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临床试验/NCT03145753
NCT03145753已完成不适用

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)"

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal4 个研究点 分布在 1 个国家目标入组 7,989 人开始时间: 2016年11月18日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

研究者

研究点 (4)

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