DRug Use & Infections in ViEtnam: TuBerculosis Control Towards Tuberculosis Elimination Among People Who Inject Drugs: Evaluation of a Community-based Intervention in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 4
- 主要终点
- Prevalence of confirmed TB cases at RDSS 1 and RDSS 4
研究概览
简要总结
The overarching purpose of the proposed research is to demonstrate that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.
详细描述
Vietnam has a strong National TB Program (NTP), but it belongs to the 20 countries with the highest TB burden in the world. A TB prevalence study among people who inject drugs (PWID) was conducted as part of the Drug use & Infections in ViEtnam (DRIVE) program, in collaboration with a local screening initiative (Zero TB Vietnam, national TB program - NTP) in 2018 in Hai Phong. While the annual TB rate in the general population of Vietnam is 0.13%, this study found an alarming prevalence of confirmed TB cases from 1.8% to 5.6% among PWID. Some populations, such as people who inject drugs (PWID), combine a very high risk of TB and low access to TB care. Based on the investigators experience in operational research among PWID and their expertise in TB, they designed an intervention to end TB among a highly vulnerable population such as PWID, through significant community involvement.
They hypothesize that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.
The DRIVE-TB intervention will use four repeated large-scale randomized driven sampling surveys (RDSS) to identify TB-infected PWID in the community. During RDSS 1 and 4 all participants will undergo a questionnaire on TB symptoms, and have CRP, chest X-ray, and sputum collection for Xpert MTB-RIF®. In RDSS 2 and 3, participants will be screened through the best screening algorithm (elaborated in RDSS1). Participants from all RDSS will also be screened for LTBI through Tuberculin Skin Test (TST). Moreover the 3HP ancillary study, a therapeutic cohort will assess the acceptability, safety, adherence, and cost of a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) to prevent TB disease among RDSS 2 participants with a positive QuantiFERON test result will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •18 years of age or older
- •Self-declaring injecting heroin or any other drug
- •Positive urine test for heroin or methamphetamine
- •Presence of recent injection site marks
排除标准
- •Unable to understand or refused to sign informed consent
- •Patients currently under treatment for active TB
- •Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study, including very severe clinical condition
- •Person deprived of freedom by a judicial or administrative decision
结局指标
主要结局
Prevalence of confirmed TB cases at RDSS 1 and RDSS 4
时间窗: 2 years between RDSS 1 and 4
次要结局
- The feasibility and efficacy of the TB mass screening(Through study completion, an average of 2 years)
- Proportion of confirmed TB cases who have initiated TB treatment among those who have attended the referral TB center for confirmation in RDSS 1, 2, 3.(Up to one year)
- Assess TB awareness(2 years)
- Prevalence of active TB and LTBI among PWID contacts(1 year)
- Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.(At baseline)
- The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.(2 years)
- The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong(2 years)
- Safety of the 3HP regimen,(3 months after inclusion in RDSS2)
- HIV viremia prevalence at RDSS1(At baseline)
- Acceptability of the 3HP regimen,(3 months after inclusion in RDSS2)
- Proportion of participants who have completed a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) among those who have initiated 3HP.(3 months after inclusion in RDSS2)
- The proportion of PWID contacts actually screened for TB at the community study site.(1 year)