Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard Study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,281
- 试验地点
- 3
- 主要终点
- enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
研究概览
简要总结
The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.
详细描述
This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site.
Approximately 500 Index participants and their partners will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Index participants:
- •Age 18-45 years at the Screening visit (age verification procedures will be defined in the Study Specific Procedures [SSP] Manual)
- •Able to provide informed consent
- •Active injection drug user, defined as self-report of: a) injecting drugs approximately two or more times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
- •Reports sharing needles/syringes or drug solutions at least once in the last month
- •HIV-infected based on a study-defined testing algorithm (defined in the SSP Manual)
- •Viral load ≥1,000 copies/mL at Screening
- •Willing and able to identify, recruit, and have enrolled at least one HIV-uninfected network injection partner who is eligible for study participation according to the criteria below
- •Have no plans to move outside the study area for at least one year after study enrollment
- •Willing to participate in intervention activities, including regular phone contact
- •HIV uninfected injection partners:
- •Age 18-45 years at the Screening visit (age verification procedures will be defined in the SSP Manual)
- •Able to provide informed consent
- •Active injection drug user, defined as: a) self-report of injecting drugs approximately two times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
- •Confirmed injection partner, using referral identification cards, of index participant within the past 1 month
- •HIV-uninfected based on the study-defined testing algorithm* (defined in the Study SSP Manual)
- •Have no plans to move outside the study area for at least one year after study enrollment
排除标准
- 未提供
研究组 & 干预措施
Integrated Intervention
Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment
干预措施: Integrated Intervention (Behavioral)
Control
Standard of Care
结局指标
主要结局
enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
时间窗: 18 months
Number of participants enrolled, and number of participants with a final study visit.
HIV incidence among network injection partners of index participants
时间窗: 18 months
Number of HIV seroconversions to partners to control arm Index participants
次要结局
- Number of participants in either arm engaged in substance use treatment(18 months)
- social harms and benefits(18 months)
- HIV incidence among network injection partners of index participants in the intervention arm(18 months)
- Engagement in care for ART treatment services of control arm vs intervention(18 months)
- phylogenetics to describe HIV transmission dynamics(18 months)
- size and stability of drug using networks(18 months)