Contemporary clinical trials最新文献

{"title":"Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol","authors":"Dong-Woo Kang ,&nbsp;Salvatore Ficarra ,&nbsp;Rebekah L. Wilson ,&nbsp;Alicia K. Morgans ,&nbsp;Paul L. Nguyen ,&nbsp;Timothy R. Rebbeck ,&nbsp;David J. Einstein ,&nbsp;Hajime Uno ,&nbsp;Matthew Mossanen ,&nbsp;Danielle M. Hill ,&nbsp;Paola Gonzalo-Encabo ,&nbsp;Mary K. Norris ,&nbsp;John Gardiner ,&nbsp;Darryl Tjogas ,&nbsp;Jocelyn Greer ,&nbsp;Christina M. Dieli-Conwright","doi":"10.1016/j.cct.2025.107973","DOIUrl":"10.1016/j.cct.2025.107973","url":null,"abstract":"<div><h3>Background</h3><div>Black men in the US are 1.8 and 2.2 times more likely to develop and die from prostate cancer (PCa) than non-Hispanic White men, respectively, and have the highest incidence globally. Furthermore, Black men undergoing androgen deprivation therapy (ADT) for PCa face a higher risk of cardiovascular disease (CVD) compared to men of other racial groups. Therefore, we have designed a randomized controlled trial (RCT) to investigate the impact of exercise on CVD risk factors among Black man undergoing ADT.</div></div><div><h3>Methods</h3><div>The POWER trial is a dual-arm RCT designed to examine the effects of a 16-week, culturally tailored, remotely supervised cardiovascular and strength exercise program on Black men with PCa receiving ADT. Sixty-two patients will be randomized in a 1:1 allocation to either the exercise intervention or a waitlist control group. The patient population includes adult males who self-identify as Black, receiving ADT for at least four months prospectively at the time of recruitment. The primary outcome is the CVD risk assessed using the Framingham Risk Score. The secondary and exploratory outcomes include physical fitness and function, patient-reported outcomes, and clinical events at a one-year follow-up.</div></div><div><h3>Discussion</h3><div>The POWER Trial evaluates a culturally tailored exercise program for Black men with PCa undergoing ADT, focusing on improving cardiovascular health. The findings of the study are expected to inform a larger phase clinical trial to examine long-term CVD-related clinical outcomes. Ultimately, our findings and subsequent trials would narrow the gap in health disparities among the communities of Black men with PCa.</div><div><strong>Trial registration</strong>: <span><span>NCT05327465</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107973"},"PeriodicalIF":2.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198451","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":"BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa","authors":"Fredrick Katongole ,&nbsp;Tiyara Arumugam ,&nbsp;Angus Jennings ,&nbsp;Constantine Mutata ,&nbsp;Patrick Ssebunya ,&nbsp;Charity Wamboi ,&nbsp;Alexandra Green ,&nbsp;Mutsa Bwakura-Dangarembizi ,&nbsp;Cissy Kityo ,&nbsp;Abraham Siika ,&nbsp;Moherndran Archary ,&nbsp;Lungile Jafta ,&nbsp;Stella Namukwaya ,&nbsp;Janet Seeley ,&nbsp;Henry Mugerwa ,&nbsp;Simon Walker ,&nbsp;Naomi Apoto ,&nbsp;Margaret J. Thomason ,&nbsp;Deborah Ford ,&nbsp;Sarah L. Pett ,&nbsp;Eram David Williams","doi":"10.1016/j.cct.2025.107963","DOIUrl":"10.1016/j.cct.2025.107963","url":null,"abstract":"<div><h3>Background</h3><div>Novel strategies to improve ART adherence, retention in care and quality of life among adolescents living with HIV (ALHIV) are needed. Short-Cycle Therapy (SCT) with 4/5 sequential days on ART, 2/3 days off ART per week has shown non-inferior virological outcomes and high acceptability, but most data are in adults and are very limited for dolutegravir (DTG)-based SCT.</div></div><div><h3>Methods</h3><div>BREATHER Plus is an ongoing 96-week non-inferiority randomised trial evaluating efficacy, safety and acceptability of SCT (5 sequential days on, 2 days off at the weekend) with DTG/tenofovir (TNV)-based triple ART versus continuous (daily) therapy (CT) in ALHIV. Participants are aged 12 to &lt;20 years in Kenya/South Africa/Uganda/Zimbabwe, virologically suppressed (Viral Load (VL) &lt;50copies/mL) for ≥12 months at enrollment, with no prior treatment failure. Randomisation is 1:1 to SCT versus CT. VL monitoring for clinical management is 6–12 monthly aligning with standard-of-care. The primary outcome is confirmed virological rebound ≥50 copies/mL by 96 weeks. The trial employs the Smooth Away From Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event risk in the CT arm. Secondary outcomes include HIV resistance, toxicities, patient-reported outcomes and cost-effectiveness. Enrolment of 470 participants completed in June 2023.