Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Monitoring of PrEP by nurses

    Other intervention

    Monitoring of PrEP by nurses

  • Monitoring of PrEP by physicians

    Other intervention

    Monitoring of PrEP by physicians

Treatment groups

504 Participants
are divided into 2 treatment groups
Group A: Follow-up visits for PrEP prescription conducted by a physician.Active comparator 1 intervention
Group B: Follow-up visits for PrEP prescription conducted by a nurse under the same conditions.Experimental treatment 1 intervention

Trial outcomes

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

Time frame
Up to 12 months

Secondary outcomes

1

Occurrence of sexually transmitted infection (STI)

Assessed by PCR testing for Chlamydia and Neisseria gonorrhoeae, and serological testing for syphilis)

Time frame
At baseline
2

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
3

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
4

Tolerability of PrEP

Plasma creatine level

Time frame
At baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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