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

April 8, 2026 updated by: French National Agency for Research on AIDS and Viral Hepatitis
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • CDAG (Free Anonymous Screening Consultation) center
      • Nice, France
        • CDAG (Free Anonymous Screening Consultation) center
      • Paris, France
        • CDAG (Free Anonymous Screening Consultation) center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
Other: A1 group
During the normal opening hours of five testing centers, clients with a conventional test.
Biological: blood test: conventional test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • Principal Investigator: Vernay Vaisse Chantal, DGAS DPMIS Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimated)

July 16, 2010

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AO00439-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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