Effective Aids Treatment and Support in the Free State (FEATS): Adherence and Nutritional Support for Effective and Sustainable Antiretroviral Treatment in Resource Constrained Settings
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 648
- 试验地点
- 12
- 主要终点
- CD4 count
研究概览
简要总结
The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups:
- Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme.
- Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter
- Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.
详细描述
The study has three main objectives, each with a set of more specific aims:
Objective 1: Present a broader view of treatment success
In order to achieve this objective, the study aims to:
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts labour productivity and time allocation of patients and other household members
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts household welfare
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts educational and health outcomes for children in households with patients on antiretroviral treatment
Objective 2: Develop a model of the determinants of treatment success
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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-positive
- •Eligible for public sector ARV treatment (CD4<200 and/or WHO stage 4)
- •Commenced ARV treatment in past 4 weeks
- •Patient resident in town/village where ART clinic located
排除标准
- •HIV-negative
- •Not eligible for public sector ARV treatment
- •Had not commenced ARV treatment
- •Commenced ARV treatment longer than one month ago
- •Patient not resident in town/village where ART clinic
研究组 & 干预措施
2
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group
干预措施: ARV peer adherence support (PAS) (Behavioral)
1
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment only group
干预措施: ARV treatment (Drug)
2
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group
干预措施: ARV treatment (Drug)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
干预措施: ARV peer adherence support (PAS) (Behavioral)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
干预措施: Nutritional support (Dietary Supplement)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
干预措施: ARV treatment (Drug)
结局指标
主要结局
CD4 count
时间窗: 6-monthly
RNA viral load
时间窗: 6-monthly
Haemoglobin
时间窗: 6-monthly
self-reported adherence (CASE index)
时间窗: 6-monthly
health-related quality of life (EQ-5D/EQ-VAS)
时间窗: 6-monthly
anthropometrics
时间窗: monthly to 6-monthly
food security (USDA scales)
时间窗: 6-monthly
time allocation/physical activity levels
时间窗: 6-monthly
household welfare
时间窗: 6-monthly
次要结局
- mental health (HADS/MHI scales)(6-monthly)
- labour force participation(6-monthly)
- employment status(6-monthly)
- self-reported sexual behaviour(6-monthly)
- school attendance/performance(6-monthly)