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临床试验/NCT07313995
NCT07313995招募中不适用

Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia

Arba Minch University2 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2026年5月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
304
试验地点
2
主要终点
TB preventive therapy initiation

研究概览

简要总结

Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population. Specifically, tuberculosis in children and newly diagnosed TB cases show there is current transmission of TB; to reduce this transmission and to attain the end TB strategy, preventing household TB transmission plays a great role. However, initiation and completion of TB preventive therapy (TPT) among close contacts of index TB patients are suboptimal. Some of the identified factors of low TPT initiation and completion are insufficient patient education, inadequate understanding of TPT, health professionals' perception, parental knowledge, and belief. The digital health intervention is currently being studied as a suggested health intervention that improves the utilization of health care services, including treatment adherence. A systematic review shows that TB treatment outcomes improved with the use of patient education, counseling, text reminders, and digital health technologies. However, other literature indicates controversial results, including our systematic review result, which identified that video directly observed therapy and text message (digital intervention) have no significant effect on TPT completion. In addition, the studies are scarce; therefore, this study aims to assess the effect of video-based education intervention combined with text message reminder (digital health intervention) in improving the initiation and completion of TPT among close contacts of drug-sensitive pulmonary TB patients in South Ethiopia.

The study hypothesizes that digital health intervention for close contacts of index drug-sensitive pulmonary TB patients will lead to higher TPT initiation and completion rates than standard care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All household and close contacts of drug-sensitive pulmonary TB patients
  • Living in the catchment area of the selected health facility
  • Willing to stay for at least 4 months in the catchment area

排除标准

  • Individuals with a known allergy to TPT drugs or those contraindicated for TPT drugs
  • Close contacts screened as symptomatic for TB
  • Close contacts with drug-resistant TB
  • Temporary residents staying for less than 4 months

研究组 & 干预措施

Control

No Intervention

In this arm, the participants will receive standard of care based on the national TB and TB/HIV guidelines.

Digital health intervention

Experimental

In this arm, the participants will receive standard care and a digital health intervention, which is video-based health education through a mobile phone.

干预措施: Digital health intervention (Behavioral)

结局指标

主要结局

TB preventive therapy initiation

时间窗: It will be up to 3 months.

The primary outcome of this study will be the number of close contacts to index TB patients who initiated TPT (mean change of TPT initiation from the baseline)

TB preventive therapy completion

时间窗: It will be up to 4 months.

The second primary outcome of this study will be the number of close contacts to index TB patients who completed TPT (the mean change of TPT completion in relation to baseline data)

次要结局

  • TB prevalence(within 4 months)
  • Contact investigations(12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gistane Ayele

Principal Investigator

Arba Minch University

研究点 (2)

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