Chapagain Ram Hari, Adhikari Santosh, Kunwar Kshitij, Thapa Prabhat, Maharjan Jessica, Giri Bishnu Rath, Shrestha Nisha Jyoti, Shrestha Anil Kumar, Shrestha Sanjeet Kumar, Tamang Suresh Man, Kim Deok Ryun, Saluja Tarun, Wartel Anh, Lynch Julia, Song Katerina Rok
OCV-S Study Site, Kanti Children's Hospital, Kathmandu, Nepal.
National Academy of Medical Sciences (NAMS), Kathmandu, Nepal.
Vaccine X. 2024 Nov 22;21:100585. doi: 10.1016/j.jvacx.2024.100585. eCollection 2024 Dec.
Pediatric vaccine clinical trials are crucial for evaluating and ensuring the safety and efficacy of new vaccines for children. However, in low-resource settings like Nepal, where clinical trials are relatively new, recruitment and retention of participants are challenging particularly due to diverse parental backgrounds, motivations and concerns. As such, parental motivations, perceived barriers, and experiences of participating in pediatric vaccine trial in Nepal, which hasn't previously been explored, needs to be understood.
We performed face-to-face exit interviews from April 6, 2022 to June 7, 2022, with parents whose children participated in the phase III clinical trial of the Oral Cholera Vaccine - Simplified (OCV-S) using a structured questionnaire on motivations for enrolling and barriers faced during the trial. Data were initially cleaned and encoded in Microsoft Excel before being analyzed with R version 4.3.1. Descriptive statistics were used to summarize demographic and other participants' characteristics. Bivariate and multivariate analyses, using odds ratios and their 95% confidence intervals, applying a significance level of 0.05 was used to analyze relationship between participant characteristics and trial experiences. Additionally, thematic analysis was performed on responses to open-ended questions.
A total of 258 parents responded, out of which 252 (97.7 %) were first-time clinical trial participants with median age of 32 years. A majority, 196 (76.0 %), had a positive initial attitude towards the trial, and 204 (79.1 %) reported a positive overall experience. The primary motivations for participation included the potential health benefits for their children (56.2 %, n = 145). Despite 69 (26.7 %) participants receiving discouraging information from others, only 4 (5.8 %) were influenced by it. Most participants (n = 219, 84.9 %), felt that the trial had met their expectations. Challenges faced included loss of time (n = 30, 11.6 %) and missed school for children (n = 22, 8.5 %). Nonetheless, 179 participants (69.4 %) expressed a willingness to enroll their children in future trials. Participants who received specific details about the study before visiting the study site were significantly more likely to report positive experience, with an adjusted odds ratio of 1.97 (95 % CI: 1.03 - 3.72).
Majority of parents were supportive of their children's participation in the OCV-S trial, motivated largely by anticipated health benefits for their child. Key barriers identified included logistical issues, costs (both financial and opportunity costs), misinformation, and concerns about trial procedures and potential side effects. Focus on reducing logistical and participation-related burdens, catering of trial-specific information, enhancing the clarity of the informed consent process, addressing safety concerns proactively and implementing continuous follow-up can help improve participation rates and retention in future trials. The high level of enthusiasm for clinical trials among parents, despite these barriers, highlights the promising potential for future research endeavors in Nepal.
儿科疫苗临床试验对于评估和确保儿童新型疫苗的安全性和有效性至关重要。然而，在尼泊尔这样资源匮乏的地区，临床试验开展时间相对较短，招募和留住参与者颇具挑战，尤其是由于家长背景、动机和担忧各不相同。因此，有必要了解尼泊尔此前未被探索过的家长参与儿科疫苗试验的动机、感知到的障碍以及经历。
我们于2022年4月6日至2022年6月7日对其子女参与口服霍乱疫苗简化版（OCV-S）三期临床试验的家长进行了面对面的退出访谈，使用一份关于参与动机和试验期间所面临障碍的结构化问卷。数据最初在Microsoft Excel中进行清理和编码，然后使用R 4.3.1版本进行分析。描述性统计用于总结人口统计学和其他参与者特征。使用优势比及其95%置信区间进行二元和多变量分析，应用0.05的显著性水平来分析参与者特征与试验经历之间的关系。此外，对开放式问题的回答进行了主题分析。
共有258名家长做出回应，其中252名（97.7%）是首次参与临床试验的家长，中位年龄为32岁。大多数家长，即196名（76.0%），对试验最初持积极态度，204名（79.1%）报告总体体验良好。参与的主要动机包括对孩子潜在的健康益处（56.2%，n = 145）。尽管69名（26.7%）参与者从他人那里得到了令人气馁的信息，但只有4名（5.8%）受到了影响。大多数参与者（n = 219，84.9%）认为试验达到了他们的期望。面临的挑战包括时间损失（n = 30，11.6%）和孩子缺课（n = 22，8.5%）。尽管如此，179名参与者（69.4%）表示愿意让他们的孩子参加未来的试验。在访问研究地点之前收到研究具体细节的参与者报告积极体验的可能性显著更高，调整后的优势比为1.97（95% CI：1.03 - 3.72）。
大多数家长支持他们的孩子参与OCV-S试验，主要动机是预期对孩子的健康有益。确定的主要障碍包括后勤问题、成本（经济成本和机会成本）、错误信息以及对试验程序和潜在副作用的担忧。专注于减少后勤和参与相关的负担、提供特定于试验的信息、提高知情同意过程的清晰度、积极解决安全问题以及实施持续随访有助于提高未来试验的参与率和保留率。尽管存在这些障碍，但家长对临床试验的高度热情凸显了尼泊尔未来研究工作的广阔潜力。
