Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)
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ABSTRACT:
SUBMITTER: Aventin A
PROVIDER: S-EPMC4660345 | biostudies-literature | 2015 Jan
REPOSITORIES: biostudies-literature
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Project description:Background: Hospitalizations for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with increased mortality and decreased quality of life. Replicate hospital discharge studies were initiated to examine efficacy and safety of once-daily tiotropium HandiHaler® versus placebo, in addition to usual care, in patients discharged from the hospital after an AECOPD. Methods: Both studies were randomized, placebo-controlled, double-blind, parallel-group, multicenter, with inclusion/exclusion criteria providing a diverse COPD patient cohort hospitalized for ≤14 days with AECOPD. Patients received tiotropium or placebo, initiated within 10 days post-discharge. Target recruitment was 604 patients/study and planned duration was event-driven, ending after 631 clinical outcome events across both studies. Inability to reach targeted site numbers and patient recruitment/retention difficulties led to early study termination. Recruitment/retention challenges and protocol amendment impacts were assessed qualitatively to understand the major issues. Results: Over 18 months, 219 patients were enrolled; 158 were randomized and 61 failed screening. Premature treatment discontinuation occurred in 49(31%) patients, of whom 20(41%) completed health status follow-up. All-cause, 30-day hospital readmission was low (8[5%] patients). A total of 154(98%) patients had a concomitant diagnosis and most took pulmonary medication pre-randomization (143[91%]) and during study treatment (144[92%]). Inclusion/exclusion criteria changes failed to improve recruitment. Recruitment/retention barriers were identified, relating to patient and clinician factors, health care infrastructure, and clinical practices. Conclusions: Although AECOPD hospitalization is clinically important and incurs high costs, significant challenges exist in studying this population in clinical trials after hospitalization. Studies are needed to evaluate effective management of AECOPD patients at high risk of adverse clinical outcomes.
| S-EPMC5764840 | biostudies-literature
Project description:BackgroundResearch on effective recruitment and retention strategies for adolescents and young adults suffering from posttraumatic stress disorder is scarce. The aim of the current study was to provide data on recruitment sources, barriers, and facilitators for participation in a randomized controlled trial for young individuals with histories of sexual and/or physical abuse.MethodsStudy participants aged 14 to 21 were asked to complete a checklist on individual sources of recruitment, barriers, and facilitators for participation in the trial. Fifty-three out of the 80 study participants who were contacted completed the checklist (66.3%).ResultsMost respondents reported multiple recruitment sources, with online and media advertising search strategies indicated most frequently (45.4% of all mentions), followed by practitioner-referred sources (38.7%). Respondents' reported barriers included additional demands of the trial (60.3%), followed by distress caused by having to talk about painful topics (15.5%). The most frequently indicated facilitators were the organizational setting (55.1%) and monetary incentives (22.2%), followed by social support (12.0%) and non-monetary incentives (10.2%). No significant differences were observed between adolescent and young adult respondents with the exception that adolescents reported significantly more frequently that they had learned about the trial from their caregiver.ConclusionsOur findings permit the formulation of recommendations for planning and conducting trials with this clientele. Future research is needed on how specific barriers can be effectively overcome.
| S-EPMC7164245 | biostudies-literature
Project description:The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for underrepresented (UR) faculty in biomedical fields. Regulatory approval and recruitment for the Building Up Trial took place during the COVID-19 pandemic and the anti-racism movement. The pandemic and anti-racism movement personally and professionally impacted the target population and made recruitment challenging at both the institution and participant level. The target sample size for this study was 208 postdoctoral fellows or early-career faculty across 26 predominately white institutions. Challenges and adaptations are described. The Building Up Trial was delayed by 3 months. In total, 225 participants from 26 institutions were enrolled. Participants are predominately female (80%), Hispanic/Latinx (34%) or non-Hispanic/Latinx Black (33%), and early-career faculty (53%). At the institution level, obtaining Institutional Review Board (IRB) approval through a single Institutional Review Board (sIRB) posed the biggest challenge. We adapted to COVID-19-related challenges through simplifying sIRB forms, modifying study practices, and increasing communication with institutions. Recruiting UR postdoctoral fellows and faculty during the COVID-19 pandemic and anti-racism movement was challenging but not impossible. Studies should be prepared to modify study and recruitment policies to overcome additional barriers posed by the pandemics.
| S-EPMC8596076 | biostudies-literature
Project description:In the past 3 years, we have witnessed the completion of four randomized phase III studies in neuroendocrine tumors and the approval of two new drugs, everolimus and sunitinib, for the treatment of patients with well-differentiated pancreatic neuroendocrine tumors. These studies demonstrate a shift from case series and single-arm studies toward prospective, randomized controlled clinical trials and evidence-based therapy in the neuroendocrine tumor field. However, the clinical development of these agents also highlights the potential challenges awaiting other new drugs in this area. Herein, we discuss the strengths and weaknesses of the most recent phase II and phase III neuroendocrine tumor studies and discuss how limitations inherent in current trial design can lead to potential pitfalls. We also discuss how trial design can be improved, with the hope of increasing the number of drugs successfully developed to treat patients with neuroendocrine tumors.
