Clinical trial NCT03145753: Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)
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)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
HCV Coinfection
Keywords: HIV testing program
HCV testing program
education
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-05-09
Enrollment: 7989
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* A prior HIV diagnosis,
* have already been included in the DRIVE 03 study,
* inability to understand the Spanish language.

Primary outcomes:
measure: Number of New HIV HIV/HCV Diagnosis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro de Salud Garcia Noblejas
city: Madrid
country: Spain
facility: Hospita Ramon y Cajal
Study officials:
affiliation: Hospita Camon y Cajal, IRYCIS
name: Maria Jesus Pérez Elías, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: