Contemporary clinical trials最新文献

{"title":"Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa","authors":"Diana Anena ,&nbsp;Elizabeth Chappell ,&nbsp;Rashidah Nazzinda ,&nbsp;Cecilia Kiilu ,&nbsp;Moses Chitsamatanga ,&nbsp;Tiyara Arumugam ,&nbsp;Alexandra Green ,&nbsp;Cissy Kityo Mutuluuza ,&nbsp;Mutsa Bwakura-Dangarembizi ,&nbsp;Abraham Siika ,&nbsp;Moherndran Archary ,&nbsp;Lungile Jafta ,&nbsp;Stella Namukwaya ,&nbsp;Janet Seeley ,&nbsp;George Akabwai ,&nbsp;Henry Mugerwa ,&nbsp;Lisanne Bevers ,&nbsp;David Burger ,&nbsp;Simon Walker ,&nbsp;Alasdair Bamford ,&nbsp;Sarah L. Pett","doi":"10.1016/j.cct.2025.108213","DOIUrl":"10.1016/j.cct.2025.108213","url":null,"abstract":"<div><h3>Background</h3><div>Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.</div></div><div><h3>Methods</h3><div>LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- &lt; 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.</div></div><div><h3>Conclusion</h3><div>LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.</div><div><strong>Trial registration:</strong> This trial has been registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05154747</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108213"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145942790","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":"Increasing HPV vaccine promotion by dental providers: A clinical trial protocol","authors":"D. Brad Rindal,&nbsp;Stephen Asche,&nbsp;Elyse Kharbanda,&nbsp;Bryan Michalowicz,&nbsp;Don Worley,&nbsp;Meghan Jaka,&nbsp;Kay Kromrey,&nbsp;Linda Fletcher,&nbsp;Amanda Gillesby,&nbsp;Sarah Basile,&nbsp;Patricia L. Mabry","doi":"10.1016/j.cct.2026.108222","DOIUrl":"10.1016/j.cct.2026.108222","url":null,"abstract":"<div><h3>Background</h3><div>Human papillomavirus is a prevalent DNA virus and the leading cause of both oropharyngeal and cervical cancer. Despite the availability of an effective vaccine (HPV-V), uptake is below national targets. A behavioral intervention, Increasing HPV Vaccine Uptake – Delivered in Dental Settings (HPV-V Uptake-DDS), was developed to support dental providers in promoting HPV-V to their patients to help close this gap.</div></div><div><h3>Objectives</h3><div>This protocol for an efficacy trial of HPV-V Uptake-DDS is designed to increase HPV-V promotion by dental practitioners, and subsequent vaccine uptake among adolescent and young adult patients.</div></div><div><h3>Methods</h3><div>The trial will be conducted in dental clinics in a single midwestern health system utilizing a prospective, two-arm, parallel, cluster-randomized controlled design. Eighteen clinics will be randomly assigned to either the intervention or usual care. The intervention includes didactic training, clinical decision support tool embedded in the electronic dental record, tip sheet, patient education handout, and practitioner performance reports. The primary outcome is change in HPV-V promotion by practitioners. Secondary outcomes include change in HPV-V uptake by patients and changes in three behavioral mechanisms: practitioner knowledge, self-efficacy, and fear of negative consequences related to HPV-V promotion. Outcomes will be captured from the electronic health record, practitioner surveys, patient or guardian surveys, and state vaccination registries.</div></div><div><h3>Conclusions</h3><div>The protocol for a clinical trial will test the efficacy of the intervention and the measurement of behavioral mechanisms of action will inform which components of the intervention of needed to address barriers in different practice settings.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108222"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145976431","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":"Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing","authors":"Jinghua An ,&nbsp;Maisha Huq ,&nbsp;Erin Speiser ,&nbsp;Sherry Grumet ,&nbsp;Beth N. Peshkin ,&nbsp;Emily Heidt ,&nbsp;Lucile Adams-Campbell ,&nbsp;Christopher Grisham ,&nbsp;Samuel Tundealao ,&nbsp;Rose Yesha ,&nbsp;Deborah Toppmeyer ,&nbsp;Claudine Isaacs ,&nbsp;Lia Sorgen ,&nbsp;Naomi Tan ,&nbsp;Anupama Hooda-Nehra ,&nbsp;Melanie A. Nix ,&nbsp;Dorothy J. Reed ,&nbsp;Jimmie Staton ,&nbsp;Marc D. Schwartz ,&nbsp;Anita Y. Kinney","doi":"10.1016/j.cct.2026.108217","DOIUrl":"10.1016/j.cct.2026.108217","url":null,"abstract":"<div><h3>Background</h3><div>Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.</div></div><div><h3>Methods</h3><div>Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.</div></div><div><h3>Discussion</h3><div>This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.</div><div>Trial registration number: The trial is registered on <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06073626</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108217"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003198","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 reservation-based clinical trial on inflammatory biomarkers in American Indian/Alaska Native cancer patients: Rationale and design of the adaptive prehab approaches in cancer healing and education (APACHE) program","authors":"Jennifer Erdrich ,&nbsp;Melissa M. Carton ,&nbsp;Adriena Hernandez ,&nbsp;Dominique Nosie-Romo ,&nbsp;Amanda Huber ,&nbsp;Trevor Chapman ,&nbsp;Colter Sanchez ,&nbsp;William R. Montfort ,&nbsp;Jennifer W. Bea ,&nbsp;Angela Yung ,&nbsp;Cynthia A. Thomson","doi":"10.1016/j.cct.2026.108231","DOIUrl":"10.1016/j.cct.2026.108231","url":null,"abstract":"<div><div>Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108231"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008681","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":"Remote delivery of a mindfulness-based intervention for adults with tics: Protocol of a randomized controlled trial","authors":"Hannah E. Reese ,&nbsp;W. Alan Brown ,&nbsp;Yaerin H. Wallenberger ,&nbsp;Kesley A. Ramsey ,&nbsp;Lauren E. Browning ,&nbsp;Joshua Rooks ,&nbsp;Neda F. Gould ,&nbsp;Jeannie-Marie Leoutsakos ,&nbsp;Tamar Mendelson ,&nbsp;Alexandria H. Chang ,&nbsp;Joseph F. McGuire","doi":"10.1016/j.cct.2026.108224","DOIUrl":"10.1016/j.cct.2026.108224","url":null,"abstract":"<div><div>Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments—including behavior therapy and pharmacotherapy—are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108224"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988542","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":"Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency","authors":"Amy Gawad ,&nbsp;Jessica Mendoza ,&nbsp;Megan Singleton ,&nbsp;Ryan Majkowski ,&nbsp;Erica Hopkins ,&nbsp;Jordyn Carll ,&nbsp;Cindy MacInnis ,&nbsp;Daniel Amirault ,&nbsp;Bahiyyah Jackson ,&nbsp;Nichol McBee ,&nbsp;Andrew Mould ,&nbsp;Lindsay M. Eyzaguirre ,&nbsp;Cecilia Pessoa-Gingerich ,&nbsp;Shmuel Shoham ,&nbsp;David Sullivan ,&nbsp;Karen Lane","doi":"10.1016/j.cct.2025.108207","DOIUrl":"10.1016/j.cct.2025.108207","url":null,"abstract":"<div><div>We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12–15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108207"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838279","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":"Enhancing effect of cognitive control training on rTMS treatment in depression: A study protocol for a multicenter randomized controlled trial","authors":"Iris Dalhuisen ,&nbsp;Marloes Wurkum ,&nbsp;Chris Bervoets ,&nbsp;Eric Constant ,&nbsp;Eric van Exel ,&nbsp;Mickaël Hiligsmann ,&nbsp;Alexander Sack ,&nbsp;Teresa Schuhmann ,&nbsp;Indira Tendolkar ,&nbsp;Thierry Verplancke ,&nbsp;Ben Wijnen ,&nbsp;Chris Baeken ,&nbsp;Philip van Eijndhoven","doi":"10.1016/j.cct.2025.108212","DOIUrl":"10.1016/j.cct.2025.108212","url":null,"abstract":"<div><h3>Introduction</h3><div>Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), yet some patients only show partial or no response. Recent efforts to enhance rTMS efficacy have focused on combining rTMS with adjunctive interventions, such as psychotherapy, which may yield synergistic effects rather than merely additive effects. Cognitive control training (CCT) activates similar underlying neural circuits as rTMS and has demonstrated antidepressant potential. Given the time-intensive nature of rTMS, augmenting it with CCT may offer a pragmatic, time-efficient and potentially cost-effective solution to increase the therapeutic response of rTMS. This study aims to investigate whether rTMS augmented with CCT is more (cost-) effective in reducing depressive symptoms as opposed to rTMS alone.