Contemporary clinical trials最新文献

{"title":"Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD).","authors":"Matisyahu Shulman, Sarah Meyers-Ohki, Patricia Novo, Scott Provost, Kaitlyn Ohrtman, Paul Van Veldhuisen, Neal Oden, Michael Otterstatter, Genie L Bailey, David Liu, John Rotrosen, Roger D Weiss, Edward V Nunes","doi":"10.1016/j.cct.2025.107816","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107816","url":null,"abstract":"<p><strong>Introduction and background: </strong>The three medications approved to address OUD are effective in decreasing opioid use and morbidity and mortality; however, their utility is limited by high rates of dropout from treatment. The CTN-0100 trial will develop an evidence base for strategies to improve retention on buprenorphine and extended-release naltrexone.</p><p><strong>Research design and methods: </strong>The National Drug Abuse Treatment Clinical Trials Network (CTN) study CTN-0100, \"Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy\" (RDD), is a multicenter, randomized, non-blinded trial enrolling more than a thousand patients from 18 community-based substance use disorder treatment programs. Participants are adult volunteers seeking to initiate medication treatment for OUD (MOUD). Individuals choose between buprenorphine or extended-release injectable naltrexone. The trial randomizes participants choosing buprenorphine, in a 3 × 2 factorial design, to a medication condition (standard-dose sublingual buprenorphine, high-dose sublingual buprenorphine, or extended-release injectable buprenorphine) and to a behavioral condition (Medical Management or Medical Management plus a digital therapeutic (smartphone) app). Individuals choosing extended-release naltrexone are randomized only to a behavioral condition. Participants receive study medication for 74 weeks and are then followed for a further 24 weeks. The primary outcome is successful retention on MOUD at 26 weeks (six months), with 50- and 74-week retention among the secondary outcomes.</p><p><strong>Discussion/conclusion: </strong>Dropout from treatment is a major barrier to the effectiveness of MOUD. The CTN-0100 study will determine whether strategies such as high dose sublingual or extended-release buprenorphine, or an app-based behavioral intervention improve retention on MOUD.</p><p><strong>Clinicaltrials: </strong>gov Identifier: NCT04464980.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107816"},"PeriodicalIF":2.0,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022366","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":"Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial.","authors":"Nia S Mitchell, Rebecca North, Anna Hung, Kathryn N Porter Starr, Connie W Bales, Cynthia J Coffman","doi":"10.1016/j.cct.2025.107815","DOIUrl":"10.1016/j.cct.2025.107815","url":null,"abstract":"<p><strong>Background: </strong>Obesity and frailty are positively linked. Compared to other groups, older African American women have the highest rates of both obesity and frailty. Several academic weight loss interventions have shown that older adults can lose weight and improve physical function through diet and exercise. However, these programs do not have infrastructure for dissemination. Take Off Pounds Sensibly (TOPS) is a peer-led, community-based weight loss program with TOPS has a nationwide infrastructure that facilitates dissemination. Retrospective analyses showed that TOPS participants could lose a clinically significant amount of weight and maintain the loss for up to 7 years. This study will evaluate how TOPS participation affects weight change; physical function; cardiovascular disease risk factors; quality of life; and healthcare utilization among older African American women.</p><p><strong>Methods: </strong>We are recruiting 104 older African American women aged ≥55 years with a BMI ≥ 27 kg/m² to participate in a 6-month randomized wait-list controlled trial where TOPS is facilitated by a dietitian in weekly meetings. The primary goal of the intervention is for participants to lose at least 5 % of their initial weight. Outcomes will be collected at study visits at baseline, 3 months, and 6 months.</p><p><strong>Discussion: </strong>If successful, this study will show that the TOPS program would be an option to treat excess weight and poor physical function among older African American women.