跳至主要内容
临床试验/NCT00996528
NCT00996528进行中(未招募)3 期

Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 1,239 人开始时间: 2007年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Jane Rotheram-Borus

Professor, Semel Institute and the Department of Psychiatry

University of California, Los Angeles

研究点 (1)

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