DRIVE (DRug Use and Infections in ViEtnam) Project : Ending the HIV Epidemic Among Persons Who Inject Drugs in Hai Phong, Viet Nam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,546
- 试验地点
- 1
- 主要终点
- Incidence of HIV in the PWID population
研究概览
简要总结
The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam.
详细描述
Injection drug use is driving HIV epidemics in low/middle-income countries in Eastern Europe, Central Asia and Southeast Asia. "Combined prevention and care", including needle/syringe programs (NSP), medication-assisted treatment for opiate dependence, and antiretroviral treatment, has greatly reduced HIV incidence among persons who inject drugs (PWID) in many high-income areas, to where the "HIV epidemics" among PWID have "ended." There is now the need for a convincing demonstration that an HIV epidemic can be ended in a low/middle income setting. The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. The researchers define "ending the epidemic" as reducing HIV incidence to 0.5/100 person-years at risk.
Data collection will include recruitment using repeated community based respondent driven sampling (RDS) surveys, once per year among PWID in Hai Phong. Participants will be given a quantitative questionnaire and tested for HIV and Hepatitis C (HCV). Peer support groups will be mobilized to help recruit PWID and assist in educations on the benefits of early ART, access to methadone, antiretroviral treatment and psychiatric services, and ways to prevent HIV and HCV transmission through safe injection practices and safe sex. Additionally, the investigators will develop large cohorts of HIV positive and HIV negative PWID to closely document behaviors trends, HIV incidence, and the obstacles of the access and retention in HIV care and methadone. It has been shown that it is possible to end HIV epidemics among PWID in several high income countries. This study will build upon the knowledge and results gained in high income settings to achieve viral suppression among HIV positive PWID and reduce HIV/HCV incidence in order to "end the HIV epidemic" among persons who inject drugs in Haiphong.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •capable of giving informed consent and participating in study activities
- •history of drug injection (confirmed by visual inspection or subject knowledge of injecting procedures)
- •currently using an injectable drug (heroin or methamphetamine
- •confirmed by urine test), not on MMT at initial recruitment
- •willingness to participate in follow up studies, and expecting to remain in Haiphong for 2 years
排除标准
- •less than 18 years of age
- •on MMT at initial recruitment
- •refusal to participate in follow-up studies
- •no history of drug injection
- •not currently using injectable drug (heroin or methamphetamine)
- •not capable of giving informed consent
- •those not expecting to remain in Haiphong for at least 2 years
结局指标
主要结局
Incidence of HIV in the PWID population
时间窗: up to 48 months
Incidence of HIV in the PWID population to be calculated in person-years
次要结局
- Number of participants with unsuppressed viral load(up to 48 months)
- Cost-Effectiveness ratio as compared to baseline(baseline, 3 years, 7 years, 10 years, and 20 years)
- Incremental costs averted(up to 20 years)
- Lifetime medical costs(up to 20 years)