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临床试验/NCT02872805
NCT02872805已完成不适用

Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2019年11月1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
298
试验地点
1
主要终点
Successful transition

研究概览

简要总结

One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. The Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the ART continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.

详细描述

The specific aims of ADAPT are: 1. To inform strategies for transition services in resource-limited settings; 2. To examine the developmental, clinical, and other factors that predict a successful transition; and, 3. To gain fundamental insight on implementation barriers among African adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups including: Adolescent patients, parents and health care providers. To address aim 2, the investigators will conduct a cluster randomized clinical trial. The two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. The investigators will enroll 300 patients (150 patients in each arm). The sites will be assigned to either the intervention arm or a control arm. The primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. Secondary outcomes, as recommended by focus group participants will also be measured. To examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a Generalized Estimating Equation (GEE) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. The finding from this study will guide institution of best practices for transitioning adolescents in Nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.

研究设计

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

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected patients between the ages of 16-19 years of age
  • Patients who have been in care at the study site facility for a minimum of 1 year
  • Patients who plan to transition their HIV care to one of the selected study sites
  • Patients who are able to provide informed consent

排除标准

  • HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
  • Patients planning to transition their HIV care outside the selected study facilities

结局指标

主要结局

Successful transition

时间窗: 9 months after transition occurs

ADAPT focuses on a service primary outcome, successful transition, which is defined as two consecutive kept appointments at the designated adult clinic within 9 months of transition

Viral load suppression

时间窗: 12 months after transition occurs

viral load (VL)\<400 at 12 months post-transition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicki Tepper

Associate Professor of Pediatrics

University of Maryland, Baltimore

研究点 (1)

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