</div></div><div><h3>Discussion</h3><div>BREATHER Plus is the first randomised trial specifically evaluating DTG/TNV-triple based SCT. Rapid roll-out of DTG and a pragmatic approach to VL monitoring mean results will be generalisable to ALHIV across sub-Saharan Africa. If SCT provides non-inferior virological suppression to CT, it may offer choice for ALHIV on how they take their ART.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107963"},"PeriodicalIF":2.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191595","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":"Protocol for a pragmatic trial to enhance quality safety, and patient experience in chronic obstructive pulmonary disease (EQuiP-COPD)","authors":"Lucas M. Donovan ,&nbsp;Laura C. Feemster ,&nbsp;Margaret P. Collins ,&nbsp;Emily E. Gleason ,&nbsp;Kevin Josey ,&nbsp;Kevin I. Duan ,&nbsp;Robert Plumley ,&nbsp;Scott Coggeshall ,&nbsp;Travis Hee Wai ,&nbsp;Valentina Petrova ,&nbsp;Logan Trenaman ,&nbsp;Melissa Atwood ,&nbsp;Philip Ballance ,&nbsp;Arianne K. Baldomero ,&nbsp;Fiona Gillen ,&nbsp;Jennifer Gunter ,&nbsp;Julianne Isaac ,&nbsp;Henna Kara ,&nbsp;Kenneth W. Kizer ,&nbsp;Allison A. Lambert ,&nbsp;David H. Au","doi":"10.1016/j.cct.2025.107961","DOIUrl":"10.1016/j.cct.2025.107961","url":null,"abstract":"<div><div>Chronic obstructive pulmonary disease (COPD) affects nearly 26 million Americans, causes functional impairment and reduced quality of life, and is the fifth leading cause of death. Evidence-based therapies can reduce morbidity and improve symptoms, but too few patients receive them. Moreover, many patients receive unnecessary treatments that increase risks of harm. Systematic and population-based approaches are needed to address the widespread gaps in care. Among these, high-quality evidence shows that proactive electronic consultations to primary care providers can improve COPD care quality and clinical outcomes. While effective, these strategies rely on pulmonary specialists who are a scarce and costly resource nationwide. Given their relevant expertise, there is increasing interest around clinical pharmacist-led population management of COPD, but the effectiveness of this approach is unclear. We designed the cluster-randomized EQuiP-COPD trial to test the non-inferiority of clinical pharmacist relative to pulmonary specialist-led population health management of COPD. The primary outcome is the composite endpoint of COPD exacerbation, pneumonia, all-cause hospitalization, or death. Secondary outcomes will compare disease-related quality of life, quality of care, costs incurred by patients and caregivers, and heterogeneity of treatment effect. We will also conduct qualitative interviews among patients and staff to elicit experiences with the intervention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107961"},"PeriodicalIF":2.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172858","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":"The Grief Navigation Trial: A multi-site pragmatic comparative effectiveness trial of two interventions to support parents after their child's unexpected or traumatic death","authors":"Elaf Agha ,&nbsp;Carolyn Sutter ,&nbsp;Ifeoluwadolapo Ojewuyi ,&nbsp;Emily M. Abramsohn ,&nbsp;Megan Andriano ,&nbsp;Christal Bell ,&nbsp;Anna L. Calix ,&nbsp;Jamie Lynn Cherry ,&nbsp;Kim Downing ,&nbsp;Tina Flower ,&nbsp;Michelle Halm ,&nbsp;Ashley Hayes ,&nbsp;Marie E. Heffernan ,&nbsp;JaShawn Hill ,&nbsp;C. Zoe Hoeppner ,&nbsp;Meghan Jacobson ,&nbsp;Jacquelyn Jennings ,&nbsp;Leslie Kula-Leitner ,&nbsp;SuYeon Lee ,&nbsp;Deborah R. Major ,&nbsp;Ryan Westerberg","doi":"10.1016/j.cct.2025.107962","DOIUrl":"10.1016/j.cct.2025.107962","url":null,"abstract":"<div><h3>Background</h3><div>In the US, ~60,000 people &lt;25 years old die annually. Forty-five percent of pediatric deaths occur traumatically, and the parents' or caregivers' (hereafter ‘parents’) sole contact with the healthcare system is often the coroner or medical examiner (ME). Parents experience mental and physical health problems following their child's death. There are no evidence-based interventions for MEs supporting bereaved parents. Scalable, systems-level interventions are needed to connect bereaved parents to grief and social care support. This research will build upon the experience of Missing Pieces, a community organization that supports families after pediatric death, and CommunityRX, an evidence-based social care intervention that supports patients and caregivers. This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.