Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Time from randomization to the initiation of antiretroviral therapy (ART)
研究概览
简要总结
This research examines the effectiveness of an intervention that employs seek, test, and treat strategies for Vietnamese injection drug users (IDU) and their network members, by ensuring that high risk individuals are sought for HIV testing and promptly referred to and maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be referred to HIV care through a two-arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.
详细描述
Opioid injection and HIV infection are major public health problems in Vietnam. Injection drug users (IDUs) have a high burden of HIV infection (20% HIV prevalence, nationally; 6% mortality per year) and the high rate of HIV transmission continues (HIV incidence, 5% per year). The investigators propose an intervention that employs the seek, test, and treat strategies for the IDU population and their network members, by ensuring that high risk individuals are sought for HIV testing, promptly referred to and maintained on ART, while HIV prevention interventions provided to the many who test HIV-negative, as well as those who test HIV-positive. The intervention will seek and test IDUs and their network members in the community, particularly those who are recently released from drug treatment centers. HIV-positive IDUs will be referred to HIV care through a two arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, antiretroviral adherence, and treatment outcome.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Recently released from drug treatment centers;
- •Positive HIV serology;
- •Meet criteria for ART initiation according to Vietnam's national guidelines;
- •Provide informed consent for the study; and
- •Reside in study area and do not plan to move away in the next 18 months.
排除标准
- •Currently on ART;
- •Co-enrollment in other HIV interventional research study;
- •Unwilling to provide locator information.
结局指标
主要结局
Time from randomization to the initiation of antiretroviral therapy (ART)
时间窗: At month 3
次要结局
- HIV-1 RNA levels(At months 6 and 12)
- CD4+ counts(At months 6, 12, and 18)
研究者
Vu Minh Quan
Assistant Professor
Johns Hopkins University