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临床试验/NCT03651453
NCT03651453已完成不适用

Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings

Yale University2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年10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
164
试验地点
2
主要终点
PrEP Uptake

研究概览

简要总结

To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.

详细描述

To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

A controlled un-blinded pilot study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).

排除标准

  • Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent

结局指标

主要结局

PrEP Uptake

时间窗: 12 months

PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.

次要结局

  • Changes in PrEP receptiveness(12 months)
  • PrEP Adherence by Self Report(12 months)
  • Changes in HIV risk behaviors(12 months)
  • PrEP Adherence by Pharmacy Refill(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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