</div></div><div><h3>Methods</h3><div>This pragmatic, comparative effectiveness randomized controlled trial uses a hybrid type 1 implementation-effectiveness design to compare: (1) CommunityRx-Bereavement (the “high touch” intervention), a personalized resource referral intervention involving Grief Navigator support; and (2) general bereavement support information (the “low touch” intervention), including community resources, shared by text message. Parents of deceased children (&lt;25 years old) are referred by MEs to Missing Pieces and cases are randomized. The primary outcomes are complicated grief and self-efficacy for finding resources, evaluated ~6.5 months post-child's death. By taking a community-engaged research approach, community collaborators were included to inform research methods, materials, and dissemination plans.</div></div><div><h3>Discussion</h3><div>This work fills a knowledge gap regarding evidence-based practices for supporting families after the traumatic or unexpected death of their child.</div></div><div><h3>Trial registration</h3><div><span><span>NCT06136260</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107962"},"PeriodicalIF":2.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172870","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":"Implementing individualised physiotherapy using the Specific Treatment of Problems of the Spine (STOPS) approach for chronic low back pain in Bangladesh: Protocol for a prospective sequential comparison clinical trial","authors":"Mohammad Ali ,&nbsp;Jon J. Ford ,&nbsp;Ahmed Hossain ,&nbsp;Musa Sani Danazumi ,&nbsp;Andrew J. Hahne","doi":"10.1016/j.cct.2025.107960","DOIUrl":"10.1016/j.cct.2025.107960","url":null,"abstract":"<div><h3>Background</h3><div>Chronic low back pain (CLBP) is a major global health issue, with a particularly high burden in low- and middle-income countries (LMICs) due partly to inadequate evidence-based management. The Specific Treatment of Problems of the Spine (STOPS) approach offers individualised, biopsychosocial-based physiotherapy shown to be effective in Australia. This trial aims to evaluate the implementation, effectiveness, and cost-effectiveness of the STOPS approach to individualised physiotherapy compared to usual physiotherapy care in Bangladesh.</div></div><div><h3>Methods</h3><div>A three-phase prospective sequential comparison trial will be conducted with eligible participants aged 18–65 years presenting for physiotherapy with CLBP at two centres in Bangladesh. Phase 1 will evaluate the usual physiotherapy care, and Phase 3 will evaluate individualised physiotherapy according to the STOPS approach. Phase 2 involves training physiotherapists and assistants in STOPS. Patients in Phases 1 &amp; 3 will undergo 10 sessions of physiotherapy over 10 weeks, with an 11th booster session at 6 months. Primary outcomes are activity limitation (Oswestry Disability Index) and pain intensity (Numerical Rating Scales for back and leg pain) at 5, 10, 26 and 52 weeks. Secondary outcomes include global effect, patient satisfaction, work interference, psychosocial risk factors, quality of life, mental health, sleep, catastrophizing and self-efficacy. Qualitative interviews will explore patient and therapist experiences.</div></div><div><h3>Results</h3><div>Quantitative and qualitative data will be analysed to assess implementation feasibility, cost-effectiveness, and treatment outcomes.</div></div><div><h3>Conclusion</h3><div>Individualised physiotherapy using the STOPS approach could improve treatment outcomes for CLBP in Bangladesh.</div></div><div><h3>Clinical trial registration</h3><div><span><span>NCT05880212</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107960"},"PeriodicalIF":2.