Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV

NCT ID: NCT03671291

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2021-10-03

Brief Summary

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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

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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

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Virus-HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Recently infected with HIV

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.

Group Type EXPERIMENTAL

self-administrated questionnaire

Intervention Type BEHAVIORAL

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.

Interventions

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self-administrated questionnaire

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Marseille

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Hospital Purpan

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

Hôpital de la Croix-Rousse

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

University Hospital of Saint-Etienne

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role collaborator

Tourcoing Hospital

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role collaborator

Saint Antoine University Hospital

OTHER

Sponsor Role collaborator

Tenon Hospital, Paris

OTHER

Sponsor Role collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role collaborator

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role collaborator

Bicetre Hospital

OTHER

Sponsor Role collaborator

Pitié-Salpêtrière Hospital

OTHER

Sponsor Role collaborator

Bichat Hospital

OTHER

Sponsor Role collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Poizot-Martin, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

Locations

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Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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ANRS 95041 Missed Opportunity

Identifier Type: -

Identifier Source: org_study_id

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