- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030689
Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing (ALSO)
"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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vanina OLIVERI
- Phone Number: +33 492034254
- Email: oliveri.v@chu-nice.fr
Study Locations
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-
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Nice, France, 06200
- Recruiting
- Hopital l'Archet Service Infectiologie
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Contact:
- Irit TOUITOU, PhD
- Phone Number: +33 492035847
- Email: touitou.i@chu-nice.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Axis 2
Inclusion Criteria:
- Major
- being diagnosed HIV positive after a VihTest
Exclusion Criteria:
- Minor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive VihTest
Time Frame: 548 days
|
Number of patients enrolled in the study with demographics, risk factors, clinical therapeutic and biological characteristics
|
548 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pascal PUGLIESE, MD, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-PP-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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