Impact on New HIV/HCV Infection Diagnoses and Costs of Two HIV/HCV Testing Programs "Education and Support Only" Versus "Education and Support Plus a Resourced External Program (DRIVE 03)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,989
- 试验地点
- 4
- 主要终点
- Number of New HIV HIV/HCV Diagnosis
研究概览
简要总结
Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and indicator conditions (RE&IC) questionnaire resulted in same rate of new HIV infection diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP) or EDSUP plus a resourced external program (DRIVE 03).
Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs. EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4 PCC´s, not previously included in the study will be offered to participate. HIV testing program will be evaluated by measuring absolute number of new diagnosed infections (NDI) HIV/HCV and costs. Other outcomes considered will be people assigned and offered to participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in care, HIV/HCV treatment and control/eradication will be also monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have attended to one of the PCC´s randomized to DRIVE 03 HIV testing program,
- •Be 18-70 years
- •Have understood, accept and sign the written informed consent, and in case of inability, it will be signed by the legal representative.
排除标准
- •A prior HIV diagnosis,
- •have already been included in the DRIVE 03 study,
- •inability to understand the Spanish language.
研究组 & 干预措施
HIV/HCV Education plus Testing
In this arm education should be provided and also resources for testing, HIV/HCV rapid tests and Testing staff different from clinical practice resources
干预措施: HIV/HCV Education plus Testing (Other)
HIV/HCV Education
In this arm only education should be provided
干预措施: HIV/HCV Education (Other)
结局指标
主要结局
Number of New HIV HIV/HCV Diagnosis
时间窗: 2 months
次要结局
未报告次要终点
