Using Short Message Service Reminders, Phone Calls and Mobile Money Incentives to Enhance Linkage to Care of Presumptive Tuberculosis Patients in Uganda: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,355
- 试验地点
- 5
- 主要终点
- Completion of TB diagnosis
研究概览
简要总结
The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients.
This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test. Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.
详细描述
The major challenge in meeting the WHO's End TB Strategy- reducing TB deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. Patients can be lost to follow-up after being identified as presumptive TB cases and never get to test for TB (pre-diagnosis LTFU) or those who test and are confirmed to have TB, can also be lost and never start TB treatment (pre-treatment LTFU). A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and ART. However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients.
This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test.
The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii) phone call only iv) SMS and MM incentive v) Phone call and MM incentive
Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants will not be blinded to the study arm though data analysis will be blindly conducted.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumptive TB patient (cough, fever, night sweats, weight loss)
- •Requested to have GeneXpert testing
- •Aged between 18 and 65 years
- •Current resident in the study districts
- •Willing to sign informed consent
- •Owning a mobile phone
- •Able to read
排除标准
- •Participant plans to move out of the study area in the next 3 months
- •Participation in another related study such as SMS, phone call or mobile money incentive and others
结局指标
主要结局
Completion of TB diagnosis
时间窗: 30 days (from being identified as presumptive TB patient)
This will include completing TB diagnosis using laboratory investigations (GeneXpert) 30 days after being identified as presumptive. This will also include the patient receiving results when ready.
Median time to completing TB diagnosis
时间窗: Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis
The time a participant took to complete diagnosis from when they were presumed for TB.
次要结局
- Median time to initiating treatment(Up to 30 days. Determined as Time from when the patient is confirmed to have TB to when they initiate TB treatment)
- Acceptability of the intervention(Through study completion, an average of two months)
- Initiation of TB treatment(30 days after being confirmed with TB)