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临床试验/NCT05656287
NCT05656287招募中不适用

My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and Medication Adherence in Rural Uganda

Mbarara University of Science and Technology1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2022年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
242
试验地点
1
主要终点
Medication adherence rates among patients

研究概览

简要总结

The goal of this clinical trial is to develop My Mobile Wallet- a behavioral and economic intervention to support tuberculosis treatment adherence in rural southwestern Uganda. The main question[s] it aims to answer are: • Determine the optimal design and develop My Mobile Wallet as an intervention to support tuberculosis medication adherence • Assess the initial feasibility and acceptability of using My Mobile Wallet to support tuberculosis medication. Participants will use My Mobile Wallet intervention for a period of six months. Researchers will compare My Mobile Wallet intervention versus standard care to see if there is an impact on tuberculosis medication adherence.

详细描述

Tuberculosis is a serious public health concern which kills more people annually than HIV and malaria combined. Worldwide, nearly 10 million people develop tuberculosis and nearly 2 million people die from tuberculosis annually. Low-income countries account for more than 90% of tuberculosis cases and deaths. Uganda faces a high burden of tuberculosis with a prevalence rate of 253 per 100,000 people and an incidence rate of 201 per 100,000 people. Additionally, tuberculosis is a leading cause of death among individuals living with HIV/AIDS.

Poor treatment adherence limits the success of tuberculosis treatment and increases tuberculosis transmission. The treatment success rate in Uganda stands at 75%, below the national target of 90%. Poor tuberculosis medication adherence can lead to treatment failure, development of drug-resistant TB, and secondary transmission. Importantly, treatment for multi-drug resistant (MDR) tuberculosis is difficult to tolerate, prolonged, and expensive.

Uganda currently spends US$105 (on transport refund and food incentives) per month on each MDR-TB patient from the time they are discharged (after the initial six months of hospitalization) until treatment completion (one year). This translates to a cost of $1,260 per patient for the 12 months of treatment. Currently, Uganda has about 16,000 MDR-TB patients. The My Mobile Wallet intervention supports treatment adherence, potentially preventing drug resistance, thereby relieving the country of the financial burden associated with MDR-TB treatment. Importantly, treatment for MDR-TB is difficult to tolerate, prolonged, and leads to productivity loss for patients and their caregivers, which negatively affects the economic development of the country.

Socio-economic determinants of health are a major driver of tuberculosis infection and non-adherence. Although tuberculosis treatment that works well has existed since the 1940s, many people delay seeking treatment, struggle with medication adherence, and/or do not complete their treatment because of behavioral and socio-economic factors. Preliminary data from the ongoing K43 (K43TW010388) study indicate that financial insecurity constrains medication adherence. Tuberculosis leads to the loss of productivity of patients and their caregivers, resulting in additional costs for patients (e.g., in form of transport to the clinic), and may lead to loss of employment for fear of spreading the disease to other people.

Moreover, having tuberculosis is associated with other negative socioeconomic consequences, such as divorce, school interruptions for children, and social exclusion, in addition to the hardship of deteriorating health. Currently in Uganda, 53% of tuberculosis patients take loans and/or sell property to meet the costs of their tuberculosis care. Two in every 10 people (21% of the population) live on $1.25 a day or less in Uganda, making saving for health difficult amidst other immediate competing interests. Because tuberculosis disproportionately affects the poorest in the population, its poverty-aggravating effects are felt more by those who are already vulnerable. Interventions are necessary to overcome the poverty-based structural barriers to tuberculosis treatment, including unconditional transportation to clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with TB per the clinic records (TB patients living with HIV will also be eligible)
  • Starting TB treatment now or been on TB treatment for <2 weeks
  • Owning a mobile phone
  • Aged 18 years and older
  • Live in Mbarara District
  • Willing to grow hair on the head and to allow a small thatch of it/hair (10-25 strands/0.02 ng/mg) to be cut at month 2 and 4 in the study
  • Willing and able to give consent.

排除标准

  • Unable to use mobile money-based SMS (train and test this skill at recruitment)
  • Severe mental condition limiting the ability to provide consent

结局指标

主要结局

Medication adherence rates among patients

时间窗: 6 months

Number of patients in the intervention arm with higher adherence as electronically ascertained by the Wisepill device

次要结局

  • TB treatment completion(6 months)
  • Mortality(6 months)
  • Cure rate(6 months)
  • Clinic Attendance(6 months)
  • Number of patients who used the intervention(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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