Improving Participation in AMC Clinical Trials (IMPACTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 14
- 主要终点
- Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
研究概览
简要总结
This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
详细描述
PRIMARY OBJECTIVES:
I. To identify participant-level factors affecting recruitment of potentially eligible participants in AIDS Malignancy Clinical Trials Consortium (AMC) studies at core and affiliated sites.
SECONDARY OBJECTIVES:
I. To describe the socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites.
II. To characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected participants
- •Cancer or anal dysplasia diagnosis
- •Offered informed consent on an AMC interventional clinical trial
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Inability to provide informed consent
结局指标
主要结局
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
时间窗: Up to 2 weeks
The proportion of individuals who are screened and agree to enroll in a clinical trial will be estimated with the binomial proportion and its 95% confidence interval.
次要结局
- Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites(Up to 2 weeks)
- Means by which volunteers are referred to a particular study(Up to 2 weeks)
- Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial(Up to 2 weeks)
- Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial(Up to 2 weeks)