Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia
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
- 是
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
In this arm, the participants will receive standard of care based on the national TB and TB/HIV guidelines.
Digital health intervention
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
Gistane Ayele
Principal Investigator
Arba Minch University
