跳至主要内容
临床试验/NCT06171919
NCT06171919招募中不适用

Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions

University of Central Florida1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
HIV viral load using polymerase chain reaction (PCR)

研究概览

简要总结

The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.

详细描述

Formerly incarcerated individuals are impacted by health-harming legal needs and risks, including lack of access to HIV care, unsafe housing safety, unstable employment, and other issues that often disrupt HIV care. Providing access to legal services can address barriers to HIV care and improve HIV care continuum outcomes for formerly incarcerated individuals. The proposed study, led by the University of Central Florida (Hispanic Serving Institution), together with the University of Miami, and Hope and Help Inc., aims to pilot test a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to optimize timely HIV linkage, retention and viral suppression among formerly incarcerated individuals. MLPs have been used by social justice-oriented medical, health, social, and legal service practices to identify and address health-harming legal needs and risks that create barriers to treatment, care, and recovery for several health conditions. MLPs offer an integrated structural intervention that could improve HIV care continuum and psychosocial outcomes among formerly incarcerated individuals. Our CTI-MLP intervention package consists of: 1) training for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health-harming legal needs and risks impacting formerly incarcerated individuals, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) training for case managers and court advocate on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-locating legal services in health care agencies through MLP inter-organizational partnership; and 5) tailoring and implementing organizational best-practices in communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. In year 1, the investigators will engage a local community advisory board, scientific advisory board, and legal expert panel to finalize protocols and the Medical Legal Partnership Training Manual. In year 2, the investigators will implement the training and pilot test a CTI-MLP initiative with formerly incarcerated individuals living with HIV (n=100). Over a 6-month period, the team will collect (1) patients' health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life; (2) data on legal needs and risk factors; (3) patient HIV care clinical outcomes; and (4) clinic-level indicators, including provider-patient communication and readiness for continued implementation and sustainability. The study will be guided by Reach, Effectiveness, Adoption, Implementation, and Maintenance and Consolidated Framework for Implementation Research frameworks. Active engagement will ensure the effective translation and dissemination of our findings into practice. Completion this project will result in an innovative, evidence-based, community driven structural intervention to improve HIV care continuum outcomes among formerly incarcerated individuals.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Living with HIV (as confirmed by medical record)
  • HIV viral load of more than 200 copies/mL (as confirmed by medical record)
  • Report history of incarceration
  • Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
  • No intent to relocate within the 6 months following their enrollment in the study.

排除标准

  • Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study

研究组 & 干预措施

CTI-MLP approach

Experimental

To finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc.

干预措施: Organizational Partnerships (Other)

CTI-MLP assessment

Experimental

To assess the feasibility and acceptability of a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to improve HIV care continuum outcomes among formerly incarcerated individuals and determine the most efficient mechanisms for CTI-MLP delivery

干预措施: HIV Continuum Care (Other)

结局指标

主要结局

HIV viral load using polymerase chain reaction (PCR)

时间窗: 6 months

HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test

HIV linkage and retention and antiretroviral therapy adherence using surveys

时间窗: 6 months

次要结局

  • Quality of Life checklist(1 year)
  • Mental health indicators survey(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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