Food Incentives for TB Treatment Compliance in East Timor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- proportion of patients who successfully complete TB treatment and achieve cure.
研究概览
简要总结
This study will examine whether food is a cost-effective method for improving treatment compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally available, locally acceptable, cheap and highly nutritious food at the clinic will encourage patients to come for daily directly observed treatment, and thus improve the chance of TB cure and decrease the chance of the development of TB drug resistance. Primary outcome will be successful completion of treatment and secondary outcomes will include treatment compliance and clinical and biological measures of nutritional improvement.
详细描述
We propose to conduct a randomised controlled trial of a food intervention to improve compliance in East Timor. Patients will be diagnosed in the usual way and given the opportunity to enrol in the study. Consenting individuals will be randomised to receive the intervention (meal at the clinic daily during the first two months of treatment and a food parcel fortnightly during the other six months of treatment) or standard care (nutritional advice only). The primary outcome will be TB cure rates and the secondary outcomes will include response to treatment (weight gain, decreased symptoms, sputum clearance) and percentage of days attended at the clinic. In conjunction with this study of TB treatment compliance we will collect blood samples to measure micro-nutrient changes in response to the food intervention. A cost-effectiveness analysis of the intervention will also be performed.
We plan to do a pilot study in three urban clinics in Dili to establish feasibility and provide pilot data for other funding applications so that, if the intervention does improve compliance, and funding applications are successful, we can expand the project to include rural districts in conjunction with the National TB Control Program. Ultimately, the health outcome addressed by this project is improved control of tuberculosis in a high burden, low income setting. Better compliance with tuberculosis treatment at the community level will contribute to this process.
TRIAL OBJECTIVES AND PURPOSES
The specific objectives of the project are:
- Design a locally appropriate food intervention to improve adherence to TB treatment and TB treatment outcomes in East Timor; and
- Conduct a study of the intervention in three clinics in Dili. If this pilot study is successful, we will use our experience and pilot data to obtain funds to generalise the intervention to rural clinics as well.
- Food incentives are an achievable, effective method of encouraging full adherence to DOTS and thus improved cure rates in East Timor;
- Locally available, whole food supplements are a cost-effective intervention to improve cure rates in East Timor; and
- Lessons learned in East Timor are adaptable to other settings in other parts of the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older;
- •Have sputum smear positive or sputum smear negative pulmonary or extrapulmonary TB, using the standard NTP definitions for these diagnoses;
- •Have never received more that one month of anti-tuberculosis treatment in the past (that is, only new cases of TB will be included).
- •Agree to continue treatment at the clinic of diagnosis for the full eight month course of treatment.
- •Not pregnant.
- •Agree to enrol in the study.
排除标准
- •Children less than 18 years of age,
- •TB patients who have previously received treatment for TB for more than one month,
- •Not willing to continue treatment at the clinic for the full course.
- •TB Patient who are currently pregnant,
- •TB patients who are not willing to enrol in the study.
结局指标
主要结局
proportion of patients who successfully complete TB treatment and achieve cure.
次要结局
- proportion of clinic visits compared with expected
- response to treatment measures: symptoms (cough, sputum, fever);
- changes in weight;sputum clearance;
- micronutrient measurements.