Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months
研究概览
简要总结
The importance of good nutrition and food security among people living with HIV infection (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is increasingly recognized as an important barrier to retention in care and adherence to antiretroviral therapy (ART). However, there are few studies demonstrating that food and nutrition assistance programs can improve HIV-related outcomes. This study will address this gap by comparing the effectiveness of three models for short-term support for PLHIV. Food insecure women and men on ART will be randomized into one of three groups: 1) nutrition assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash transfers. The investigators will compare the effect of the three approaches on ART adherence and retention in care after 6, 12, and 24-36 months of follow-up. The investigators hypothesize that NAC plus short-term support in the form of food or cash assistance will result in better adherence to ART and retention in care than NAC alone, and that the effects of NAC plus food assistance will be the same as NAC plus cash assistance. The results from the study will provide evidence about which assistance modalities for PLHIV work best to improve ART adherence and retention in care, and under what conditions. This study will be conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have poor or borderline food consumption and 7.4 percent of people are living with HIV infection.
详细描述
The investigators will randomize 785 food insecure women and men who recently initiated ART (determined with the Household Hunger Scale1) into one of three groups: 1) NAC alone , 2) NAC plus food assistance, or 3) NAC plus cash transfers. Food assistance will be a standard food ration consisting of maize flour, groundnuts, and beans. The cash transfer will be the equivalent value as the food ration (approximately $13 USD/month). Participants will receive the monthly food ration or cash transfer for up to six months if they continue to receive monthly HIV care (the standard of care). The investigators will compare the effect of NAC and food or cash assistance to the effect of NAC alone on ART adherence and retention in care at 6, 12, and 24-36 months (Objective #1). The investigators will also compare the effectiveness of NAC plus food assistance and NAC plus cash transfers to determine if their effects are the same (Objective #2).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age;
- •living with HIV infection;
- •initiated antiretroviral therapy (ART) for HIV infection in the last 90 days;
- •food insecure, as measured with the Household Hunger Scale; and
- •willing and able to provide written informed consent for the study.
排除标准
- •PLHIV who are severely malnourished (BMI<18.5) will be excluded from the study, as these individuals require therapeutic food support (ready-to-use food products for nutritional recovery). In this study, we will enroll food insecure PLHIV who are at risk of malnutrition but are not severely malnourished (BMI>18.5).
结局指标
主要结局
Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months
时间窗: Baseline, 6 months, 12 months
ART adherence will be measured with the medication possession ratio (MPR), the proportion of time an individual is in possession of \>1 ARV or prescription for ARV. MPR is computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval, and has been shown to be associated with short-term virologic outcomes. We will determine the proportion of patients with MPR ≥95% in each of the study arms.
次要结局
- Change from baseline in Food Security at 6 months and 12 months(Baseline, 6 months, 12 months)
- Change from baseline in Viral Suppression at 6 months and 12 months(Baseline, 6 months, 12 months)
- Change from baseline in Body Mass Index (BMI) at 6 months and 12 months(Baseline, 6, and 12 months)
- Change from baseline of Medication Possession Ratio (MPR) at 12-36 months(12-36 months)
- Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months(Baseline, 6 months, 12 months, and 24-36 months)
- Change from baseline in Weight at 6 months and 12 months(Baseline, 6 months, 12 months)
- Retention in Care at 12-36 months(12-36 months)
研究者
Sandra McCoy
Assistant Adjunct Professor
University of California, Berkeley