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132243","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":"Evaluating brain mechanisms of combined vagus nerve stimulation and mindfulness training for migraine: A randomized 2 × 2 factorial clinical trial protocol","authors":"Zev Schuman-Olivier ,&nbsp;Frances Marin ,&nbsp;Lillian D. Kinder ,&nbsp;Michael Datko ,&nbsp;Kassandra Round ,&nbsp;Sarasa Tohyama ,&nbsp;Ronald G. Garcia ,&nbsp;Randy L. Hirschtick ,&nbsp;Robert R. Edwards ,&nbsp;Rebecca Erwin Wells ,&nbsp;Hsinlin T. Cheng ,&nbsp;Riccardo Barbieri ,&nbsp;Nouchine Hadjikhani ,&nbsp;Marco L. Loggia ,&nbsp;Ted J. Kaptchuk ,&nbsp;Timothy T. Houle ,&nbsp;Bruce R. Rosen ,&nbsp;Vitaly Napadow","doi":"10.1016/j.cct.2025.107947","DOIUrl":"10.1016/j.cct.2025.107947","url":null,"abstract":"<div><h3>Background</h3><div>Migraine is a major cause of disability and efficacious interventions are needed. In this mechanistic study, we investigate the combined, and potentially synergistic, effects of a multimodal intervention combining Mindfulness-Based Stress Reduction (MBSR) and transcutaneous auricular Vagal Nerve Stimulation (taVNS) for migraine.</div></div><div><h3>Methods</h3><div>We utilize a modified double-blinded, placebo-controlled, 2 × 2 factorial randomized longitudinal design to assess the effects of an 8-week MBSR intervention with concomitant Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) taVNS on migraine pathophysiology primary outcomes. We will enroll 150 patients with migraine (4–20 headache days/month). After a run-in month of daily diaries, we expect to randomly assign <em>N</em> <em>=</em> <em>96</em> participants to one of four treatment groups: (1) MBSR+RAVANS taVNS, (2) MBSR+Sham taVNS, (3) Nature Education Control (NEC) + RAVANS taVNS, or (4) NEC + Sham taVNS. Before and after intervention, participants have three in-person assessments (a 7 T MRI scan, an autonomic/sensory testing (AST) visit, and a 3 T PET-MRI scan). The primary outcomes for this study assess (1) central sensitization (brainstem/cortical response to trigeminal sensory afference), (2) autonomic dysfunction (High Frequency-Heart Rate Variability (HF-HRV) response to stressors), and (3) neuroinflammation (PET[¹¹<em>C</em>]PBR28 signal).</div></div><div><h3>Results</h3><div>Funded by NIH (P01AT009965), registered (<span><span>NCT03592329</span><svg><path></path></svg></span>). Final longitudinal outcomes will be collected by May 2025.</div></div><div><h3>Conclusion</h3><div>This mechanistic study is designed to investigate both independent and synergistic neurobiological effects of MBSR and RAVANS taVNS interventions on three distinct pathophysiological mechanisms of migraine. This research will elucidate the mechanistic and potentially synergistic effects of behavioral interventions (e.g., mindfulness) and device-based treatments (e.g., taVNS) for migraine.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107947"},"PeriodicalIF":2.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144123423","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":"Comparing primary-tertiary multidisciplinary collaborative care with usual care in community patients with atrial fibrillation: The protocol for a cluster randomized controlled trial","authors":"Yongqi Wang ,&nbsp;Jun Huang ,&nbsp;Dexing Zhang ,&nbsp;Junrong Jiang ,&nbsp;Yumei Xue ,&nbsp;Wenjing Zhao ,&nbsp;Hai Deng ,&nbsp;Shulin Wu ,&nbsp;Xudong Liu","doi":"10.1016/j.cct.2025.107957","DOIUrl":"10.1016/j.cct.2025.107957","url":null,"abstract":"<div><h3>Background</h3><div>The community health service centers (CHCs) are becoming the major undertakers in China in the prevention and treatment of chronic cardiovascular and cerebrovascular diseases such as atrial fibrillation (AF). The objective of this study was to evaluate the effect of a standardized model of primary-tertiary multidisciplinary collaborative care (PTCC) compared to usual care on AF patients in the community settings.