Virus-HIVNCT03671291
Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV
A study testing self-administrated questionnaire in people with Virus-HIV, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Virus-HIV
- What is being tested?
- self-administrated questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2019to 3 Oct 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Understanding and speaking French
- Affiliated in or beneficiary of a Social Security (excluding State Medical Aid or AME that aren't considered as Social Security coverage)
- Men and women with a diagnosis of HIV infection known for less than three months and with recent HIV infection established on:
- a diagnostic confirmation test by Western Blot (WB) or Immuno Blot showing incomplete pattern.
- OR Previous HIV negative screening test performed within 6 months of diagnosis.
Who cannot join
- Less than 18 years old
- Unable to understand French
- Not affiliated to a social security coverage
- Under guardianship or under curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
Marseille, 13009
About this study
Official title: National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.
Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.
Read the detailed description
Pre-exposure prophylaxis is a new strategy to prevent the occurrence of new cases of HIV. This prophylaxis strategy is based on taking antiretroviral drugs (ARV) before and after exposition to a risk of HIV infection which can reduce drastically the contamination with HIV. A certain groups of population based on their sexual orientation, for instance man who have sex with man (MSM), is among the groups that are highly exposed to this risk. To reduce this risk, French national regulatory authority (ANSM), firstly through temporary usage recommendation followed by a marketing authorization extension, allowed the prescription of these antiretroviral molecules to persons presenting eligibility criteria as defined by regulatory authority. Despite these preventive measures, the incidence of HIV such as the MSM group still high. The missed opportunity studies has as objectives to try to disentangle real obstacles of PrEP use in France and to optimize PrEP criteria if needed.
- Conditions
- Virus-HIV
- Being tested
- self-administrated questionnaire
- Keywords
- VIH, PrEP, risk factors, Prevention, Access to care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administrated questionnaireBehavioural
Persons who the biological parameters or past screening show that they were recently infected with HIV cf. eligibility criteria, will, after obtaining his consent, answer a series of questions through a self-administrated questionnaire that will take approximately 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Recently infected with HIV | Experimental | Men and women recently infected with HIV and have been eligible for PrEP based on the recommendation of french national regulatory agency regarding the prescription of Truvada® in prophylaxis to HIV exposure. The potential reasons behind these missed opportunity of Pre-exposure prophylaxis will be studied through a self-administrated questionnaire. Receives: Behavioral: self-administrated questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients eligible for PrEP at the time of HIV infection
Quantify and describe among newly diagnosed people with HIV the missed opportunities for PrEP treatment for HIV infection prevention
Measured: The needed time to answer to the questionnaire : 40 min to 1 hour.
Secondary outcomes (4)
Taking a risky behaviour for HIV infection
Better identify risk taking exposures to HIV contamination and determine the adequacy of the criteria for access to pre-exposure treatment with current practices. For this, questions concerning the frequency of unprotected sex, the number of partners and the type of sexual practices are collected in the self-questionnaire.
Measured: The needed time to answer to the questionnaire : 40 min to 1 hour.
Awareness and level of knowledge of the PrEP strategy
Study the individual factors associated with the knowledge, representations, acceptance and prescription of PrEP in order to evaluate the hindrance to the establishment of PrEP and the persistence of infections despite the availability of this new strategy of preventive treatment. For this, the questionnaire asks about the knowledge of the existence of this prevention tool, the antecedent of PrEP intake, and the potential reasons for not taking PrEP.
Measured: The needed time to answer to the questionnaire : 40 min to 1 hour.
Access to care
Evaluate the impact of healthcare professionals on missed opportunities for PrEP through the access to general or hospital physicians and screening history. Comparing percentage of new infections among new HIV diagnosis in order to study regional disparities in term of HIV screening access according to city/region and area.
Access to care, meaning frequency of visit to, the nature of, health care facilities (hospital, urban doctor, anonymous screening center…), discussed items during consultation with physician etc. These kind of informations will help to appreciate if access to care in all its dimension is correlated to HIV infection risk.
These different criteria will be compared by region to determine whether regional disparities in access to care occurred.
Measured: The needed time to answer to the questionnaire : 40 min to 1 hour.
Availability of PrEP
Study the structural and demographic factors associated with missed opportunities for PrEP (regional disparities in access to PrEP).
A questionnaire for each participating center asks about the type of consultations offered, the presence of specific consultations and support for PrEP, the active file of people under PrEP and will determine if there is a center and / or region effect for taking PrEP. Collected information will shed the light on potential relation between logistic means and availability of PrEP
Measured: The needed time to answer to the questionnaire : 40 min to 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start3 Apr 2019
- Primary completion3 Oct 2020
- Study completion3 Oct 2021
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 Virus-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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- University Hospital, Marseille, University Hospital, Grenoble, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier, Hospital Purpan, University Hospital, Bordeaux, Hôpital de la Croix-Rousse, Centre Hospitalier Universitaire Dijon, University Hospital of Saint-Etienne, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire de Besancon, Tourcoing Hospital, University Hospital, Strasbourg, Nantes University Hospital, Centre Hospitalier Régional d'Orléans, Rennes University Hospital, Saint Antoine University Hospital, Tenon Hospital, Paris, Saint-Louis Hospital, Paris, France, Hôpital Necker-Enfants Malades, Bicetre Hospital, Pitié-Salpêtrière Hospital, Bichat Hospital, University Hospital Center of Martinique
- Responsible party
- Sponsor
- Investigators
- Isabelle Poizot-Martin, Dr, Principal investigator, Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671291
- Sponsor's protocol ID
- ANRS 95041 Missed Opportunity
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We need to make a concertation with PI and scientists.
