Clinical trial NCT03671291: Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV
Official title: National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virus-HIV
Keywords: VIH
PrEP
risk factors
Prevention
Access to care
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Marseille
name: University Hospital, Grenoble
name: Centre Hospitalier Universitaire de Nice
name: University Hospital, Montpellier
name: Hospital Purpan
name: University Hospital, Bordeaux
name: Hôpital de la Croix-Rousse
name: Centre Hospitalier Universitaire Dijon
name: University Hospital of Saint-Etienne
name: University Hospital, Clermont-Ferrand
name: Centre Hospitalier Universitaire de Besancon
name: Tourcoing Hospital
name: University Hospital, Strasbourg
name: Nantes University Hospital
name: Centre Hospitalier Régional d'Orléans
name: Rennes University Hospital
name: Saint Antoine University Hospital
name: Tenon Hospital, Paris
name: Saint-Louis Hospital, Paris, France
name: Hôpital Necker-Enfants Malades
name: Bicetre Hospital
name: Pitié-Salpêtrière Hospital
name: Bichat Hospital
name: University Hospital Center of Martinique
First posted: 2018-09-14
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Less than 18 years old
* Unable to understand French
* Not affiliated to a social security coverage
* Under guardianship or under curatorship

Primary outcomes:
measure: Percentage of patients eligible for PrEP at the time of HIV infection
timeFrame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Secondary outcomes:
measure: Taking a risky behaviour for HIV infection
timeFrame: The needed time to answer to the questionnaire : 40 min to 1 hour.
measure: Awareness and level of knowledge of the PrEP strategy
timeFrame: The needed time to answer to the questionnaire : 40 min to 1 hour.
measure: Access to care
timeFrame: The needed time to answer to the questionnaire : 40 min to 1 hour.
measure: Availability of PrEP
timeFrame: The needed time to answer to the questionnaire : 40 min to 1 hour.
Other outcomes:
Locations:
city: Marseille
country: France
facility: Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
Study officials:
affiliation: Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
name: Isabelle Poizot-Martin, Dr
role: PRINCIPAL_INVESTIGATOR
References: