Clinical trial NCT04030689: Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Seropositivity
HIV Testing
Keywords: HIV Testing
Combined HIV prevention
Linkage to care
Implementation plan
Cost-effectiveness
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Axis 2 Major patient diagnosed HIV positive after a VihTest in a Private Laboratory in Paris or in the Alpes Maritimes.

Brief 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.

Detailed 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.

Eligibility criteria: Axis 2

Inclusion Criteria:

* Major
* being diagnosed HIV positive after a VihTest

Exclusion Criteria:

* Minor

Primary outcomes:
measure: Positive VihTest
timeFrame: 548 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopital l'Archet Service Infectiologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pascal PUGLIESE, MD
role: PRINCIPAL_INVESTIGATOR
References: