Trial record 17 of 29 for:    " June 30, 2010":" July 30, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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).


Condition Intervention
HIV Infections
Biological: blood test: rapid finger-stick blood specimen test
Biological: blood test: conventional test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • the feasibility of community-based rapid HIV testing. testing with community-based rapid testing [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A 2
During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
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
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.
Biological: blood test: conventional test
.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164462

Locations
France
CDAG (Free Anonymous Screening Consultation) center
Marseille, France
CDAG (Free Anonymous Screening Consultation) center
Nice, France
CDAG (Free Anonymous Screening Consultation) center
Paris, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Vernay Vaisse Chantal DGAS DPMIS Marseille
  More Information

Additional Information:
No publications provided

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     History of Changes
Other Study ID Numbers: AO00439-48
Study First Received: July 15, 2010
Last Updated: December 26, 2012
Health Authority: Authorities: France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014