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临床试验/NCT01031745
NCT01031745已完成2 期

Contingency Management in the Delivery of HAART to Drug Users in Chennai, India

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年5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
120
试验地点
2
主要终点
Time to initiation of HAART

研究概览

简要总结

Drug use (DU) is a major risk factor for HIV infection in many regions of the world. However, as highly active antiretroviral therapy (HAART) has been rolled out in South and South East Asia, less than 2% of individuals initiated on HAART were drug users (DUs) or former DUs, despite the fact that approximately 20% of HIV infections in the region are ascribed to DU. India is home to about 2.4 million HIV-infected individuals. Though, injection drug users contribute to only about 3% of all HIV infections in India; it is estimated that there are between 168,000 and 1.1 million DUs in India with HIV prevalence about 30%. Novel approaches are needed to engage disenfranchised populations in HIV care in lower and middle income countries, where the burden of HIV disease is growing. Incentive-based strategies (or contingency management) have been shown to be effective in reducing illicit drug use, smoking cessation, and weight loss. Short-term pilot studies have also shown that incentive-based strategies can improve electronically-monitored rates of adherence to HAART in the US, and a recent study in Africa showed that a small incentive approximately doubled the rate that individuals returned to learn the results of their HIV test. However, to date there is no experience with the use of incentive-based interventions to improve engagement into care and risk-reduction among out-of-care HIV-infected DUs in developing world settings. The investigators propose to conduct pilot randomized trial comparing a voucher incentive strategy to a control condition to improve engagement in HIV care and HIV treatment outcomes among out-of-care, treatment-eligible, HIV-infected DUs in Chennai, India. Subjects in the incentive arm will be eligible to earn incentive vouchers for 1) initiating HAART at a government-sanctioned HIV treatment clinic, 2) adherence to scheduled follow-up visits at the HIV clinic, and 3) achieving suppression of HIV RNA. Subjects will be enrolled from a mature research venue in Chennai, YR Gaitonde Centre for Substance Abuse-related Research (YRGCSAR), which focuses the epidemiology and natural history of HIV in DUs. Preliminary data from this pilot study will be used to inform the design of a phase-III study.

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

  • 18 years of age or older
  • Provide written informed consent
  • Provide a history of injection or non-injection drug use in prior 30 days
  • Documented evidence of HIV infection
  • Be ART naïve (by self-report)
  • Satisfy Indian National Guidelines for initiation of HAART (any of the following)
  • Absolute CD4+ count < 200 cells/ µl
  • AIDS-defining illness with any CD4+ count
  • Absolute CD4+ count between 200 - 350 cell/ µl with HIV-related symptoms

排除标准

  • Indicates an intention to migrate in the next 12 months
  • Any medical or psychiatric condition that the study physician believes to be a contraindication to study participation.
  • Enrolled in another HIV treatment program

结局指标

主要结局

Time to initiation of HAART

时间窗: 12 months

次要结局

  • Attendance at HIV treatment visits(12-months)
  • HAART possession ratio (a surrogate of medication adherence based on pharmacy fill data)(12-months)
  • Proportion with HIV RNA < 400 copies/mL at 6- and 12-months(12-month)
  • Changes in absolute CD4 count from baseline at 6- and 12-months(12-months)

研究者

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

Gregory M. Lucas

Professor of Medicine

Johns Hopkins University

研究点 (2)

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