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临床试验/NCT03600103
NCT03600103已完成不适用

Technology Based Community Health Nursing to Improve cART Adherence and Virologic Suppression in Youth Living With HIV (TECH-N 2 CHECK-IN): A Regional Multi-site Study

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年7月11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
76
试验地点
4
主要终点
Viral suppression

研究概览

简要总结

Human immunodeficiency virus (HIV) infection has disproportionately persisted as a public health threat to adolescents and young adults (AYA) from minority communities in the United States. HIV has evolved into a chronic disease, which can be managed in the outpatient setting with antiretroviral therapy (ART) designed to achieve virologic suppression and life expectancy equivalent for uninfected individuals. Community health nurse (CHN) interventions have been shown to increase access to appropriate resources, enhance health care utilization, and promote risk-reducing behavior among AYA. Use of short messaging service (SMS) messaging can further enhance clinical care by improving attendance at medical visits, medication adherence, and communication with the health care team.Investigators have used these two modalities in randomized trials of youth with complex sexually transmitted infections (STIs) in low-income minority communities with high feasibility and acceptability amongst AYA and families, remarkable improvements in visit completion, medication adherence, and reduction in recurrent STIs. The overarching goal of this project is to build on the evidence from this trial and to re-purpose the intervention for Young people living with HIV (YLHIV) in the same community who are having challenges with care and medication non-adherence.Investigators aim to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care control group using a randomized trial design. The central hypothesis is that the intervention will result in higher rates of adherence to ART and virologic suppression. Investigators have demonstrated investigators' interdisciplinary team's capacity to follow urban AYA in the community, utilizing the combination of CHNs and outreach workers to optimize care according to national standards. TECH2CHECK aims to enroll 120 YLHIV followed at clinics specializing in HIV care in the Baltimore-Washington Metropolitan area and Jacksonville, Florida who are challenged with treatment adherence and randomizing participants to receive TECH2CHECK vs. standard of care. Results of this trial will inform best practices for engaging YLHIV by addressing the distal component of the continuum, critical to achieving the elusive 90-90-90 HIV goals.

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
Single (Investigator)

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants should be aged 12-25 years old diagnosed with HIV
  • Eligible for ART, VL>20 copies/ml
  • English speaking (>95% current clinic population)
  • Aware of their HIV status
  • Permanently reside in the Baltimore/Washington Metropolitan area or Jacksonville, Florida
  • Willing to sign informed consent (including allowing communication with the participant's primary care provider). Informed consent includes being willing to complete study procedures; including randomization and community-based follow-up by our team.

排除标准

  • Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair effective participation
  • Severe illness requiring hospitalization at the time of enrollment. This will be assessed at the team meetings designed to generate referrals.

结局指标

主要结局

Viral suppression

时间窗: 18 months

Viral suppression will be assessed by measuring plasma HIV-1 RNA (copies/mL). Viral suppression is defined as a viral load \<20 copies/mL.

次要结局

  • Adherence to care as assessed by patient visits(18 months)
  • Adherence to care as assessed by HRSA retention measure(18 months)
  • Management Cost difference(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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