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临床试验/NCT00443378
NCT00443378已完成不适用

Computer Assisted Rx Education for HIV-Positives: CARE+

University of Washington4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2006年3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
240
试验地点
4
主要终点
HIV-1 viral load

研究概览

简要总结

This study evaluates an interactive computer counseling tool to help HIV-positive individuals develop an integrated health promotion plan incorporating antiretroviral (ART) adherence and HIV transmission risk reduction. We hypothesize that evidence-based counseling for ART adherence support and for HIV transmission risk reduction can be delivered effectively in a self-administered computer tool.

详细描述

Strict adherence to ART regimens is necessary for viral suppression and to avoid development of viral resistance, yet average ART adherence among HIV-positive individuals in North America is only 55%. Focused prevention efforts are key to reduce secondary HIV transmission to sexual and needle-sharing partners, yet many HIV patients do not receive counseling about these behaviors from their providers. Despite the global pandemic and a rising HIV incidence among some US populations, few health promotion interventions have integrated ART adherence with transmission risk reduction for people living with HIV. Most of the efficacious adherence or prevention interventions to date are not practical to scale up, as they require intense staff training and quality assurance and can be delivered to relatively few individuals at any one time.

An interactive health communication tool promises the possibility of a cost-effective adjunct to existing human-delivered counseling, or a stand-alone intervention when no other counseling would otherwise be offered.

This RCT of one such tool -- CARE+ --will provide empiric evidence of the benefits and limits of a computerized health promotion intervention to integrate ART adherence with transmission prevention for individuals with HIV. CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.

Comparison: The CARE+ longitudinal RCT compares clinical and behavioral outcomes of CARE+ users to a control arm which assesses audio computer-assisted self-interview risk behaviors only. Participants were recruited and enrolled at two study sites, 1) an urban outpatient HIV clinic and 2) a community based AIDS Service Organization.

Aim 1: Identify common elements of adherence and transmission behaviors, health communication needs, and technology attitudes (n=30 interviews); incorporate into CARE+ and test software usability (n=30). Aim 2: Randomized clinical trial of HIV-positive adults on ART. Arm 1: CARE+ (n=120); Arm 2: computer risk assessment only (n=120). Arms 1 and 2 perform baseline, 3-, 6-, and 9-month session. Compare outcomes: a) ART adherence by plasma HIV viral load, CD4, self-report and b) HIV transmission sexual risk behaviors at follow-up. Aim 3: Provide data for HIV transmission dynamics impact modeling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • HIV positive
  • currently taking highly active antiretroviral medication

排除标准

  • unable to understand spoken English
  • unable to give informed consent

结局指标

主要结局

HIV-1 viral load

时间窗: 0,3,6 and 9 months

Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence)

时间窗: 0,3,6 and 9 months

Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk)

时间窗: 0,3,6 and 9 months

CD4 cell count

时间窗: 0,3,6 and 9 months

次要结局

  • Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months(0,3,6 and 9 months)

研究者

申办方类型
Other

研究点 (4)

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