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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood test: rapid finger-stick blood specimen test
blood test: conventional test
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CDAG (Free Anonymous Screening Consultation) center
  • CDAG (Free Anonymous Screening Consultation) center
  • CDAG (Free Anonymous Screening Consultation) center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

A 2

B group

A1 group

Arm Description

During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test

During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing

During the normal opening hours of five testing centers, clients with a conventional test.

Outcomes

Primary Outcome Measures

the feasibility of community-based rapid HIV testing. testing with community-based rapid testing

Secondary Outcome Measures

Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center

Full Information

First Posted
July 15, 2010
Last Updated
December 26, 2012
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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1. Study Identification

Unique Protocol Identification Number
NCT01164462
Brief Title
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)
Acronym
DRAG
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A 2
Arm Type
Other
Arm Description
During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
Arm Title
B group
Arm Type
Other
Arm Description
During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing
Arm Title
A1 group
Arm Type
Other
Arm Description
During the normal opening hours of five testing centers, clients with a conventional test.
Intervention Type
Biological
Intervention Name(s)
blood test: rapid finger-stick blood specimen test
Intervention Type
Biological
Intervention Name(s)
blood test: conventional test
Primary Outcome Measure Information:
Title
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing
Secondary Outcome Measure Information:
Title
Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vernay Vaisse Chantal
Organizational Affiliation
DGAS DPMIS Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDAG (Free Anonymous Screening Consultation) center
City
Marseille
Country
France
Facility Name
CDAG (Free Anonymous Screening Consultation) center
City
Nice
Country
France
Facility Name
CDAG (Free Anonymous Screening Consultation) center
City
Paris
Country
France

12. IPD Sharing Statement

Links:
URL
http://anrs.fr
Description
((legal sponsor's website))

Learn more about this trial

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

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