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

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.

Study Overview

• Status: Completed
• Conditions: Virus-HIV
• Intervention / Treatment: Behavioral: self-administrated questionnaire

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 Type: Interventional
• Enrollment (Actual): 596
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The needed time to answer to the questionnaire : 40 min to 1 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	The needed time to answer to the questionnaire : 40 min to 1 hour.

Collaborators and Investigators

• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Centre Hospitalier Universitaire Dijon; University Hospital, Montpellier; University Hospital, Bordeaux; University Hospital, Clermont-Ferrand; Saint-Louis Hospital, Paris, France; Saint Antoine University Hospital; Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Besancon; University Hospital, Grenoble; Rennes University Hospital; Nantes University Hospital; Tourcoing Hospital; Centre Hospitalier Régional d'Orléans; Bicetre Hospital; University Hospital, Marseille; Pitié-Salpêtrière Hospital; University Hospital, Strasbourg; University Hospital Center of Martinique; Hospital Purpan; Hôpital de la Croix-Rousse; University Hospital of Saint-Etienne; Tenon Hospital, Paris; Hôpital Necker-Enfants Malades; Bichat Hospital
• Investigators: Principal Investigator: Isabelle Poizot-Martin, Dr, Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): October 3, 2020
• Study Completion (Actual): October 3, 2021

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Access to care; risk factors; PrEP; Prevention; VIH
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: ANRS 95041 Missed Opportunity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We need to make a concertation with PI and scientists.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No