跳至主要内容
临床试验/NCT03281343
NCT03281343进行中(未招募)不适用

Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
Rates of linkage to community-based PrEP care

研究概览

简要总结

Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. This study aims to improve linkage to community-based PrEP care to reduce HIV acquisition in a high-need, underserved community.

详细描述

Incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention.

To date, very little research has been done to improve linkage to PrEP care among US women. The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote PrEP initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based PrEP care upon release from incarceration. The long-term goal of this line of research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women post-release from incarceration. The present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (RCT) of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets CDC indications for PrEP; likely to be incarcerated for less than 6 months; able to understand and speak English and to provide written and verbal informed consent

排除标准

  • 未提供

结局指标

主要结局

Rates of linkage to community-based PrEP care

时间窗: 3 Months post-release

Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.

次要结局

  • PrEP Adherence(3 Months and 6 Months post-release)
  • Alcohol and Drug Use(6-months)
  • PrEP Care Retention(3 Month clinical appointments (+/- 1 month))
  • Depressive Symptoms(6-months)
  • HIV Risk Behavior(6-months)
  • Treatment Received and Medications/Pregnancies(6-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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