Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 入组人数
- 1,239
- 试验地点
- 1
- 主要终点
- Social support
研究概览
简要总结
The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.
详细描述
There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Furthermore, while clinics are the typical sites for treating each of these health problems, this proposal will examine a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention will encourage mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman and their children
- •Age 18 or older
- •Informed consent
排除标准
- •Psychosis, neurological damage, inability to communicate with interviewer
- •Inability to give consent
结局指标
主要结局
Social support
时间窗: 18 months
Children's peer relationships at seven and a half years
Maternal adherence to HIV-related and general health routines
时间窗: 18 months
Maternal alcohol use on the AUDIT
HIV-related transmission acts
时间窗: 18 months
Maternal HIV transmission acts
Baby's health status
时间窗: 18 months
Children's behavioral and cognitive adjustment and school achievement
Mental health
时间窗: 18 months
Maternal Depression on the Edinburgh Postnatal Depression Scale (EPDS)
次要结局
未报告次要终点
研究者
Mary Jane Rotheram-Borus
Professor, Semel Institute and the Department of Psychiatry
University of California, Los Angeles
