Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing

HIV Seropositivity Clinical Trial

— ALSO  

Official title:

"Au Labo Sans Ordo ": A 12 Month Local Experimentation of Free HIV Testing Without Prescription in Private Medical and Biological Laboratories in Paris and in the Alpes-Maritimes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030689
• Other study ID #: 19-PP-11
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Vanina OLIVERI
• Phone: 492034254
• Email: oliveri.v[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The program " Au labo sans ordo " aims to increase HIV testing coverage, in order to improve the first stage of the HIV care cascade in Paris and the Alpes-Maritimes, areas facing a much higher HIV epidemic than the other regions in metropolitan France. Both departments are engaged in the Fast Track Cities Initiative.

Description:

The program relies on the hypothesis that the opportunity to get tested for HIV for free (called VihTest) in any Private Laboratory (PL), without prior appointment nor prescription, combined with an intense targeted promotion and communication strategy, will significantly increase the testing coverage. This offer might remove some of the multiple barriers to HIV testing and ease the move to action, in particular within key affected populations which contribute to the largest part of the epidemic dynamic.

This program offers a new access to HIV testing. It is developed jointly by local authorities, the health insurance and state regional health agencies, in response to the very low increase of HIV testing coverage despite a diversification of the testing supply and national recommendations for generalized and repeated HIV testing within key populations.

The experimentation will be implemented for 12 months in all Private Laboratories in Paris (164) and the Alpes-Maritimes (107), targeting a 15% increase in the total volume of tests performed outside of hospital settings.

The evaluation process will focus on:

Axis 1 : The number of tests performed and the number of new HIV diagnosis considering the potential substitution effect towards the current testing provision through CeGIDD (free Centers for Information, Diagnosis and Testing) and community-based outreach testing programs.

Axis 2 : The linkage to care following an HIV positive test will be organized and documented and the characteristic of HIV+ population diagnosed after VihTest will be describe (ALSO_PARCOURS) Axis 3: The characteristics of the program's users will be collected and compared 1) to those of PL attendants with a medical prescription for an HIV test and 2) to CeGIDD clients.

Axis 4: The feasibility and acceptability of the program by the PL's staff will be documented using detailed qualitative questionnaire; Axis 5: The cost-effectiveness of scaling-up such a testing strategy and its budgetary impact will be assessed through a microcoasting evalutation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Axis 2

Inclusion Criteria:

• Major

• being diagnosed HIV positive after a VihTest

Exclusion Criteria:

• Minor

Related Conditions & MeSH terms

• HIV Seropositivity
• HIV Testing

Intervention

Other:
• data collected from patient file
socio-demographics, previous HIV testing history, history of HIV contamination, clinics HIV related data will be collected for each patient who notified his non-objection to participate to this non interventional study.

Locations

Country	Name	City	State
France	Hopital l'Archet Service Infectiologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive VihTest	Number of patients enrolled in the study with demographics, risk factors, clinical therapeutic and biological characteristics	548 days