HIVDRIVERNCT02413632
Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
A study testing creation of a STIs score risk and validation of a STIs score risk in people with HIV, run by Hopital Foch at 17 sites in France.
Trial summary
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- creation of a STIs score risk and validation of a STIs score risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 17 sitesFrance
- Study dates
- Apr 2015to 14 Apr 2017
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive outpatients
- Men who have sex with men
- Speaking, literate french
- Having a french health insurance or an equivalent
- Asymptomatic for a STI the appointment day
Who cannot join
- Men who never had sex with men
- Protected adults (adults under guardianship)
- Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CH Argenteuil
Argenteuil, 95107
CHU Ambroise Paré
Boulogne-Billancourt, 92104
CHU Louis Mourier
Colombes, 92700
Hôpital Raymond Poincaré
Garches, 92380
CH Marne La Vallée
Jossigny, 77600
Hôpital Mignot-centre hospitalier de versailles
Le Chesnay, 78150
CH Bicetre
Le Kremlin-Bicêtre, 94275
Hôpital Franco-Britannique
Levallois-Perret, 92300
CHU Necker
Paris, 750015
Hôtel Dieu
Paris, 75004
Hôpital de Saint-Antoine
Paris, 75012
Institut Mutualiste Montsouris
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
CHU St Louis
Paris, 75475
CHI Poissy/ Saint-Germain en Laye
Saint-Germain-en-Laye, 78100
Hopital Foch
Suresnes, Hauts DE Seine, 92150
CHI Villeneuve Saint-Georges,
Villeneuve-Saint-Georges, 94190
About this study
Official title: Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.
Read the detailed description
Main objectives are :
create and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).
determine the prevalence of asymptomatic STIs in a population of HIV-positive MSM
Secondary objectives are :
compare 2 screening strategies regarding STIs in HIV-positive MSM (systematic screening vs screening according to self-declared risk factors) conduct a cost-efficiency analysis of both strategies evaluate patients' knowledge of STIs develop a DRIVER digital tool that will be made available to patients on websites, mobile apps…
Position of the problem :
Over the past 15 years, a resurgence of symptomatic STIs has been observed at both at the global and at the local (French) level. This has been true for gonorrhea since 2008, for syphilis since 2000 and for lymphogranuloma venereum since 2003. The epidemiology of asymptomatic STIs has not been studied as thoroughly but asymptomatic carriage of Neisseria gonorrhoeae and Chlamydia trachomatis as well as latent syphilis account for at least half of cases declared in the past few years. The population of HIV-positive MSM is the demographic category with the highest rates of STIs. In addition, risky sexual attitudes are on the rise in the MSM population in general (in 2010, the French RESIST Network reported that condom use during anal penetrations between males had dropped from 49% in 2008 to 37% in 2010).
Screening practices are currently center- and healthcare-provider dependant. Study will allow a comparison of screening practices thanks to a score that will be built, validated and made available to clinicians and patients.
