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临床试验/NCT03226873
NCT03226873已完成不适用

Assessing the Feasibility and Acceptability of a Peer Outreach and Navigation Intervention to Increase Pre-exposure Prophylaxis Uptake Among Women at High Risk for HIV

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
PrEP prescription filled

研究概览

简要总结

This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.

详细描述

Women who engage in exchange sex (i.e., sex in exchange for money, drugs, or other services) remain are at substantial risk for HIV infection. (1-6) Due to a confluence of social and structural factors, exchange sex is relatively prevalent among women from socially and economically marginalized groups, such as women who are transgender, unstably housed/homeless and/or those who use and/or inject drugs. (1-3, 19-23) The overarching goal of this research is to decrease new HIV infections among women who engage in exchange sex. Daily oral HIV pre-exposure prophylaxis (PrEP) is an innovative method of HIV prevention that women, themselves, can control; as such, PrEP has the potential to reduce the risk of HIV acquisition among women who engage in exchange sex. Therefore, the investigators developed a theory-guided behavioral intervention (PrEP-UP) which utilizes street-based peer outreach and navigation to increase access to PrEP and promote PrEP uptake among women involved in exchange sex. Specifically, PrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP care visits. The objective of this study is to assess the feasibility and acceptability of PrEP-UP. To implement PrEP-UP, the investigators will collaborate with an established community-based organization (CBO) in East Harlem, NY, which uses street-based peer outreach and navigation to connect individuals to needed health and social services. Medical and pharmacy records will be reviewed to assess PrEP initiation. The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk behaviors, perceived HIV risk, and PrEP-related knowledge, attitudes, and self-efficacy to assess for temporal changes in these variables. Additionally, individual interviews will be conducted post-intervention with a subset of the women as well as the CBO staff and leadership to access acceptability of the 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

  • ≥18 years old
  • fluent in English
  • self-identifies as female or male-to-female transgender (or on the spectrum)
  • Exclusion Criteria
  • Incapable of providing informed consent (i.e., acutely intoxication, active psychosis, etc.)

排除标准

  • 未提供

研究组 & 干预措施

Peer Navigation

Experimental

PrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP visits.

干预措施: Peer Navigation (Behavioral)

结局指标

主要结局

PrEP prescription filled

时间窗: 4-12 weeks

Obtained from medical and/or pharmacy records

次要结局

  • HIV risk behaviors(week 0, 4-12)
  • HIV risk perception(week 0, 4-12)
  • Interest in PrEP(week 0)
  • PrEP appointment scheduled(week 0-12)
  • PrEP appointment acceptance(week 0)
  • PrEP appointment attendance(week 0-12)
  • PrEP-related knowledge(week 0, 4-12)
  • PrEP-related attitudes(week 0, 4-12)
  • PrEP-related self-efficacy(week 0, 4-12)

研究者

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

Brianna Norton

Assistant Professor of Medicine (GIM)

Montefiore Medical Center

研究点 (1)

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