Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: HIV Infection; HCV Coinfection

Treatments: Other: HIV/HCV Education; Other: HIV/HCV Education plus Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03145753

PI16/00551

Details and patient eligibility

About

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.

Enrollment: 7,989 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7,989 participants in 2 patient groups

HIV/HCV Education plus Testing

Experimental group

Description:

In this arm education should be provided and also resources for testing, HIV/HCV rapid tests and Testing staff different from clinical practice resources

Treatment:

Other: HIV/HCV Education plus Testing

HIV/HCV Education

Active Comparator group

Description:

In this arm only education should be provided

Treatment:

Other: HIV/HCV Education