</div></div><div><h3>Methods</h3><div>In this international multicenter clinical trial, 132 adult patients with depression will be randomized to receive rTMS either augmented with CCT or placebo task. The trial consists 30 rTMS sessions over eight weeks, followed by a follow-up period up to one year. The primary outcome is the change in depressive severity, assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17) after eight weeks of treatment. Secondary outcomes include an economic evaluation and response and remission after 8 weeks of treatment as well as during follow-up.</div></div><div><h3>Discussion</h3><div>The present study aims to improve the (cost-)effectiveness of rTMS by concurrently combining rTMS with CCT. Findings may support the development of more cost-effective, personalized interventions for the treatment of depression.</div></div><div><h3>Trial registration</h3><div>This trial is registered within the Overview of medical research in the Netherlands, OMON (code: NL-OMON57187, date: 18 December 2024).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108212"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905728","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 type I hybrid effectiveness trial of strategies to prevent suicide attempts among adults recently released from jail","authors":"Diane M. Wisnieski ,&nbsp;Rebecca C. Rossom ,&nbsp;Lauren M. Weinstock ,&nbsp;Jennifer Johnson ,&nbsp;Kathleen Miley ,&nbsp;Brandon A. Gaudiano ,&nbsp;Madeline B. Benz ,&nbsp;Caitlin Borgert-Spaniol ,&nbsp;Hannah R. Graves ,&nbsp;Rachael Norwood ,&nbsp;Rowyda Kazan ,&nbsp;Colleen Starkey ,&nbsp;Hanmin Kim ,&nbsp;Linda Fletcher ,&nbsp;Sheryl Kane ,&nbsp;Yong Hu ,&nbsp;Zachary Farrell ,&nbsp;Sarah Strong ,&nbsp;Hsueh-Han Yeh ,&nbsp;Ted Miller ,&nbsp;Brian K. Ahmedani","doi":"10.1016/j.cct.2025.108184","DOIUrl":"10.1016/j.cct.2025.108184","url":null,"abstract":"<div><h3>Background</h3><div>Over 20 % of all adult suicide deaths in the U.S. occur within one year following jail release. Individuals may have increased access to lethal means, be faced with numerous financial, legal, and social stressors, and encounter a resurgence of legal problems. Suicide prevention interventions have demonstrated effects. Widespread implementation of these interventions for individuals leaving jail detention could have a significant impact on national suicide rates.</div></div><div><h3>Methods</h3><div>The 5S Study (Syncing, Screening, and Services for Suicide Prevention among Health &amp; Jail Systems) aims to prevent suicide attempts among adults aged 18+ who are recently released from jail. Data from public jail release reports are synced with electronic health record (EHR) systems to enable proactive health system outreach. Those randomized to the intervention are contacted and consented, undergo a suicide risk screening and create a safety plan. Care Coordinators connect participants to health services. High risk participants, identified by the Patient Health Questionnaire (PHQ-9), are offered the Coping Long Term with Active Suicide Program (CLASP), an evidence-based suicide prevention intervention. Those randomized to control are never contacted and receive usual care. There is a waiver of consent for the control condition and a waiver of written consent for the intervention condition.</div></div><div><h3>Discussion</h3><div>The 5S Study uses data linkage between EHRs and jails to identify and connect with those recently released from jail, a population historically at high risk. Trial results will highlight best practices for syncing these data and offering support during the transition back to the community.