Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)
NCT ID: NCT01164462
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
357 participants
INTERVENTIONAL
2010-03-31
2011-04-30
Brief Summary
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Detailed Description
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Issue: The working hypothesis is that the current screening system is not sufficiently suitable for MSM. A community-based rapid HIV testing program could better target the high risk MSM population and shorten the delay between risky behaviour and HIV testing.
Design: This intervention could enable the assessment of the feasibility of community-based rapid HIV testing. Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation or Centre de dépistage anonyme et gratuit in French) center testing with community-based rapid testing. A pre-study phase is first realised to characterize those in the MSM population undergoing HIV testing, before promoting and then beginning the survey. During the normal opening hours of five testing centers, clients will be randomized to have a rapid finger-stick blood specimen test or a conventional test. During evenings and week-ends (i.e. when the centers are closed) only community based rapid HIV testing will be proposed.
Schedule: The pre-study phase is planned for the first quarter of 2009. Promotion of the survey will begin one month before the experimental study which in turn will start in the third quarter of 2009 and will run for 7 months. The end of data analyses is planned for the end of 2010.
Outcome: We will compare HIV population exposure, screening history and the frequency of primary HIV infection diagnosis. We expect to find that those MSM who undergo community based HIV testing during evenings or week-ends, is a population who take repeated sexual risks and who have repeated HIV testing. We also expect to find that this form of testing will be characterized in terms of satisfaction as non-inferior compared to the classic one. In the long term, and if the results are confirmed, rapid HIV testing could be extended to strictly community-based sites.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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A 2
During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
blood test: rapid finger-stick blood specimen test
blood test: conventional test
B group
During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing
blood test: rapid finger-stick blood specimen test
blood test: conventional test
A1 group
During the normal opening hours of five testing centers, clients with a conventional test.
blood test: conventional test
Interventions
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blood test: rapid finger-stick blood specimen test
blood test: conventional test
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Able to give written consent
* able to give written authorization for lifting anonymity if there is doubt of results
* Covered by French Social Security
Exclusion Criteria
* treated by antiretroviral
* woman
18 Years
MALE
Yes
Sponsors
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French National Agency for Research on AIDS and Viral Hepatitis
OTHER_GOV
Responsible Party
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Principal Investigators
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Vernay Vaisse Chantal
Role: PRINCIPAL_INVESTIGATOR
DGAS DPMIS Marseille
Locations
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CDAG (Free Anonymous Screening Consultation) center
Marseille, , France
CDAG (Free Anonymous Screening Consultation) center
Nice, , France
CDAG (Free Anonymous Screening Consultation) center
Paris, , France
Countries
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Related Links
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((legal sponsor's website))
Other Identifiers
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AO00439-48
Identifier Type: -
Identifier Source: org_study_id