined ROC with BWL recommendations (ROC+BWL), a treatment approach that may address the unique needs of this phenotype. The current study is a 3-arm randomized controlled trial comparing the ROC+BWL program to BWL and an active comparator on body mass index. Two hundred ninety-three adults with high FR and OW/OB were randomized to 1 of 3 treatment arms and will complete 6 months of treatment and assessment visits over 18 months: baseline, during treatment, post-treatment (6 months), 6-month follow-up (12 months) and 12-month follow-up (18 months). This study could provide important evidence regarding the ROC+BWL program among individuals with high FR and OW/OB and may inform future precision medicine approaches for OW/OB.</div><div>Clinical trials # <span><span>NCT05004883</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107970"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rifampicin combination therapy versus targeted antimicrobial monotherapy in the oral antimicrobial treatment phase of staphylococcal prosthetic joint infection (RiCOTTA-trial): protocol for a randomized, controlled, open-label, non-inferiority trial","authors":"Jaap L.J. Hanssen ,&nbsp;Esther Y. van Hulten ,&nbsp;Pieter K. Bos ,&nbsp;Olav P. van der Jagt ,&nbsp;A.J. Jolanda Lammers ,&nbsp;Rachid Mahdad ,&nbsp;Peter A. Nolte ,&nbsp;Edgar J.G. Peters ,&nbsp;Rudolf W. Poolman ,&nbsp;Jetze Visser ,&nbsp;Matthijs P. Somford ,&nbsp;Karin Veerman ,&nbsp;Stephan B.W. Vehmeijer ,&nbsp;Imro N. Vlasveld ,&nbsp;Wierd Zijlstra ,&nbsp;Rutger van Geenen ,&nbsp;Jan Geurts ,&nbsp;Maarten Röling ,&nbsp;Marjan Wouthuyzen-Bakker ,&nbsp;Henk Scheper ,&nbsp;Mark G.J. de Boer","doi":"10.1016/j.cct.2025.107972","DOIUrl":"10.1016/j.cct.2025.107972","url":null,"abstract":"<div><h3>Background</h3><div>Rifampicin-combination therapy is currently the first-choice oral antimicrobial regimen for staphylococcal prosthetic joint infections (sPJI) treated by debridement, antibiotics and implant retention (DAIR). Lack of high quality evidence to substantiate this recommendation and a high drug discontinuation rate of this regimen warrant investigation of alternative antimicrobial strategies.</div></div><div><h3>Method</h3><div>The <em>Rifampicin Combination Therapy</em> versus <em>Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection</em> (RiCOTTA)-trial is a multicenter, non-inferiority, open-label, randomized controlled trial evaluating monotherapy (without rifampicin) versus rifampicin-combination therapy in the oral treatment phase of sPJI managed with DAIR. The trial is currently enrolling patients in 18 hospitals. Randomization takes place one to seven days before the switch from intravenous to oral therapy. Total antibiotic treatment duration is 12 weeks and the total follow-up time is 15 months. Eligible patients are adults with knee or hip sPJI managed by DAIR. Primary outcome is treatment success one year after finishing antimicrobial treatment, defined as the absence of: i. PJI related re-surgery, ii. PJI related antibiotic treatment after the initial treatment of 12 weeks, iii. PJI related ongoing use of antibiotics at end of follow-up, iv. Death. Enrolment of 316 patients is needed to confirm non-inferiority of monotherapy with a power of 80 %, non-inferiority margin of 10 % and based on an estimated treatment success of 85 %.</div></div><div><h3>Conclusion</h3><div>Demonstrating non-inferiority of antimicrobial monotherapy during the oral treatment phase of DAIR would enable a more patient-tailored approach when managing sPJI.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107972"},"PeriodicalIF":2.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144204626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"INSPIRing action to prevent diabetes (INSPIRA): Rationale and description of a pilot intervention combining peer support and food voucher incentives to increase engagement in a community health worker-led diabetes prevention program","authors":"Michele Heisler ,&nbsp;Grecia Quiroga ,&nbsp;Felix Valbuena ,&nbsp;Ken Resnicow ,&nbsp;Shelley Stoll ,&nbsp;Dina H. Griauzde ,&nbsp;Timothy Hofer ,&nbsp;Jeffrey T. Kullgren","doi":"10.1016/j.cct.2025.107971","DOIUrl":"10.1016/j.cct.2025.107971","url":null,"abstract":"<div><h3>Background</h3><div>Engagement in Diabetes Prevention Programs (DPPs) helps prevent or delay progression to type 2 diabetes, but engagement in these is low, especially among low-income and Black or Latina/o adults. While financial incentives can increase engagement, offering these is not feasible for safety net health systems. The INSPIRA Study is thus assessing the feasibility, acceptability, and preliminary effectiveness of a program that supplements a community health worker (CHW)-led DPP with mutual peer support and healthy food vouchers as incentives for engagement.</div></div><div><h3>Design</h3><div>Single site pilot randomized trial.</div></div><div><h3>Setting</h3><div>A federally qualified health center that serves predominantly Latina/o adults.</div></div><div><h3>Participants</h3><div>142 adults with prediabetes and BMI ≥25 kg/m2.</div></div><div><h3>Interventions</h3><div>Participants are randomized to either a 6-month version of a CHW-led DPP or to the INSPIRA intervention that supplements a six-month CHW-led DPP group with being matched with a peer partner in the same DPP cohort and the opportunity to earn weekly healthy food vouchers for attending that week's DPP session. Peer partners who both engage in at least one peer support call with each other and attend that week's session each earn double the amount in food vouchers (“yoked incentives”).</div></div><div><h3>Main outcome measures</h3><div>Between-group differences in number of weekly sessions attended and changes in weight. Surveys and interviews will assess acceptability and feasibility. Changes in A1c, waist circumference, diet quality, and parameters for sample size calculations for a larger RCT will also be examined.</div></div><div><h3>Discussion</h3><div>This pilot will inform a longer-term trial to evaluate both effectiveness and implementation of INSPIRA in clinical practice.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107971"},"PeriodicalIF":2.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}