- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01164462
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM) (DRAG)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Studies have shown that knowing one's own HIV positive status, may lead to a reduction in sexual risk behaviours. The introduction of new forms of rapid HIV testing in urban areas, may be of benefit to the public health sector, notably in identifying primary HIV infection, preventing secondary HIV transmission and decreasing the spread of HIV infection. Studies have also shown that rapid HIV testing, which yields same-day results, enables a greater number of individuals in populations at risk to become aware of their HIV status.
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Marseille, Frankrig
- CDAG (Free Anonymous Screening Consultation) center
-
Nice, Frankrig
- CDAG (Free Anonymous Screening Consultation) center
-
Paris, Frankrig
- CDAG (Free Anonymous Screening Consultation) center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- men who have sex with men
- 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:
- who have had a previous diagnosis of seropositivity
- treated by antiretroviral
- woman
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: A 2
During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
|
|
Andet: B group
During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing
|
|
Andet: A1 group
During the normal opening hours of five testing centers, clients with a conventional test.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing
|
Sekundære resultatmål
Resultatmål |
---|
Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Vernay Vaisse Chantal, DGAS DPMIS Marseille
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AO00439-48
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