Contemporary clinical trials最新文献

{"title":"Time-restricted eating in patients with metabolic syndrome: A protocol paper for a feasibility clinical trial","authors":"Bárbara Piñeiro ,&nbsp;Jennifer Kue ,&nbsp;Jennifer Costa ,&nbsp;Ashley Santiago ,&nbsp;John Msaddi ,&nbsp;Kalie Nuss ,&nbsp;Hariom Yadav ,&nbsp;Laura Szalacha ,&nbsp;Usha Menon","doi":"10.1016/j.cct.2026.108223","DOIUrl":"10.1016/j.cct.2026.108223","url":null,"abstract":"<div><div>Recent studies have evaluated Time-Restricted Eating (TRE) as a promising dietary behavioral intervention for weight loss and cardiometabolic risk factor improvement. Yet the results are mixed. We describe a TRE protocol, a behavioral dietary intervention where all calorie intake is limited to 10-h eating window followed by a 14-h fasting period, without altering diet quality and quantity. This study aims to determine the feasibility and acceptability of a 12-week TRE intervention among patients with metabolic syndrome. Dietary lifestyle changes can decrease risk in metabolic syndrome, but such changes are difficult to implement and sustain. This is a pilot feasibility study with a single-arm group. A total of 40 adult patients with metabolic syndrome are being enrolled. Participants document their daily eating patterns through MyCap app. The primary outcome is to assess the feasibility and acceptability of the intervention, including recruitment, program delivery, adherence and patient satisfaction. Secondary outcome measures include changes in weight, blood pressure, sleep, quality of life, and biological measures including gut microbiome, HbA1c, lipids, and thyroid function. Findings of this pilot study will provide novel insights into improving information health markers in individuals with metabolic syndrome, as well as inform the feasibility and sustainability of this dietary intervention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108223"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146002908","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 impact of prescribed versus achieved resistance training intensity on strength, body composition, and psychological health in women survivors of breast cancer: Protocol for the EFICAN 2.0 randomized trial","authors":"Alba Esteban-Simón ,&nbsp;David M. Díez-Fernández ,&nbsp;Andrés Baena-Raya ,&nbsp;Alejandro Pérez-Castilla ,&nbsp;Andrea Rodriguez-Solana ,&nbsp;Máriam Ramos-Teodoro ,&nbsp;Antonio Pérez-Romero ,&nbsp;Manuel A. Rodríguez-Pérez ,&nbsp;Alberto Soriano-Maldonado","doi":"10.1016/j.cct.2026.108225","DOIUrl":"10.1016/j.cct.2026.108225","url":null,"abstract":"<div><h3>Background</h3><div>Strength training (ST) is recommended for survivors of breast cancer due to its health-related benefits. However, the optimal method for prescribing ST intensity in this population remains unexplored.</div></div><div><h3>Objective</h3><div>To compare the effects of three intensity prescription methods on muscular strength, body composition, physical function and psychological health in survivors of breast cancer; and to examine how the training intensity progresses over time according to each method.</div></div><div><h3>Methods</h3><div>A three-arm randomized trial will be conducted with 60 women survivors of breast cancer randomly allocated to: (1) daily estimated one-repetition maximum (1RM) using individual load-velocity relationship; (2) initial 1RM estimation via load-velocity relationship, without daily updates; or (3) initial 1RM estimation via a 10RM test, without daily updates. The intervention includes a 2-week familiarization phase and an 8-week intervention phase. Training intensity will be prescribed between 60 and 75% 1RM, following the American College of Sports Medicine guidelines. Primary outcomes include muscle strength, physical function, cardiorespiratory fitness, fatigue, pain, quality of life, anxiety, and depressive symptoms. The secondary outcome is the difference between prescribed and achieved training intensity, which will be continuously monitored in all groups using a linear velocity transducer, and analyzed over time. Adherence, adverse events, and deviations from the protocol will be recorded.</div></div><div><h3>Conclusion</h3><div>This trial will provide novel insights into the effects of different ST intensity prescription methods on physical and psychological outcomes in survivors of breast cancer. It will also determine whether traditional approaches achieve intended training intensities, thereby advancing knowledge on exercise prescription in oncology.