Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- : To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM.
研究概览
简要总结
To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)
详细描述
The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV negative on any FDA approved HIV test within 10 days of starting PrEP 18 years and older
- •No medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator
- •Able to understand and sign consent in English or with other language interpreter
- •Able to stay in the state catchment area of the license health care provider
- •No use of PrEP for more than 30 days in the last year
排除标准
- •HIV positive
- •If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) <30 mg/g
- •<18 years of age
- •No access to Internet or devise for telehealth
- •Cis-gender Women
研究组 & 干预措施
Open Label Descovy
Descovy for PrEP
干预措施: Descovy (Drug)
结局指标
主要结局
: To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM.
时间窗: 18 months
Offer PrEP care via tele-health to reduce obstacles that clients have in coming to clinic.
次要结局
- To increase the number and proportion of individuals who are still taking PrEP and engaged in care at the end of 6 months by 30% and remain HIV negative including those who identify as Black and/or Latino MSM.(18 months)
- To assess the acceptability and implementation of the intervention by both patients and clinic staff.(18 months)
研究者
Cindy Firnhaber
Principal Investigator
Vivent Health