Human Immunodeficiency Virus Pre-exposure Prophylaxis Program in General Practice - Trial NCT06258876

Timeline & Enrollment

Primary Outcome

Percentage of patients still on PrEP

Summary

The Human Immunodeficiency Virus (HIV) epidemic persists in France, with approximately 6000
 new cases per year. Various prevention tools against HIV exist, including condoms, regular
 testing, Post-Exposure Prophylaxis (PEP), HIV treatment for seropositive partners, single-use
 disposable injection equipment for drug use and pre-exposure prophylaxis (PrEP).
 
 Continuous or on-demand PrEP with tenofovir disoproxil fumarate/emtricitabine has proven
 effective in reducing the risk of HIV infection. France was the first European country to
 authorize PrEP, leading to an unprecedented impact on seropositivity discovery rates in 2018,
 with a 7% decrease in new infections compared to 2017.
 
 However, the effectiveness of PrEP can be hindered by challenges in retaining users within
 the healthcare system. According to the EPIPHARE report, which has been monitoring Truvada®
 or generic PrEP use since 2017, a substantial proportion of new users do not receive PrEP
 renewal in the first 6 months after initiation. Such early interruptions, increasing in
 frequency, affected around a quarter of individuals who initiated PrEP in the second half of
 2021.
 
 A recent study reported that these early interruptions have a significant detrimental impact
 on PrEP effectiveness in real life, especially among those under 30 years old and in
 socio-economic precarious situations.
 
 The main barriers to PrEP adherence are multifactorial, including social precarity, limited
 PrEP access, and a low perception of HIV risk. To address this, in France, general
 practitioners have been authorized to issue initial PrEP prescriptions since June 1, 2021.
 
 The future challenge is to increase PrEP use and optimize retention to combat the HIV
 epidemic, relying significantly on general medicine. The goal of our study is to broaden PrEP
 access by optimizing its initial prescription in general medicine and to assess user
 retention in PrEP care through the established partnership between general practitioners and
 patients.
 
 The research will be conducted in collaboration between Saint Louis Hospital in the 10th
 arrondissement of Paris and general practitioners willing to participate in the study,
 located in the 3rd, 10th, 11th, 13th, and 19th arrondissements. Participating general
 practitioners may be in private practice, employed in health centers, or working in health
 houses.
 
 As part of the study, general practitioners will receive training from the infectious
 diseases department of Saint-Louis and Lariboisière hospitals. This training will be both
 theoretical and practical, with the opportunity to attend initiation and follow-up PrEP
 consultations in the department. A dedicated phone line in the infectious diseases department
 of Saint Louis Hospital will be available for participating general practitioners seeking
 specialized advice. They will be encouraged to register as PrEP prescribers in their
 appointment scheduling software.
 
 Patients will be informed of the study objectives and its process by the general
 practitioner, and their oral non-opposition will be collected.
 
 Each inclusion consultation will last approximately 20-40 minutes, allowing the general
 practitioner to prescribe PrEP, conduct the usual care consultation, and collect clinical,
 demographic, socio-economic, lifestyle, medical history, and patient vaccination data on a
 dedicated data collection form.
 
 The follow-up duration will be two years, with consultation frequency matching that of
 regular PrEP follow-ups, and data collection will occur at M6, M12, M18, and M24 using a
 dedicated data collection form.
 
 Data collected during inclusion and follow-up consultations will be anonymized and integrated
 into the electronic Clinical Report Form. During each PrEP consultation (initiation and
 follow-up), general practitioners will provide patients with a PrEP prescription if the
 pre-PrEP biology report allows it (according to HAS (Haute Autorité de Santé)
 recommendations).
 
 For patients who have not been attending consultations, a telephone survey will be offered to
 inquire about PrEP continuation and collect information on follow-up or reasons for stopping
 PrEP.

ICD-10 Classifications