T'Cher, Take Charge: Increasing PrEP Awareness, Uptake and Adherence Through Health Care Empowerment and Addressing Social Determinants of Health Among Racially Diverse Trans Women in the Deep South
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CrescentCare
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- PrEP uptake
研究概览
简要总结
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
详细描述
The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Declaration of willingness to comply with all study procedures and availability during the study
- •Age 18 years old or older
- •Male sex designated at birth
- •Identify as trans woman, woman or another gender identity not associated with being a man
- •Desire to use or re-start PrEP
- •HIV uninfected
- •Speaks English or Spanish
- •Live in the New Orleans metropolitan statistical area (which includes 8 parishes)
排除标准
- •Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
- •Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
- •Concurrent or planned enrollment in a research study that provides PrEP
- •Unwilling to attend quarterly follow-up visits, which will include survey participation
- •Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
结局指标
主要结局
PrEP uptake
时间窗: 24 months
The proportion of participants enrolled in the study who begin to take PrEP
Social determinant stressors
时间窗: 24 months
The proportion of participants enrolled in the study who address social determinant stressors
Health care empowerment
时间窗: 24 months
The proportion of participants enrolled in the study who report improved healthcare empowerment
次要结局
- Patterns and correlates of PrEP adherence(24 months)
研究者
Narquis Barak
Principal Investigator
CrescentCare