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临床试验/NCT06845774
NCT06845774Enrolling By Invitation不适用

Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia

Hilary L Surratt, PhD2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月25日最近更新:
干预措施

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

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

Active Comparator

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

Experimental

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

发起方
Hilary L Surratt, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hilary L Surratt, PhD

Professor

University of Kentucky

研究点 (2)

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