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

HIV Infection Clinical Trial

— DRIVE  

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)"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145753
• Other study ID #: PI16/00551
• Status: Completed
• Phase: N/A
• Start date: November 18, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: May 2017
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7989
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coinfection
• HCV Coinfection
• HIV Infection
• HIV Infections
• Infection

Intervention

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.
• HIV/HCV Education
Only education and support will be provided in this arm

Locations

Country	Name	City	State
Spain	Centro de Salud Garcia Noblejas	Madrid
Spain	Hospita Ramon y Cajal	Madrid

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of New HIV HIV/HCV Diagnosis		2 months