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Antiretroviral Medication

nPEP for Human Immunodeficiency Virus Infection

Phase 2

Waitlist Available

Led By Allison Chris, MD, FRCPC, CCFP

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study Summary

This trial will test two ways to improve follow-up care for people taking post-exposure prophylaxis for HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure

Secondary outcome measures

Completion of each scheduled follow-up activity (blood tests and clinic visits)

Diagnosis of incident HIV

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of TAF/FTC/ELV/cobi-based nPEP]

+6 more

Other outcome measures

Assessment of cost on heathcare system

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: ARM 3 = NURSE-LED nPEPExperimental Treatment2 Interventions

PEP will be delivered by a sexual health clinic nurse operating under a medical directive.

Group II: ARM 2 = NO TEXT MESSAGING SUPPORTExperimental Treatment1 Intervention

PEP will be delivered according to the standard of care by an infectious diseases physician. Participants will not receive text message reminders or "check-in".

Group III: ARM 1 = TEXT MESSAGING SUPPORTExperimental Treatment2 Interventions

PEP will be delivered by ID physician and participants will receive weekly text message "check-ins" and optional automated text appointment reminders via the WelTel system.

Group IV: ARM 4 = ID PHYSICIAN-LED nPEP,Active Control1 Intervention

PEP will be delivered according to the standard of care by an infectious diseases physician.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

537 Previous Clinical Trials

447,105 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,279 Total Patients Enrolled

CIHR Canadian HIV Trials NetworkNETWORK

40 Previous Clinical Trials

6,145 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently underway for this experiment?

"Clinicaltrials.gov reveals that this medical study is still searching for qualified participants and has so far recruited since its original posting on November 4th 2021, with the last update being made 19 days later."

Answered by AI

What other experiments regarding nPEP have been conducted?

"Currently, the number of active clinical trials for nPEP stands at 98; with 22 in their final phase. Although these studies are primarily concentrated around Boylston, Massachusetts, they span across 1609 sites worldwide."

Answered by AI

To what extent is this medical study being attended by individuals?

"Affirmative, clinicaltrials.gov indicates that this experiment is currently accepting volunteers. This trial was originally listed on November 4th 2021 and underwent a revision on the 19th of November 2021; it needs to enroll approximately 434 individuals between three different medical institutions."

Answered by AI

What adverse effects can patients anticipate with nPEP?

"The safety of nPEP was rated a 2 by the Power team as this is still at Phase 2, meaning there is proof of its security but none for efficacy."

Answered by AI

What conditions has nPEP been shown to effectively address?

"A common application of nPEP is for the management of antiretroviral agents. It can also be leveraged to counter conditions like treatment naivety, lack of darunavir resistance, and HIV-1 infections."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing the Delivery of HIV nPEP

2021. "Optimizing the Delivery of HIV nPEP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03259698.