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临床试验/NCT03584282
NCT03584282已完成不适用

Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

University of Washington2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年7月11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
21
试验地点
2
主要终点
Acceptability of Text Messaging

研究概览

简要总结

Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.

详细描述

Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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
是

入选标准

  • •Meets the clinic's eligibility criteria for PrEP
  • •18 years of age or older
  • •HIV-negative
  • •Cisgender man or individual on the trans gender variant spectrum who has sex with men
  • •Ability to understand, read, and speak English
  • •Reports meth use in the past 3 months
  • •Has a cell phone able to send and receive text messages

排除标准

  • •PrEP use in the prior month,
  • •Discomfort or anxiety with regards to text messaging.
  • •Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.

研究组 & 干预措施

Standard of Care

No Intervention

Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions.

Text Messaging

Active Comparator

Participants in this group will receive the text messaging intervention.

干预措施: Text Messaging (Behavioral)

Peer Navigation

Active Comparator

Participants in this group will receive the peer navigator intervention.

干预措施: Peer Navigation (Behavioral)

Text Messaging and Peer Navigation

Active Comparator

Participants in this group will receive both the text messaging and peer navigation interventions.

干预措施: Text Messaging (Behavioral)

Text Messaging and Peer Navigation

Active Comparator

Participants in this group will receive both the text messaging and peer navigation interventions.

干预措施: Peer Navigation (Behavioral)

结局指标

主要结局

Acceptability of Text Messaging

时间窗: 6 months

Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.

Acceptability of Peer Navigation

时间窗: 6 months

Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.

次要结局

  • PrEP Persistence(6 months)
  • PrEP Adherence(6 months)

研究者

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

Joanne Stekler, MD MPH

Associate Professor, School of Medicine: Allergy and Infectious Diseases

University of Washington

研究点 (2)

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