← Back to Search
Antiretroviral Medication
Optimizing the Delivery of HIV nPEP
Toronto, Canada
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
No Placebo-Only Group
Summary
This trial will test two ways to improve follow-up care for people taking post-exposure prophylaxis for HIV.
See full description
Eligible Conditions
- Human Immunodeficiency Virus (HIV) Infection
- HIV Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreOther study objectives
Assessment of cost on heathcare system
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Closest Location:HIV Prevention Clinic (Toronto General Hospital)· Toronto, Canada· 743 miles
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
570 Previous Clinical Trials
459,334 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,409 Previous Clinical Trials
26,539,986 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
6,005 Total Patients Enrolled
Allison Chris, MD, FRCPC, CCFPPrincipal InvestigatorToronto Public Health
Darrell HS Tan, MD, FRCPC, PhDPrincipal InvestigatorUnity Health Toronto
Isaac I Bogoch, MD, FRCPC, MScPrincipal InvestigatorToronto General Hospital