Maintaining HIV Risk Reduction Among Needle Exchangers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Maintenance of HIV risk-free drug behavior (measured at Month 12)
研究概览
简要总结
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.
详细描述
Depression and injection drug use often come hand-in-hand. This is especially true in populations with limited access to mental health care and with a high risk of illness and HIV transmission. Depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of HIV. This cycle has created a significant public health problem. It is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. This study will evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk behaviors in depressed intravenous drug users.
Participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. Participants in the treatment group will meet with a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. Participants in the treatment group may also receive referrals for other services if necessary. Participants assigned to receive no treatment will be contacted at Months 3 and 9 to verify their contact information; they will also receive any necessary referrals. All participants will partake in interviews at baseline and Months 6 and 12 to assess changes in HIV risk behavior and depressive symptoms.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
- •Score of greater than 14 on the Hamilton Rating Scale for Depression
- •Current opiate or cocaine use
- •History of injection equipment sharing
- •English-speaking
排除标准
- •History of injection equipment sharing within 6 months of study entry
- •Currently at risk for suicide
- •Currently experiencing symptoms of psychosis
- •Currently taking any other psychotropic medication
- •Diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or paranoid disorder
- •Informed that treatment with antidepressant medications is medically inadvisable
结局指标
主要结局
Maintenance of HIV risk-free drug behavior (measured at Month 12)
次要结局
- Reduction in depressive symptoms (measured at Month 12)
