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临床试验/NCT05912842
NCT05912842招募中1 期

Forging Sustainable Solutions for HIV Continuity of Care Through Medical-legal Partnerships

Temple University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
200
试验地点
2
主要终点
Viral Suppression

研究概览

简要总结

The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment.

详细描述

A health-harming legal need is a social problem that adversely affects a person's health or access to health care and which is better remedied through the combination of legal care and health care. Medical legal partnerships (MLPs) have been underutilized as structural interventions; however, they could help improve HIV care continuum outcomes in health care organizations. The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment. Two health care organizations serving PLWH Philadelphia, PA that do not currently provide any form of legal services to their patients will participate in this trial (n=200 PLWH). The proposed study is in response to PA-20-141: Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional). It is also responsive to two of the areas of high priority research of NIMH Division of AIDS Research (Develop and test interventions to improve HIV treatment outcomes; Advance the development and testing of interventions delivered beyond the individual level). Completion of this project will result in the development of an intervention package to optimize HIV services for a highly vulnerable population whose HIV care is affected by health-harming legal needs.

研究设计

研究类型
Interventional
分配方式
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

  • Living with HIV (as confirmed by medical record)
  • 18 years or older
  • HIV viral load of more than 200 copies/mL (as confirmed by medical record)
  • 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

结局指标

主要结局

Viral Suppression

时间窗: 6 months

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

次要结局

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10(6 months)
  • Engagement in HIV Care(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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