</div><div><strong>Trial Registration</strong>: <span><span>https://clinicaltrials.gov/study/NCT06506344</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108184"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760862","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 influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT","authors":"Shannon K. Runge ,&nbsp;Elizabeth M. Hudak ,&nbsp;Jade A. Sutfin ,&nbsp;Victor R. Dobrovolskiy ,&nbsp;Jerri D. Edwards","doi":"10.1016/j.cct.2025.108206","DOIUrl":"10.1016/j.cct.2025.108206","url":null,"abstract":"<div><h3>Background/Purpose</h3><div>Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators – former study participants – enhanced intervention adherence or study retention in a clinical trial among healthy older adults.</div></div><div><h3>Methods</h3><div>We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (<em>N</em> = 268) by assigning a subsample of participants to peer navigators (<em>n</em> = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention.</div></div><div><h3>Results</h3><div>Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (<em>SD</em> = 5) with 16 years of education (<em>SD</em> = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, <em>t</em>(134.2) = −6.0, <em>p</em> &lt; .001; participants with a navigator completed an average of 5 more sessions (<em>M</em> = 20, <em>SD</em> = 3) compared to those without a navigator (<em>M</em> = 15, <em>SD</em> = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), <em>X</em>² (1, <em>N</em> = 261) = 10.0, <em>p</em> = .002.</div></div><div><h3>Conclusions</h3><div>Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed.</div><div>The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, <span><span>https://clinicaltrials.gov/study/NCT03528486</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108206"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843537","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":"Testing the effects of a text message intervention on depression and distress among Latino dementia caregivers: A randomized controlled trial protocol","authors":"Jaime Perales-Puchalt ,&nbsp;Mariana Ramírez-Mantilla ,&nbsp;Henry P. Moore ,&nbsp;Idaly Velez-Uribe ,&nbsp;Vanessa Sepulveda-Rivera ,&nbsp;Rachel Ruiz ,&nbsp;Mónica Fracachán-Cabrera ,&nbsp;Yesenia Herrera ,&nbsp;Christina Baker ,&nbsp;Antonio Miras-Neira ,&nbsp;Becky Bothwell ,&nbsp;Heidi Anderson ,&nbsp;Tina Lewandowski ,&nbsp;Francisco J. Diaz ,&nbsp;K. Allen Greiner ,&nbsp;Kristine Williams ,&nbsp;Eric D. Vidoni ,&nbsp;Edward Ellerbeck ,&nbsp;Jeffrey M. Burns","doi":"10.1016/j.cct.2025.108214","DOIUrl":"10.1016/j.cct.2025.108214","url":null,"abstract":"<div><h3>Background</h3><div>Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention on depression and distress among informal Latino dementia caregivers. We will also assess mechanisms of action.</div></div><div><h3>Methods</h3><div>We are enrolling 288 Latino dementia informal caregivers 18 or older into a parallel group RCT. Participants randomized to the intervention group receive a remote, asynchronous, bilingual, bi-directional, 6-month texting program focused on dementia education, skill-building and community resources. The control group enters a 7-month waitlist after which they are offered the same intervention as the intervention group. Randomization is stratified by each of the four recruitment sites at a 1:1 ratio. Outcomes (e.g., caregiver depressive symptomatology, distress) are measured via surveys at baseline, 3, 6 and 7 months.</div></div><div><h3>Conclusions</h3><div>This RCT addresses two priority areas: eliminating dementia disparities and optimizing caregiver support. Findings have the potential to make clinical and policy-relevant contributions by providing appropriate caregiver support to Latinos in a highly scalable way.</div><div>Protocol version/date: 1/14/2025.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108214"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899342","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}