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临床试验/NCT01061762
NCT01061762已完成2 期

HIV Treatment Adherence Intervention for People With Poor Literacy Skills

University of Connecticut2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
450
试验地点
2
主要终点
Unannounced Phone Based Pill Counts for Medication Adherence

研究概览

简要总结

Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. Effective strategies for improving adherence in patients with poor health literacy must be tailored to achieve optimal adherence and therefore viral suppression. This proposal requests support to conduct a randomized clinical trial of a theory-based HIV treatment adherence intervention tailored for people with low-literacy skills.

详细描述

Adherence to antiretroviral medications is necessary to achieve sufficient HIV suppression and nonadherence can lead to the development of treatment resistant genetic variants of HIV. Research has demonstrated that people living with HIV/AIDS who have low-levels of health literacy experience greater treatment non-adherence than their higher-literacy counterparts. Interventions are urgently needed to improve treatment adherence in people with poor literacy skills. This application proposes to test a theory based behavioral intervention for improving HIV treatment adherence in people living with HIV/AIDS who have low-literacy skills. Grounded in the Information - Motivation - Behavioral Skills (IMB) model of health behavior change, the experimental intervention has been tailored for people with low-levels of health literacy and has been pilot tested in preliminary intervention development research. The intervention is delivered in three one-on-one counseling sessions and one maintenance-focused booster session. The intervention will be conducted in a community care setting in Atlanta. Men and women will be recruited from a AIDS services and infectious disease clinics throughout the Atlanta metropolitan area. Following screening, informed consent and baseline assessments participants will be randomly assigned to receive one of three conditions: (a) Theory-based literacy tailored treatment adherence intervention; (b) standard of care non-tailored time-matched adherence counseling intervention; (c) noncontaminating time-matched attention control intervention. Participants will be followed for 12-months observation. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence, self-report and objective medication adherence, and viral load. The study will test the hypothesis that a theory-based HIV treatment adherence intervention that is tailored for people with low-literacy will improve HIV treatment adherence and health relative to the standard and attention control conditions. The study will also examine the influence of IMB theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to address treatment adherence among people with poor literacy skills. If shown effective, the intervention model will be ready for immediate dissemination to clinical and community adherence enhancement services for people living with HIV-AIDS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

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

  • 18 years or older,
  • HIV positive,
  • receiving antiretroviral medications, and
  • score below cut-off on a standard health literacy test.

排除标准

  • 未提供

结局指标

主要结局

Unannounced Phone Based Pill Counts for Medication Adherence

时间窗: Baseline, monthly for 12 months

次要结局

  • Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skills(Baseline, 3, 6, and 9 months)

研究者

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

Seth Kalichman

Professor

University of Connecticut

研究点 (2)

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