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临床试验/NCT03248778
NCT03248778已完成不适用

Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China

Yale University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
readiness to disclose

研究概览

简要总结

Specific aims of the 1-year project are to pilot test the disclosure support intervention by (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10 HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence, social support, and disclosure stress, efficacy, readiness, and completion). The intervention will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention (4 weeks), and 12-week follow-up (16 weeks) assessments.

详细描述

HIV disclosure to children has been shown to strengthen family relations and increase assistance with medical care, reinforcing the parent's willingness to live. Some Chinese children aware of their parents HIV diagnosis do exhibit emotional and social dysfunction; however, adequate support from caregivers (e.g., grandparents or even their HIV+ parents) can improve the children's quality of life and academic performance. There is a clear need for practical interventions to address parental distress around HIV disclosure in China, where cultural norms often emphasize family identity and cohesion and underscore the need for family-based programs, which have been shown to be feasible and efficacious for HIV-affected families.

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
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

  • HIV+ mother ≥18 years of age,
  • not psychotic or demented;
  • receiving clinical care at the Ditan hospital,
  • a mother of an HIV-negative child of age 13-25 years who does not know about the mother's infection;
  • well enough to attend study sessions as the clinic.

排除标准

  • no psychotic or demented

研究组 & 干预措施

disclosure-support counseling

Experimental

干预措施: disclosure-support counseling intervention (Behavioral)

Treatment as Usual

No Intervention

结局指标

主要结局

readiness to disclose

时间窗: 16 weeks

This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire

次要结局

  • quality of life via Medical Outcomes Study HIV Health Survey(16 weeks)
  • depression via the Center for Epidemiologic Studies Depression Scale (CES-D)(16 weeks)
  • adherence(16 weeks)
  • social support using the HIV Social Support tool(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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