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临床试验/NCT01760759
NCT01760759已完成不适用

Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

UConn Health4 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
4
主要终点
self-report of medication adherence

研究概览

简要总结

In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.

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
None

入排标准

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

入选标准

  • age > 18 years
  • initiating or on an antiretroviral therapy regimen and have a viral load >200 copies/mL in the past 6 months
  • one or more risk factors for poor adherence
  • English speaking
  • willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
  • able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form

排除标准

  • living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
  • participating in another antiretroviral therapy adherence study
  • uncontrolled psychiatric disorders
  • significant cognitive impairment

研究组 & 干预措施

Usual care

No Intervention

Patients receive usual care from their medical providers.

Usual care plus cell phone reminders

Experimental

Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.

干预措施: cell phone reminders (Behavioral)

Usual care, reminders & contingency management for adherence

Experimental

Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.

干预措施: cell phone reminders (Behavioral)

Usual care, reminders & contingency management for adherence

Experimental

Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.

干预措施: contingency management for adherence (Behavioral)

结局指标

主要结局

self-report of medication adherence

时间窗: Week 48

change in copies of human immunodeficiency virus per milliliter

时间窗: Week 48

次要结局

未报告次要终点

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Rash

Assistant Professor

UConn Health

研究点 (4)

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