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临床试验/NCT03049332
NCT03049332已完成不适用

Self- and Family-management Intervention in HIV+ Chinese Women

Yale University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
retention rates

研究概览

简要总结

This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.

详细描述

The study will be conducted in 3 phases.

Phase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.

Phase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.

Phase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Inclusion criteria for HIV+ women.
  • be at least 18 years of age,
  • be able to give informed consent for the study and to cognitively participate,
  • be receiving clinical care at Ditan Hospital and SPHCC,
  • have been diagnosed with HIV within the past 12 months,
  • have disclosed their status to at least one family member and willing to invite that family member to the intervention,
  • be well enough to attend counseling sessions at the hospital, and
  • be able to attend follow-up visits at the hospital.
  • Inclusion criteria for family members.
  • be 18 years of age,
  • be able to give informed consent for the study and to cognitively participate,
  • have a female family member who is HIV+, and is currently receiving clinical care at Ditan Hospital and SPHCC,
  • be a family member who are taking care of the female HIV+ family member,
  • be well enough to attend counseling sessions at the hospital, and
  • be able to attend follow-up visits at the hospital.

排除标准

  • Exclusion criteria for HIV+ women
  • history of an affective illness such as depression or bipolar disease,
  • are under age 18, or
  • are unwilling or unable to bring a family member to participate in the study.
  • Exclusion criteria for family members.
  • have a history of an affective illness such as depression or bipolar disease,
  • are under age 18,
  • or are unwilling or unable to come with their HIV+ family member to participate the study.

结局指标

主要结局

retention rates

时间窗: 6 months

the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member

compliance with data collection procedures

时间窗: 6 months

includes attending counseling sessions and completing questionnaires

acceptability

时间窗: 6 months

including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview

feelings of safety

时间窗: 6 months

family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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