跳至主要内容
临床试验/NCT05343169
NCT05343169进行中(未招募)不适用

Evaluation of a Community-based Education, Navigation, and Support (CENS) Intervention to Reduce Opioid-related Harms Among Military Veterans

New York University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Change in Opioid Overdose Risk Behaviors Scale

研究概览

简要总结

Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health diagnoses than their "service-connected" counterparts. Due to these vulnerabilities and the observed barriers to testing and treatment among veterans-especially substance- and mental health-related stigma, drug naiveté, and limited support networks-veterans who use opioids represent a critical target for interventions designed to mitigate overdose and HIV/HCV risk behaviors. For socially isolated veterans and veterans with limited access to healthcare, programs that work outside of formal healthcare institutions and agencies are desperately needed. This application proposes to achieve the following Aims: 1) Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors; 2) Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., mental health, pain/OUD severity, age) intervention effectiveness; and 3) Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. The proposed intervention will be delivered by veteran peer outreach workers. The study will recruit 300 veterans with opioid use disorder to participate in a randomized controlled trial. The CENS intervention will engage 150 participants in ongoing educational sessions, healthcare and treatment navigation, and social support (involving both one-on-one and group social integration protocols) designed to improve self-efficacy, reduce self-stigma, increase service and healthcare utilization, and bolster knowledge. This study stands to contribute a timely, culturally-tailored innovation to overdose and HIV/HCV prevention-as-usual that, informed by the theory of triadic influence, directly confronts the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.

详细描述

The U.S. remains in a public health crisis involving opioid-related morbidity and mortality,1 and military veterans have been disproportionately impacted. Among veterans who use VA hospitals, the prevalence of OD deaths from non-synthetic opioids roughly doubled between 2001 and 2009, and deaths among this population have continued to rise dramatically, showing a 65 percent increase from 2010 to 2016 alone. This trend is grounded in high rates of concurrent prescription opioid (PO) and benzodiazepine use, but transitions from POs to heroin9 have been a recent driver of OD mortality and the disproportionately high HIV and HCV infection rates among veterans.1 Additionally, much of the scientific knowledge about health risks among veterans who use opioids (VWUO) comes from VA samples, which represent less than half of all military veterans. Veterans who do not have VA access or choose not to use it, include many of those most historically disadvantaged and at greatest risk of opioid-related harm. Rates of 'other than honorable' discharges for active duty personnel with alcohol or substance use issues have increased, excluding them from VA care and resulting in underestimates of opioid-related harms among the broader veteran population. For example, the prevalence of HCV infection-driven primarily by injection drug use-has been estimated at 11-18% among veterans who utilize the VA but up to 45% among the sizable population of homeless veterans, most of whom do not. Irrespective of benefit status, many veterans with substance and alcohol use disorders avoid substance use treatment, healthcare, and supported social services, such as opioid agonist therapy, housing and employment assistance, syringe service programs, mental health treatment, and HIV/HCV testing and treatment. Social isolation and a sense of alienation from civilian society have long represented important barriers to working with veteran populations and highlight the need for targeted, culturally sensitive interventions that reach at-risk veterans in community settings.

This application proposes to address this need by evaluating a community-based peer intervention for veterans with opioid use disorder that aims to reduce risk behaviors for opioid-related overdose and HIV/HCV infection. The use of peer-based outreach is designed to reach veteran subpopulations experiencing homelessness, mental health challenges, and significant barriers to healthcare access. Specifically, the intervention to be evaluated will overcome barriers at the three different levels underpinning the theory of triadic influence. Intrapersonal-level barriers for veterans include mental health problems (including PTSD, depression, suicidal ideation), chronic pain, low self-efficacy for behavior change and service involvement, competing priorities related to poverty and homelessness, and distrust of medical systems. Social/interpersonal-level barriers include social isolation, fears of treatment-related stigma (related to military culture), including concerns about the potential impact of seeking treatment on career progression and difficulties interacting with civilians. Last, sociocultural and structural-level barriers, include threats to future career progression represented by a mental health or OUD diagnosis and insufficient education to navigate complex health systems.

The intervention draws on the work of the study team and its experience implementing peer-delivered overdose prevention. This application presents a randomized control trial protocol for assessing a 9-month peer-based intervention employing dedicated veteran specialists to deliver each of the intervention components-education, healthcare/service navigation and social support. These components are all designed to facilitate decreased opioid-related HIV/HCV and OD risk behaviors at the end of the 9-month exposure. The study's specific aims are as follows:

Aim 1: Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors (OD/HIV/HCV). The team will use targeted, venue-based sampling to recruit a total of 300 veterans with opioid use disorder. Participants will be randomly assigned (150 each arm) to the 9-month CENS intervention or a 9-month standard naloxone-plus-referrals control and assessed at baseline and at 3-, 6- and 9-months post-baseline, then again at 15-months post-baseline to assess durability of effects. Effectiveness will be measured by treatment and supportive social service utilization and self-reported change in opioid OD52 and HIV/HCV57 risk behaviors.

Aim 2: Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., treatment experiences, pain and OUD severity, gender, age) intervention effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Veteran status
  • Adult (18+) age
  • Current nonmedical use of opioids
  • Current clinical (DSM-5) opioid use disorder of any level of severity

排除标准

  • Unable to speak English
  • Unable to provide informed consent.

研究组 & 干预措施

CENS Intervention

Experimental

Peer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention

干预措施: Overdose Education and Naloxone Distribution (Behavioral)

CENS Intervention

Experimental

Peer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention

干预措施: Advanced Education in Safer Substance Use, Treatment, and Self-Care (Behavioral)

CENS Intervention

Experimental

Peer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention

干预措施: Social Service and Health Navigation (Behavioral)

CENS Intervention

Experimental

Peer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention

干预措施: Peer Social Support (Behavioral)

Control

Other

Participants will receive Overdose Education and Naloxone and referrals to treatment

干预措施: Overdose Education and Naloxone Distribution (Behavioral)

结局指标

主要结局

Change in Opioid Overdose Risk Behaviors Scale

时间窗: 9 months follow-up assesment

Change in Overdose Risk Behavior Scale score, from baseline to 9 months. Min Score= 0 Max Score = 660 Higher scores indicate more engagement in overdose risk behaviors

Change in HIV/HCV Risk Behaviors

时间窗: 9 months follow-up assessment

Change in HIV/HCV risk behaviors as measured by the National HIV Behavioral Surveillance System questions about unsafe sexual and injection risk, from baseline to 9 month follow up.

次要结局

  • HIV/HCV Testing(9 months follow-up assessment)
  • Health service utilization(9 months follow-up assessment)
  • Drug Treatment(9 months follow-up assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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