青少年参与结核病临床试验的促进因素和障碍。

IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES International Journal of Tuberculosis and Lung Disease Pub Date : 2024-05-01 DOI:10.5588/ijtld.23.0519
J M Mangan, K N C Hedges, M M Salerno, K Tatum, B Bouwkamp, M W Frick, L McKenna, G Muzanyi, M Engle, J Coetzee, J Yvetot, M Elskamp, D Lamunu, M E Theunissen Tizora, D Namutamba, R E Chaisson, S Swindells, P Nahid, S E Dorman, E Kurbatova
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引用次数: 0

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。结核病试验联盟第 31 项研究/艾滋病临床试验组 A5349(S31/A5349)招募了年仅 12 岁的青少年。我们对研究者和协调者描述的青少年招募、入组和保留的促进因素和障碍进行了评估。方法对招募了青少年参与者的研究机构的六名研究者和未招募青少年参与者的研究机构的六名研究者进行了访谈。此外,还与来自注册机构的研究协调员和来自非注册机构的研究协调员分别进行了两次焦点小组讨论。研究人员和协调人员将青少年的成功注册归功于外部合作伙伴关系的建立和培养、适应青少年日程安排的灵活性、员工的参与、从多个地点进行招募、专职招募人员在现场工作以接触潜在参与者、创造对青少年友好的环境以及有效的沟通。非招募地点主要受到规章制度的限制。对未来试验的改进建议主要集中在研究规划和试验场地的准备工作上。
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Facilitators and barriers to adolescent participation in a TB clinical trial.

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..

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来源期刊
CiteScore
4.90
自引率
20.00%
发文量
266
审稿时长
2 months
期刊介绍: The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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