Skip to main content
OpenTrials
Completed

NCT Number: NCT03671291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Virus-HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Marseille, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-administrated questionnaire

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Bicetre Hospital
  • Bichat Hospital
  • Centre Hospitalier Régional d'Orléans
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire de Nice
  • Hospital Purpan
  • Hôpital Necker-Enfants Malades
  • Hôpital de la Croix-Rousse
  • Nantes University Hospital
  • Pitié-Salpêtrière Hospital
  • Rennes University Hospital
  • Saint Antoine University Hospital
  • Saint-Louis Hospital, Paris, France
  • Tenon Hospital, Paris
  • Tourcoing Hospital
  • University Hospital Center of Martinique
  • University Hospital of Saint-Etienne
  • University Hospital, Bordeaux
  • University Hospital, Clermont-Ferrand
  • University Hospital, Grenoble
  • University Hospital, Marseille
  • University Hospital, Montpellier
  • University Hospital, Strasbourg

Registry information

Official study title

National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 14, 2018
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.