Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of participants with substance abuse
研究概览
简要总结
The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.
详细描述
There continues to be a gap in the extant literature on the relationship between substance abuse and achievement of viral suppression (VS) through adherent antiretroviral treatment (ART) or PrEP uptake among transgender women which warrants further investigation. Harmful alcohol and illicit drug use associated with substance use disorders (SUD) have been independently linked to condomless sex and hinder engagement in ending the HIV epidemic (EHE) prevention initiatives, including HIV retention in care and adherence to treatment to achieve viral suppression and PrEP use.
Transgender women are among the most at risk group of sexually active populations, yet least likely to be aware of and/or use preexposure prophylaxis (PrEP) to prevent HIV transmission.5 PrEP and routine HIV/STI screening, are effective approaches to reduce HIV incidence in marginalized at-risk populations and are consistent with the US National HIV/AIDS strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Male at birth
- •Identify as a woman/transgender woman
- •Should not be consistently using PrEP (less than four doses per week)
- •Should not have any known allergy or adverse reaction to PrEP or the active drug tenofovir in ART. One of the goals of the study is to move more people into a PrEP program
- •Be able to speak and understand spoken English and/or Spanish (including persons who cannot read or write)
- •Have a smart phone that can take pictures
排除标准
- •Unwilling to adhere to study procedures
- •Participation in an HIV vaccine trial
- •Have a life-threatening SUD*
- •Any condition, that in the opinion of the study staff, would make participation in the study unsafe, or interfere with achieving the study objective such as medical conditions which prevents the use of PrEP
- •Unable to provide consent
结局指标
主要结局
Number of participants with substance abuse
时间窗: 1 year
The rate of change of substance abuse incidence for both arms
次要结局
- Rate of substance use in transgender women(1 year)