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

Virus-HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671291
• Other study ID #: ANRS 95041 Missed Opportunity
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: October 3, 2021

Study information

• Verified date: July 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: October 3, 2021
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Virus-HIV

Intervention

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.

Locations

Country	Name	City	State
France	Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite	Marseille

Sponsors (25)

Lead Sponsor

Collaborator

French National Agency for Research on AIDS and Viral Hepatitis

Bicetre Hospital, Bichat Hospital, Centre Hospitalier Régional d'Orléans, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire Dijon, Hôpital de la Croix-Rousse, Hôpital Necker-Enfants Malades, Hospital Purpan, 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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.