Self- and Family-management Intervention in HIV+ Chinese Women
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
- acceptability
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
- 否
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.
研究组 & 干预措施
All participants
HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.
干预措施: self- and family-management intervention sessions (Behavioral)
结局指标
主要结局
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
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
次要结局
未报告次要终点