在非洲首次肺炎球菌人类感染研究中用于招募健康志愿者的招募策略：来自马拉维布兰太尔的经验教训。
Recruitment strategies used to enrol healthy volunteers in the first pneumococcal human infection study in Africa: Lessons from Blantyre, Malawi.
作者信息
Nsomba Edna, Chirwa Anthony E, Ngoliwa Clara, Nkhoma Vitumbiko, Liwonde Pemphero, Mangani Edward, Reuben Modesta, Chimgoneko Lorensio, Makhaza Lumbani, Kudowa Evaristar, Henrion Marc Y R, Toto Neema, Gordon Stephen B, Dula Dingase
机构信息
Clinical and Experimental Medicine, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Southern Region, P.O. Box 30096, Malawi.
Department of Medicine, Queen Elizabeth Central Hospital, Blantyre, Southern Region, P.O. Box 95, Malawi.
出版信息
Wellcome Open Res. 2025 Feb 26;9:216. doi: 10.12688/wellcomeopenres.19271.2. eCollection 2024.
BACKGROUND
Human Infection Studies (HIS) also known as Controlled Human Infection Models (CHIM) are a relatively new concept in African countries to clinicians, scientists, and communities alike. We have introduced HIS/CHIM studies to Malawi during the last four years by developing an experimental human pneumococcal carriage model. This CHIM was used to test the efficacy of a licensed 13-valent Pneumococcal Conjugate Vaccine (PCV13) against experimental nasal pneumococcal carriage. Traditional and digital recruitment strategies into this novel trial were explored.
OBJECTIVES
To describe various methods of recruitment in this first CHIM study in Malawi.
METHODS
The clinical trial within the context of which these data were recorded was registered with the Pan African Clinical Trials Registry (REF: PACTR202008503507113) on 03 August 2020. The project was conducted at the Malawi Liverpool Wellcome Programme (MLW) in Blantyre, Malawi between April 2021, and September 2022. Source populations were college students and community members within Blantyre. Recruitment strategies included sharing study information in written or visual form, community sensitization meetings, snowball contacts (word of mouth from previous volunteers), branded clothing and participating in radio and television programs.
RESULTS
299 volunteers attended screening clinic, of whom 278 were recruited. Sixty-six recruited volunteers (23.7%) were college students and 212 (76.3%) were from the community. Snowball word-of-mouth contacting was the most successful recruitment strategy, with 201 (72.3%) participants recruited using this method. 195 (70.1%) were men of whom 149 (76.4%) joined the study through snowballing.
CONCLUSION OR RECOMMENDATION
Using a variety of recruitment strategies led to successful recruitment in this novel controlled human infection study. Most participants were recruited through snowballing.
背景
人体感染研究（HIS），也被称为受控人体感染模型（CHIM），对于非洲国家的临床医生、科学家和社区来说，是一个相对较新的概念。在过去四年里，我们通过建立一个实验性人体肺炎球菌携带模型，将人体感染研究/受控人体感染模型研究引入了马拉维。这个受控人体感染模型被用于测试一种已获许可的13价肺炎球菌结合疫苗（PCV13）预防实验性鼻腔肺炎球菌携带的效果。我们探索了将传统和数字招募策略应用于这项新试验的方法。
目的
描述马拉维第一项受控人体感染模型研究中的各种招募方法。
方法
记录这些数据的临床试验于2020年8月3日在泛非临床试验注册中心注册（注册号：PACTR202008503507113）。该项目于2021年4月至2022年9月在马拉维布兰太尔的马拉维利物浦惠康计划（MLW）开展。目标人群是布兰太尔的大学生和社区成员。招募策略包括以书面或视觉形式分享研究信息、社区宣传会议、滚雪球式联系（由之前的志愿者口口相传）、品牌服装以及参与广播和电视节目。
结果
299名志愿者前往筛查诊所，其中278人被招募。66名被招募的志愿者（23.7%）是大学生，212人（76.3%）来自社区。滚雪球式口口相传是最成功的招募策略，有201名（72.3%）参与者通过这种方法被招募。195名（70.1%）是男性，其中149名（76.4%）通过滚雪球式方法参与了研究。
结论或建议
在这项新型受控人体感染研究中，使用多种招募策略实现了成功招募。大多数参与者是通过滚雪球式方法招募的。
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