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108225"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146002831","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":"Handling missing data in longitudinal randomized clinical trials within the framework of targeted learning under MAR and MNAR","authors":"Man Jin","doi":"10.1016/j.cct.2026.108245","DOIUrl":"10.1016/j.cct.2026.108245","url":null,"abstract":"<div><div>Missing data is a common issue in longitudinal randomized clinical trials (RCTs), where the effect of treatment is estimated by a pre-specified statistical model. The targeted learning approach, through targeted maximum likelihood estimation (TMLE), has been suggested and evaluated in both clinical trials and observational studies to deal with missing data under the assumption of missing at random (MAR).</div><div>In this research project, we propose methods for handling missing data in longitudinal RCTs Within the framework of targeted learning through longitudinal maximum likelihood estimation (LTMLE), with missing data mechanisms MAR and missing not at random (MNAR). The methods are applied to a real public RCT dataset.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108245"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146096856","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 multimodal lifestyle intervention program targeting the muscle and gut to improve metabolic health among Indian adults with (pre)diabetes: Design of the GUT-DM randomized trial","authors":"Shinjini Bhattacharya ,&nbsp;Ardy van Helvoort ,&nbsp;Annemie M.W.J. Schols ,&nbsp;Sucharita Sambashivaiah","doi":"10.1016/j.cct.2026.108228","DOIUrl":"10.1016/j.cct.2026.108228","url":null,"abstract":"<div><h3>Introduction</h3><div>Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medication. Recent evidence has indicated improvement in glycemia with gut-centric interventions (probiotics, prebiotics, or synbiotics) among (pre)diabetic patients. This study aims to explore the effect of a lifestyle intervention (exercise and dietary modification) with/without synbiotics on metabolic, physical, mental and gut health of (pre)diabetic Indian adults compared to standard of care (SOC).</div></div><div><h3>Methods and analysis</h3><div>The calculated sample-size is 108 participants (including 25% dropouts), both sexes, 25–75 years of age, body mass index (BMI)18.5–34.9 kg/m² with either fasting, postprandial glucose or HbA1c above normal as per the American Diabetes Association (ADA, 2024). Participants will be randomized into one of 3 groups: SOC, lifestyle modification with synbiotics (LS + SYN), or lifestyle modification with placebo (LS + PLA). SOC group will follow routine practice, LS + SYN group will receive multimodal lifestyle-intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation, while LS + PLA group will be enrolled for the same intervention with placebo supplementation for 12 weeks. Changes in metabolic, physical, mental and gut health will be compared between the 3 groups.</div></div><div><h3>Discussion</h3><div>This exploratory randomized trial will assess the effectiveness of a multimodal lifestyle intervention with a gut centric approach in the management of different domains of health among (pre)diabetic adults. Since both lifestyle and gut-centric interventions individually have provided promising results, it is important to understand their combined effect to optimize management of this disease.</div></div><div><h3>Trial registry</h3><div>Clinical trials registry-India (CTRI), registration number: CTRI/2022/08/045096.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108228"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003126","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":"Assessing the cost-effectiveness of two psychoeducational interventions for people with cancer and their caregivers: An economic evaluation of the multi-country DIAdIC trial","authors":"Peter May ,&nbsp;Samantha Smith ,&nbsp;Mariama Jallow ,&nbsp;Tracy Kalinjuna ,&nbsp;Aline De Vlemnick ,&nbsp;Orphé Matthys ,&nbsp;Vincent Van Goethem ,&nbsp;Mogens Groenvold ,&nbsp;Suzanne Guerin ,&nbsp;Elena Turola ,&nbsp;Evi Bakker ,&nbsp;Kevin Brazil ,&nbsp;Richard Harding ,&nbsp;Laurel Northouse ,&nbsp;Peter Hudson ,&nbsp;Joachim Cohen ,&nbsp;Charles Normand ,&nbsp;On behalf of the DIAdIC consortium","doi":"10.1016/j.cct.2026.108240","DOIUrl":"10.1016/j.cct.2026.108240","url":null,"abstract":"<div><h3>Background</h3><div>Cancer is among the largest drivers of morbidity and mortality worldwide, causing physical, psychological and emotional strain for both patients and caregivers.