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临床试验/NCT04263441
NCT04263441已完成不适用

Navigating Insurance Coverage Expansion (NICE): A Collaboration to Increase Access to Care for Black and Hispanic Men Who Have Sex With Men and Transgender Persons

University of Chicago6 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2018年10月18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
630
试验地点
6
主要终点
Delayed Linkage

研究概览

简要总结

The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care, referrals to other HIV-associated health services, and health outcomes. The study population is Black and Hispanic men who have sex with men (MSM) and transgender persons who are at higher risk for HIV.

The study team will be testing the hypotheses that in-person health insurance enrollment assistance results in positive outcomes with regard to linkage to and retention in HIV-related health care. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

详细描述

The overall goal of this study is to test whether providing in-person assistance in enrolling in private health insurance or Medicaid for the first time, changing to a different insurance plan, or understanding how to use current insurance policies following HIV testing will (1) increase the proportion of participants who obtain health insurance; (2) result in better health outcomes among participants; (3) improve the linkage and retention rates of participants, especially those diagnosed with HIV; and (4) increase linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Black or Hispanic men who have sex with men (MSM) or transgender persons
  • 18 or older

排除标准

  • Cisgender women
  • Cisgender men who have not had anal or oral sex with a man in last 2 years

结局指标

主要结局

Delayed Linkage

时间窗: 90 days

Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed

Linkage

时间窗: 30 days

Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed

Retention

时间窗: 365 days

Proportion of HIV positive participants who completed at least 2 HIV-related medical visits within 12 months after their baseline HIV test was performed. Visits must be separated by at least 3 months.

Early Retention

时间窗: 183 days

Proportion of HIV negative participants who completed at least 2 medical visits within 6 months after their baseline HIV test was performed, regardless of whether they enrolled in PrEP.

次要结局

  • Retention(365 Days)
  • Enrolled in Insurance(At study enrollment)
  • Changed Insurance(At study enrollment)
  • Viral Suppression(365 days)
  • Maintained Status(365 days)
  • Linkage(365 Days)
  • Viral Load Reduction(91 days)
  • Medicaid Enrollment(At study enrollment)
  • Private Insurance Enrollment(At study enrollment)
  • Market place enrollment(At study enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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