Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM) (DRAG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01164462
First received: July 15, 2010
Last updated: December 26, 2012
Last verified: December 2012

July 15, 2010
December 26, 2012
March 2010
April 2011   (final data collection date for primary outcome measure)
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01164462 on ClinicalTrials.gov Archive Site
Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)
Not Provided

Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
HIV Infections
  • Biological: blood test: rapid finger-stick blood specimen test
    .
  • Biological: blood test: conventional test
    .
  • A 2
    During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
    Interventions:
    • Biological: blood test: rapid finger-stick blood specimen test
    • Biological: 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
    Interventions:
    • Biological: blood test: rapid finger-stick blood specimen test
    • Biological: blood test: conventional test
  • A1 group
    During the normal opening hours of five testing centers, clients with a conventional test.
    Intervention: Biological: blood test: conventional test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01164462
AO00439-48
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Vernay Vaisse Chantal DGAS DPMIS Marseille
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP