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临床试验/NCT02785302
NCT02785302已完成不适用

CATCH: Comprehensive Assessment of Transition and Coordination for HIV-Positive Youth as They Move From Adolescent to Adult Care

University of North Carolina, Chapel Hill14 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
14
主要终点
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)

研究概览

简要总结

This is a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. To achieve this goal, the transition process is characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff.

详细描述

The changes associated with transition to adult clinical care may increase the likelihood that an adolescent will drop out of care, which results in poorer outcomes. Disengagement from care has implications for health. Disruption in medication can increase viral load (VL), and intensify the potential for co-morbidities and transmission efficiency . Thus, successful transition to adult care is especially important for HIV-positive adolescents (compared to other chronic diseases) as they will need to maintain clinic visits and medication adherence across their lifespan to remain healthy and maintain a low VL to reduce the potential for transmission in the context of other developmental and psychosocial changes and challenges. The ultimate goal of this study is to represent the key places - youth, adolescent clinic and adult clinic - where transition interventions could be targeted and to collect data to capture the key elements and modifiable variables at each level. This study will contribute to existing research by providing transition research on HIV, which differs from other congenital or acquired chronic conditions due to it being an infectious disease; by prospectively following youth as they transition; and by providing transition research from the perspective of receiving adult clinics. It will also illustrate how each level- youth, adolescent clinic and adult clinic - is situated within a specific context and how these levels interact to affect transition outcomes.

This is a multi-method, longitudinal design research study. Subjects must be enrolled in ATN 125 at the time of the ATN 135 baseline visit. There will be no randomization procedures. During the 39-week study, surveys will be administered to adolescents and young adults transitioning to adult care via Audio Computer Assisted Self Interviews (ACASIs), which will collect data on individual (e.g., psychosocial and behavioral) and clinical factors affecting transition at 0 and 39 weeks. Demographic, biomedical, antiretroviral therapy (ART) and healthcare utilization visit information collected through ATN 125 medical chart abstraction will also become part of the ATN 135 subject dataset. One-time phone surveys and interviews with AMTU and adult clinic staff will also be conducted to collect information on transition protocols as well as review of any documentation of existing transition protocols (e.g., transitioning SOP). Outcome measures will include pre- and post-transition VL and other measures of physical and psychosocial health status to compare individuals with different patterns and outcomes of transition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)

时间窗: 39 weeks

Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)

时间窗: 39 weeks

Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)

时间窗: 39 weeks

次要结局

  • Preparedness of Adult Clinics to Receive Behaviorally-Infected HIV-Positive Youth Transitioning from Adolescent Clinics(1 day)
  • Transition Protocols at AMTUs and Adult Clinics(1 day)
  • Transition Processes at AMTUs and Adult Clinics(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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