Virus-HIV Clinical Trial
Official title:
National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.
Verified date | July 2022 |
Source | ANRS, Emerging Infectious Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite | Marseille |
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 |
France,
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. |
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