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临床试验/NCT04193787
NCT04193787已完成不适用

Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members

University of Connecticut2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Retention Rate

研究概览

简要总结

This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):

  • To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID.
  • To determine the preliminary efficacy of the EPIC-P intervention in terms of increasing adherence to PrEP and primary HIV prevention among high-risk PWID.

详细描述

A non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk people who inject drugs (PWID) with opioid dependence (N=100). Since the aim of this pilot study is to establish whether the EPIC-P intervention is feasible/acceptable among at-risk PWID in a community-based setting, proposed is a non-comparative design. With the hopes to target PWID who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (RDS), a chain referral method with demonstrated success in recruiting hard-to-reach populations. Initial RDS participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. Participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. Importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the EPIC-P intervention.

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
All
接受健康志愿者

入选标准

  • Residing in the Greater New Haven area;
  • Confirmed HIV-negative;
  • Reporting injection drug use (past 3 months) with substantial ongoing risk for HIV acquisition;
  • Started on PrEP (within the last week).

排除标准

  • Not on PrEP;
  • Not available during the full duration of the study;
  • Cannot speak English;
  • Unable to provide consent;
  • Anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.

结局指标

主要结局

Retention Rate

时间窗: Up to 6 months

To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.

次要结局

  • PrEP Adherence VAS(Up to 6 months)
  • PrEP Adherence DBS(Up to 6 months)
  • PrEP Adherence Pharmacy(Up to 6 months)
  • Acceptability(Up to 6 months)
  • HIV Incidence(Up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roman Shrestha

Assistant Professor

University of Connecticut

研究点 (2)

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