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临床试验/NCT03569592
NCT03569592已完成不适用

Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS

Drexel University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1月22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
120
试验地点
2
主要终点
Overdose attitudes

研究概览

简要总结

The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations.

The research has the following aims:

  • Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated;
  • Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and
  • Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.

详细描述

The goal of this research is to establish best practices to address overdose risk in people exiting incarceration, people living with HIV/AIDS (PLWHA), and both populations simultaneously. This contribution is important because this evidence has applications for correctional facilities and HIV clinical practice throughout the United States. The contributions of the proposed pilot study are: to provide evidence on the effectiveness of a targeted intervention on these two high-risk groups, generate exploratory data on predictors of overdose risk specific to HIV status and recent incarceration, and provide context about overdose risk and responses to witnessed overdoses in the first month after release.

In this study, incarcerated PLWHA in the Philadelphia Department of Prisons will be offered overdose training while incarcerated and naloxone (Narcan) at release. Study participants will be given a pre-test on overdose knowledge and attitudes and receive the overdose prevention intervention. Those who are still incarcerated one month later will receive a post-test on overdose knowledge and attitudes. Approximately one month after study participants are released from jail, they will be given a one-month follow-up survey that assesses: overdose knowledge and attitudes (post-test 2), information on personal or witnessed overdoses since release, health and post-incarceration related information, and characteristics of drug use since release. Approximately 20 study participants will participate in a semi-structured interview 4-6 weeks after their release on their experiences with the overdose prevention 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

  • HIV-positive
  • Age 18 and over
  • Speaks English
  • plans to live in Philadelphia area after release

排除标准

  • More than 10 months remaining on a sentence or release date unknown

结局指标

主要结局

Overdose attitudes

时间窗: time of training until one month after release from jail

The scale is adapted from the Opioid Overdose Attitudes Scale (OOAS). OOAS subscales measure overdose response competence (10 items), concerns (8 items), \& readiness (10 items). Likert scale options include "Completely Agree", "Agree", "Unsure", "Disagree", and "Completely Disagree" with a score of 1 to 5 assigned to each item. The total score range on the initial measure is summed from the subscales from 28-140 points (1-50 points on subscale competence, 1-40 points on subscale concerns, and 1-50 points on subscale readiness), with higher scores indicating favorable attitudes. The adapted scale also assesses: overdose response competence (4 questions), concerns (3 questions), and readiness (4 questions). Scoring is identical to the full scale, with possible subscales scores ranging from 1-20 for overdose competence, 1-15 for concerns about responding to an overdose, and 1-20 for readiness to respond to an overdose. Scores are summed for a total score range of 11-55. Higher scores in

Overdose knowledge

时间窗: time of training until one month after release from jail

The scale is adapted from the Opioid Overdose Knowledge Scale (OOKS). OOKS subscales measure overdose risks, signs, actions to take in a witnessed overdose, \& naloxone use. It has 4 multiple choice questions, 4 forced-choice questions, and 6 true/false statements. Each correct answer is 1 point and incorrect answers are 0. Subscale ranges are 0-9 for overdose risks, 0-10 for signs, 0-11 for actions to take in a witnessed overdose, and 0-15 for naloxone use. The total score range is summed from subscale scores from 0 to 45, with higher scores indicating greater knowledge. The adapted scale assesses the same domains and consists of 4 multiple choice questions, 1 forced-choice question, and 6 true/false statements. Each correct answer is 1 point and incorrect answers are 0. Subscale ranges are 0-5 for overdose risks, 0-4 for overdose signs, 0-5 for overdose actions, and 0-6 for naloxone use. Scores are summed for a total number of 20 points, with higher scores indicating greater knowled

次要结局

  • Witnessed overdoses(1 month (release from jail until one month after release))
  • Status of naloxone kit(one month after release from jail)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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