Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258876
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-23
Brief Title:
Human Immunodeficiency Virus Pre-exposure Prophylaxis Program in General Practice
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Mise en Place et rétention en médecine générale dun Programme de Prophylaxie pré-exposition du VIH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrEPInTheCity
Brief 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 fumarateemtricitabine 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
Continuous or on-demand PrEP with tenofovir disoproxil fumarateemtricitabine 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None