Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provid… (NCT07695493) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis
504 participantsStarted 2026-09-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing nurse-led versus physician-led monitoring for PrEP — would nurse-led care be considered equally safe and appropriate for my specific situation, or are there reasons I might need physician oversight?
2Since the trial is listed as 'not yet recruiting,' how long might I realistically have to wait before I could even be considered for enrollment, and what would my PrEP monitoring look like in the meantime?
3The study is measuring compliance to PrEP as its main outcome — does my current lifestyle, work schedule, or support system suggest I might face challenges with adherence that this kind of monitoring could help address?
4Because this trial is listed as Phase NA, meaning it's focused on care delivery rather than testing a new drug, what does that mean for my safety compared to a standard PrEP prescription through my regular doctor?
5If this trial ends up not being a good fit for me right now, what does standard PrEP monitoring look like at this clinic, and how does that compare to what the trial is offering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.