Maternal HIV Disclosure to School Children: RCT of Family-based Intervention (Amagugu)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Change in disclosure
研究概览
简要总结
The purpose of this trial is to test whether, compared to the normal Standard of Care at primary health care clinics, a home-based counseling intervention ( the 'Amagugu' Counseling Intervention), will increase the number of HIV-infected mothers who are able to disclose their own HIV status to their primary school-aged children. The investigators also wish to examine whether the intervention improves the quality of the maternal-child relationship, emotional and well-being of the child and social support.
详细描述
Research aim
The primary aim of this clinical trial is to test the efficacy of an intervention which aims to increase rates of maternal HIV disclosure to HIV-uninfected children aged 6-9 years.
Secondary aims include to improve:
- health promotion and custody planning for mothers and their children;
- maternal and child mental health;
- family functioning and the quality of mother-child relationship;
Hypothesis
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother tested HIV-positive at least 6 months prior to the enrolment date
- •Mother has initiated HIV treatment or is established in pre-ART care
- •Mother has an HIV-uninfected child aged 6-9 years resident in her home
- •Mother has not yet disclosed to this child or other children in the household under 9 years of age
- •Mother has the physical and mental capacity for participation as assessed by the Clinic Research Assistant and Department of Health Staff
排除标准
- •Mother received her HIV-positive result less than 6 months ago
- •Mother has not yet undergone or received results of her first CD4 test to confirm pre-ART status
- •Mother does not have an HIV-uninfected child or other children under the age of 9 years resident in the home
- •Mother has previously participated in the Amagugu intervention
- •Mother is resident in the home, but migrates for work on more than five consecutive days of each week
- •Mother is identified as psychotic or delusional based on the study staffs' judgement, or is unable to give signed informed consent
结局指标
主要结局
Change in disclosure
时间窗: Baseline, 3 months, 6 months and 9 month post baseline
Measures the proportion of HIV-infected women in the intervention and control arms who, within 3, 6 and 9-months disclose their HIV status to their 6-9 year old HIV-uninfected child.
次要结局
- Change in maternal anxiety scores(Baseline, 3 months, 6 months and 9 month post baseline)
- Change in quality of the parent-child relationship(Baseline, 3 months, 6 months and 9 month post baseline)
- Change in maternal depression scores(Baseline, 3 months, 6 months and 9 month post baseline)
- Change in the quality of family functioning(Baseline, 3 months, 6 months and 9 month post baseline)
- Change in health promotion(Baseline, 3 months, 6 months, 9 months post baseline)
- Change in custody planning(Baseline, 3 months, 6 months and 9 month post baseline)
- Change in child mental health scores(Baseline, 6 months and 9 month post baseline)