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107815"},"PeriodicalIF":2.0,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001519","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":"Developing a cost-effective and efficient safety case management solution for data coordinating center projects.","authors":"Katrina D Burson, Michelle H Walter, Jeanette O Auman, Jennifer Beverly, James W Pickett, Brian Erman, Kristin Zaterka-Baxter","doi":"10.1016/j.cct.2025.107809","DOIUrl":"10.1016/j.cct.2025.107809","url":null,"abstract":"<p><p>A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107809"},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001534","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":"Evaluation of the safety and efficacy of isotretinoin in treatment of COVID-19 : A randomized controlled clinical trial.","authors":"Lamia H Elgarhy, Sabah H El-Ghaiesh, Eman Hamed, Wagdy Abdelfatah","doi":"10.1016/j.cct.2025.107813","DOIUrl":"10.1016/j.cct.2025.107813","url":null,"abstract":"<p><p>The pandemic of SARS-CoV2 is not only limited to the health issues and fatalities encountered in a worldwide overwhelming burden but also the social, economic, and well-being devastation. Many trials were done to find a safe and reliable therapy for COVID-19. Isotretinoin was reported as a possible therapy for COVID-19 through the mining of post-transcriptomic and genomic datasets, which revealed isotretinoin as a potent down-regulator of the ACE2 protein the crucial gateway of SARS-CoV2 to hijack host cells. A total of 106 patients with mild to moderate COVID-19 were recruited. Patients were randomized into two groups and treated with the Standard Care (STD) protocol of the Ministry of Health, Egypt, or the STD in combination with isotretinoin (0.5 mg/kg/day) for 5 days. The study involved 66 (63 %) females and 39 (37 %) males, median age 42 years (interquartile 32-55.5 y). The main findings revealed a significant reduction in the time to improvement in the isotretinoin-treated (6.6 ± 2 d) compared to the STD-treated patients (10.4 ± 3.3). Survival analysis (HR: 4.1, 95 % CI: 2.5-6.6) in comparison to the STD-treated patients. The main adverse event reported during the therapeutic duration was the dryness of the skin, which was of acceptable tolerability through skin care instructions to the patients. The data presented herein highlights the efficacy of isotretinoin in the management of mild to moderate COVID-19 patients with a significant reduction of the time to recovery. The adverse events reported were tolerable and did not outweigh the therapeutic benefits.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107813"},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001539","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 randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder.","authors":"Julianne D Jett, Diana Tyutyunnyk, Rachael Beck, Katharine Palmer, Danielle Ryan, Jesus Sanchez, Douglas L Weeks, Sterling M McPherson, Naomi Chaytor, Brian Kiluk, Martin A Javors, Brett C Ginsburg, Sean Murphy, Nathalie Hill-Kapturczak, Michael G McDonell","doi":"10.1016/j.cct.2025.107807","DOIUrl":"10.1016/j.cct.2025.107807","url":null,"abstract":"<p><strong>Background: </strong>Contingency management (CM) is an intervention for alcohol use disorder (AUD) that reinforces abstinence, as confirmed by alcohol biomarkers. CM is usually brief (12-16 weeks) despite evidence that longer interventions have better long-term outcomes. Most CM models are in-person which can also be a barrier for treatment. Studies of longer duration telehealth-based CM models are needed.</p><p><strong>Aims: </strong>To determine if a telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention and 12-month follow-up. We will evaluate the impact of CM on alcohol-related outcomes, determine if Addiction Neuroclinical Assessment variables are associated with outcomes in follow-up, and whether savings related to decreased alcohol use offset intervention costs.</p><p><strong>Methods: </strong>Adults with AUD residing in the United States will be recruited via online advertising. Research procedures will be conducted virtually. Participants who submit a PEth-positive blood sample (≥20 ng/mL) at enrollment will be randomized to 26 weeks of either 1) online cognitive behavior therapy (CBT4CBT) with rewards not contingent on PEth results (Control group) or 2) CBT4CBT with a maximum of $1,820 of rewards contingent on PEth results (CM group). Efficacy outcomes of PEth-negative tests (primary) and PEth-defined excessive drinking (≥200 ng/mL; secondary) will be assessed. Predictors of intervention outcomes and economic viability will also be investigated.</p><p><strong>Discussion: </strong>If this telehealth-delivered PEth-based CM intervention reduces alcohol use and is cost-effective, it could be used to provide effective treatment to millions of individuals with AUD who do not receive in-person care.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107807"},"PeriodicalIF":2.