HIV InfectionPREVINCT07695493
Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis
A study testing Monitoring of PrEP by nurses and Monitoring of PrEP by physicians in people with HIV Infection and Pre Exposure Prophylaxis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Pre Exposure Prophylaxis
- What is being tested?
- Monitoring of PrEP by nurses and Monitoring of PrEP by physicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Randomized Trial Evaluating the Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis
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
Read the 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.
- Conditions
- HIV Infection, Pre Exposure Prophylaxis
- Being tested
- Monitoring of PrEP by nurses, Monitoring of PrEP by physicians
- Keywords
- HIV infection, Pre exposure Prophylaxis (PrEP)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of PrEP by nursesOther
Monitoring of PrEP by nurses
Monitoring of PrEP by physiciansOther
Monitoring of PrEP by physicians
| Study group | Role | What they receive |
|---|---|---|
| Follow-up visits for PrEP prescription conducted by a physician. | Active comparator | Not described Receives: Other: Monitoring of PrEP by physicians |
| Follow-up visits for PrEP prescription conducted by a nurse under the same conditions. | Experimental | Not described Receives: Other: Monitoring of PrEP by nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Secondary outcomes (11)
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Measured: At baseline
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Measured: At 6 months
Occurrence of sexually transmitted infection (STI)
Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)
Measured: At 12 months
Tolerability of PrEP
Plasma creatine level
Measured: At baseline
Tolerability of PrEP
Plasma creatine level
Measured: At 6 months
Tolerability of PrEP
Plasma creatine level
Measured: At 12 months
PrEP adherence
Number of patient visits completed during the year and Tenofovir diphosphate concentrations
Measured: At 12 months
Treatment acceptability among participants
Number of participants who discontinued follow-up and reasons for discontinuation
Measured: Up to 12 months
Incidence of HIV infection
HIV infection during follow up (positive serology or HIV RNA)
Measured: 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…)
Measured: Up to 12 months
Patient and caregiver satisfaction
Focus groups
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, randomized, controlled, multicenter, open-label, two-arm parallel-group, non-inferiority trial.
- Masking
- None (open label)
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695493
- Sponsor's protocol ID
- APHP230860
- Acronym
- PREVI
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Trial Evaluating the Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis
- ClinicalTrials.gov ID
- NCT07695493
- Acronym / sponsor ID
- PREVI / APHP230860
- Conditions
- HIV Infection, Pre Exposure Prophylaxis
- Keywords
- HIV infection, Pre exposure Prophylaxis (PrEP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic, randomized, controlled, multicenter, open-label, two-arm parallel-group, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Follow-up visits for PrEP prescription conducted by a physician. | Active comparator | Other: Monitoring of PrEP by physicians |
| Follow-up visits for PrEP prescription conducted by a nurse under the same conditions. | Experimental | Other: Monitoring of PrEP by nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of PrEP by nursesMonitoring of PrEP by nurses | Other | Follow-up visits for PrEP prescription conducted by a nurse under the same conditions. |
| Monitoring of PrEP by physiciansMonitoring of PrEP by physicians | Other | Follow-up visits for PrEP prescription conducted by a physician. |
Primary outcome
Compliance to PrEP
Time frame: 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
11 secondary outcomes
Occurrence of sexually transmitted infection (STI)
Time frame: At baseline
Occurrence of sexually transmitted infection (STI)
Time frame: At 6 months
Occurrence of sexually transmitted infection (STI)
Time frame: At 12 months
Tolerability of PrEP
Time frame: At baseline
Tolerability of PrEP
Time frame: At 6 months
Tolerability of PrEP
Time frame: At 12 months
PrEP adherence
Time frame: At 12 months
Treatment acceptability among participants
Time frame: Up to 12 months
Incidence of HIV infection
Time frame: Up to 12 months
Cost of care
Time frame: Up to 12 months
Patient and caregiver satisfaction
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of PrEP by nurses and Monitoring of PrEP by physicians in people with HIV Infection and Pre Exposure Prophylaxis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte Loze, Nurse (01.42.49.48.52 ext. +33, benedicte.loze@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to PrEP (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.