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Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis.利福喷丁四个月方案联合或不联合莫西沙星治疗结核病。
N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.
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Towards early inclusion of children in tuberculosis drugs trials: a consensus statement.关于儿童尽早纳入结核病药物试验的共识声明。
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青少年参与结核病临床试验的促进因素和障碍

Facilitators and barriers to adolescent participation in a TB clinical trial.

作者信息

Mangan J M, Hedges K N C, Salerno M M, Tatum K, Bouwkamp B, Frick M W, McKenna L, Muzanyi G, Engle M, Coetzee J, Yvetot J, Elskamp M, Lamunu D, Tizora M E Theunissen, Namutamba D, Chaisson R E, Swindells S, Nahid P, Dorman S E, Kurbatova E

机构信息

Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.

Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, New York, NY.

出版信息

Int J Tuberc Lung Dis. 2024 May 1;28(5):243-248. doi: 10.5588/ijtld.23.0519.

DOI:10.5588/ijtld.23.0519
PMID:38659142
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11500608/
Abstract

BACKGROUNDThe inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.METHODSInterviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.RESULTSInvestigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.CONCLUSIONProactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial..

摘要

背景将青少年纳入结核病药物试验对于开发安全、适合儿童的结核病预防和治疗方案至关重要。结核病试验联盟研究31/艾滋病临床试验组A5349（S31/A5349）招募了年仅12岁的青少年。我们评估了研究者和协调员所描述的青少年招募、入组和留用的促进因素和障碍。方法对来自招募青少年参与者的研究点的6名研究者和来自未招募研究点的6名研究者进行了访谈。此外，对来自招募研究点的研究协调员进行了2个焦点小组访谈，对来自未招募研究点的研究协调员进行了2个焦点小组访谈。讨论内容被转录、分析、总结，总结内容由社区研究顾问组成员和研究小组代表进行审查以确保内容效度。结果研究者和协调员将青少年的成功入组归因于外部伙伴关系的建立和培养、灵活适应青少年日程安排、工作人员的参与、从多个地点进行招募、有专门的招募工作人员在现场接触潜在参与者、营造对青少年友好的环境以及有效的沟通。未招募研究点主要受到法规的阻碍。对未来试验改进的建议集中在研究规划和研究点准备方面。结论与服务青少年的机构建立积极的伙伴关系和开展合作有助于识别并减少将他们纳入本试验的障碍。

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