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临床试验/NCT02753049
NCT02753049Unknown不适用

Adherence Connection for Counseling, Education, and Support (ACCESS): A Proof of Concept Study

New York University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change in Serum HIV RNA quantitative viral load

研究概览

简要总结

This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide the advanced knowledge, skills, and experience for the candidate's career transition to an independent nurse scientist. Her long term goal is to become a leading nurse scientist in designing, implementing, and evaluating technology supported behavioral interventions targeted for improved disease self-management (i.e. medication adherence, retention in care) among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre and post-doctoral interdisciplinary research traineeships, the candidate has begun to develop the knowledge-base and skills necessary for this goal.

This award details a 3-year scope of mentored career development through which she will gain the foundation for future research endeavors. Specifically, the goals of this proposal are to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of expert researchers; 2) acquire expertise in health informatics for implementation of technology supported behavioral interventions, health disparities, and advanced qualitative and mixed methods design and analysis through firsthand experience, didactic interactions with mentors, and graduate level coursework; 3) build a network of colleagues and collaborators within New York University and elsewhere through this research and participation at national and international meetings; and 4) prepare and submit a federal research grant (R-21) based upon the skills and findings from this award period.

The specific research project through which she will accomplish these goals is a proof of concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and addresses the challenge of adherence to antiretroviral treatment among HIV-infected adolescents and young adults. A mixed method design is proposed and the specific aims are to: 1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive behavioral intervention delivered via remote videoconferencing using smartphones; 2) Obtain initial estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported ART adherence, beliefs and knowledge about antiretroviral treatment, adherence self-efficacy, and healthcare utilization (retention in HIV care). In summary, the ACCESS adherence intervention is consistent with the National Institute of Nursing Research (NINR) call for the development of novel interventions to deliver personalized care and real-time health information for patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 29 Years(Child, 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

Change in Serum HIV RNA quantitative viral load

时间窗: Serum HIV RNA quantitative viral load will be measured at baseline and at 8 weeks, 16 weeks, and 24 weeks post-intervention.

Serum HIV RNA quantitative viral load results will be available for medical record data extraction at four time points, baseline (pre-intervention), and weeks 8, 16 \& 24 post-intervention. The primary outcome variable of adherence as measured with serum HIV-RNA will be dichotomized as a binary variable (\< 48 copies/ml; \> 48 copies/ml), indicating viral suppression. An interval estimate of the odds ratio will indicate the potential impact of ACCESS on viral suppression, with Chi-Square or Fisher's Exact Test for statistical significance.

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

Ann-Margaret Dunn Navarra

Assistant Professor

New York University

研究点 (1)

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