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Completed

NCT Number: NCT03145753

Education vs Education Plus Intervention in HIV/HCV Diagnosis (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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Garcia Noblejas, Madrid, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Only education and support will be provided in this arm

Primary outcomes

  1. Number of New HIV HIV/HCV Diagnosis

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study 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)"

Acronym: DRIVE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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