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临床试验/NCT03304912
NCT03304912已完成不适用

Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs

Drexel University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年4月3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
105
试验地点
1
主要终点
PrEP Uptake at Week 1

研究概览

简要总结

Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.

详细描述

This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • HIV sero-negative
  • Age ≥18 years
  • Reporting non-prescription injection drug use and any of the following:
  • Syringe sharing
  • Injecting drugs with a HIV-positive partner
  • Recent opioid agonist treatment but still injecting drugs
  • Sex exchange
  • Inconsistent condom use
  • Recent bacterial sexually transmitted infection (STI)
  • and/or sex with a HIV-positive partner

排除标准

  • HIV seropositivity
  • Currently taking PrEP
  • Pregnant, breastfeeding or trying to become pregnant
  • Previous enrollment in the study

结局指标

主要结局

PrEP Uptake at Week 1

时间窗: 1 week

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

次要结局

  • PrEP Uptake at Week 12(12 weeks)
  • PrEP Uptake at Week 24(24 weeks)
  • PrEP Adherence Based on Urinalysis at 12 Weeks(12 weeks)
  • PrEP Adherence Based on Self-report at 12 Weeks(12 weeks)

研究者

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

Alexis Roth

Assistant Professor

Drexel University

研究点 (1)

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