HIV InfectionsDRAGNCT01164462
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)
A study testing blood test: rapid finger-stick blood specimen test and blood test: conventional test in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- blood test: rapid finger-stick blood specimen test and blood test: conventional test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- who have had a previous diagnosis of seropositivity
- treated by antiretroviral
- woman
Trial locations and contacts
3 sites in 1 country.
France3 sites
CDAG (Free Anonymous Screening Consultation) center
Marseille
CDAG (Free Anonymous Screening Consultation) center
Nice
CDAG (Free Anonymous Screening Consultation) center
Paris
About this study
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).
Read the 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.
- Conditions
- HIV Infections
- Being tested
- blood test: rapid finger-stick blood specimen test, blood test: conventional test
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test: rapid finger-stick blood specimen testBiological
blood test: conventional testBiological
| Study group | Role | What they receive |
|---|---|---|
| A 2 | Other | During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test Receives: Biological: blood test: rapid finger-stick blood specimen test; Biological: blood test: conventional test |
| B group | Other | During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing Receives: Biological: blood test: rapid finger-stick blood specimen test; Biological: blood test: conventional test |
| A1 group | Other | During the normal opening hours of five testing centers, clients with a conventional test. Receives: Biological: blood test: conventional test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing
Secondary outcomes (1)
Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vernay Vaisse Chantal, Principal investigator, DGAS DPMIS Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164462
- Sponsor's protocol ID
- AO00439-48
- Acronym
- DRAG
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2010
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lorente N, Preau M, Vernay-Vaisse C, Mora M, Blanche J, Otis J, Passeron A, Le Gall JM, Dhotte P, Carrieri MP, Suzan-Monti M, Spire B; ANRS-DRAG Study Group. Expanding access to non-medicalized community-based rapid testing to men who have sex with men: an urgent HIV prevention intervention (the ANRS-DRAG study). PLoS One. 2013 Apr 16;8(4):e61225. doi: 10.1371/journal.pone.0061225. Print 2013.
PubMed 23613817
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT01164462
- Acronym / sponsor ID
- DRAG / AO00439-48
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A 2 | Other | Biological: blood test: rapid finger-stick blood specimen test, Biological: blood test: conventional testDuring the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test |
| B group | Other | Biological: blood test: rapid finger-stick blood specimen test, Biological: blood test: conventional testDuring evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing |
| A1 group | Other | Biological: blood test: conventional testDuring the normal opening hours of five testing centers, clients with a conventional test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- who have had a previous diagnosis of seropositivity
- treated by antiretroviral
- woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood test: rapid finger-stick blood specimen test | Biological | A 2, B group |
| blood test: conventional test | Biological | A 2, A1 group, B group |
Primary outcome
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing
1 secondary outcome
Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 23613817Lorente N, Preau M, Vernay-Vaisse C, Mora M, Blanche J, Otis J, Passeron A, Le Gall JM, Dhotte P, Carrieri MP, Suzan-Monti M, Spire B; ANRS-DRAG Study Group. Expanding access to non-medicalized community-based rapid testing to men who have sex with men: an urgent HIV prevention intervention (the ANRS-DRAG study). PLoS One. 2013 Apr 16;8(4):e61225. doi: 10.1371/journal.pone.0061225. Print 2013.
- ((legal sponsor's website))Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernay Vaisse Chantal principal investigator
DGAS DPMIS Marseille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test: rapid finger-stick blood specimen test and blood test: conventional test in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.