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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT04030689
Collaborator
(none)
50
1
21
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: data collected from patient file

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Other
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
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Axis 2

Each patient diagnosed HIV positive following VihTest test will be invited to participate to ALSO-Parcours; This program aimed to decribe the link to care for this population and to make a descriptive analysis of this HIV+ patients.

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.

Outcome Measures

Primary Outcome Measures

  1. Positive VihTest [548 days]

    Number of patients enrolled in the study with demographics, risk factors, clinical therapeutic and biological characteristics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Axis 2

Inclusion Criteria:
  • Major

  • being diagnosed HIV positive after a VihTest

Exclusion Criteria:
  • Minor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital l'Archet Service Infectiologie Nice France 06200

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Pascal PUGLIESE, MD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04030689
Other Study ID Numbers:
  • 19-PP-11
First Posted:
Jul 24, 2019
Last Update Posted:
Jul 8, 2020
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Nice
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2020