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临床试验/NCT00972699
NCT00972699已完成2 期

Mentor Mothers: A Sustainable Family Intervention in South African Townships

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,200
试验地点
2
主要终点
Baby's health status

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 Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH.

详细描述

South Africa's HIV/AIDS epidemic, one of the worst in the world, has shown little evidence of decline and is indicative of the urgent need to focus on both preventative and treatment intervention efforts (UNAIDS, 2006). In South Africa, close to one in three women who attend public antenatal clinics are living with HIV (UNAIDS, 2006). In KwaZulu-Natal (KZN) - one of the worst affected provinces - as many as 40% to 60% of pregnant women attending antenatal services are living with HIV (Rochat et al., 2006; Kharsany et al., 2004).

HIV infection in pregnant women raises a number of issues that are not faced by HIV-infected men or non pregnant women (Ojikutu & Stone, 2005) and has particular implications for the successful prevention of mother-to-child transmission (Raisler & Cohn, 2005). Most women learn their HIV status for the first time during antenatal testing, which can be distressing and may introduce or further compound psychological, social and health risks in the antenatal and post natal period (Firn & Norman, 1995; Patel V, Rahman A, Jacob KS, & Hughes M, 2004; Patel, DeSouza, & Rodrigues, 2003; Rochat et al., 2006; Shisana et al., 2005; Stein et al., 2005). Research on the uptake of treatment for HIV indicates that poor mental health and a lack of social support are associated with lowered uptake of HAART (Cook et al., 2006), lowered adherence to anti-retroviral medication (Ammassari, Trotta, Murri, & et al., 2002; DiMatteo, Lepper, & Croghan, 2000; Ickovics et al., 2001; Starace et al., 2002)and increased disease progression (Ickovics et al., 2001).

Fortunately, HIV testing and access to antiretroviral drugs (ARV) to prevent mother-to-child transmission (PMTCT) from HIV positive pregnant women to their babies are currently being scaled up in South Africa (Civil Society HIV and AIDS Congress, 2005; Department of Health, 2005). While the potential exists to cut transmission to babies from mothers living with HIV(MLH), maternal HIV disease has been demonstrated to have negative consequences on maternal mental health and social support and children's emotional, social and developmental outcomes and adjustment - both as a result of chronic HIV illness and as a result of the psychological and social burden of HIV on care giving (Stein et al., 2005; Krebs, Stein, & Rochat, 2005; Stein et al., 2005; Sherr, 2005; Dunn, 2005; Hough, Brumitt, Templin, Saltz, & Mood, 2003).

While PMTCT programs provide the opportunity for women to prevent transmission through medical and feeding interventions, the needs of mothers living with HIV extend well beyond this. The psychosocial challenges facing mothers living with HIV are substantial and, if children are to have positive outcomes, it is necessary to provide mothers living with HIV with the support, skills and knowledge to protect and promote their own health and well-being, that of their babies, and, hopefully, their partners (Rochat et al., 2006; Stein et al., 2005; 2006).

The goal of this randomized trial then is to test an intervention to improve the health and well-being of HIV positive mothers and their babies during pregnancy and the early postpartum period through the implementation of a clinic-based mentor mothers' peer support program(also referred to as Project Masihambisane) and dissemination of health information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • 18 years or older, pregnant, and HIV+
  • Enrolled in the PMTCT program at the study site clinic
  • Receiving medical care from study site clinic
  • Residing in study area for duration of study
  • No psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
  • Ability to give informed consent as judged by an interviewer

排除标准

  • Less than 18 years, or not pregnant, or not HIV+
  • Not enrolled in the PMTCT program at the study site clinic
  • Not receiving medical care from study site clinic
  • Not residing in study area for duration of study
  • Psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
  • Clinical provider (nurse or physician) believes it is not in the best interest of the MLH
  • Unable to give informed consent

结局指标

主要结局

Baby's health status

时间窗: 6 days after birth; 6 months after birth; 12 months after birth

次要结局

  • Maternal adherence: baby's and mother's health.(6 days after birth; 6 months after birth; 12 months after birth)

研究者

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

Mary Jane Rotheram-Borus

Principal Investigator

University of California, Los Angeles

研究点 (2)

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