| S-EPMC3662843 | biostudies-literature
Project description:BackgroundThe Betel Nut Intervention Trial (BENIT; ClinicalTrials.gov - NCT02942745) is the first known randomized intervention trial specifically designed for areca nut chewers in the western Pacific region who want to quit. The current study is a separate, exploratory study that examined the experiences of the BENIT facilitators during its implementation in Guam and Saipan of the Northern Mariana Islands and the extent to which the BENIT protocol was adapted to meet the participants' and facilitators' needs.MethodsAll six BENIT program facilitators completed an online survey consisting of quantitative (Likert scale) and qualitative (open-ended) questions. Survey items were grouped as follows: facilitator demographics, prior training and preparation, BENIT experience, beliefs about the program's effectiveness, and beliefs about protocol adaptations.ResultsMost of the facilitators felt prepared to deliver the BENIT program after several weeks of moderately intensive training. Facilitators felt the BENIT program was generally effective and that the "trigger logs" and "self-monitoring logs" worked as intended. However, they also noted that more time and support would have been helpful to overcome some of the obstacles inherent to implementing a novel program.ConclusionThe current findings can be used to inform, modify, and tailor subsequent areca nut cessation programs in Micronesian communities and to improve future versions of BENIT.
| S-EPMC10809568 | biostudies-literature
Project description:BackgroundComplex innovative design trials are becoming increasingly common and offer potential for improving patient outcomes in a faster time frame. FOCUS4 was the first molecularly stratified trial in metastatic colorectal cancer and it remains one of the first umbrella trial designs to be launched globally. Here, we aim to describe lessons learned from delivery of the trial over the last 10 years.MethodsFOCUS4 was a Phase II/III molecularly stratified umbrella trial testing the safety and efficacy of targeted therapies in metastatic colorectal cancer. It used adaptive statistical methodology to decide which sub-trial should close early, and new therapies were added as protocol amendments. Patients with newly diagnosed metastatic colorectal cancer were registered, and central laboratory testing was used to stratify their tumour into molecular subtypes. Following 16 weeks of first-line therapy, patients with stable or responding disease were eligible for randomisation into either a molecularly stratified sub-trial (FOCUS4-B, C or D) or non-stratified FOCUS4-N. The primary outcome for all studies was progression-free survival comparing the intervention with active monitoring/placebo. At the close of the trial, feedback was elicited from all investigators through surveys and interviews and consolidated into a series of recommendations and lessons learned for the delivery of similar future trials.ResultsBetween January 2014 and October 2020, 1434 patients were registered from 88 UK hospitals. Of the 20 drug combinations that were explored for inclusion in the platform trial, three molecularly targeted sub-trials were activated: FOCUS4-D (February 2014-March 2016) evaluated AZD8931 in the BRAF-PIK3CA-RAS wildtype subgroup; FOCUS4-B (February 2016-July 2018) evaluated aspirin in the PIK3CA mutant subgroup and FOCUS4-C (June 2017-October 2020) evaluated adavosertib in the RAS+TP53 double mutant subgroup. FOCUS4-N was active throughout and evaluated capecitabine monotherapy versus a treatment break. A total of 361 (25%) registered patients were randomised into a sub-trial. Feedback on the experiences of delivery of FOCUS4 could be grouped into three main areas of challenge: funding/infrastructure, biomarker testing procedures and trial design efficiencies within which 20 recommendations are summarised.ConclusionAdaptive stratified medicine platform studies are feasible in common cancers but present challenges. Our stakeholder feedback has helped to inform how these trial designs can succeed and answer multiple questions efficiently, providing resource is adequate.
| S-EPMC9036145 | biostudies-literature
Project description:BackgroundDesign and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and different regulatory requirements. STREAM was an MDR-TB clinical trial that recruited over 1000 participants. We documented challenges and best practices/lessons learned from the site perspective to improve implementation of future trials.MethodsWe conducted a voluntary survey of trial staff at all sites to obtain information on challenges encountered and best practices/lessons learned from implementation of the STREAM trial. Respondents were asked to identify substantive aspects of trial implementation from a list that included: trial administration, laboratory strengthening/infrastructure, pharmacy and supply chain management, community engagement, regulatory and ethics requirements, health economics, and other (respondent designated) about which a practical guide would be useful to improve future trial implementation. For each aspect of trial implementation selected, respondents were asked to report challenges and best practices/lessons learned during STREAM. Lastly, respondents were asked to list up to three things they would do differently when implementing future trials. Summary statistics were generated for quantitative data and thematic analysis was undertaken for qualitative data.ResultsOf 67 responses received from 13 of 15 sites, 47 (70%) were included in the analyses, after excluding duplicate or incomplete responses. Approximately half the respondents were investigators or trial coordinators. The top three aspects of trial implementation identified for a best practices/lessons learned practical guide to improve future trial implementation were: trial administration, community engagement, and laboratory strengthening/infrastructure. For both challenges and best practices/lessons learned, three common themes were identified across different aspects of trial implementation. Investment in capacity building and ongoing monitoring; investment in infrastructure and well-designed trial processes; and communication and coordination between staff and meaningful engagement of stakeholders were all thought to be critical to successful trial implementation.ConclusionsExisting practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation.
