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

NCT03145753 | Completed DMC

• 1 other identifier: PI16/00551
• Study Type: interventional
• Target: 7,989
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infection; HCV Coinfection

Keywords

HIV testing program; HCV testing program; education

Outcome Measures

Primary Outcomes (1)

• Number of New HIV HIV/HCV Diagnosis

  2 months

Study Arms (2)

HIV/HCV Education plus Testing

EXPERIMENTAL

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

HIV/HCV Education

ACTIVE COMPARATOR

In this arm only education should be provided

Other: HIV/HCV Education

Interventions

HIV/HCV Education plus Testing OTHER

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.

HIV/HCV Education plus Testing

HIV/HCV Education OTHER

Only education and support will be provided in this arm

HIV/HCV Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Centro de Salud Garcia Noblejas

Madrid, 28034, Spain

Location

Hospita Ramon y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Maria Jesus Pérez Elías, MD, PhD

  Hospita Camon y Cajal, IRYCIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: November 18, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 12, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)