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临床试验/NCT06810973
NCT06810973Enrolling By Invitation不适用

Substance Use and HIV Action for Reentry and Engagement.

Emory University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Linkage to ART

研究概览

简要总结

This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.

详细描述

The goal of this jail-based study is to test an intervention aimed at helping individuals with substance use disorder (SUD) who have HIV or are at high risk of contracting HIV maintain medications for managing or preventing HIV when transitioning back to the community. Approximately 75% of individuals in jail have SUD and a subset of this group either has HIV or is at risk of seroconversion. People living with HIV require antiretroviral medications to suppress the virus to non-infectious levels, but these medications are often discontinued during the chaotic period following release from jail. Those at risk of HIV can also take antiretroviral therapy as a preventive measure to lower the risk of seroconversion.

Preliminary data suggest that SUCCESS-E, a strengths-based case management and peer navigation program developed via a pilot grant, can help connect individuals to medical care upon release to ensure continued drug therapy. A manual for delivering SUCCESS-E was previously developed to guide case managers and peer navigators.

In this phase, 100 eligible individuals will be enrolled from the Fulton County Jail (FCJ). Participants will be randomly assigned to one of two groups: SUCCESS-E intervention or controls receiving an enhanced version of the jail's discharge planning services.

Data will be collected through medical chart reviews, baseline and follow-up surveys with participants (each taking less than an hour), and single-visit interviews with approximately 30 stakeholders (jail staff, community advocates, and individuals post-program). These key informant interviews will typically last less than an hour and will be recorded for qualitative analysis. Data will also be collected to estimate the cost of delivering the intervention.

The project will apply implementation science to introduce innovations in case management for transitioning individuals from jail back to the community. The case management intervention will be delivered to individuals with HIV or those at high risk of seroconversion, both in jail and post-release. If proven effective, this strategy could help reduce the incidence of new HIV cases by maintaining viral suppression in individuals with HIV and ensuring that those at risk for HIV seroconversion remain on preventive therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •for Participants:
  • •Cis- and transgender men and women
  • •Able to understand and give informed consent
  • •Willing to participate in study activities
  • •People with HIV (PWH) or people at high risk of seroconversion (PHRS)
  • •History of SUD, defined as a score of 2 or more items in the past year on the Justice Community Opioid Innovation Network (JCOIN) SUD assessment tool
  • •Resident of study jail and agree to participate in the SUCCESS-E program, or released from study jail within six weeks, and agree to participate in the SUCCESS-E program
  • •Inclusion Criteria for Participants in R61 KIIs:
  • •Participant who completed the intervention or
  • •A jail administrator/staff member
  • •Able to give informed consent
  • •Willing to participate in study activities

排除标准

  • •Uncontrolled serious mental illness or moderate to severe intellectual impairment, and/or cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)
  • •Admission to a prison facility (Federal or state)

研究组 & 干预措施

SUCCESS-E

Experimental

Participants with SUD, living with HIV or at high risk for seroconversion, will be placed in strength-based case management, delivered by a case manager and peer navigators, both in jail and in the community, leading to linkage and retention in healthcare and SUD treatment.

干预措施: SUCCESS-E (Behavioral)

Control Group

Other

Participants not placed in the intervention group will have healthcare services inform them of possible medical homes for HIV/PrEP care and a list of referral sites for follow-up SUD care.

干预措施: Enhanced Standard of Care (Behavioral)

Key informant interviews (KII)

Other

Jail staff and community members willing to participate in Key Informant Interviews (KIIs)

干预措施: Key Informant Interviews (Behavioral)

结局指标

主要结局

Linkage to ART

时间窗: 3 months

Linkage to ART care for individuals with lived experience of HIV or PrEP for PHRS.

Program Retention

时间窗: 3 months

Program Retention at 3 months

次要结局

未报告次要终点

研究者

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

Anne C Spaulding

Associate Professor

Emory University

研究点 (1)

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