An interventional study of Monitoring of PrEP by nurses and Monitoring of PrEP by physicians in HIV Infection and Pre Exposure Prophylaxis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 504 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Monitoring of PrEP by physicians
Other: Monitoring of PrEP by nurses
Monitoring of PrEP by nurses
Monitoring of PrEP by physicians
Compliance to PrEP
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
Time frame: Up to 12 months
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Time frame: At baseline
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Time frame: At 6 months
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Time frame: At 12 months
Tolerability of PrEP
Plasma creatine level
Time frame: At baseline
Tolerability of PrEP
Plasma creatine level
Time frame: At 6 months
Tolerability of PrEP
Plasma creatine level
Time frame: At 12 months
PrEP adherence
Number of patient visits completed during the year and Tenofovir diphosphate concentrations
Time frame: At 12 months
Treatment acceptability among participants
Number of participants who discontinued follow-up and reasons for discontinuation
Time frame: Up to 12 months
Incidence of HIV infection
HIV infection during follow up (positive serology or HIV RNA)
Time frame: Up to 12 months
Cost of care
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…)
Time frame: Up to 12 months
Patient and caregiver satisfaction
Focus groups
Time frame: At 12 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris