Improving Food Security and Nutrition to Promote ART Adherence in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- ART uptake and adherence
研究概览
简要总结
The purpose of this three-year study is to develop, implement, and pilot test a culturally appropriate, multi-component nutrition intervention for people living with HIV and food insecurity in Honduras, which is among the Latin America nations with the highest HIV prevalence rates. The investigators specific aims are to:
- Explore the relationships between food security, nutrition, and HIV treatment access, utilization, and adherence, and examine key mediators and moderators of these relationships.
- Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
- Evaluate the preliminary effectiveness of the intervention on (1) food security and nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects, and opportunistic infections).
- Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.
详细描述
The project will be conducted in two phases. Phase 1 involves qualitative, formative research methods to (1) gain understanding of availability and cost of the local foods and the regular diet, (2) evaluate the level of food security among people living with HIV, including intra-household food distribution patterns, and assess the nutritional status of HIV affected individuals, and (3) examine the role that food security and nutrition play in HIV treatment access, utilization and adherence. Phase 2 consists of developing and pilot-testing a multi-component nutrition intervention through a randomized, controlled trial conducted at 4 HIV clinics in Honduras, with two clinics randomly assigned to receive the intervention and two clinics to serve as the comparison group. Patients at each of the 4 sites will receive nutrition counseling, following the guidelines currently proposed by the World Health Organization (WHO) as the standard of care for HIV-infected individuals. In addition, clients at the intervention sites will receive food assistance in the form of a food-aid basket, designed ad hoc to address their macro and micronutrient needs.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered at the clinic
- •Age 18 or older
- •If not on ART, CD4 < 350*
- •Living in the area for the past year.
排除标准
- •Deterioration of clinical status such that requires diet or nutrition therapy
- •Cannot understand or speak Spanish
研究组 & 干预措施
Diet/nutrition counsel+food aid
Intervention. Patients enrolled in the intervention group will receive a multi-component intervention that includes dietary and nutritional counseling and food assistance (food aid basket)
干预措施: Diet/nutrition counsel+food aid (Behavioral)
dietary/nutritional counseling
Patients enrolled in the comparison arm will receive dietary and nutrition counseling designed to help them meet their nutrition needs, based on foods which are locally available, culturally acceptable and within their budget.
干预措施: Dietary/nutrition counsel (Other)
结局指标
主要结局
ART uptake and adherence
时间窗: Monthly during 12 of follow-up
Nutritional status
时间窗: Monthly during 12 months of follow-up
Nutritional status will be assess by anthropometry every month during follow-up
次要结局
- HIV clinical outcomes(At 6 and 12 months of follow-up)