| S-EPMC9869607 | biostudies-literature
Project description:BackgroundRecruiting large samples of diverse sexual and gender minority adolescent and young adults (AYAs) into HIV intervention research is critical to the development and later dissemination of interventions that address the risk factors for HIV transmission among substance-using, sexual and gender minority AYAs.ObjectiveThis paper aimed to describe the characteristics of the samples recruited via social media and in-person methods and makes recommendations for strategies to recruit substance-using, sexual and gender minority AYAs, a hardly reached population that is a priority for HIV prevention research.MethodsUsing data from a randomized control trial of an HIV and substance use intervention with sexual and gender minority AYAs, aged 15 to 29 years in southeastern Michigan (n=414), we examined demographic and behavioral characteristics associated with successful recruitment from a range of virtual and physical venues.ResultsWe found that paid advertisements on Facebook, Instagram, and Grindr offered the largest quantity of eligible participants willing to enroll in the trial. Instagram offered the largest proportion of transgender masculine participants, and Grindr offered the largest proportion of Black/African American individuals. Although we attempted venue-based recruitment at clubs, bars, community centers, and AIDS service organizations, we found it to be unsuccessful for this specific hardly reached population. Social media and geobased dating applications offered the largest pool of eligible participants.ConclusionsUnderstanding factors associated with successful recruitment has the potential to inform effective and efficient strategies for HIV prevention research with substance-using, sexual and gender AYAs.Trial registrationClinicalTrials.gov NCT02945436; https://clinicaltrials.gov/ct2/show/NCT02945436.International registered report identifier (irrid)RR2-10.2196/resprot.9414.
| S-EPMC8686481 | biostudies-literature
Project description:Background/aimsYoung adults are at risk of weight gain, but little is known about designing effective weight control trials for young adults or how to recruit and retain participants in these programs. The Choosing Healthy Options in College Environments and Settings (CHOICES) study evaluated the effectiveness of a weight gain prevention intervention for 2-year college students. We describe the methods used to recruit and retain the colleges and their students, describe the sample and discuss recommendations for future studies.MethodsStudents were recruited into a 24-month trial of a weight control intervention with assessment periods at baseline, 4-, 12- and 24-month follow-up.ResultsWe successfully recruited 441 students through partnerships with three 2-year colleges through a variety of campus-based methods. Ultimately, 83.4% of the randomized cohort participated in the 24-month assessment period. Those retained more often were White (p = 0.03) compared to those who dropped out or were lost to follow-up; no other socio-demographic factor (e.g. gender, ethnicity and education), body mass index, body fat, waist circumference or weight status was observed to differ between randomly assigned groups.ConclusionTwo-year colleges and their students are interested in participating in weight-related trials and partnering with universities for research. Researchers must work closely with administrators to identify benefits to their institutions and to resolve student-level barriers to recruitment and retention. Our experiences from the Choosing Healthy Options in College Environments and Settings study should be useful in identifying effective recruitment and retention methods for weight gain prevention trials among young adults.
| S-EPMC4785077 | biostudies-literature
Project description:IntroductionRecruiting racial/ethnic minorities in smoking cessation trials is a priority. This study described lessons learned from recruiting a diverse sample of African American, White, and Hispanic/Latinx smokers in a smoking cessation trial.MethodsWe implemented a 42-month recruitment campaign utilizing reactive (e.g., word-of-mouth, newspaper, radio, online ads, flyers, community partnerships) and proactive (e.g., direct invitations) strategies. We included 821 participants in the analysis. We described our recruitment strategies' implementation, their enrollment yield and rate (number enrolled/number screened) by race/ethnicity, and direct cost-per-participant (CPP: total cost/number of enrolled) for paid strategies.ResultsEnrollment yields were higher using reactive strategies than proactive strategies (94.3% vs. 5.7%). The top source of enrollment was word-of-mouth among African Americans (36%) and Whites (44%), and flyers among Hispanics/Latinxs (34%). Proactive recruitment, word-of-mouth, and flyers were more successful among African Americans than other groups. Newspaper and online ads were more successful among Hispanics/Latinxs than other groups (P < .05). Word-of-mouth was cost-free and yielded 23.1% of enrollment. The most economic method among paid strategies was flyer distribution (CPP = $47.6; yield 17.5%), followed by newspaper ($194.7; 23.7%) and online advertisements ($264.6; 24.0%). Radio and television ads were the most expensive and produced the least participant yield ($4,755.6; 0.8%).ConclusionRecruiting racially/ethnically diverse samples into smoking cessation clinical trials requires implementing multiple strategies and adjusting these strategies based on their enrollment yield and cost. Word-of-mouth, flyers, and newspaper and online ads were more successful among racial/ethnic minorities. Flyers and newspaper ads were the most economic methods for recruitment.
| S-EPMC8511330 | biostudies-literature