</div></div><div><h3>Methods</h3><div>This study is a two-arm, prospective, multicenter, cluster randomized controlled, non-inferiority trial. A total of 220 AF patients aged 65 years or more will be recruited from 16 CHCs in the Yuexiu District of Guangzhou, China. The 16 CHCs will be randomly assigned to the PTCC intervention group and usual care control groups (1:1). The interventions will last for two years, and the survey will be conducted at baseline, 3-month, 6-month, 12-month, and 24-month. The baseline information from AF patients will be collected through face-to-face interviews with a standardized questionnaire or retrieval of health records and medical treatment records, and the following-up data will be collected by regular telephone calls or outpatient face-to-face interviews at each follow-up. The primary endpoint is the anticoagulation rate and the secondary outcomes include AF-related adverse events (cardiovascular mortality, cardiovascular and non-cardiovascular hospitalizations, major adverse cardiovascular events, stroke, major bleeding, clinically relevant non-major bleeding), health-related quality of life, and cost-effectiveness.</div></div><div><h3>Discussion</h3><div>The implementation of the PTCC program in AF patients may provide evidence for the management of AF patients and promote their prognosis in community.</div><div><strong>Trial registration number:</strong> This study is registered at the Chinese Clinical Trial Registry (ChiCTR2200057242).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107957"},"PeriodicalIF":2.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144115306","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":"Study Protocol(s) for Antiretroviral Improvement among Medicaid EnrolleeS (AIMS): A Cluster-Randomized Controlled Trial Leveraging Real-time Administrative Claims to Support Antiretroviral Prescription Adherence","authors":"April D. Kimmel ,&nbsp;Kathy K. Byrd ,&nbsp;Michael Stirratt ,&nbsp;Delton Harris ,&nbsp;Rachel Stallings ,&nbsp;Rose S. Bono ,&nbsp;Andrew Mitchell ,&nbsp;Rebecca Dillingham ,&nbsp;Caressa Palmer ,&nbsp;Elliot Popoff ,&nbsp;Zhongzhe Pan ,&nbsp;Karen Ingersoll ,&nbsp;Bassam Dahman ,&nbsp;AIMS study team","doi":"10.1016/j.cct.2025.107959","DOIUrl":"10.1016/j.cct.2025.107959","url":null,"abstract":"<div><h3>Introduction</h3><div>Retention in care and antiretroviral therapy (ART) adherence are major clinical and public health challenges in the treatment of HIV in the United States. Traditional data to care (D2C) approaches use health department surveillance data to promote retention in HIV care, with challenges in the timeliness of data and inconclusive findings. Earlier identification of people with HIV who are at risk of loss from care—such as when an ART prescription is not filled—represents a new direction for D2C (D2C-Rx or prescription-based D2C).</div></div><div><h3>Methods</h3><div>We designed the Antiretroviral Improvement among Medicaid EnrolleeS (AIMS) study, a D2C-Rx initiative in Virginia, which leveraged real-time administrative claims from Virginia Medicaid and HIV surveillance data from Virginia Department of Health (April 2023–June 2024). AIMS was a statewide cluster-randomized, controlled trial comparing a phased, multi-level program of support (intervention) to usual care, among Virginia Medicaid enrollees without current ART prescriptions. Support included a provider-level component for those with no prior ART prescription and patient-level component for those with a &gt; 30–90-day late ART prescription refill(s). We hypothesized that AIMS would increase HIV viral suppression and improve ART adherence at 12 months compared to usual care. We describe the original study protocol and discuss changes implemented to the study design and program implementation. We also consider key methodologic contributions, as well as limitations and challenges to patient- and provider-level enrollment, such as ART prescription data accuracy.</div></div><div><h3>Ethics and dissemination</h3><div>This study was reviewed and approved by the Institutional Review Board of Virginia Commonwealth University (HM20018229).</div></div><div><h3>Registration</h3><div>The trial is registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05477485</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107959"},"PeriodicalIF":2.