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

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)
• Overall Status: Completed
• CT.gov ID: NCT03145753
• Collaborator: Instituto de Salud Carlos III (Other)
• Enrollment: 7,989
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site: 3994.5
• Patients Per Site Per Month: 384.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection; HCV Coinfection	Other: HIV/HCV Education plus Testing; Other: HIV/HCV Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7989 participants
• 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.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
• 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)"
• Actual Study Start Date: Nov 18, 2016
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIV/HCV Education plus Testing In this arm education should be provided and also resources for testing, HIV/HCV rapid tests and Testing staff different from clinical practice resources	Other: HIV/HCV Education plus Testing; 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.
Active Comparator: HIV/HCV Education In this arm only education should be provided	Other: HIV/HCV Education; Only education and support will be provided in this arm

Outcome Measures

Primary Outcome Measures

1. Number of New HIV HIV/HCV Diagnosis [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Salud Garcia Noblejas	Madrid		Spain	28034
2	Hospita Ramon y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Instituto de Salud Carlos III

Investigators

• Principal Investigator: Maria Jesus Pérez Elías, MD, PhD, Hospita Camon y Cajal, IRYCIS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• ClinicalTrials.gov Identifier: NCT03145753
• Other Study ID Numbers: PI16/00551
• First Posted: May 9, 2017
• Last Update Posted: Feb 12, 2019
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: HIV testing program; HCV testing program; education
• Additional relevant MeSH terms: Infections; Coinfection

Study Results

No Results Posted as of Feb 12, 2019