Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire
研究概览
简要总结
To identify the most important barriers and facilitators to the participation of cisgender women living with HIV in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.
The investigators expect to propose pragmatic solutions to enhance participation of HIV-positive cisgender women in clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Cisgender women
- •Adult (>18 years) HIV-infected
- •Informed consent documented by signature
- •Patients under stable antiretroviral therapy
- •French speaking (sufficient fluency for a conversation)
排除标准
- •Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
- •Incapable of discernment
结局指标
主要结局
Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire
时间窗: through study completion, an average of 1 year
Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to the participation of women in clinical trials.
Evaluation of mechanisms leading to refusal of trial participation through a questionnaire
时间窗: through study completion, an average of 1 year
Specific questions will be asked during a face-to-face interview to understand mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.
次要结局
- Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study(through study completion, an average of 1 year)
研究者
Calmy Alexandra
Professor
University Hospital, Geneva