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

Primary Purpose

Virus-HIV

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self-administrated questionnaire
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virus-HIV focused on measuring VIH, PrEP, risk factors, Prevention, Access to care

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recently infected with HIV

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
September 5, 2018
Last Updated
July 22, 2022
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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
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1. Study Identification

Unique Protocol Identification Number
NCT03671291
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
October 3, 2020 (Actual)
Study Completion Date
October 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus-HIV
Keywords
VIH, PrEP, risk factors, Prevention, Access to care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recently infected with HIV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self-administrated questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients eligible for PrEP at the time of HIV infection
Description
Quantify and describe among newly diagnosed people with HIV the missed opportunities for PrEP treatment for HIV infection prevention
Time Frame
The needed time to answer to the questionnaire : 40 min to 1 hour.
Secondary Outcome Measure Information:
Title
Taking a risky behaviour for HIV infection
Description
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.
Time Frame
The needed time to answer to the questionnaire : 40 min to 1 hour.
Title
Awareness and level of knowledge of the PrEP strategy
Description
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.
Time Frame
The needed time to answer to the questionnaire : 40 min to 1 hour.
Title
Access to care
Description
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.
Time Frame
The needed time to answer to the questionnaire : 40 min to 1 hour.
Title
Availability of PrEP
Description
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
Time Frame
The needed time to answer to the questionnaire : 40 min to 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Poizot-Martin, Dr
Organizational Affiliation
Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We need to make a concertation with PI and scientists.

Learn more about this trial

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

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