HIV Infection, Pre Exposure Prophylaxis
Conditions
Keywords
HIV infection, Pre exposure Prophylaxis (PrEP)
Brief summary
Assess the quality of care and the satisfaction of patients and caregivers when the monitoring of people on HIV pre-exposure prophylaxis (PrEP) is provided by nurses instead of physicians
Detailed description
The HIV/AIDS epidemic remains uncontrolled in France, with approximately 5,000 to 6,000 new cases reported each year. Since January 2016, HIV pre-exposure prophylaxis (PrEP)-which involves taking a single oral tablet containing two antiretroviral drugs-has been available in France. The effectiveness of this PrEP has been demonstrated, with a relative reduction in HIV incidence of nearly 97% when PrEP is taken correctly. However, only nearly 50,000 people are using PrEP in France in 2024, which is far short of the targets needed to control the epidemic. Indeed, the population of men who have sex with men (MSM) at risk of HIV infection is estimated at over 200,000, and the number of heterosexuals on PrEP is negligible, even though 40% of new HIV diagnoses involve heterosexuals from countries with high prevalence (Sub-Saharan Africa). Furthermore, these 50,000 people on PrEP represent only 64% of the \>120,000 people who have started PrEP since 2016, indicating that many have discontinued this prophylaxis over time. One of the challenges in implementing PrEP stems from the small number of trained hospital and primary care physicians and their limited time availability to provide a PrEP care. Since 2022, PrEP training programs in medical settings, involving nurses, have been implemented to train them to monitore people on PrEP. This involvement of nurses would help increase the availability of PrEP, free up doctors' time for complex cases, and enhance the value of nursing work. However, there has been no evaluation of this care provided by nurses to people on PrEP in terms of quality, acceptability, satisfaction among people on PrEP, nurses, and doctors, or its cost-effectiveness. The aim of our study is therefore to assess whether the care provided to subjects on PrEP by these nurses is as good, well-accepted, and satisfactory for subjects and caregivers as it would be if the care were provided solely by physicians.
Interventions
OTHERMonitoring of PrEP by nurses
Monitoring of PrEP by nurses
OTHERMonitoring of PrEP by physicians
Monitoring of PrEP by physicians
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A pragmatic, randomized, controlled, multicenter, open-label, two-arm parallel-group, non-inferiority trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male sex assigned at birth, aged ≥ 18 years * Individual at risk of HIV infection * Currently receiving PrEP care and willing to continue follow-up in a hospital setting * Receiving care at a hospital setting by a physician and not objecting to follow-up by a nurse * Having received complete information about the study and having provided a free written informed consent * Affiliated with a social security system (beneficiary or entitled individual) or covered by State Medical Aid (AME).
Exclusion criteria
* Individual with confirmed HIV infection * Currently receiving nurse care in a hospital setting * Having renal impairment (creatinine clearance \< 60 mL/min) * Unable to provide informed consent * Not affiliated with a social security system or not covered by State Medical Aid (AME) * Under legal guardianship or curatorship * Deprived of liberty by judicial or administrative decision, or individuals receiving psychiatric care under Article L1121-6 of the French Public Health Code
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to PrEP | Up to 12 months | Compliance to PrEP is defined by a composite criterion comprising: * Presence at scheduled follow-up visits at 0, 6, and 12 months AND * Undergoing an HIV screening test before each visit to allow for the prescription of PrEP if the result is negative (+/-14 days) AND * Prescription of PrEP at each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of sexually transmitted infection (STI) | At baseline | Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis) |
| Tolerability of PrEP | At baseline | Plasma creatine level |
| PrEP adherence | At 12 months | Number of patient visits completed during the year and Tenofovir diphosphate concentrations |
| Treatment acceptability among participants | Up to 12 months | Number of participants who discontinued follow-up and reasons for discontinuation |
| Incidence of HIV infection | Up to 12 months | HIV infection during follow up (positive serology or HIV RNA) |
| Cost of care | Up to 12 months | From the perspectives of the healthcare system, patients, and health insurance : Incremental or decremental cost-effectiveness ratio (Cost per patient, Time spent in consultations, Number of prescribed labs and tests, and Number and duration of any hospitalizations…) |
| Patient and caregiver satisfaction | At 12 months | Focus groups |
Contacts
CONTACTBénédicte Loze, Nurse
CONTACTJérôme Lambert, MD PhD
Outcome results
None listed