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临床试验/NCT06068283
NCT06068283尚未招募不适用

LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
LOTUS Feasibility

研究概览

简要总结

The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.

详细描述

The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people who use drugs. LOTUS provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people who use drugs face, and critical need for HIV prevention mHealth interventions tailored to the unique needs of this population, the current study seeks to accomplish the following aim. The primary aim is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention in a single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use measures will be collected at baseline, 3-, and 6-months to assess LOTUS feasibility, acceptability, and preliminary impact. The investigators hypothesize that participants in the LOTUS intervention will find the intervention to be feasible and usable, and that they will demonstrate significant improvements in HIV prevention service use at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (n = 20) to gain feedback on the intervention characteristics, as defined by the Consolidated Framework for Implementation Research, and to elicit suggestions for improvement in anticipation of a future large-scale randomized controlled trial.

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
Female
接受健康志愿者

入选标准

  • 18 years of age or older
  • Report weekly or daily use of opioids and/or stimulants in the past 6 months
  • Meet current CDC eligibility criteria for PrEP
  • Report low levels of HIV prevention service engagement in the past 6 months
  • Not currently, or planning on becoming, pregnant during the study
  • Owns a smartphone with internet web-browsing capabilities

排除标准

  • 17 years of age or younger
  • Does not report weekly or daily use of opioids and/or stimulants in the past 6 months
  • Does not meet current CDC eligibility criteria for PrEP
  • Report high levels of HIV prevention service engagement in the past 6 months
  • Currently, or planning on becoming, pregnant during the study
  • Does not own a smartphone with internet web-browsing capabilities

研究组 & 干预措施

LOTUS Intervention Arm

Experimental

A mobile, WebApp-based platform to access the LOTUS intervention content.

干预措施: LOTUS mHealth Intervention Group (Behavioral)

结局指标

主要结局

LOTUS Feasibility

时间窗: 6 months

The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.

HIV Prevention Service Engagement

时间窗: 6 months

The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP

LOTUS Acceptability

时间窗: 6 months

The acceptability of the LOTUS mHealth intervention will be measured via the System Usability Scale (SUS), with possible scores ranging from 10-50 and higher scores indicating higher acceptability.

次要结局

  • Stigma(6 months)
  • Attitudes and Perceptions(6 months)

研究者

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

Stephanie Meyers

Assistant Professor

University of California, San Diego

研究点 (2)

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