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
PREVI
1 other identifier
interventional
504
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 10, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
July 10, 2026
July 1, 2026
2 years
July 6, 2026
July 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 12 months
Secondary Outcomes (11)
Occurrence of sexually transmitted infection (STI)
At baseline
Occurrence of sexually transmitted infection (STI)
At 6 months
Occurrence of sexually transmitted infection (STI)
At 12 months
Tolerability of PrEP
At baseline
Tolerability of PrEP
At 6 months
- +6 more secondary outcomes
Study Arms (2)
Follow-up visits for PrEP prescription conducted by a physician.
ACTIVE COMPARATORFollow-up visits for PrEP prescription conducted by a nurse under the same conditions.
EXPERIMENTALInterventions
Monitoring of PrEP by nurses
Monitoring of PrEP by physicians
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 10, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 10, 2026
Record last verified: 2026-07