Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2019 by French National Agency for Research on AIDS and Viral Hepatitis

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
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

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT03671291

First received: September 5, 2018
Last updated: July 2, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
Virus-HIV

Behavioral : self-administrated questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • Taking a risky behaviour for HIV infection [ Time Frame: The needed time to answer to the questionnaire : 40 min to 1 hour. ]
    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.
  • Awareness and level of knowledge of the PrEP strategy [ Time Frame: The needed time to answer to the questionnaire : 40 min to 1 hour. ]
    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.
  • Access to care [ Time Frame: The needed time to answer to the questionnaire : 40 min to 1 hour. ]
    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.
  • Availability of PrEP [ Time Frame: The needed time to answer to the questionnaire : 40 min to 1 hour. ]
    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

Estimated Enrollment: 400
Study Start Date: April 3, 2019
Estimated Study Completion Date: December 1, 2021
Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

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

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03671291

Contacts

Contact:   Helene Laroche, Dr 00 33 4 91 74 49 66 Helene.LAROCHE@ap-hm.fr
Contact:   Caroline Lions 00 33 4 91 74 56 96 Caroline.LIONS@ap-hm.fr

Locations

France
Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite Recruiting
Marseille, France, 13009
Contact: Helene Laroche, dr    00 33 4 91 74 49 66    Helene.LAROCHE@ap-hm.fr
Contact: Caroline Lions    00 33 4 91 74 56 96    Caroline.LIONS@ap-hm.fr
Sub-Investigator: Isabelle Poizot-Martin, dr

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
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

Investigators

Principal Investigator: Isabelle Poizot-Martin, Dr Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT03671291   History of Changes  
Other Study ID Numbers: ANRS 95041 Missed Opportunity  
Study First Received: September 5, 2018  
Last Updated: July 2, 2019  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

VIH
PrEP
risk factors
Prevention
Access to care

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on July 22, 2019
This information is provided by ClinicalTrials.gov.