Type of study : Prospective, non randomized, multicentric and cross-sectional Timeline : Study duration : 18 months Beginning of study : March 2015
- Conditions
- HIV
- Being tested
- creation of a STIs score risk, validation of a STIs score risk
- Keywords
- HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creation of a STIs score riskOther
Also called First period
4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
validation of a STIs score riskOther
Also called Second period
DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
| Study group | Role | What they receive |
|---|---|---|
| First period | Other | creation of a STIs score risk
pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing Receives: Other: creation of a STIs score risk |
| Second period | Other | validation of a STIs score risk
pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing Receives: Other: validation of a STIs score risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexually Transmitted Infections risk score in men HIV positive
Construction of a STI risk score
Measured: 6 months
Secondary outcomes (3)
cost-efficacy of a targeted screening versus universal screening
conduct a cost-efficiency analysis of both strategies
Measured: 12 months
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
patients' knowledge of STIs will be evaluate
Measured: 3 months
prevalence of asymptomatic STIs in a population of HIV-positive MSM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Louis Hospital, Paris, France, Bicetre Hospital, Hotel Dieu Hospital, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Hôpital Franco-Britannique, Institut Mutualiste Montsouris, Hôpital Lagny Marne la Vallée, Hôpital Raymond Poincaré, Centre Hospitalier Argenteuil, Hôpital Louis Mourier, Hospital Ambroise Paré Paris
- Responsible party
- Sponsor
- Investigators
- David ZUCMAN, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413632
- Sponsor's protocol ID
- 2014/50
- Other IDs
- 2014-A01358-39
- Acronym
- DRIVER
- Status last verified
- Aug 2017
- First submitted
- 7 Mar 2015
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02413632
- Acronym / sponsor ID
- DRIVER / 2014/50
- Conditions
- HIV
- Keywords
- HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Saint-Louis Hospital, Paris, France, Bicetre Hospital, Hotel Dieu Hospital, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Hôpital Franco-Britannique, Institut Mutualiste Montsouris, Hôpital Lagny Marne la Vallée, Hôpital Raymond Poincaré, Centre Hospitalier Argenteuil, Hôpital Louis Mourier, Hospital Ambroise Paré Paris
- Study start
- Apr 2015
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 10 Apr 2015 (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.
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.
Detailed description
Main objectives are :
create and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).
determine the prevalence of asymptomatic STIs in a population of HIV-positive MSM
Secondary objectives are :
compare 2 screening strategies regarding STIs in HIV-positive MSM (systematic screening vs screening according to self-declared risk factors) conduct a cost-efficiency analysis of both strategies evaluate patients' knowledge of STIs develop a DRIVER digital tool that will be made available to patients on websites, mobile apps…
Position of the problem :
Over the past 15 years, a resurgence of symptomatic STIs has been observed at both at the global and at the local (French) level. This has been true for gonorrhea since 2008, for syphilis since 2000 and for lymphogranuloma venereum since 2003. The epidemiology of asymptomatic STIs has not been studied as thoroughly but asymptomatic carriage of Neisseria gonorrhoeae and Chlamydia trachomatis as well as latent syphilis account for at least half of cases declared in the past few years. The population of HIV-positive MSM is the demographic category with the highest rates of STIs. In addition, risky sexual attitudes are on the rise in the MSM population in general (in 2010, the French RESIST Network reported that condom use during anal penetrations between males had dropped from 49% in 2008 to 37% in 2010).
Screening practices are currently center- and healthcare-provider dependant. Study will allow a comparison of screening practices thanks to a score that will be built, validated and made available to clinicians and patients.
Type of study : Prospective, non randomized, multicentric and cross-sectional Timeline : Study duration : 18 months Beginning of study : March 2015
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First period | Other | Other: creation of a STIs score riskcreation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing |
| Second period | Other | Other: validation of a STIs score riskvalidation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive outpatients
- Men who have sex with men
- Speaking, literate french
- Having a french health insurance or an equivalent
- Asymptomatic for a STI the appointment day
Key exclusion criteria (3 listed)
- Men who never had sex with men
- Protected adults (adults under guardianship)
- Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
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 |
|---|---|---|
| creation of a STIs score riskAlso: First period4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea) | Other | First period |
| validation of a STIs score riskAlso: Second periodDRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea) | Other | Second period |
Primary outcome
Sexually Transmitted Infections risk score in men HIV positive
Time frame: 6 months
Construction of a STI risk score
3 secondary outcomes
cost-efficacy of a targeted screening versus universal screening
Time frame: 12 months
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
Time frame: 3 months
prevalence of asymptomatic STIs in a population of HIV-positive MSM
Time frame: 6 months
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 16 Jul 2018.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
David ZUCMAN, MD principal investigator
Hôpital Foch
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creation of a STIs score risk and validation of a STIs score risk in people with HIV, run by Hopital Foch at 17 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Sexually Transmitted Infections risk score in men HIV positive (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2018.