Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PrEP Initiation
研究概览
简要总结
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. This study will integrate telehealth PrEP care within local health departments to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be at least 18 years of age
- •report at least one occasion of injection drug use in the past month
- •report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
- •be a documented client of the county health department-based SSP at the time of study entry
- •express willingness to participate in a multi-session intervention and follow-up
排除标准
- •HIV-positive status
- •current PrEP care.
研究组 & 干预措施
Standard of Care
One session standard of care (SOC) PrEP education (an in-use PrEP intervention based on CDC guidelines) with active referral to a local PrEP provider.
干预措施: CDC PrEP with active referral (Behavioral)
Integrated Telehealth Care
A multi-session PrEP education and intervention session that provides tailored PrEP education onsite combined with point-of-care PrEP testing and telehealth access to a PrEP provider.
干预措施: TelePrEP (Behavioral)
结局指标
主要结局
PrEP Initiation
时间窗: 6 months post-baseline
Number of participants initiating PrEP
PrEP Initiation
时间窗: 3 months post-baseline
Number of participants initiating PrEP
次要结局
- PrEP Persistence(6 months post-baseline)
- PrEP adherence(6 months post-baseline)
- PrEP Persistence(3 months post-baseline)
- PrEP adherence(3 months post-baseline)
研究者
Hilary L Surratt, PhD
Professor
University of Kentucky
