跳至主要内容
临床试验/NCT05640648
NCT05640648已完成不适用

Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

Yale University1 个研究点 分布在 1 个国家目标入组 10,477 人开始时间: 2022年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10,477
试验地点
1
主要终点
Completion of TB Evaluation

研究概览

简要总结

In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade. Drawing on prior experiences, the investigators have recently developed a novel strategy to enhance the implementation of routine contact investigation procedures. This user-centered implementation strategy was created through serial prototyping guided by human-centered design (HCD) and employs communities of practice (CoP) as an adjunctive adaptation and sustainment strategy. The investigators are now conducting a stepped-wedge, cluster-randomized implementation trial in 12 study sites in Uganda to determine if the resulting user-centered implementation strategy enhances the delivery of TB contact investigation and other implementation outcomes, and also improves health outcomes.

详细描述

The trial has 3 major aims: (1) to compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced, "user-centered" implementation strategy versus a standard implementation strategy in a stepped-wedge, cluster-randomized implementation trial; (2) to identify processes and contextual factors that influence the implementation, effectiveness, and public health impact of the enhanced delivery strategy for TB contact investigation; and (3) to compare the costs and epidemiological impact of the enhanced and standard implementation strategies for TB contact investigation. The enhanced, user-centered strategy will employ two major components: a) a branded, participant-centered strategy consisting of implementation facilitation tools previously developed using human-centered design; and b) Communities of Practice, a community-health worker-centered, continuous quality improvement strategy. The goal is to improve the delivery of standard TB contact investigation following Uganda National TB & Leprosy Programme guidelines. The investigators hypothesize that the enhanced, user-centered strategy will result in a greater proportion of close contacts completing TB evaluation than the standard strategy. They further hypothesize that successful implementation will be deemed feasible, acceptable, and appropriate by patients and CHWs and that it will increase self-efficacy and perceived social support among CHWs. Finally, the investigators hypothesize that models evaluating the impact of the user-centered strategy when delivered nationwide will find it cost-effective and able to reduce national TB incidence over a 10-year horizon.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding of the assigned intervention is not feasible with the stepped-wedge cluster randomized implementation trial design, because interventions are implemented at the health-facility level and all health facilities receive the standard strategy followed by the enhanced, user-centered strategy. Community Health Workers will collect all data, and adjudicate all outcomes, except TB diagnoses and treatments initiated which will be collected from on-site National TB and Leprosy Programme registers. Where possible, the investigators and study staff, except for the statistician and data manager, will be blinded to any aggregated analyses of TB outcomes by study period.

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Standard Implementation Strategy Period

Active Comparator

During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.

干预措施: Standard Implementation Strategy (Behavioral)

Enhanced Contact Investigation Intervention Period

Experimental

The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques and will be delivered as a branded package named for an inspirational Luganda phrase that is translated as "We are together with you." Implementation facilitation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.

干预措施: User-Centered Implementation Strategy (Behavioral)

结局指标

主要结局

Completion of TB Evaluation

时间窗: 60 days

The percentage of participants (close contacts) who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date

次要结局

  • TB Yield (Diagnosis and Treatment Initiation)(60 days)
  • Initiation of TB Preventative Therapy(60 days)
  • Number of Contacts Diagnosed With Active TB(60 days)
  • Number of Contacts Initiating TB Preventative Therapy(60 days)
  • TB Yield (All Contacts)(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验