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001506","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":"Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial.","authors":"Brooke T Nezami, Carmina G Valle, Heather M Wasser, Lex Hurley, Karen E Hatley, Deborah F Tate","doi":"10.1016/j.cct.2025.107808","DOIUrl":"10.1016/j.cct.2025.107808","url":null,"abstract":"<p><strong>Background: </strong>Young adults (YAs) are underrepresented in behavioral health and weight loss interventions and express interest in flexible, highly tailored programs. Mobile interventions are a lower-burden, scalable approach to providing behavioral support. Just-in-time-adaptive interventions (JITAI) promise to deliver the \"right\" support at the \"right\" time using real-time data from smartphones and sensors. JITAIs hold promise for promoting behavior changes needed for weight loss (dietary intake, activity, and self-weighing); however, there is limited evidence for selecting treatment components and levels of adaptation that are needed for success.</p><p><strong>Methods: </strong>The AGILE (Adaptive Goals and Interventions for Lifestyle Enhancement) trial utilizes the Multiphase Optimization Strategy (MOST) framework and a 2⁵ full factorial experimental trial to test the efficacy of 5 intervention components, each with two levels, on weight loss among 608 YAs recruited from around the United States. All participants will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation leads to greater weight loss, we will test standard versus adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Assessments will occur at baseline, 3 months, and 6 months.</p><p><strong>Conclusions: </strong>Results of this trial will be used to create an optimized JITAI for weight loss in young adults.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107808"},"PeriodicalIF":2.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001540","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":"Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) - A randomized comparative-effectiveness study of two remotely delivered mind-body interventions for older adults with cognitive decline.","authors":"Linda L Chao, Deborah E Barnes, Margaret A Chesney, Wolf E Mehling, Jennifer A Lee, Cynthia Benjamin, Helen Lavretsky, Linda Ercoli, Prabha Siddarth, Katherine L Narr","doi":"10.1016/j.cct.2025.107811","DOIUrl":"10.1016/j.cct.2025.107811","url":null,"abstract":"<p><strong>Background: </strong>Research suggest that mind-body movement programs have beneficial effects on cognitive outcomes for older adults with cognitive decline. However, few studies have directly compared specific approaches to mind-body movement or studied the impact of remote program delivery.</p><p><strong>Methods: </strong>In a 3-arm randomized controlled trial (RCT) for older adults with cognitive impairment, we are comparing a multidomain mind-body program that emphasizes movement, body awareness, personal meaningfulness, and social connection, and a traditional Chinese mind-body exercise (Tai Chi) to a health and wellness education control condition. All 3 interventions are delivered remotely two times per week (onehour per session) for 12 weeks. The two active interventions are live-streamed. Outcomes are assessed prior to, after, and 6-months after the interventions. The co-primary outcomes are changes on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) and brain functional connectivity in the Default Mode Network (DMN). Secondary outcomes include measures of specific cognitive domains (e.g., executive function, attention), mobility, and self-report measures of general well-being, quality of life, social engagement, self- and attention-regulation.</p><p><strong>Conclusion: </strong>This RCT will directly compare the effects of two mind-body movement programs versus an education control delivered remotely over 12 weeks on cognitive, neuroimaging, and participant-reported outcomes. If successful, these programs may provide scalable strategies for slowing cognitive decline, which could potentially delay dementia onset in some individuals.</p><p><strong>Trial registration id: </strong>NCT05217849.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107811"},"PeriodicalIF":2.0,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982652","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":"Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT).","authors":"Katarina Wang, Jeanette Wong, Leslie Avilez, Kristan Olazo, Samuel Olanrewaju, Charles E McCulloch, Rena Pasick, Shreya Patel, Ma Somsouk, Urmimala Sarkar","doi":"10.1016/j.cct.2025.107810","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107810","url":null,"abstract":"<p><strong>Background: </strong>Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT.</p><p><strong>Methods: </strong>We will test a multilevel intervention with one safety-net system across 12 primary care clinics - a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a \"best practices bundle\" to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care.</p><p><strong>Results: </strong>For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy.</p><p><strong>Discussion: </strong>This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting.</p><p><strong>Trial registration: </strong>NCT, NCT06191185. Registered 20 December 2023, https://clinicaltrials.gov/study/NCT06191185.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107810"},"PeriodicalIF":2.0,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982614","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":"Growing up without violence (GWV): Study protocol for a cluster randomised trial and process evaluation of a school-based intervention preventing adolescent sexual exploitation in Brazil.","authors":"Ligia Kiss, Agnese Iuliano, Ana Paula Portella, Heloína Paiva, Malini Pires, Baptiste Leurent","doi":"10.1016/j.cct.2024.107802","DOIUrl":"10.1016/j.cct.2024.107802","url":null,"abstract":"<p><strong>Background: </strong>Sexual exploitation of children and adolescents (SECA) is a mostly invisible phenomenon, having negative impacts on adolescents' health and well-being. There is increasing awarenessof preventative strategies to reduce sexual exploitation of children and adolescents, but limited evidence on their effectiveness and mechanisms. This project addresses this gap through the impact and process evaluation of 'Growing Up Without Violence' (GWV), the largest intervention in Brazil tackling SECA.</p><p><strong>Methods: </strong>We will conduct a two-arm cluster randomised trial (CRT) with parallel assignment in the municipalities of Cabo de Santo Agostinho and Jaboatão dos Guararapes, in Brazil. We will randomly allocate 30 schools to intervention and 30 to wait-list control arms. In each of these schools, we will randomly select independent samples of fifty students (aged 12 to 17) to participate in baseline and endline surveys. We will invite students to self-complete pre-programmed questionnaires in a private school space, under the supervision of trained researchers. Our main analysis is a cross-sectional comparison between control and intervention schools of students' levels of basic knowledge for identifying appropriate and inappropriate sexual advances and acts (primary outcome). Secondary outcomes include knowledge of risks of online sexual exploitation, willingness to report incidents of sexual abuse and exploitation, and recall of exposure SECA preventive training content.</p><p><strong>Discussion: </strong>To our knowledge, this is the first large-scale rigorous evaluation of an intervention to prevent SECA in Brazil. Findings will inform our strategies and future interventions to prevent SECA.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107802"},"PeriodicalIF":2.0,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969856","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 representation of special populations: An approach to the inclusion of women veterans in VA clinical trials.","authors":"Karen M Goldstein, Elizabeth M Yano, Paula P Schnurr, Lori A Bastian, Susan Alton Dailey, Alyssa Pomernacki, Diane Carney, Jennifer M Gierisch, Alison B Hamilton, Andrea Nevedal, Dawne Vogt, Susan M Frayne","doi":"10.1016/j.cct.2025.107812","DOIUrl":"10.1016/j.cct.2025.107812","url":null,"abstract":"<p><p>The under-recruitment of historically marginalized populations into clinical trials thwarts equitable inclusion of individuals who could benefit from healthcare innovations and limits the generalizability of results. For decades, the Veterans Health Administration (VA) has conducted large clinical trials that impact clinical guidelines for veterans and civilians alike. Within the VA, women are a numeric minority, and recruitment of this population into trials is challenged by gender-specific care structures, distinct demographic characteristics, and mistreatment such as higher rates of military sexual trauma and harassment on VA grounds. We describe our approach to enhancing the inclusion of women veterans in clinical trials through the VA Women's Enhanced Recruitment Program (WERP) as developed for the VA Cooperative Studies Program. This information is relevant to clinical trial teams seeking to include women veterans in their trials. Our findings also have implications for other researchers seeking equitably increase participation of marginalized populations so that findings are generalizable to broader populations.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107812"},"PeriodicalIF":2.0,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142977926","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}