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109837","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":"Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating","authors":"Wai Sze Chan,&nbsp;Wing Yee Cheng","doi":"10.1016/j.cct.2025.107955","DOIUrl":"10.1016/j.cct.2025.107955","url":null,"abstract":"<div><h3>Background</h3><div>Negative emotional eating (NEE) refers to overeating in response to negative emotions. The efficacy of cue exposure therapy (CET) for treating NEE has not been evaluated in a full-scale randomized controlled trial (RCT). Moreover, previously tested CET did not fully utilize theory-informed intervention strategies. Hence, an enhanced version of CET (<em>E</em>-CET) is here developed and evaluated. <em>E</em>-CET will integrate theory-informed intervention strategies including (1) exposures that incorporate food cues, emotional cues, and idiosyncratic contextual cues, (2) homework exposures, and, (3) explicit instructions to violate the conditioned stimulus-unconditioned stimulus (CS-US) expectancies maintaining NEE. <em>E</em>-CET is hypothesized to promote greater reductions in NEE than an active control, behavioral lifestyle intervention (BLI), and its efficacy will be mediated by the reduction in the believability of CS-US expectancies.</div></div><div><h3>Methods</h3><div>This is a parallel-group RCT. One-hundred-and-thirty-eight participants with recurring NEE will be randomly assigned to <em>E</em>-CET or BLI, and attend six individual sessions. The primary outcome is the change in the emotional eating subscale score measured by the Dutch Eating Behavior Questionnaire at posttreatment, 3-month, and 12-month follow-up from baseline. Secondary and mechanistic outcomes include changes in NEE measured by ecological momentary assessments, caloric consumption, and the believability in CS-US expectancies.</div></div><div><h3>Discussion</h3><div>If shown to be efficacious, <em>E</em>-CET can be implemented to reduce NEE. This study will be the first experimental evaluation of the mediating effects of CS-US expectancy violation in the working of <em>E</em>-CET for NEE to inform developments of the theories on CET and NEE.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107955"},"PeriodicalIF":2.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144107486","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":"Subgroup differences in calcium metabolism in response to dietary sodium: Rationale, design, and methods of a randomized, controlled, crossover dietary intervention in healthy adults","authors":"Sisi Cao ,&nbsp;Christina Vialva ,&nbsp;Shirin Hooshmand ,&nbsp;Mark Kern ,&nbsp;Gina N. Woods ,&nbsp;Scott Roesch ,&nbsp;Connie M. Weaver","doi":"10.1016/j.cct.2025.107956","DOIUrl":"10.1016/j.cct.2025.107956","url":null,"abstract":"<div><div>The growing interest in personalized nutrition stems from a deeper understanding of subgroup differences in response to environmental factors, including diet. Preliminary evidence in Black and White adolescent girls showed that Black girls retain more calcium and excrete more sodium compared to White girls on a high sodium diet. However, little is known about calcium absorption efficiency across other races or age groups. This report outlines the rationale and design of a planned randomized controlled trial aimed at investigating calcium absorption and calcium and sodium excretion in response to diets high (typical Western diet) and low (recommended) in sodium in Black, White, Hispanic, and Asian adults. It is hypothesized that fractional calcium absorption and urinary sodium excretion will vary by subgroup, with Blacks predicted to have the highest rates and Whites the lowest, and intermediate responses in Hispanics and Asians. Participants will undergo two 2-day dietary intervention arms, with biospecimen collection following each arm. Primary outcomes include fractional calcium absorption and urinary calcium excretion, and secondary outcomes comprise urinary sodium excretion and blood pressure. Findings from this study could advance precision nutrition by informing strategies to alleviate osteoporosis and cardiovascular diseases risks across different race/ethnicity groups.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107956"},"PeriodicalIF":2.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109845","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}