Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)
Condition: HIV Infection; HCV Coinfection
MeSH terms: Infections; Coinfection
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): HIV/HCV Education plus Testing; HIV/HCV Education
Intervention type(s): Other; Other
Intervention description(s): Education included a half day educational program and the provision of supporting materials to enhance HIV testing, such as a clinical decision algorithm to perform HIV test and clinical remainders to help meet with the current Spanish Early Diagnosis HIV Testing Recommendations. Half day educational program, to promote early diagnosis of HIV, HCV, in a Primary Care Health Area.To Improve knowledge and current trends in the prevention, diagnosis and management of HIV infection among non health professionals specialists in infectious diseases.DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures.The study activities will be carried out by the trained testing staff.; Only education and support will be provided in this arm
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: DRIVE study (Diagnóstico Rápido de la Infección por VIH/HCV en España, in English Rapid HIV/HCV testing in Spain) was designed to investigate the different aspects of HIV testing. DRIVE 01 and 02 had been already completed and communicated.
This new study has been designed as a prospective randomized clustered crossover study in one Health Care Area of Madrid Spain, to compare two implementation HIV/HCV testing programs: only EDSUP vs. EDSUP plus a resourced HIV/HCV testing program which provide rapid HIV/HCV tests, and testing staff to conduct all procedures.
Four PCC´c belonging to the influenced area of Ramón y Cajal Area will be randomized 1:1 to receive sequentially any of the two HIV/HCV testing programs.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HIV testing program; HCV testing program; education