Publications
Lions C, Laroche H, Mora M, Pialoux G, Cotte L, Cua E, Piroth L, Molina JM, Salnikova M, Maradan G, Poizot-Martin I, Spire B. Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study. HIV Med. 2023 Feb;24(2):191-201. doi: 10.1111/hiv.13367. Epub 2022 Aug 9.
PubMed 35943165
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
- National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.
- ClinicalTrials.gov ID
- NCT03671291
- Acronym / sponsor ID
- ANRS 95041 Missed Opportunity
- Conditions
- Virus-HIV
- Keywords
- VIH, PrEP, risk factors, Prevention, Access to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- University Hospital, Marseille, University Hospital, Grenoble, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier, Hospital Purpan, University Hospital, Bordeaux, Hôpital de la Croix-Rousse, Centre Hospitalier Universitaire Dijon, University Hospital of Saint-Etienne, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire de Besancon, Tourcoing Hospital, University Hospital, Strasbourg, Nantes University Hospital, Centre Hospitalier Régional d'Orléans, Rennes University Hospital, Saint Antoine University Hospital, Tenon Hospital, Paris, Saint-Louis Hospital, Paris, France, Hôpital Necker-Enfants Malades, Bicetre Hospital, Pitié-Salpêtrière Hospital, Bichat Hospital, University Hospital Center of Martinique
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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.
Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.
Detailed description
Pre-exposure prophylaxis is a new strategy to prevent the occurrence of new cases of HIV. This prophylaxis strategy is based on taking antiretroviral drugs (ARV) before and after exposition to a risk of HIV infection which can reduce drastically the contamination with HIV. A certain groups of population based on their sexual orientation, for instance man who have sex with man (MSM), is among the groups that are highly exposed to this risk. To reduce this risk, French national regulatory authority (ANSM), firstly through temporary usage recommendation followed by a marketing authorization extension, allowed the prescription of these antiretroviral molecules to persons presenting eligibility criteria as defined by regulatory authority. Despite these preventive measures, the incidence of HIV such as the MSM group still high. The missed opportunity studies has as objectives to try to disentangle real obstacles of PrEP use in France and to optimize PrEP criteria if needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recently infected with HIV | Experimental | Behavioral: self-administrated questionnaireMen and women recently infected with HIV and have been eligible for PrEP based on the recommendation of french national regulatory agency regarding the prescription of Truvada® in prophylaxis to HIV exposure. The potential reasons behind these missed opportunity of Pre-exposure prophylaxis will be studied through a self-administrated questionnaire. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- Understanding and speaking French
- Affiliated in or beneficiary of a Social Security (excluding State Medical Aid or AME that aren't considered as Social Security coverage)
- Men and women with a diagnosis of HIV infection known for less than three months and with recent HIV infection established on:
- a diagnostic confirmation test by Western Blot (WB) or Immuno Blot showing incomplete pattern.
Key exclusion criteria (4 listed)
- Less than 18 years old
- Unable to understand French
- Not affiliated to a social security coverage
- Under guardianship or under curatorship
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 |
|---|---|---|
| self-administrated questionnairePersons who the biological parameters or past screening show that they were recently infected with HIV cf. eligibility criteria, will, after obtaining his consent, answer a series of questions through a self-administrated questionnaire that will take approximately 40 minutes. | Behavioural | Recently infected with HIV |
Primary outcome
Percentage of patients eligible for PrEP at the time of HIV infection
Time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Quantify and describe among newly diagnosed people with HIV the missed opportunities for PrEP treatment for HIV infection prevention
4 secondary outcomes
Taking a risky behaviour for HIV infection
Time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Awareness and level of knowledge of the PrEP strategy
Time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Access to care
Time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Availability of PrEP
Time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.
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 35943165Lions C, Laroche H, Mora M, Pialoux G, Cotte L, Cua E, Piroth L, Molina JM, Salnikova M, Maradan G, Poizot-Martin I, Spire B. Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study. HIV Med. 2023 Feb;24(2):191-201. doi: 10.1111/hiv.13367. Epub 2022 Aug 9.
- Individual participant dataSharing planned: Undecided. We need to make a concertation with PI and scientists.
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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.
Isabelle Poizot-Martin, Dr principal investigator
Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administrated questionnaire in people with Virus-HIV, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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 6 inclusion and 4 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 1 site 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?
Percentage of patients eligible for PrEP at the time of HIV infection (time frame: The needed time to answer to the questionnaire : 40 min to 1 hour.). 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 NCT03671291, 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.