</div></div><div><h3>Aim</h3><div>We estimated the cost-effectiveness of two dyadic psychoeducational interventions (FOCUS+ and iFOCUS) compared to usual care for people with advanced cancer and their primary family caregiver.</div></div><div><h3>Methods</h3><div>This was an economic evaluation within a clinical trial. Patient-caregiver dyads were recruited in Belgium, Denmark, Ireland, Italy, Netherlands and the UK from 2021 to 2023. We estimated costs by combining questionnaire responses with unit costs in euros (€) for 2022 and calculated outcomes as quality-adjusted life years (QALYs). Primary endpoint was 12 weeks, with secondary analysis at 24 weeks (trial exit).</div></div><div><h3>Results</h3><div>We recruited 431 dyads (140 FOCUS+, 148 iFOCUS, 143 usual care), of whom 281 (65%) participated to trial end. In primary analysis, estimated treatment effect of FOCUS+ versus usual care on total costs was +€253 (95% CI: −1440 to +3466), and estimated effect on QALYs was +0.010 (−0.02 to +0.04). For iFOCUS compared to usual care, the estimated effects were -€178 (−3047 to +2059) and − 0.001 (−0.04 to +0.04). Estimated incremental cost-effectiveness compared to usual care was highly uncertain in primary analysis, and in sensitivity analyses to timeframe and perspective.</div></div><div><h3>Conclusion</h3><div>Two dyadic, psychoeducational interventions for people with advanced cancer and their caregivers were not found to have a significant effect on costs, QALYs or cost-effectiveness compared to usual care. Multiple additional lessons for future trials in serious illness have been identified.</div></div><div><h3>Trial registration</h3><div>Registration on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> on 12/11/2020, identifier <span><span>NCT04626349</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108240"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040632","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 single-arm, multi-component behavior change technique (BCT) intervention to develop a walking habit among caregivers for persons with Alzheimer disease and related dementias (ADRD)","authors":"Danielle Miller ,&nbsp;Luis Jordan ,&nbsp;Sherene Lambert ,&nbsp;Ashley M. Goodwin ,&nbsp;Liron Sinvani ,&nbsp;Alexandra Perrin ,&nbsp;Ying Kuen Cheung ,&nbsp;Karina W. Davidson ,&nbsp;Mark J. Butler","doi":"10.1016/j.cct.2026.108248","DOIUrl":"10.1016/j.cct.2026.108248","url":null,"abstract":"<div><div>Even low to moderate physical activity is critical in improving and maintaining physical health and well-being. Caregivers of people living with Alzheimer disease and related dementias (ADRD) are a burdened population and, as such, can experience challenges with managing even modest increases in physical activity while caring for others. While some interventions have been proposed to increase physical activity, many fail to consider the unique needs of caregivers of people with ADRD.</div><div>The purpose of this 12-week decentralized behavioral trial is to test the efficacy of a multi-component, personalized text-message delivered BCT intervention to encourage the formation of a daily walking habit among caregivers of persons with ADRD assessed by Fitbit activity trackers via the key mechanism of behavior change (MoBC) of behavioral automaticity. Formation of a daily walking habit will be defined as attainment of walking 1000 or more additional steps during the same one-hour period on 7 consecutive days as set up in a personalized walking plan. We will also evaluate the association of habit formation attainment with changes in behavioral automaticity, association between longitudinal behavioral automaticity and habit formation attainment over time, and the heterogeneity of treatment effects between participants.</div><div>Results will advance science about behavioral habit formation among caregivers for persons with ADRD and determine whether behavioral automaticity acts as the primary MoBC for the effect on this BCT intervention on daily habitual walking.</div><div>This trial is registered on <span><span>www.ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>https://clinicaltrials.gov/study/NCT06803797</span><svg><path></path></svg></span>); NCT #: NCT06803797.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108248"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099547","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 Clinical Trial Referral Ambassadors program to promote clinical trial referrals within rural community hospitals: A formative program evaluation study","authors":"Deborah Carey ,&nbsp;Cheri Tolle ,&nbsp;John Kim ,&nbsp;Timothy Mullett ,&nbsp;Aurora Occa ,&nbsp;Anne E. Ray ,&nbsp;Jerod L. Stapleton","doi":"10.1016/j.cct.2026.108247","DOIUrl":"10.1016/j.cct.2026.108247","url":null,"abstract":"<div><h3>Background</h3><div>Community hospitals often lack research infrastructure, leading to fewer research opportunities for patients and low trial accrual rates. In practice, community hospitals can develop partnerships with academic facilities to refer patients for research opportunities but there is a dearth of research related to facilitating such referrals. We developed and implemented the Clinical Trial Referral Ambassadors (CTRA) training program to support trial referral efforts by nurses and clinic staff at community hospitals. This report describes CTRA and results from a formative evaluation.</div></div><div><h3>Methods</h3><div>CTRA was designed to create clinical research referral “Ambassadors” among nurses and research staff at community hospitals who can speak confidently to physicians and patients about the referral process and assist in facilitating referral activities. CTRA is grounded in best practices for community oncology training programs and includes didactic and interactive sessions, communication skills building, and self-assessment/discussions. The program evaluation included a post-training survey to assess acceptability and preliminary outcomes.</div></div><div><h3>Results</h3><div>Of the 25 individuals enrolled in CTRA, 13 (52%) attended all training sessions and 9 (36%) engaged in at least one session. Training acceptability ratings (evaluation survey <em>n</em> = 16) were favorable and participants reported high levels of confidence in their ability to refer patients, understanding of trials, and motivation to increase referrals after CTRA.</div></div><div><h3>Conclusion</h3><div>Preliminary evidence suggests the CTRA is acceptable and increased participants' knowledge, motivation, and skills for referring patients to clinical research. Future directions include identifying strategies to bolster CTRA participation and testing the impact of CTRA on trial referral rates.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108247"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099560","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":"Impact of clinical trial virtualization on recruitment in underserved communities for a type 2 diabetes mHealth intervention","authors":"Elizabeth Campbell ,&nbsp;Andrea Cassells ,&nbsp;T.J. Lin ,&nbsp;Jacqeline Cortez Lainez ,&nbsp;Arlene Smaldone ,&nbsp;Pooja Desai ,&nbsp;Haomiao Jia ,&nbsp;George Hripcsak ,&nbsp;Jonathan Tobin ,&nbsp;Lena Mamykina","doi":"10.1016/j.cct.2026.108250","DOIUrl":"10.1016/j.cct.2026.108250","url":null,"abstract":"<div><h3>Objective</h3><div>Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in the past. The following study presents an approach to virtualizing an RCT for an mHealth intervention.</div></div><div><h3>Materials and methods</h3><div>Study participants were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic's onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation.</div></div><div><h3>Results</h3><div>Study participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Despite the transition to virtual protocols, we did not detect statistically significant differences in key demographic characteristics, clinical factors, or mobile device proficiency between recruitment modalities, though the small in-person sample size (<em>n</em> = 21) limits definitive conclusions about selection bias.</div></div><div><h3>Discussion</h3><div>Our study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs.</div></div><div><h3>Conclusion</h3><div>This approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108250"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124141","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":"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}