在喀麦隆和乌干达评估一项针对家庭中结核病儿童接触者管理的社区干预措施的随机临床试验的可行性。
Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda.
作者信息
Vasiliu Anca, Tiendrebeogo Georges, Awolu Muhamed Mbunka, Akatukwasa Cecilia, Tchakounte Boris Youngui, Ssekyanzi Bob, Tchounga Boris Kevin, Atwine Daniel, Casenghi Martina, Bonnet Maryline
机构信息
University of Montpellier, IRD, INSERM, TransVIHMI, Montpellier, France.
Elizabeth Glaser Pediatric AIDS Foundation, Yaoundé, Cameroon.
出版信息
Pilot Feasibility Stud. 2022 Feb 11;8(1):39. doi: 10.1186/s40814-022-00996-3.
BACKGROUND
One of the main barriers of the management of household tuberculosis child contacts is the necessity for parents to bring healthy children to the facility. We assessed the feasibility of a community intervention for tuberculosis (TB) household child contact management and the conditions for its evaluation in a cluster randomized controlled trial in Cameroon and Uganda.
METHODS
We assessed three dimensions of feasibility using a mixed method approach: (1) recruitment capability using retrospective aggregated data from facility registers; (2) acceptability of the intervention using focus group discussions with TB patients and in-depth interviews with healthcare providers and community leaders; and (3) adaptation, integration, and resources of the intervention in existing TB services using a survey and discussions with stakeholders.
RESULTS
Reaching the sample size is feasible in all clusters in 15 months with the condition of regrouping 2 facilities in the same cluster in Uganda due to decentralization of TB services. Community health worker (CHW) selection and training and simplified tools for contact screening, tolerability, and adherence of preventive therapy were key elements for the implementation of the community intervention. Healthcare providers and patients found the intervention of child contact investigations and TB preventive treatment management in the household acceptable in both countries due to its benefits (competing priorities, transport cost) as compared to facility-based management. TB stigma was present, but not a barrier for the community intervention. Visit schedule and team conduct were identified as key facilitators for the intervention.
CONCLUSIONS
This study shows that evaluating a community intervention for TB child contact management in a cluster randomized trial is feasible in Cameroon and Uganda.
TRIAL REGISTRATION
Clini calTr ials. gov NCT03832023 . Registered on February 6 2019.
背景
家庭结核病儿童接触者管理的主要障碍之一是家长需要带健康儿童前往医疗机构。我们在喀麦隆和乌干达的一项整群随机对照试验中，评估了社区干预措施用于结核病家庭儿童接触者管理的可行性及其评估条件。
方法
我们采用混合方法评估了可行性的三个方面：（1）利用医疗机构登记册中的回顾性汇总数据评估招募能力；（2）通过与结核病患者进行焦点小组讨论以及对医疗服务提供者和社区领袖进行深入访谈来评估干预措施的可接受性；（3）通过调查以及与利益相关者的讨论，评估干预措施在现有结核病服务中的适应性、整合情况和资源需求。
结果
由于结核病服务的分散化，在乌干达将同一集群中的2个医疗机构重新组合的情况下，在15个月内达到所有集群的样本量是可行的。社区卫生工作者的选拔与培训以及用于接触者筛查、预防性治疗耐受性和依从性的简化工具是实施社区干预的关键要素。由于与基于医疗机构的管理相比，该干预措施具有益处（相互竞争的优先事项、交通成本），两国的医疗服务提供者和患者都认为家庭中的儿童接触者调查和结核病预防性治疗管理干预措施是可接受的。存在结核病污名，但不是社区干预的障碍。访视时间表和团队行为被确定为干预措施的关键促进因素。
结论
本研究表明，在喀麦隆和乌干达，在整群随机试验中评估社区干预措施用于结核病儿童接触者管理是可行的。
试验注册
ClinicalTrials.gov NCT03832023。于2019年2月6日注册。
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