Nutritional Support to Improve Adherence and Treatment Completion Among HIV-Tuberculosis Co-infected Adults in Senegal, West Africa: A Randomized Pilot Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
研究概览
简要总结
Food insecurity can contribute to poor adherence to both tuberculosis treatment and antiretroviral therapy (ART). Interventions that target food insecurity have the potential to improve treatment adherence and decrease mortality. The goals of this study were to determine the cost, feasibility, acceptability, and potential impact of implementing nutritional support to improve adherence and treatment completion among HIV-TB co-infected adults in the Casamance region of Senegal, West Africa.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-Tuberculosis co-infection
- •Age ≥18 years
- •Initiating treatment for tuberculosis
- •Provide written informed consent
排除标准
- •Unwilling or unable to provide written informed consent
研究组 & 干预措施
Food basket
干预措施: Food basket (Dietary Supplement)
Ready-to-Use Therapeutic Food
干预措施: Ready-to-Use Therapeutic Food (Dietary Supplement)
结局指标
主要结局
Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
时间窗: 6 months
Acceptability, as determined by patient reported perceptions of nutritional support.
时间窗: 6 months
Costs of monthly nutritional support rations.
时间窗: 6 months
次要结局
- Adherence to antiretroviral therapy as determined by Medication Possession Ratio(6 months)
- Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks(6 months)
- CD4 cell count(6 months)
- Presence of acid fast bacteria using sputum smear microscopy(6 months)
- Results of GeneXpert(6 months)
- Nutritional status as determined by Body Mass Index(6 months)
- Nutritional status as determined by change in weight (kg)(6 months)
- Food security status measured using the Household Food Insecurity Access Scale (HFIAS)(6 months)
- Hemoglobin levels (g/dl)(6 months)
- Tuberculosis treatment adherence as determined by Medication Possession Ratio(6 months)
- Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.(6 months)
- Tuberculosis treatment completion defined as completing full course of prescribed therapy(6 months)
研究者
Noelle Benzekri
Principal Investigator
University of Washington