Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
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DOI：
10.1093/infdis/jiy094
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发表时间：
2018-06-15
影响因子：
6.4
通讯作者：
Luman, Elizabeth T.
中科院分区：
文献类型：
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作者：
Carter, Rosalind J.;Senesi, Reynold G. B.;Luman, Elizabeth T.
塞拉利昂推出抗埃博拉疫苗试验 (STRIVE) 是研究性埃博拉疫苗的 2/3 期试验，于 2015 年 4 月在塞拉利昂实施。医疗保健和埃博拉一线工作人员被随机分为立即（7 天内）或推迟（18-24 周）疫苗接种组，并从入组到疫苗接种后 6 个月进行观察，以了解安全性和埃博拉病毒病情况。有人担心很难实现高保留率和合规性，特别是对于延期的群体。试验工作人员每月对参与者进行一次电话拜访，并在需要时进行家访。保留被定义为在入组后和疫苗接种后 6 个月完成最终评估。完全合规的定义是在疫苗接种之前和之后 6 个月以及按照方案接种疫苗后完成所有每月评估。逻辑回归用于识别与这些结果相关的人口特征。在 8626 名注册参与者中，7979 名 (92.5%) 人在注册后保留（立即接种组为 95.2%，延迟接种组为 89.8%）。总体而言，68.8% 的患者在入组后完全合规（立即组为 73.4%，延期组为 64.2%）。在 7979 名接种疫苗的参与者中，95.9% 的人在接种疫苗后 6 个月后仍保留，研究组之间没有显着差异。一线工人和年轻参与者最不可能被保留，并且完全遵守规定的可能性也较低。在资源匮乏的环境下，疫苗临床试验的参与者的高保留率是可以实现的，即使是那些被分配推迟接种疫苗的参与者也是如此。年轻的参与者和一线工作人员可能需要额外的后续策略和资源。
The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a phase 2/3 trial of an investigational Ebola vaccine, was implemented in April 2015 in Sierra Leone. Healthcare and Ebola frontline workers were randomized to immediate (within 7 days) or deferred (18-24 weeks) vaccination and observed from enrollment to 6 months postvaccination for safety and Ebola virus disease. There were concerns that high retention and compliance would be difficult to achieve, particularly for the deferred group. Trial staff conducted monthly calls to participants and home visits if needed. Retention was defined as completion of the final assessment at 6 months postenrollment and postvaccination. Full compliance was defined as completion of all monthly assessments before and 6 months after vaccination and vaccination per protocol. Logistic regression was used to identify demographic characteristics associated with these outcomes. Of 8626 participants enrolled, 7979 (92.5%) were retained postenrollment (95.2% in immediate vaccination arm, 89.8% in deferred arm). Overall, 68.8% were fully compliant postenrollment (73.4% in immediate arm, 64.2% in deferred arm). Among 7979 vaccinated participants, 95.9% were retained 6 months postvaccination, with no significant difference between study arms. Frontline workers and younger participants were least likely to be retained and had a lower likelihood of full compliance. High retention of participants in a vaccine clinical trial in a low-resource setting, even among those assigned to deferred vaccination, was achievable. Younger participants and frontline workers may require additional follow-up strategies and resources.