HIV Infection Clinical Trial
Official title:
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)"
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.
n/a
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